Dissertations / Theses on the topic 'Blood Glucose Self-Monitoring'

The purpose of this study was to analyze the experiences of self-monitoring of blood glucose (SMBG) usage of adults with type 2 diabetes mellitus (T2DM) who are not using insulin. The sample consisted of 11 women and 8 men who were Caucasian Americans, 38 to 79 years of age. Data were analyzed using the grounded theory method including open and axial coding and the constant comparative method. The theory of "SMBG as a Cue in T2DM Self-Care" emerged from the data and is composed of four categories (a) Engaging, (b) Checking, (c) Responding, and (d) Establishing a Pattern. Engaging marks the beginning of SMBG. Participants began on the recommendation of their physician and monitored between 2-6 times a day. Participants monitored because of curiosity and over time reduced or kept their initial frequency. Checking occurs when the blood glucose is obtained. Two subcategories emerged: Evaluating and Validating. The main items participants evaluated or validated were the effects of foods in relation to blood glucose levels. Responding involves reacting to SMBG. Two subcategories emerged: Taking Action and Experiencing Emotion. Most actions involved changing foods consumed. Participants described feeling conflicted and "being bad" when not following through with an action. Emotions such as blame and fear were experienced when blood glucose levels were higher than normal, while happiness was experienced with normal levels. Establishing a Pattern occurs when participants decide on how often to monitor. Two subcategories emerged: Using Regularly and Using Sporadically. The pattern developed was based on obtaining "normal" blood glucose patterns or on the absence of ill symptoms of T2DM. Healthcare provider disinterest in SMBG and fingertip pain contributed to a decreased monitoring frequency. Participants described cyclical, iterative episodes of Checking, Responding, and varying their established patterns throughout their experiences with monitoring. Participants discussed the value and struggles of SMBG in a T2DM self-care regimen. The theory of SMBG as a Cue in T2DM Self-Care could be used to guide the development of effective intervention strategies to help individuals with T2DM achieve blood glucose control which, in turn, leads to avoidance of ill symptoms and complications of T2DM.

This thesis has explored the validity and application of self-monitoring of blood glucose (SMBG) in diabetes mellitus from a range of perspectives, using a variety of methods. Initially, a systematic literature review was conducted to evaluate the validity of patient generated blood glucose diaries. Concern was raised over their clinical utility as, allowing for a minimal amount of 'error', just over 50% of adult diaries could be considered 'accurate/reliable'. There was also a lack of information relating to the diaries of those with type 2 diabetes and study follow-up was of short duration. As a result, a secondary data analysis was conducted to explore the validity of diaries, over a year, in a sample of patients with type 2 diabetes. Using a range of statistical techniques, and a novel approach to determining the clinical significance of recording errors, this identified an initial learning curve for 5MBG record keeping. Our understanding of the validity of 5MBG was furthered by subsequently using this database to explore the impact of measurement error on the estimation of the relationship between mean plasma glucose and glycated haemoglobin. Measurement error led to an underestimation of the relationship. When combined with biological variation this draws into question the potential for one regression equation to represent this relationship across diverse populations. The final section of this thesis concentrates on the validity and application of SMBG when telemedicine is used between antenatal women with gestational diabetes and the diabetes team. A feasibility study was conducted for a randomised controlled trial and telemedicine review was found to allow comparable management decisions to be made in less time than face-to-face review. Staff and patients found the equipment easy to use and were positive about the potential for telemedicine to be used to replace alternate outpatient diabetes review appointments.

Routine blood glucose monitoring by patients with Type 2 diabetes mellitus (T2DM) is needed for effective management of T2DM; however, 75% of monitoring logs are returned incomplete during monthly provider follow-up appointments. As a result, effective management of the patient's medical condition is limited. To better understand the reasons for noncompliance, a quality improvement project (QIP) was initiated between July 01, 2017 and September 30, 2017, to identify barriers that prevented patients from self-monitoring of blood glucose (SMBG). No formal assessment of the patients' responses had been done, and, as a result, the deidentified, qualitative responses from the QIP were obtained for this project. The purpose of this project was to explore barriers to SMBG and to use a literature search to identify strategies for improving compliance with SMBG. The health belief model was the framework used to guide the project. Secondary data obtained from the QIP (n = 19) were analyzed and coded. Results indicated that patients' financial concerns, social support, emotional needs, and lack of diabetes education were the main barriers to daily SMBG. Recommendations to the providers were to consider each barrier before ordering the use and frequency of SMBG and to consider an appropriate strategy for promoting SMBG adherence. Addressing low compliance with SMBG may promote positive social change through improved T2DM management, self-care, adherence to daily SMBG and treatment, and improved patient quality of life.

The increasing prevalence causes great burden to global health. Although there is not yet an agreement on the effect of SMBG for non-insulin-treating type 2 DM patients in comprehensive management, some guidelines recommended all diabetes patients should conduct SMBG. This literature review of 5 meta-analyses and 13 randomized controlled clinical trials assessed the effectiveness of SMBG in glucose control (HbA1c), detection of hypoglycemia, non-glycemic outcomes and potential influence factors(duration of diabetes, baseline HaB1c level, SMBG frequency, SMBG duration, co-interventions) of SMBG efficacy on type 2 diabetes patients not using insulin. The method of this literature review is through a comprehensive electronic literature search of Ovid MEDLINE, EMBASE, the Cochrane Library and China Journals Full-text Database. Both English and Chinese language literatures were reviewed. All meta-analysis and randomized controlled trials of type 2 diabetes non-insulin-using patients taking SMBG to improve the glycemic control and other outcomes were included. In these studies, absolute HbA1c reduction, recognized episodes of hypoglycemia, wellbeing, QALY, DALY, complication morbidity, mortality were used as outcome measures if available. A score list based on the PRISMA Statement was used to evaluate the quality of meta-analyses. 5 meta-analysis all reported a statistical significant but clinical modest-moderate difference in HbA1c reduction between SMBG and non-SMBG group, a new published randomized controlled trial with small cohort enrolled in none of the meta- analyses did not support this conclusion. Evidence showed frequency of SMBG did not influence the efficacy of SMBG, co-interventions as education/consultation, regimen change played a positive roll on SMBG efficacy. Whether baseline HbA1c, duration of diabetes or SMBG itself have an effect on SMBG efficacy was still unknown. There is inadequate evidence of SMBG efficacy of detection of hypoglycemia of patient-oriented outcomes. No eligible Chinese article was defined to enroll in this review. This review did not support to suggest all type 2 diabetes patients not using insulin to conduct SMBG at the frequency the guidelines recommended. Carefully designed and longer-term trials are needed to obtain evidence that is more robust. Further investigation would provide more evidence of the characteristics of potential influence factors, which may help to define the specific population or optimal mode that guarantee the greatest efficacy of SMBG.
published_or_final_version
Public Health
Master
Master of Public Health

Up to 60% of individuals with type 2 diabetes (T2DM) do not participate in regular physical activity (PA) despite the known benefits. To encourage these individuals to increase PA behavior, this study tested the feasibility and implementation of a nurse-directed counseling intervention using continuous glucose monitoring system (CGMS). The study used a framework derived from self-efficacy theory to 1) compare changes in self-efficacy, BP and activity counts between participants receiving CGMS counseling and standard T2DM counseling, 2) examine relationships between PA self-efficacy and BP and activity counts, 3) evaluate recruitment, retention, and screening strategies, and 4) assess instrument reliability and utility. Adults (N=52) with T2DM (non-insulin requiring, inactive) were randomized to intervention (n=27) or control groups (n=25). Both groups received 90 minutes of diabetes education with a follow-up phone call at 4 weeks. The intervention group also received feedback on their own CGMS graphs and a role model's graph depicting PA related reductions in glucose levels. PA benefits/barriers were discussed and goals were set. Outcomes were recorded at 1 and 8 weeks. Participants were older (57±14 years), predominantly (90%) white, about half (52%) female, and had diabetes for 8±7 years. Relative to the control group, participants receiving the intervention had higher self-efficacy scores at 8 weeks, indicating more confidence in sticking to a PA program. Their light/sedentary activity minutes decreased significantly and moderate activity minutes increased significantly; systolic BP, A1c and BMI decreased significantly. Only self-efficacy for "Sticking to it" was positively associated with moderate activity. The most successful recruitment media was multiple newspaper press releases. Most referrals came from endocrinology physicians. Of 231 study volunteers, 106 did not meet the criterion of A1c≥7.5%. These data suggest that CGMS feedback is feasible for counseling individuals with T2DM to improve PA and may improve risk factors for diabetes-related complications. Newspaper press releases are effective for recruiting participants with T2DM. Less restrictive inclusion criteria in a larger study may allow more participation by sedentary individuals with T2DM but may reduce effect size. CGMS was well tolerated and its data aided diabetes-related teaching.

Background: Self-care is a multi-dimensional concept and has different definitions. Amongthe definitions, Orem’s definition of self-care is more consistent. Orem (1995) argues that,self-care is a personal activity to take care and maintain of own self health and illness andprevention of disease related complications. Aim: The aim of the paper was to investigate the factors that contribute to self-care behavioramong patients with Type 2 DM as argued in the literature. Method: data was collected from the following electronic databases: CINAHL, PubMed,LibHub, SweMed and Google Scholar-to find full texts. Data was analyzed through CriticalAppraisal Skill Programme. To ensure validity and reliability the author were blinded toreduce study bias and articles were selected according their quality. Result: 31 relevant studies were included in the review, among the major findings of the studywere; Age, Social support/network, high income level, high educational attainment and longType 2 DM diagnosis history had a positive predictor in Type 2 DM patients self-carecontributing factors. Conclusion: To improve a Type 2 DM patients self-care activities the present study concludedthat Demographic, Socio-Economic and Social support factors are among the positivecontributors in patients of Type 2 DM successful Self-Care activities. Key words; Blood glucose self-monitoring, self-administration, Self-care, self-medication,Type 2 Diabetes.
The aim of the paper was to investigate the factors that contribute to self-care behavior among patients with Type 2 DM as argued in the literature.

Self-monitoring of blood glucose (SMBG) can be effective in preventing poor outcomes associated with diabetes mellitus but previous research has identified that SMBG is not being undertaken in line with current recommendations. Guidance informs health professionals to educate patients on how they should self-monitor but very little is know about how patients self-monitor in the real world. In this thesis, a quantitative scoping study is first presented. This study used routine data sources to examine the levels and patterns of self-montoring in different population groups and then proceeded to a larger qualitative study to explore and question what patients are doing in practice in relation to self-monitoring, and why. This involved a qualitative multi-case study of patients, their support people, health care practitioners (HCPs) and patient diaries. Ten individuals and their nominated support people and HCPs formed ten cases among whom 21 in-depth semi-structured interviews were carried out and six patient diaries analysed. The exploratory work was framed around Stones’ version of structuration theory and uncovered a complex linkage of individual motives for monitoring, associated responses and behaviours in relation to the motive, and the underpinning attitudes and beliefs behind the motive. The following key points emerged from the analysis. People have differing relationships with their diabetes and this links with the level of engagement they have with their condition. Resistance to support people and health services was commonly observed. Experiences of diabetes reviews were important, with an identified need for them to feel more like collaboration and less like surveillance. A significant factor was the gaps and limitations in knowledge and understanding around diabetes for patients, relatives, support people and HCPs; and, finally, there was a noted maintenance of blood glucose levels higher than recommended through SMBG in several participants, which stemmed from a fear of hypoglycemic episode. The analysis concluded that although self-monitoring of blood glucose, in theory, and when considered in isolation, is a simple process to undertake, its application in the wider context of self-management and the individual is much more complicated. The process is influenced by many complex factors and generates a variety of responses and behaviours, some not in keeping with good diabetes self-management. There was a significant lack of person-centered approaches to managing diabetes which was, in part, due to existing health systems and processes. Therefore, there is a need to raise awareness of the gaps that exist in terms of such approaches as well as the gaps in knowledge and understanding of individuals with diabetes and those caring for and supporting them. In more specific terms, it is essential to develop and evaluate individual approaches to patients in relation to their self-monitoring and associated self-management in the context of their own lives, which involves the assessment of engagement and understanding around self-monitoring.

This dissertation is focused on the assessment of glucose variability (GV) in the treatment of the pathology of diabetes mellitus. GV is a risk factor for the development of diabetes complications, and its assessment combined with the evaluation of glycated hemoglobin levels is believed to be useful to characterize the functioning of glucose metabolism. Given the importance of GV in diabetes, a number of indicators to measure it from the retrospective analysis of sparse self-monitoring of blood glucose (SMBG) or continuous glucose monitoring (CGM) recordings have been proposed in the literature, but several issues are still open. For instance, some GV indicators have been developed specifically from SMBG data, and their use on CGM time-series has not been validated yet. Moreover, the availability of a large number of metrics to quantify GV gives rise to problems in terms of redundant conveyed information, and a compact way to extensively characterize GV would be desirable. Finally, the exploitation of CGM signals and GV to classify the metabolic condition of normal and diabetic subjects is a relatively unexplored problem that could deserve an investigation. These three topics are the object of this dissertation, which is specifically made up of six chapters whose content is briefly outlined below. Chapter 1 will describe the etiology of the different types of diabetes, discuss the development of diabetes complications, and introduce the technologies used to monitor blood glucose levels and the strategies exploited to manage the treatment of type 1 (T1DM) and type 2 (T2DM) diabetes mellitus. Chapter 2 will focus specifically on GV and its quantification, and, after highlighting the existing open issues, will precisely state the aims of the thesis. Chapter 3 will consider the problem of adapting some GV indicators originally developed and validated from SMBG, to the use with CGM signals. In particular, we will specifically look at low blood glucose index (LBGI) and high blood glucose index (HBGI), popular metrics that allow to provide a rapid classification of the quality of glucose control in diabetic subjects, and will provide alternate versions of these indicators adapted to the characteristics of CGMs by modeling the relationship between LBGI/HBGI values obtained from SMBG and CGM recordings. A dataset of 28 T1DM subjects monitored with both SMBG and CGM devices will be used to tune and assess the proposed methodology. Chapter 4 will address the issue of redundant information conveyed by the available GV indices by using the sparse principal component analysis (SPCA) technique as a tool to provide a parsimonious but still comprehensive characterization of GV in both T1DM and T2DM. Specifically, we will consider 25 GV indicators evaluated on CGM profiles acquired from 33 T1DM and 13 T2DM subjects as initial pool of variables. SPCA will be applied to this set of metrics and will be shown to be able to select a small subset of up to 10 indices that can save more than 60% of the original variance in both applications. The subset of metrics provided by SPCA can be used to parsimoniously describe GV in diabetes. Chapter 5 will be devoted to the assessment of the possibility of using the outputs from SPCA to build GV-based classifiers of the metabolic condition of normal and diabetic subjects. In particular, by resorting to a dataset of 55 T1DM subjects, 34 normal subjects at high risk of developing T2DM, 39 impaired glucose tolerance subjects, and 29 subjects with T2DM diagnosed, we will show that support vector machines are able to successfully classify the quality of glycemic control and the metabolic condition of disordered subjects, allowing to achieve an accuracy of classification always greater than 70%. The investigation will be performed using both the whole initial pool of 25 indicators and the parsimonious set selected by SPCA as features to design the classifiers; the fact that similar results were obtained in the two scenarios strengthens the speculation that the compact description of GV provided by SPCA is effectively comprehensive for characterizing the subjects' metabolic condition. Chapter 6 will close this dissertation, with a discussion on possible future developments of the presented investigations.
L'obiettivo di questa tesi è l'indagine del ruolo della variabilità glicemica (GV) nella patologia del diabete mellito. La GV è un fattore di rischio per lo sviluppo di complicazioni dal diabete, e la sua valutazione combinata con quella dei livelli di emoglobina glicata è ritenuta essere un elemento utile nel caratterizzare il funzionamento del metabolismo del glucosio. Data l'importanza della GV nel diabete, molteplici indicatori che permettono di ottenerne una quantificazione dall'analisi retrospettiva di segnali di self-monitoring of blood glucose (SMBG) o continuous glucose monitoring (CGM) sono stati proposti in letteratura, ma in merito esistono alcune problematiche ancora aperte. Per esempio, alcuni indici sono stati sviluppati specificamente per essere applicati su serie SMBG, ed il loro utilizzo su segnali CGM non è ancora stato validato. Inoltre, il fatto che esistano numerosi indicatori per quanticare la GV dà origine a problemi di ridondanza nell'informazione trasmessa, ed un approccio che permetta di ottenere una descrizione compatta ma esaustiva della GV sarebbe desiderabile. Infine, l'uso di segnali CGM e dell'informazione sulla GV per classificare lo stato metabolico di soggetti normali e diabetici è un problema relativamente inesplorato che potrebbe meritare di essere trattato. Questi tre argomenti sono l'oggetto di questa tesi, che risulta articolata in sei capitoli il cui contenuto è brevemente delineato di seguito. Il Capitolo 1 descriverà l'eziologia dei differenti tipi di diabete, discuterà lo sviluppo delle complicazioni da diabete, ed introdurrà le tecnologie utilizzate per monitorare la glicemia ed alcune strategie che si possono seguire per trattare il diabete mellito di tipo 1 (T1DM) e 2 (T2DM). Il Capitolo 2 verterà sulla GV e la sua quantificazione, e, dopo aver evidenziato i problemi aperti esistenti, dichiarerà precisamente gli scopi della tesi. Il Capitolo 3 considererà il problema di adattare alcuni indicatori di GV originariamente sviluppati e validati su profili SMBG, all'utilizzo su segnali CGM. In particolare, ci concentreremo su low blood glucose index (LBGI) e high blood glucose index (HBGI), indici popolari che permettono di ottenere una rapida classificazione della qualità del controllo glicemico in soggetti diabetici, e forniremo versioni alternative di questi indicatori adattate alle caratteristiche dei segnali CGM, modellando la relazione tra i valori che LBGI e HBGI assumono quando calcolati da SMBG e CGM. Un dataset di 28 soggetti T1DM monitorati con dispositivi SMBG e CGM sarà utilizzato per mettere a punto la metodologia. Il Capitolo 4 affronterà il problema della ridondanza nell'informazione fornita dagli indicatori di GV esistenti, utilizzando la sparse principal component analysis (SPCA) come approccio per fornire una descrizione parsimoniosa ma allo stesso tempo esaustiva della GV in popolazioni di soggetti con T1DM e T2DM. In particolare, considereremo 25 indicatori di GV valutati su profili CGM acquisiti da 33 soggetti con T1DM e 13 con T2DM come insieme iniziale di variabili. La SPCA sarà applicata a questo pool di indici e permetterà di selezionare un piccolo sottoinsieme di 10 indicatori che consente di preservare più del 60% della varianza originariamente spiegata dall'insieme di partenza in entrambe le applicazioni. Il sottoinsieme di indicatori fornito dalla SPCA può essere utilizzato per descrivere parsimoniosamente la GV nel diabete. Il Capitolo 5 sarà dedicato alla valutazione della possibilità di utilizzare gli output della SPCA per costruire classificatori dello stato metabolico di soggetti normali e diabetici basati sulla GV. In particolare, facendo ricorso ad un dataset di 55 soggetti con T1DM, 34 normali a rischio T2DM, 39 con impaired glucose tolerance, e 29 con T2DM diagnosticato, mostreremo che classificatori progettati su support vector machine sono capaci di discriminare con successo la qualità del controllo glicemico e la condizione metabolica di soggetti con disordini, permettendo di raggiungere un'accuratezza di classicazione sempre maggiore del 70%. Lo studio sarà condotto utilizzando sia il pool iniziale di 25 indicatori che il sottoinsieme parsimonioso fornito dalla SPCA come features per costruire i classificatori; il fatto che risultati simili siano ottenuti nei due casi rafforza la speculazione che la descrizione compatta della GV fornita dalla SPCA sia effettivamente esaustiva nel caratterizzare la condizione metabolica dei soggetti. Il Capitolo 6 chiuderà la tesi, con una discussione su possibili sviluppi futuri degli studi qui presentati.

Background: Self-monitoring of blood glucose (SMBG) can inform on the timing of hyperglycaemia; however there is currently no standardised approach to utilise these data to improve glycaemic control in type 2 diabetes patients. Aims: To assess the efficacy of structured blood glucose testing in guiding an insulin titration algorithm in poorly controlled, insulin-treated type 2 diabetes patients. The secondary aim was to compare change in HbA1c between the study subjects and matched controls receiving standard treatment. Methods: This six-month prospective intervention recruited 39 poorly controlled (HbA1C ≥ 8.5% or 69.4 mmol/mol), type 2 diabetes subjects using twice-daily biphasic insulin from two public hospitals in Tshwane, South Africa. Patients were asked to perform structured SMBG over 4 weeks and return monthly for consultations where physicians titrated insulin doses using a standardised algorithm guided by the data collected. Post-hoc analysis was performed to assess glycaemic control of study participants compared to those receiving standard treatment. Results: It was found that mean HbA1c decreased over the study period by 1.89% (95% CI: -2.46 to -1.33, p-value<0.001). Mean SMBG and mean fasting plasma glucose (FPG) decreased by 1.6 mmol/L (95% CI: -2.5 to -0.6 mmol/L, p-value: 0.002) and 1.5 mmol/L (95% CI: -2.2 to -0.2 mmol/L, p-value: 0.024), respectively. Hypoglycaemic event rate (≤3.9 mmol/L) was 33.08 events per patient-year. Total daily insulin use increased by a mean 40.12 units.day-1 (SE: 7.7, p-value<0.001); weight increased by an average 3.98 kg (95% CI: 2.56 to 5.41, p-value <0.001) over the study period. Study participants were found to have a greater mean (SE) reduction of 0.777% (0.404) in HbA1c compared to patients receiving standard care, which fell short of statistical significance (95% CI: -1.569 to 0.015%, p-value: 0.054) due to lack of power (56.5%) in the post-hoc comparison. Conclusion: A structured SMBG programme that advises monthly algorithmic insulin titration can improve glucose control in type 2 diabetes patients using insulin, with moderate hypoglycaemic events and weight gain.
Dissertation (MSc)--University of Pretoria, 2016.
National Research Foundation (NRF)
Roche Products (South Africa)
School of Health Systems and Public Health, University of Pretoria
School of Medicine, University of Pretoria
School of Health Systems and Public Health (SHSPH)
MSc
Unrestricted

Eleven participants living with non-insulin-requiring Type 2 Diabetes (T2DM) discussed their self-monitoring blood glucose (SMBG) experience. All had been recently diagnosed (< 2 years) and treated for diabetes with a self-regulating SMBG guideline for primary care practice. Their digitally-recorded interviews and photographed logbooks were analyzed thematically and interpreted through the lens of numeracy literature to answer 2 questions: 1. What is the meaning of SMBG among people with non-insulinrequiring T2DM? 2. How do people with non-insulin-requiring T2DM perceive the function of SMBG in diabetes self-management? The meanings of SMBG were patient competence, "It is easy, just a little pin prick"; patient control, "I can control it. It doesn't control me"; and patient security, "It is not that way anymore." Three periods of lived time were observed: Diagnosis "The numbers say I have diabetes"; "I just can't figure out why it does that"; and Routine "I make my numbers." Prominent numeracy functions emerged by time period. During Diagnosis primary numeracy functions included comparing SMBG results to target values. Participants expressed this experience as, "I am some kind of O.K." During applied numeracy functions included taking medication correctly. SMBG readings were experienced as a clue to the diabetes mystery, sometimes confusing the participants, "I just don't know why it does what it does," or answering questions, "Now there is no question marks." Numbers motivated some people for action "The numbers get me out a walking" or restraint "If I didn't have the numbers, I would be tempted to cheat." During Routine interpretive numeracy functioned to aid the evaluation of the efficacy of participant's health behavior change. Numbers had taken on meaning helping a person to "know where I am at." Clinical implications are suggested including adjustments to the selfregulating SMBG guideline for primary care practice. Findings are discussed in relation to personal knowledge processes (Sweeny, 1994) and related SMBG research. Participants concluded that routine SMBG is essential to maintaining and restraining health behavior. This study provides a model for use of SMBG in diabetes selfmanagement and patient perspectives on SMBG during the 2 years following T2DM diagnosis.

Objective: The aim of this study was to evaluate a new underfill-function in a POCT-instrument from HemoCue AB (Ängelholm, Sweden). The instrument is in use today among diabetes patients for self-monitoring blood glucose (SMBG). The new function is supposed to guarantee that measuring only will be performed on a sufficient sample volume to assure that the correct glucose value is received.

Methods and results: Blood samples (whole blood) from 12 patients were analysed with the instrument. Measuring were performed using different volumes in the cuvette. Full cuvette, 3µL, 2µL, 1µL and a measuring on an empty cuvette. The instrument performed measurements on all volumes added to the cuvette except for the empty cuvette. The less sample volume that was used the lower glucose values were reported by the instrument.

Conclusions: The new under fill-function did not work satisfactory. If such function would be more reliable it would be beneficial for the patient controlling hers/his bloodglucose provided that the testing procedure is being correctly done. This is very important because the results are often used to treat the patient.

Background. Diabetes requires significant disease management, patient-provider communication, and interaction between patients, family members, caregivers, and care teams. Emerging patient-facing technologies, such as cellular-enabled glucose meters, can facilitate additional care support and improve diabetes self-management. This study evaluated patient acceptability, feasibility, and efficacy of a diabetes care support program facilitated by cellular-enabled glucose meters. Methods. A two-phase study approach was taken. Get In Touch – Phase 1 (GIT-1) was a 1-month pilot involving patients with type 1 and type 2 diabetes. Get In Touch – Phase 2 (GIT-2) was a 12-month randomized controlled crossover trial involving patients with poorly-controlled type 2 diabetes. Results from GIT-1 and preliminary results from GIT-2 are presented. Results. GIT-1 participants with type 1 (n=6) and type 2 (n=10) diabetes reported the intervention and cellular-enabled glucose meter were easy to use and useful while identifying potential areas of improvement. GIT-2 participants in both the intervention (n=60) and control (n=60) groups saw significant improvements in treatment satisfaction and A1c change, with intervention participants experiencing slightly greater improvements in each after 6 months (p=0.09 and p=0.16, respectively) compared to control participants. Conclusions. Patients reported favorable acceptability of the intervention. Preliminary results from a randomized trial demonstrated potential of intervention to improve patient-reported and physiological health outcomes. Future studies should evaluate feasibility and efficacy over a longer period of time, with a greater number of participants, and targeting different populations of patients with diabetes. Provider perspectives and changes in provider behavior, clinical work flow, and caregiver burden should also be assessed.

Background. Diabetes requires significant disease management, patient-provider communication, and interaction between patients, family members, caregivers, and care teams. Emerging patient-facing technologies, such as cellular-enabled glucose meters, can facilitate additional care support and improve diabetes self-management. This study evaluated patient acceptability, feasibility, and efficacy of a diabetes care support program facilitated by cellular-enabled glucose meters. Methods. A two-phase study approach was taken. Get In Touch – Phase 1 (GIT-1) was a 1-month pilot involving patients with type 1 and type 2 diabetes. Get In Touch – Phase 2 (GIT-2) was a 12-month randomized controlled crossover trial involving patients with poorly-controlled type 2 diabetes. Results from GIT-1 and preliminary results from GIT-2 are presented. Results. GIT-1 participants with type 1 (n=6) and type 2 (n=10) diabetes reported the intervention and cellular-enabled glucose meter were easy to use and useful while identifying potential areas of improvement. GIT-2 participants in both the intervention (n=60) and control (n=60) groups saw significant improvements in treatment satisfaction and A1c change, with intervention participants experiencing slightly greater improvements in each after 6 months (p=0.09 and p=0.16, respectively) compared to control participants. Conclusions. Patients reported favorable acceptability of the intervention. Preliminary results from a randomized trial demonstrated potential of intervention to improve patient-reported and physiological health outcomes. Future studies should evaluate feasibility and efficacy over a longer period of time, with a greater number of participants, and targeting different populations of patients with diabetes. Provider perspectives and changes in provider behavior, clinical work flow, and caregiver burden should also be assessed.

Ensaio clínico, aleatorizado, prospectivo, sem cegamento, realizado em duas Unidades Básicas de Saúde, em uma cidade do interior do Estado de São Paulo, em 2011. O estudo teve como objetivo avaliar os efeitos de uma intervenção educativa sobre a automonitorização da glicemia capilar (AMGC) no domicílio, no controle metabólico. Foram constituídos dois grupos de usuários com diabetes mellitus, um grupo que participou do Programa de AMGC no domicílio e em cuidado usual (grupo controle) e um do Programa de AMGC no domicílio e de uma intervenção educativa (grupo intervenção). O estudo foi aprovado pelo Comitê de Ética em Pesquisa e registrado na Clinical Trials.gov (NCT01475422). A população do estudo foi de 342 usuários com DM. O recrutamento foi realizado por meio de convocações por agentes comunitários de saúde, correspondência via correio e contato telefônico. A amostra foi constituída por 91 usuários com DM que aceitaram participar do estudo. A alocação dos grupos foi do tipo aleatorização simples com o uso de um software estatístico. Os grupos controle e intervenção participaram de duas avaliações, uma basal e uma ao final do estudo. A basal consistiu na avaliação das variáveis sociodemográficas, das clínicas, dos hábitos de vida, das relacionadas ao Programa de AMGC, do controle metabólico e dos exames laboratoriais. A avaliação final consistiu na avaliação das variáveis de controle metabólico e exames laboratoriais. Para o grupo intervenção, foi oferecida uma intervenção educativa estruturada, em grupo, semanal, com 60 minutos de duração cada encontro, por 12 semanas. A ferramenta educativa utilizada no grupo intervenção foram os Mapas de Conversação. Para a análise, foram utilizados os testes não paramétricos Qui quadrado de Pearson e o Exato de Fischer para comparação entre proporções, o Teste Qui-quadrado de Tendência Linear para avaliação de tendências proporcionais de aumento ou redução entre as variáveis ordinais. Em todas as análises, foi adotado o nível de significância estatística de 5% (p <= 0,05). Os resultados mostraram que, ao comparar os grupos, as características foram semelhantes. A maioria era do sexo feminino, eram casados, com idade média de 62,1 anos e escolaridade de quatro a sete anos de estudo. Houve melhora nos valores de índice de massa corporal, circunferência abdominal, pressão arterial diastólica, glicemia plasmática de jejum, colesterol HDL, colesterol LDL e triglicerídeos, no grupo intervenção. O grupo controle apresentou melhora dos valores de pressão arterial sistólica e diastólica, glicemia plasmática de jejum, colesterol HDL e colesterol LDL. Houve aumento dos valores de hemoglobina glicada nos grupos intervenção e controle. Conclui-se que não houve melhora do controle metabólico, estatisticamente significante. No entanto, é possível afirmar que a intervenção educativa para AMGC no domicílio apresentou significância clínica, repercutindo de modo peculiar na saúde dos participantes
Clinical, randomized and prospective trial, without blinding, in two Basic Health Units in an inner city of the state of São Paulo. The study aims at evaluating the effects of an educative intervention over the self-monitoring of blood glucose (SMBG) at home for metabolic control. Two groups of participants were formed: one group participated in the SMBG program at home and with usual care (control group), while the other group participated in the SMBG at home and with educative intervention (intervention group). The study was approved by the Research Ethics Committee e registered in the website ClinicalTrials.gov (NCT01475422). The study had a population of 342 participants with Diabetes Mellitus. The recruiting was performed by convening of community health workers either by mail or phone call. The sample was constituted by 91 users with Diabetes Mellitus that accepted to participate in the study. The groups\' allocation was performed by simple randomization with the use of a statistical tool. The control and intervention groups participated in two evaluations: a basal evaluation and another at the end of the study. The first evaluation consists on the assessment of socio demographic variables, as well as variables related to the clinics, lifestyle, SMBG program, metabolic control and laboratorial exams. The second evaluation consists on assessing variables related to both metabolic control and laboratorial exams. For the intervention group, it was offered a structured educative intervention, in-group, weekly, with 60 minutes each meeting for 12 weeks. The educative tool used by the intervention group was the Conversation Map. For the analysis, two non-parametric tests were used. Pearson\'s chi square and Fisher\'s exact tests were used for comparing proportions. On the other hand, the chi-square test of linear trend was used to evaluate the proportional trends of either increase or decrease between the ordinal variables. For all the analysis, a significance statistical level of 5% (p <= 0.05) was adopted. Similar characteristics could be observed when comparing the results of both groups. Most part of participants were females, married, with an average age of 62.1 years old and schooling from four to seven years of study. In the intervention group, an improvement was observed in the following measures: body mass index, abdominal circumference, diastolic blood pressure, fasting plasma glucose, HDL cholesterol, LDL cholesterol and triglycerides. The control group showed improvement in measures of systolic and diastolic blood pressure, fasting plasma glucose, HDL cholesterol and LDL cholesterol. Moreover, an increase on the values of glycated hemoglobin was observed in both groups. It was observed that there was not statistical significant improvement of the metabolic control. However, it was possible to confirm that an educative intervention for SMBG at home presented a clinical significance, which in turn, resonates in a special way on the health of participants

In type 1 diabetes (T1D) exogenous insulin is administered to compensate for the absence of endogenous insulin production by pancreas beta-cells. T1D subjects must finely tune insulin doses to maintain blood glucose (BG) concentration within the normal range (70-180 mg/dl). For such a purpose, every day, T1D subjects need to frequently monitor their BG concentration and make several treatment decisions, e.g. the calculation of insulin and carbohydrate (CHO) doses to counterbalance, respectively, high and low BG values. The safety and effectiveness of T1D insulin therapies are normally assessed by clinical trials, which unfortunately are usually time-demanding, expensive and often present constraints of low numerosity and short duration, with consequently low probability of observing rare but risky situations, like severe hypoglycemia. These limitations can be overcome by the use of in silico clinical trials, based on computer simulations, that allow to test medical device-based treatments in a large number of subjects, over a long period, under reproducible conditions, at limited costs, and without implicating any risk for real subjects. A popular powerful tool to perform in silico clinical trials in T1D is the UVA/Padova T1D simulator, i.e. a model of glucose, insulin and glucagon dynamics in T1D subjects. However, to test insulin therapies in a real-life scenario, the UVA/Padova T1D simulator alone is not sufficient because a mathematical description of other fundamental components, like the device used for glucose monitoring and the patient's behavior in making treatment decisions, is required. The aim of this thesis is to design a mathematical model of T1D patients making treatment decisions fully usable for the comprehensive in silico assessment of insulin treatment scenarios. In particular, in the first part of the thesis we develop three submodels that the UVA/Padova T1D simulator requires (as complement) to pursue this scope. Specifically, we design a model of self-monitoring of blood glucose (SMBG) device, a model of minimally-invasive sensor for continuous glucose monitoring (CGM), and a model of the patient’s behavior in tuning CHO intakes and insulin doses according to SMBG and/or CGM measurements. The parameters of these models are either fitted on real data or derived from literature studies. The overall model, in the following called T1D decision-making (T1D-DM) model, can be used for several in silico experiments. To demonstrate its usefulness, in the second part of this thesis we apply the T1D-DM model to assess safety and effectiveness of nonadjunctive CGM use, i.e. the use of CGM measurements to make treatment decisions without requiring confirmatory SMBG measurements collected by fingerstick. This specific application is currently of great scientific and industrial interest for the diabetes technology research community because, until clinical evidence of its safety is provided, nonadjunctive CGM use cannot be approved by U.S. regulatory agencies, like the Food and Drug Administration. The thesis is organized in six chapters. In Chapter 1, after introducing T1D therapy, the importance of in silico clinical trials is discussed, both in general and specifically for the assessment of nonadjunctive CGM use. Then, some state-of-art simulation techniques are briefly introduced discussing their open problems. The aim of the thesis is illustrated at the end of the chapter. In Chapter 2, we analyse more in depth the limitations of the approaches currently available in the literature for the assessment of insulin treatments. In particular, we demonstrate that a recently proposed simulation method to "replay" in silico real-life treatment scenarios has domain of validity limited to small adjustments of basal insulin, calling for the development of more sophisticated techniques like that proposed in this thesis. In Chapter 3, our simulation method based on the T1D-DM model is presented. This model allows to simulate, in a real-life scenario, the glucose profiles of T1D subjects using SMBG and/or CGM to make treatment decisions. The T1D-DM model is composed of four components: A) the UVA/Padova T1D simulator, B) a model of glucose monitoring devices, C) a model of patient's behavior and treatment decisions and D) a model of the insulin pump. In particular, as far as B) is concerned, two different SMBG error models are derived by data collected with two popular SMBG devices (One Touch Ultra 2 and Bayer Contour Next USB). Using a recently published methodology which takes into account the main sensor error components, a CGM model is derived from data collected by a state-of-art CGM sensor (Dexcom G5 Mobile). Regarding C), a model of the patient's behavior in making treatment decisions based on SMBG and/or CGM, such as administration of insulin boluses and hypotreatments, is designed to simulate treatments based on i) SMBG, ii) adjunctive CGM, or iii) nonadjunctive CGM. In order to reproduce a real-life scenario, the model includes components describing the mistakes real subjects commonly make, such as miscalculation of meal CHO content and early/delayed insulin administrations. In Chapter 4 and Chapter 5, two in silico trials based on the T1D-DM model are designed to assess nonadjunctive CGM use. In the first trial, nonadjunctive CGM is compared to SMBG and adjunctive CGM over a two-week period in 100 virtual subjects. Results show that the use of CGM (both adjunctive and nonadjunctive) significantly improves glycemic control compared to SMBG, while no significant change is observed between adjunctive CGM and nonadjunctive CGM. This suggests that CGM is ready to substitute SMBG for T1D treatment. In the second trial, the impact of thresholds used for CGM hypo/hyperglycemic alerts on the performance of nonadjunctive CGM use is assessed. Results show that time in hypoglycemia is reduced by nonadjunctive CGM use with any alert setting, while time in hyperglycemia is significantly worsen by nonadjunctive CGM use, compared to SMBG, when the high alert threshold is set to 350 mg/dl or higher. Finally, the major findings of the work carried out in this thesis, its possible applications and margin of improvements are summarized in Chapter 6.
Nella terapia del diabete di tipo 1 viene somministrata insulina esogena per compensare l'assenza di secrezione di insulina da parte della beta cellule del pancreas. Per mantenere la glicemia ad un livello normale (70-180 mg/dl), i soggetti diabetici di tipo 1 devono accuratamente regolare le proprie dosi di insulina. A questo scopo, essi necessitano ogni giorno di misurare frequentemente la loro glicemia e prendere numerose decisioni terapeutiche, per esempio per calcolare le dosi di insulina e carboidrati necessarie a controbilanciare livelli glicemici rispettivamente elevati e bassi. La sicurezza e l'efficacia di terapie insuliniche per il diabete di tipo 1 sono comunemente valutate in trial clinici, i quali solitamente necessitano di tempi e costi elevati e presentano limiti di bassa numerosità e breve durata, con conseguente ridotta probabilità di osservare situazioni rare seppur rischiose, come ad esempio l'ipoglicemia severa. Queste limitazioni posso essere superate mediante trial clinici simulati, cioè basati su simulazioni al computer, che permettono di testare terapie basate su dispositivi medici in un vasto numero di soggetti, per un lungo periodo, in condizioni riproducibili, a costi limitati e senza comportare alcun rischio per i pazienti reali. Un popolare strumento per svolgere trial clinici simulati nell'ambito del diabete di tipo 1 è il simulatore UVA/Padova-T1D, un modello che descrive le dinamiche di glucosio, insulina e glucagone nei soggetti diabetici di tipo 1. Tuttavia, al fine di testare terapie insuliniche in uno scenario realistico, il simulatore UVA/Padova-T1D non è da solo sufficiente in quanto necessaria la descrizione matematica di altre componenti fondamentali, come il dispositivo utilizzato per il monitoraggio del glucosio e il comportamento del paziente nel prendere le decisioni terapeutiche. Lo scopo di questa tesi è la progettazione di un modello matematico del paziente diabetico di tipo 1 e delle decisioni terapeutiche che esso prende, utilizzabile per una completa valutazione in simulazione di terapie insuliniche. In particolare, nella prima parte della tesi vengono sviluppati i tre sottomodelli che il simulatore UVA/Padova-T1D necessita (come complemento) per raggiungere tale scopo. Nello specifico, vengono sviluppati un modello del dispositivo pungidito per il monitoraggio della glicemia (SMBG), un modello del sensore minimamente invasivo per il monitoraggio a tempo continuo della glicemia (CGM) e un modello del comportamento del paziente nel regolare le somministrazioni di carboidrati e insulina a seconda delle misure SMBG e/o CGM. I parametri di questi modelli sono fittati su dati reali o derivati da studi di letteratura. Il modello complessivo, chiamato in seguito modello decisionale del diabete di tipo 1 (T1D-DM), può essere impiegato per molti esperimenti simulati. Per dimostrare la sua utilità, nella seconda parte della tesi il modello T1D-DM viene impiegato per valutare la sicurezza e l'efficacia dell'uso "nonadjunctive" del sensore CGM, cioè l'uso delle misure CGM per prendere decisioni terapeutiche senza la necessità di confermarne le letture mediante misure SMBG raccolte con dispositivi pungidito. Questa specifica applicazione è attualmente di grande interesse scientifico e industriale nella comunità della ricerca sulle tecnologie per il diabete poiché, finché non ne viene dimostrata la sicurezza, l'uso "nonadjunctive" del CGM non può essere approvato dalle agenzie regolatorie statunitensi, come la Food and Drug Administration. La tesi è organizzata in sei capitoli. Nel capitolo 1, dopo aver introdotto la terapia del diabete di tipo 1, viene discussa l'importanza dei trial clinici simulati, sia in generale sia in maniera specifica per la valutazione dell'uso "nonadjunctive" del sensore CGM. In seguito, vengono brevemente introdotte alcune tecniche di simulazione allo stato dell'arte discutendone i problemi aperti. Lo scopo della tesi è illustrato alla fine del capitolo. Nel capitolo 2 vengono analizzate nel dettaglio le limitazioni degli approcci allo stato dell'arte per la valutazione di terapie insuliniche. In particolare, viene dimostrato che un metodo di simulazione recentemente proposto per riprodurre in simulazione scenari terapeutici della vita reale presenta un dominio di validità limitato a piccole variazioni della dose basale di insulina, suggerendo la necessità di sviluppare tecniche più sofisticate come quella proposta in questa tesi. Nel capitolo 3 viene presentato il nostro metodo di simulazione basato sul modello T1D-DM. Questo modello consente di simulare, in uno scenario che riproduce la vita reale, i profili glicemici di soggetti diabetici di tipo 1 che utilizzano dispositivi SMBG e/o CGM a supporto delle decisioni terapeutiche. Il modello T1D-DM è composto da quattro componenti: A) il simulatore UVA/Padova-T1D, B) un modello dei dispositivi per il monitoraggio del glucosio, C) un modello del comportamento del paziente nel prendere le decisioni terapeutiche e D) un modello della pompa per l'infusione di insulina. Per quanto riguarda B), due modelli dell'errore delle misure SMBG sono derivati utilizzando misure raccolte con due popolari dispositivi SMBG (lo One Touch Ultra 2 e il Bayer Contour Next). Utilizzando un metodo recentemente pubblicato che prende in considerazione le componenti principali dell'errore del sensore, viene derivato un modello delle misure CGM sulla base di dati raccolti con un sensore CGM allo stato dell'arte (Dexcom G5 Mobile). Per quanto concerne C), viene progettato un modello del comportamento del paziente nel prendere le decisioni terapeutiche sulla base di misure SMBG e/o CGM, come la somministrazione di boli di insulina e trattamenti per l'ipoglicemia, al fine di simulare terapie basate su i) SMBG, ii) uso del CGM a supporto dell'SMBG (uso "adjunctive") o iii) uso "nonadjunctive" del CGM. Per riprodurre uno scenario realistico, il modello include componenti che descrivono gli errori comunemente commessi dai pazienti reali, come per esempio gli errori nella stima della quantità di carboidrati contenuti nel pasto e ritardi/anticipi nella somministrazione delle dosi di insulina. Nei capitoli 4 e 5 vengono progettati due trial clinici simulati basati sul modello T1D-DM per valutare l'uso "nonadjunctive" del sensore CGM. Nel primo trial, l'uso "nonadjunctive" del sensore CGM è confrontato con l'uso dell'SMBG e l'uso "adjunctive" del CGM in 100 soggetti virtuali per un periodo di due settimane. I risultati dimostrano che l'uso del CGM (sia "adjunctive", sia "nonadjunctive") migliora significativamente il controllo glicemico rispetto all'uso dell'SMBG, mentre non si osservano differenze significative tra l'uso "adjunctive" e "nonadjunctive" del sensore CGM. Questo risultato suggerisce che il CGM è pronto per sostituire l'SMBG nel trattamento del diabete di tipo 1. Nel secondo trial, viene valutato come le soglie impostabili per le allerte ipo/iperglicemiche del sensore CGM influenzano le performance dell'uso "nonadjunctive" del CGM. I risultati dimostrano che l'uso "nonadjunctive" del sensore CGM consente di ridurre il tempo in ipoglicemia per qualsiasi impostazione delle allerte, mentre il tempo in iperglicemia viene significativamente peggiorato dall'uso "nonadjunctive" del sensore CGM, rispetto all'SMBG, quando la soglia dell'allerta di iperglicemia è impostata ad un valore maggiore o uguale a 350 mg/dl. Infine i risultati principali del lavoro svolto in questa tesi, nonché le possibili applicazioni e i margini di miglioramento sono riassunti nel capitolo 6.

CoordenaÃÃo de AperfeiÃoamento de Pessoal de NÃvel Superior
A prioridade no tratamento do diabetes à garantir ao paciente seu equilÃbrio metabÃlico e mantÃlo assim, propiciando um estado o mais prÃximo possÃvel da fisiologia normal do organismo. Entretanto, um dos problemas que os profissionais de saÃde encontram à a dificuldade dos pacientes seguirem o tratamento de forma regular e sistemÃtica, pois estes frequentemente sÃo portadores de outras condiÃÃes mÃrbidas, fazendo uso de vÃrias medicaÃÃes alÃm das especÃficas para o diabetes. Este fato dificulta a adesÃo e o uso correto dos esquemas propostos. O objetivo deste estudo foi investigar as caracterÃsticas de adesÃo terapÃutica de portadores de Diabetes mellitus atendidos na rede pÃblica de saÃde no municÃpio de Fortaleza, Cearà e seus fatores relacionados. Foi realizado um estudo transversal, onde foram incluÃdos 140 pacientes atendidos do AmbulatÃrio de Diabetes do Hospital UniversitÃrio Walter CantÃdio (HUWC) e 116 pacientes do Centro de SaÃde AnastÃcio MagalhÃes (CSAM) no ano de 2010, selecionados de forma sequenciada. Para mensurar a prevalÃncia da nÃo adesÃo ao tratamento foi empregado o mÃtodo do autorrelato e considerado adesÃo quando o paciente fazia uso de pelo menos 90% do tratamento proposto. Na anÃlise dos dados foram utilizados o teste de Kalmogorov-Smirnov, teste t de Student, kendall tau b e o coeficiente de contingÃncia, com nÃvel de significÃncia estatÃstica de 5% (p<0,05), utilizando-se o software SPSS (Z14.0). Dos 256 pacientes, houve predomÃnio do sexo feminino (66,8%), casados (53,5%), aposentados (39,1%), com ensino fundamental incompleto (32,4%) e renda familiar mÃdia de 1 salÃrio mÃnimo (39,8%). Quanto à doenÃa, 93,7% possuÃam diabetes tipo 2, com uma mÃdia de 10 anos de diagnÃstico, 75,4% tambÃm eram hipertensos e a principal complicaÃÃo crÃnica encontrada foi a retinopatia (35,9%). As associaÃÃes medicamentosas foram prevalentes entre os pacientes (50,4%) e as drogas de escolha foram sulfonilureia (36,3%) e metformina (66%). A atividade fÃsica foi referida por 43,8% dos pacientes e a dieta por 57%. A adesÃo ao tratamento medicamentoso foi de 74% no CSAM e 77% no HUWC. Fatores relacionados à relaÃÃo profissional-paciente, como a qualidade e frequÃncia das orientaÃÃes, mostraram-se fortemente associados à adesÃo ao tratamento (p<0,001), assim como, os fatores relacionados à doenÃa, onde pacientes com controle bom ou aceitÃvel do diabetes (p<0,007) e que nÃo possuÃam internaÃÃes obtiveram melhor adesÃo (p<0,018). Quanto à influÃncia do sistema de saÃde, pessoas mais satisfeitas e que melhor qualificaram o serviÃo apresentaram melhor adesÃo (p<0,045). Na anÃlise clÃnica houve predomÃnio do sobrepeso (39,5%) e obesidade (32%). As medidas alteradas de circunferÃncia abdominal (65,6%), cervical (68,8%) e relaÃÃo cintura-quadril (78,1%) estiveram presentes em grande parte dos pacientes do CSAM e HUWC. Os valores antropomÃtricos alterados nÃo apresentaram diferenÃa na anÃlise da adesÃo. Quanto aos exames laboratoriais, em ambos os locais, a maioria dos pacientes que apresentaram adesÃo estava com glicemia de jejum (65,1%), pÃs-prandial (61,7%) e hemoglobina glicada (68,1%) acima dos valores recomendados. Identificou-se um elevado nÃmero de fatores que podem influenciar na adesÃo ao tratamento, sendo um problema frequente na prÃtica clÃnica. As taxas nÃo satisfatÃrias de adesÃo à terapÃutica farmacolÃgica podem justificar possivelmente o mau controle metabÃlico entre os pacientes. Traduzem a necessidade de se ampliar o foco na atenÃÃo integral a estas pessoas.

Abstract Type 1 diabetes is considered to be a T cell-mediated autoimmune disease characterized by destruction of the pancreatic beta cells. Its prediction is currently based on diabetes-associated autoantibodies, giving a cumulative risk of 84% during 15 years of follow-up since seroconversion. Prediction of the timing of clinical onset has remained challenging, however. This thesis examines glucose metabolism in autoantibody-positive children with a high risk of developing type 1 diabetes. Out of a total of 14,876 children with an increased genetic risk followed up from birth in the Finnish DIPP study, 567 developed ≥2 autoantibodies during the follow-up and 255 of these (45%) were diagnosed with type 1 diabetes until the end of December 2011. The glucose parameters measured were HbA1c, OGTT and random plasma glucose with 3 to 12 months interval. Seven-day continuous glucose monitoring (CGM) was performed on an age and sex-matched cohort. We showed that rising HbA1c, impaired glucose tolerance in OGTT, random plasma glucose values of ≥7.8mmol/l and potentially CGM can predict type 1 diabetes with a median time to diagnosis of approximately one year. Our results suggest that especially HbA1c and random plasma glucose are cost-effective and improve the prediction of diabetes. These markers may be useful for monitoring the response to treatment in prevention studies
Tiivistelmä Tyypin 1 diabetesta pidetään T-soluvälitteisenä autoimmuunitautina, joka johtaa haiman beetasolujen tuhoutumiseen. Tyypin 1 diabeteksen ennustaminen perustuu tällä hetkellä diabetekseen assosioituviin vasta-aineisiin, jotka antavat 84% kumulatiivisen riskin 15 vuoden seurannassa. Taudin puhkeamisen ajankohdan ennustaminen on kuitenkin edelleen vaikeaa. Tämä väitöskirja käsittelee glukoosiaineenvaihduntaa vasta-ainepositiivisilla lapsilla, joilla on suurentunut riski sairastua tyypin 1 diabetekseen. Suomalaisessa DIPP-tutkimuksessa vasta-aineiden kehittymistä on seurattu yhteensä 14876 lapselta. Seurannan aikana 567 lasta kehitti ≥2 autovasta-ainetta ja näistä 255 (45%) sairastui tyypin 1 diabetekseen joulukuun loppuun 2011 mennessä. Glukoosiaineenvaihduntaa seurattiin tutkimalla HbA1c, OGTT ja satunnaisia verensokeriarvoja 3-12 kuukauden välein. Ikä ja sukupuolivakioidussa kohortissa tehtiin jatkuvan sokeripitoisuuden seuranta (CGM). Tutkimuksessamme nouseva HbA1c, heikentynyt sokerin sieto OGTT-kokeessa, satunnainen verensokeri ≥7.8 mmol/l ja mahdollisesti CGM ennustavat tyypin 1 diabeteksen puhkeamista. Tulostemme perusteella erityisesti kustannustehokkaat HbA1c ja satunnainen verensokeri parantavat diabeteksen ennustamista. Nämä parametrit saattavat olla hyödyllisiä myös preventiotutkimuksissa hoitovasteen seurannassa

Der Gestationsdiabetes betrifft etwa 5 von 100 Schwangeren. In unserer prospektiven, randomisierten Studie mit Crossover-Design untersuchten wir den Einfluß der Kohlenhydrataufnahme auf den Glukosestoffwechsel Schwangerer. 18 Gestationsdiabetikerinnen, 9 Frauen mit eingeschränkter Glukosetoleranz und 25 Kontrollen haben jeweils eine Woche eine kohlenhydratarme (35 Energieprozent) und eine kohlenhydratreiche (55 Energieprozent) Diät durchgeführt. Auswirkungen wurden anhand des konventionellen BZTPs und des kontinuierlich messenden Glukosesensors CGMS® untersucht. Die KH-Aufnahme wurde mittels einer Ernährungsberatung deutlich beeinflußt, und lag bei 39 % in der KH-reduzierten, und bei 49 % in der KH-reichen Woche. Nach DDG-Kriterien hatte der KH-Anteil bei keiner Gruppe einen signifikanten Einfluß bezüglich der Insulinpflicht. Dagegen waren der BZTP-Mittelwert und die AUC (area under the curve des CGMS®) der GDMs und der Kontrollen signifikant niedriger in der KH-armen Woche. In dieser Woche nahmen die Probandinnen auch eine niedrigere Energiemenge zu sich. Bei einer selektierten Untergruppe konnten wir diesen Einfluß ausgrenzen, und für die Kontrollgruppe eine signifikante Erniedrigung bezüglich der BZTP-Mediane und der AUCs nachweisen. Diese Beobachtungen belegen, daß ein höherer Kohlenhydratanteil mit erhöhten Blutzuckerwerten assoziiert ist. Außerdem wurde ein größerer Einfluß einer kohlenhydratarmen Ernährung auf die postprandialen als auf die Nüchternwerte festgestellt. Wegen der Auswirkungen auf das fetale Wachstum soll man bei Gestationsdiabetikerinnen eine kohlenhydratarme Ernährung empfehlen.
Gestational diabetes affects about 5 % of pregnancies. In our randomized prospective study with crossover design we examined the influence of carbohydrate intake on the glucose metabolism of pregnant women. 18 women with gestational diabetes, 9 with impaired glucose tolerance and 25 controls were put on a low (35 energy %) carbohydrate diet for one week and a high (55 energy %) carbohydrate diet for another. Blood glucose levels were recorded by self-monitoring and with a continuous glucose monitoring sensor (CGMS ®). Carbohydrate intake was strongly influenced by dietary advice, amounting to 39% into the low carbohydrate and 49% in the high carbohydrate week. According to DDG criteria, carbohydrate intake had no significant influence on insulin requirements. In contrast, mean blood glucose levels and the AUC (area under of the curve of the CGMS ®) were significantly lower for both gestational diabetics and controls in the low carbohydrate week. During this week, the average caloric intake was also reduced. We could exclude this influence for a selected subgroup, in which the controls displayed a significant reduction in median glucose levels and the AUCs. We could thus show that a higher carbohydrate content is associated with raised blood glucose levels. Furthermore, the influence of a low carbohydrate diet was greater on postprandial than on fasting levels. Because of the effects on fetal growth, one should recommend a low carbohydrate diet for gestational diabetics.

Introdução: O processo educativo e de suporte deve ser permanente e compartilhado, tendo o indivíduo com diabetes como o centro de toda a ação. A automonitorização glicêmica é, em geral, a primeira prática de autocuidado ensinada à criança com diabetes mellitus tipo 1 (DM1) em seu processo de autonomia no manejo da doença. Objetivos: Geral: Avaliar a efetividade da oficina educativa no desempenho da técnica de monitorização glicêmica capilar em crianças escolares com diagnóstico de DM1; Específicos: Verificar os Índices de Conformidade do procedimento da técnica de monitorização glicêmica das crianças escolares com DM1 antes e após serem submetidas à oficina educativa e comparar os Índices de Conformidade, pré- e pós-oficina, da técnica de automonitorização glicêmica das crianças com DM1 que serão submetidas à oficina educativa. Método: Trata-se de um estudo quantitativo, quase-experimental, pré-teste e pós-teste. Participaram do estudo 33 crianças escolares, de 6 a 11 anos, com DM1 há mais de um ano, usuárias de dois ambulatórios infantis de endocrinologia de um complexo hospitalar do município de São Paulo. Após a concordância dos pais e o assentimento da criança, foram assinados, respectivamente, o Termo de Consentimento Livre e Esclarecido e o Termo de Assentimento. A coleta de dados foi realizada por meio do emprego dos seguintes instrumentos: 1) Dados sociodemográficos; 2) Perfil de monitorização glicêmica e 3) Passos da técnica de monitorização glicêmica, antes da oficina educativa. Os instrumentos 2 e 3 foram reaplicados um mês e meio após o término da oficina. Resultados: Verificou-se que houve resultados estatísticos significativos para três passos da técnica de automonitorização glicêmica: trocar a lanceta do lancetador (p=0,021), pressionar o local de punção (p=0,057) e desprezar o material utilizado em recipiente adequado para perfurocortantes (p=0,004). A oficina educativa também foi eficaz para provocar mudança de comportamento nas crianças, uma vez que elas conseguiram sair de uma média de conformidade de 5,3 passos corretos da técnica de monitorização, para 6,58 passos, ou seja, passaram a executar um passo a mais em conformidade em relação ao que vinham realizando. Conclusão: A oficina educativa, por meio de atividades lúdicas, foi uma ferramenta eficaz para melhorar o desempenho da execução da técnica de automonitorização glicêmica capilar realizada por crianças escolares com DM1.
Introduction: In the case of diabetes, care must be patient-centered and the educational process and support must be permanent and shared. Blood glucose monitoring is generally the first practice of self-care taught to children with diabetes mellitus type 1 (DM1) to grant them autonomy to manage their disease. Objectives: General: To evaluate the effectiveness of the educational workshop on the performance of the capillary blood glucose monitoring technique in school children diagnosed with DM1; Specific: To check Compliance Indices of the blood glucose monitoring technique of school children with DM1 before and after being subjected to the educational workshop and to compare Compliance Indices, pre- and post-workshop, of the glucose monitoring technique of children with DM1 to be submitted to the educational workshop. Method: This is a quantitative quasi-experimental pretest and posttest study. The study included 33 school children, 6-11 years of age, with DM1 for more than a year, attended at two endocrinology pediatric clinics of a hospital complex in São Paulo. The Informed Consent Form and the Child Assent Form were signed by parents and children, respectively, upon agreeing with the protocol. Data collection was conducted through the use of the following instruments: 1) sociodemographic data; 2) glycemic profile monitoring and 3) steps for the glucose monitoring technique before the educational workshop. Steps 2 and 3 were reapplied six weeks after the end of the workshop. Results: We found that there were statistical significant results for three steps of the self-monitoring blood glucose technique: replacing the lancet of the lancing device (p = 0.021), press the puncture site (p = 0.057) and dispose of the material used in a suitable container for needles and other sharps (p = 0.004). The educational workshop was also effective to promote behavior changes in children, as they were able to move from an average of 5.3 correct steps in the compliance monitoring technique, to 6.58 steps. Therefore, they started to perform one more step correctly than they had previously done. Conclusion: The educational workshop using play activities was an effective tool to improve the performance of the capillary blood glucose monitoring technique performed by school children with DM1.

A Diabetes Mellitus Gestacional é definida como intolerância à glicose durante a gestação, excluídos os casos de diabetes pré-gestacional. A telemedicina tem sido citada como ferramenta útil para proporcionar melhor qualidade à saúde de portadores de doenças crônicas. Objetivo: analisar a influência da orientação telefônica feita por um profissional de saúde sobre os resultados da automonitorização glicêmica em pacientes com diabetes mellitus gestacional. Método: estudo randomizado controlado-cego, longitudinal, com gestantes diagnosticadas com diabetes gestacional, acompanhadas no Setor de Endocrinopatias e Gestação da Clínica Obstétrica do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo atendidas no período de agosto de 2012 a maio de 2014. O diagnostico de DMG foi realizado por meio de glicemia de jejum e teste de tolerância à glicose de 75 gramas. As pacientes foram convidadas a participar da pesquisa após receberem instruções de uma equipe multiprofissional. Foram alocadas, de acordo com a randomização em dois grupos: Grupo 1 (receberiam ligação telefônica três dias após as orientações multiprofissionais, n=122) e grupo 2 (não receberiam ligação telefônica n= 122),. A enfermeira ligou para as pacientes e aplicou questionário sobre manuseio do aparelho para verificação da glicemia capilar, dieta, horário de aferições, desconforto e dificuldade em realizar a automonitorização glicêmica. Foram analisados os valores glicêmicos por meio das porcentagens de valores alterados, de hiperglicemia, de hipoglicemia e da média glicêmica nos sete primeiros dias após a participação no grupo multiprofissional. O número de aferições glicêmicas e as respostas ao questionário aplicado durante o contato telefônico também foram analisados. Resultados: Não houve diferença estatisticamente significativa entre os grupos quanto à cor, idade, presença de outras doenças clínicas maternas e quanto ao tipo de teste usado para diagnóstico de diabetes mellitus gestacional. Analisando os valores da glicemia capilar, o grupo que recebeu orientações telefônicas apresentou menor porcentagem de valores alterados (p= 0,001), menor frequência de hiperglicemia (p= 0,002) e maior número de aferições da glicemia capilar (p= 0,001). Conclusões: O contato telefônico influenciou significativamente o número de aferições da glicemia capilar e a frequência de resultados alterados, especialmente na hiperglicemia, sugerindo ser essa ferramenta útil na melhora da atenção a gestantes portadoras de diabetes gestacional
Gestational Diabetes Mellitus (GDM) is defined as glucose intolerance during pregnancy, excluding cases of pre-gestational diabetes. Telemedicine has been cited as useful tool to provide better quality health care for patients with chronic diseases. Objective: To analyze the influence of telephone advice, by a health care professional, on the results of blood glucose monitoring in patients with gestational diabetes. Method: A randomized controlled blind trial, in pregnant women diagnosed with gestational diabetes, attended in Setor de Endocrinopatias e Gestação da Clínica Obstétrica do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo was carried out from August 2012 to May 2014 The diagnosis of GDM was made by means of fasting glucose and glucose tolerance test 75 grams. Patients were invited to participate in the study after receiving instructions from a multidisciplinary team. According to randomization, patients were allocated into two groups: Group 1 (receive phone call three days after multidisciplinary instructions, n = 122) and group 2 (not receive phone call, n = 122). The nurse called the patient and applied questionnaire on handling the device for checking blood glucose, diet, time of measurements, discomfort and difficulty in performing the blood glucose monitoring. Glycemic values were analyzed by means of the percentage of abnormal values, hyperglycemia, hypoglycemia and glycemic average in the first seven days after participation in the multidisciplinary group. The number of glucose measurements and the questionnaire answer questionnaire were also analyzed. Results: There was no statistically significant difference between groups regarding race, age, presence of other maternal medical illnesses and the type of test used to diagnose gestational diabetes. Analyzing the glycemic values , a group that received telephone guidelines showed lower percentage of abnormal values (p = 0.001), lower incidence of hyperglycemia (p = 0.002) and greater number of measurements of blood glucose (p = 0.001) Conclusion: The telephone contact significantly influenced the number of measurements of blood glucose and the frequency of abnormal results, especially in hyperglycemia, suggesting that this is useful tool in improving attention to pregnant women with gestational diabetes

Diabetes mellitus (DM) é uma das principais causas de doença renal crônica terminal. Na doença renal diabética (DRD) observa-se um curso bifásico no padrão glicêmico, na fase inicial o aumento da resistência insulínica induz a hiperglicemia e, com perda progressiva da taxa de filtração glomerular, há redução na depuração dos medicamentos anti-hiperglicemiantes e insulina, aumentando o risco de hipoglicemias. Portanto, diante da perda da função renal, a reavaliação da terapia hipoglicemiante e ajustes constantes nas doses de insulina são necessários, com intuito de otimizar o controle glicêmico e minimizar seus efeitos colaterais. A revisão da literatura mostra diversos pontos sem resposta, principalmente relacionados à dose, ajuste da terapia insulínica, seguimento e monitoração do controle glicêmico em portadores de DM e DRC. O objetivo deste ensaio randomizado, cruzado, controlado foi comparar o controle glicêmico do tratamento com insulina glargina à insulina NPH em portadores de DM2 e DRD estágios 3 e 4. Pacientes e métodos: Trinta e quatro pacientes foram randomizados para receber insulina glargina uma vez ao dia ou insulina NPH em três aplicações diárias. Insulina lispro foi prescrita três vezes ao dia, em aplicações pré-prandiais nos dois grupos. Após 24 semanas de terapia, os pacientes tiveram seu esquema de insulina trocado para terapia insulínica oposta. Testes laboratoriais foram realizados após 12, 24, 36 e 48 semanas de estudo. O sistema de monitorização continua de glicose (CGMS) foi instalado ao término de cada terapia. Resultados: Dos 34 pacientes incluídos, 29 completaram as 48 semanas propostas no estudo, 2 pacientes perderam seguimento por má adesão e 3 pacientes não completaram o estudo em decorrência a eventos adversos (1 óbito, 1 ingresso em hemodiálise e 1 evento cardiovascular, todos em uso de insulina NPH). Após 24 semanas de tratamento com insulina glargina houve uma redução estatisticamente significante da média da HbA1c de 8,86 ± 1,4% para 7,95 ± 1,1% (p=0,0285), esta diferença não foi observada com a insulina NPH (8,21 ± 1,29% para 8,44 ± 1,32%). Durante o uso de insulina glargina o número de eventos noturnos de hipoglicemia foi menor comparado a insulina NPH (p=0,046); além disso, hipoglicemia grave ocorreu apenas na terapêutica com NPH. Conclusão: O tratamento com insulina glargina foi associado a melhor controle glicêmico e a redução do risco de hipoglicemia noturna quando comparada à insulina NPH,em pacientes portadores de DM e DRC estágios 3 e 4
Diabetes mellitus is the leading cause of chronic kidney disease (CKD). Kidney disease diagnosis and its progression require re-evaluation of hypoglycemic therapy and constant dosing adjustments, to optimize glycemic control and minimize its side effects. Long acting insulin analogs and its pharmacokinetics have not been studied in different stages of kidney disease, nor is there consensus defining appropriate dose adjustment in patients with type 2 diabetes (T2DM) and CKD. The aim of this randomized, cross-over, open-label controlled clinical trial is to compare the glycemic response to intensive insulin treatment with NPH insulin or insulin glargine in T2DM patients and CKD stages 3 and 4. The primary efficacy end point was change in A1C from baseline. Thirty-four patients were randomized to receive insulin glargine once a day or NPH insulin, three times a day. Insulin lispro was prescribed as prandial insulin to both groups. After six months, patients switched to the other insulin therapy group. Laboratory tests were performed at baseline at 12, 24, 36 and 48 weeks. A continuous glucose monitoring system was implemented after 24 weeks and at the end of protocol. Results: Total of 29 subjects have completed the two branches of study, 2 patients dropped out due to low compliance and other 3 patients as a result of adverse events (1 death, 1 ingress on dialysis program, 1 cardiovascular event; all of them were on NPH therapy). After 24 weeks, average of A1c decreased on glargine group compared to baseline 8,86 ± 1,4% to 7,95 ± 1,1% (p=0,0285), but this difference was not observed on NPH group. There were no differences of insulin doses between both groups. Glargine group showed a tendency of lower risk of nocturnal hypoglycemia compared to NPH group (p=0,046). Conclusion: Insulin glargine improved glycemic control by reducing HbA1c without gain weight and with reduced tendency toward nocturnal hypoglycemic events compared with NPH insulin

Avec une incidence de plus en plus élevée, le diabète de type 1 (DT1) constitue un problème majeur de santé. Le contrôle glycémique est la mesure nécessaire pour la prévention des complications chroniques du DT1. Cependant, ce contrôle a pour conséquences la survenue des effets secondaires comme l’hypoglycémie et la prise de poids, avec des impacts négatifs significatifs sur la santé et la qualité de vie des patients. A partir des données de l’essai DCCT (Diabetes Control Complications Trial) réalisé entre les Etats Unis et le Canada de 1983 à 1993, qui a inclus 1441 patients atteints de DT1, nous avons étudié les déterminants et les conséquences de l’hypoglycémie (sévère ou non). Dans un premier temps, nous avons étudié la variation de l’hémoglobine glyquée (HbA1c) après un épisode d’hypoglycémie sévère (HS). Cette étude nous a permis de montrer que la survenue d’une HS a été suivie d'une augmentation modeste mais significative de l'HbA1c 3 mois plus tard. Ce résultat suggère que l’hypoglycémie sévère pourrait constituer un obstacle majeur à la réalisation d'un contrôle glycémique optimal chez les patients atteints de DT1 et doit être prise en compte dans les programmes éducatifs et thérapeutiques chez ces patients. Dans un deuxième temps, nous avons étudié l’association entre la fréquence de l’hypoglycémie non sévère détectée par auto-surveillance de la glycémie (SMBG) et l’incidence des hypoglycémies sévères. Il a été établi que l'hypoglycémie non sévère est un facteur prédictif majeur des épisodes d’hypoglycémie sévère chez les patients atteints de DT1. Les données sur l’auto-surveillance glycémique du DCCT sont très similaires aux pratiques actuelles en matière de soins de routine et nos résultats renforcent les stratégies préventives actuelles en matière d’hypoglycémie sévère chez les patients atteints de DT1. Enfin, dans une troisième partie, nous mis en évidence une association entre les hypoglycémies non sévères et le gain de poids dans le DT1. Nous avons observé qu'un taux plus élevé d'hypoglycémies non sévères, basé sur l’auto-surveillance glycémique, était significativement associé à une prise de poids plus importante, indépendamment des autres facteurs comme sur le sexe, l'âge, la durée du diabète, la variation de l’HbA1c et le type de traitement. Cette conséquence négative nécessite la mise place d’une stratégie de prise en charge des hypoglycémies et des programmes d'éducation spécifiques visant à réduire le gain de poids dans le DT1
With an increasing incidence, type 1 diabetes is a major health problem. Glycemic control is the necessary measure for the prevention of chronic complications of type 1 diabetes. However, this control is associated with side effects such as hypoglycemia and weight gain, so with significant negative impacts on health and the quality of life of patients. Based on data from DCCT (Diabetes Control Complications Trial), the United States-Canada trials from 1983 to 1993, which included 1441 patients with type 1 diabetes, we examined the determinants and the impact of hypoglycemia (severe or not), in patients with type 1 diabetes. First, we studied the variation of glycated hemoglobin (HbA1c) after an episode of severe hypoglycaemia (SH). We showed that the occurrence of SH was followed by a modest but significant increase in HbA1c 3 months later in all participants. This result suggests that severe hypoglycaemia may be a major barrier to achieving optimal glycemic control in patients with T1D, and should be considered in educational and therapeutic programs for these patients. Second, we studied the association between the frequency of non-severe hypoglycemia detected by self-monitoring of blood glucose (SMBG) and the incidence of severe hypoglycaemia. Non-severe hypoglycaemia has been shown to be a major predictor of episodes of severe hypoglycaemia in patients with T1D. Data on glycemic self-monitoring of DCCT is very similar to current routine care practices and our results reinforce current preventive strategies for severe hypoglycemia in T1D patients. Third, we investigated the association between non-severe hypoglycemia and weight gain in type 1 diabetes. Higher rate of non-severe hypoglycemia, based on self-monitoring of blood glucose, was significantly associated with greater weight gain. This association was independent of factors such as sex, age, duration of diabetes, change in HbA1c and type of treatment. This negative consequence requires the implementation of a hypoglycemic management strategy and specific educational programs aimed at reducing weight gain in type 1 diabetes

碩士
國立中興大學
高階經理人碩士在職專班
103
For a long time, since all food intake is more refined, coupled with genetic problems, with the patients of diabetes are increasing in worldwide. To ensure a timely diabetic diet and blood glucose levels, the product of blood glucose monitoring has become an indispensable necessity, not only for the patients of diabetes, but alsoto be a preventive medical product. Based on the Global Diabetes Foundation (WDF),it shows that in 2008 the global market size of blood glucose monitoring products was US$27 billion, and it might reach to US$44.72 billion in 2015. Such a huge opportunity naturally flourishes the blood glucose monitoring industry, which has become a major target market for the medical material manufacturer of blood glucose monitoring. Among the large number of competitors, what kind of strategy you have to use to compete with the competitors, strengthening their own skills and competitive advantage, achieving the expected performance, and becoming the industry leader The main purpose of this study is to explore the relationship between competitive action and response, and performance of the domestic manufacturer of blood glucose monitoring industry. Then we sort out the optimal competitive strategy for home blood glucose monitoring industry, and provide suggestions of competitive strategy to Taiwan''s Hebei companyto expand into the global market. After this study and inference statistical analysis found, home blood glucose monitoring industry lies in its main competitive global market. Performance of strategic competitive actions would create superior tactical competitive action. And mergers and acquisitions, enter new markets and strategic alliances are more effective competitive action type. Revenue Performance contribution composite of competitive action arising, will be greater than a single competitive behavior.

Thesis (M.S.)--University of Wisconsin-Madison, 1993.
Typescript. eContent provider-neutral record in process. Description based on print version record. Includes bibliographical references (leaves 112-126).

碩士
長榮大學
醫務管理學系碩士班
101
Background: The number of diabetic patients has increased continuously in recent years, causing a great threat to the health of Taiwanese citizens as well as a huge burden to the society’s medical expenses. Diabetes is a chronicle disease and to manage its condition requires patients’ long-term cooperation with doctors’ instructions regarding diet, regular exercises and medications. According to the treatment guidelines, when their condition is stable, diabetic patients’ HbA1c value should be below 7. However, based on the statistics from 2004, 30.8% of diabetic patients presented an HbA1c value between 8.0% and 9.4%, while 34.7% of patients above 9.5%, suggesting that most diabetic patients failed to control their blood glucose level effectively. Only when diabetic patients learn to monitor their blood glucose level using a glucose meter and to adjust their lifestyle accordingly can patients successfully manage their blood glucose level. Yet, studies have showed that only 30% of diabetic patients have used a blood glucose meter. By exploring reasons why patients choose to use or not use a glucose meter, promotional projects can be designed to encourage patients to monitor their blood glucose and therefore, to help them successfully maintain a stable blood glucose level. Research Objective: To explore reasons why non-insulin using adult patients of type-two diabetes choose to monitor or not their blood glucose level. Research Methodology: The theoretical framework of this study combines the health beliefs model together with the information-motivation-behavioral skills(IMB) model and the social support theory. The research structure includes nine aspects of demographic information, perceived susceptibility, perceived severity, social companionship, instrumental support, informational support, perceived benefits, perceived barriers and behavioral skills. The researcher adopted a cross-sectional questionnaire to interview non-insulin using adult patients of type-two diabetes between July and October in 2012. A total of 304 copies of valid questionnaires were collected. The samples were randomly recruited from three medical centers or regional hospitals where more than 10,000 diabetic patients received out-patient services. The collected data was processed using SPSS 18.0. Besides of descriptive statistics, a T-test, chi-square test, factor analysis, multiple linear regression analysis and logistic regression were conducted. Research Results 1. Among 304 respondents, 47.4% of them had the habit of using a glucose meter. Compared to patients who did not use a glucose meter, patients who did were averagely younger (t=6.20, df=281.26, p<0.0005) and had a shorter course of disease (t=5.9, df=301.17, p<0.0005). The majority of them possessed an educational degree of high school or middle school (χ2=44.87, df=3, p<0.0005) and their diet was mostly taken care of by themselves or their spouses (χ2=6.98, df=2, p=0.030). Also, more of them had a job (χ2=28.30, df=1, p<0.0005), while most of whose monthly salary was between 15000 and 79999 NTD (χ2=39.2, df=3, p<0.0005). In terms of complications, patients who used a glucose meter experienced fewer complications (t=-5.057, df=302, p<0.0005). 2. Compared to patients who did not use a glucose meter, patients who did had a higher score in perceived susceptibility (t=12.97, df=294.16, p<0.0005), perceived severity, social companionship (t=14.19, df=274.44, p<0.0005), instrumental support, informational support (t=12.01, df=278.97, p<0.0005), perceived benefits (t=11.69, df=302.00, p<0.0005), and behavioral skills (t=10.11, df=286.03, p<0.0005). Also, this group of patients had more sources of social companionship (t=10.65, df=270.35, p<0.0005), instrumental support (t=14.59, df=282.37, p<0.0005) and informational support (t=9.8，df=258.72，p<0.0005). On the other hand, their score in perceived barriers was lower than patients who did not use a glucose meter (t=-11.84, df=247.93, p<0.0005). 3. Patients who used a glucose meter considered it most convenient to measure their glucose level at home and less inconvenient at workplaces. They felt that it was easy to seek someone’s help when they experienced difficulties measuring their blood glucose level and to purchase necessary supplies when running out. In addition, they had been fully informed by medical personnel of the frequency and the time to measure their blood glucose level. 4. The logistic regression analysis showed that factors associated with improving patients’ likelihood of measuring their blood glucose level included high behavioral skills (β=1.702，S.E=0.573，Wald=2.968，p=0.003). Conclusion and Suggestions In terms of instrumental and informational support, patients who use a glucose meter often receive more help from others regarding blood glucose control and have a stronger ability of searching for important information on their own as well as more sources of support. Thus, it is suggested to discover more relevant individuals or groups that can assist patients and provide them with educational materials or leaflets, so that patients would have more sources of instrumental and informational support. On the other hand, it is important to scrutinize the sources and content of the information in order to prevent patients’ willingness to measure their glucose level being compromised and their condition worsened due to inappropriate information. When patients’ perceived susceptibility, perceived severity, instrumental support and informational support are improved, they are more likely to use a blood glucose meter.

碩士
國立臺中教育大學
諮商與應用心理學系碩士班
105
The purpose of this qualitative research study was to explore the factors affecting the implementation of home insulin therapy and self-monitoring of blood glucose in middle-aged diabetic patients with poor glycemic control using semi-structured in-depth interviews. Purposive sampling was used to enroll ten patients who were invited to be interviewed, and the contents of these interviews were then analyzed. This investigation of middle-aged diabetic patients with poor glycemic control revealed the following results: 1. Diabetes treatment-related factors—the difficulties of knowledge and behavior:(1)Difficulties performing insulin therapy—lack of understanding of the importance of the connection between insulin effect and their dietary intake; the burden of inconvenience that insulin imposes on daily life; the uncertainty as to whether insulin therapy can improve blood sugar; fear of pain caused by insulin injections.(2)Difficulties performing self-monitoring of blood glucose—little time to measure blood sugar due to work responsibilities; the high cost of blood glucose measurement; inability to comply with monitoring of postprandial blood sugar; inconvenience of going out with a blood glucose monitor; the discomfort caused by the lancet and the difficulty of performing blood glucose measurement; testing blood sugar only when feeling under the weather. 2. Insecurities caused by the disease:(1)Concerns about hypoglycemia— negative impact on life induced by hypoglycemia; the impact of interactions with other diabetic patients; worries about the risk of hypoglycemia at work; anxiety about hypoglycemia sequelae; not wanting others to know that they have hypoglycemia.(2)Concerns about complications—fear that they may require dialysis or amputation, or develop retinal lesions, etc.(3)Concerns about disease instability has a psychological and physiological impact.(4) Anxiety about social stigma—fear that they will be stigmatized if they inject insulin in public; fear that others may mistake insulin injections for drug abuse; belief that injecting insulin and injecting several times daily represents a more serious condition; caring about others' misunderstanding that injecting insulin will lead to dialysis; and concerns that others may think the presence of blood after an insulin shot somehow puts people at risk of becoming infected. 3. Diabetes knowledge and self-efficacy factors:(1)Lack of knowledge and proper targeting of glycemic control: the target value of glycemic control is inconsistent with the physician's suggestion.(2)The lack of self-efficacy in insulin dosage adjustment: thinking that the insulin dose adjustment is useless; adjusting diet instead of adjusting insulin dosage: concern that there will be side effects after the increasing insulin dose or simply forgetting to increase the dose.(3)Lack of self-efficacy in glycemic control: lack of confidence in controlling blood sugar, including diet and exercise therapy. 4. Unable to change lifestyle habits and health responsibilities: (1) Unable to adjust lifestyle habits: unable to adhere to lifestyle changes; it is difficult to change eating habits.(2) Unable to take the responsibility of self-managing for health: difficulty in complying with doctor's orders, including diabetes diet and insulin treatment, insulin dosage adjustment, regular exercise, and blood sugar measurement. 5. Family support factors:(1)Lack of understanding of insulin and glycemic control by family members: no knowledge of insulin therapy, hypoglycemia treatment, and diabetes diet; do not want to understand how to control blood sugar; can not cope with diabetes diet; family worries that increased insulin dose will lead to exacerbations.(2)Poor family support may cause psychological problems. Finally, the findings of this study may be used as a reference and guide for diabetic patient support groups, medical practitioners, and health care workers, as well as a starting point for future research.

碩士
臺北醫學大學
醫學資訊研究所
105
Title of Thesis：Usage of Wearable Devices for Recording Self-Monitoring of Blood Glucose Among Prediabetes Patients Author：Wan-Ling Chiu Thesis advised by ： Yu-Hsuan Shao, MHS, PhD Taipei Medical University, Graduate Institute of Biomedical Informatics The World Health Organization (WHO) released a report on Diabetes, which requires attention to the prevention and treatment of diabetes. Taiwan''s diabetes should be estimated to be over 1.5 million. The wearable devices and application software can help people to restore health, these case has Prediabetes but they don''t consciously, and in this stage can return to normal blood glucose range. Using wearable devices to do Self-Monitoring of Blood Glucose (SMBG).Let blood glucose Stable in the normal range. Result is using wearable device can reduce blood glucose than handwritten and control. Which affect the most is living habits and the health care awareness.

University of Technology Sydney. Faculty of Health.
Background: Globally the burden of diabetes is increasing. Self-monitoring of blood glucose (SMBG) has been recommended as part of diabetes management, irrespective of treatment, for 50 years. There is evidence that SMBG does not clinically improve glycaemic control in all patients with non-insulin treated type 2 diabetes (NITT2DM). Funding and practice models are influenced by stakeholders, including industry and patient advocacy groups. Yet how Australian HCPs formulate their views regarding SMBG has not been studied. Aim: This research is designed to inform our understanding of the factors that influence Australian HCP’s perceived value of SMBG for patients with NITT2DM and to review the evidence for SMBG analysing social, political and economic trends influencing recommendations. Method: Following a review of evidence and detailed review of policy documents, using a Qualitative Descriptive method, qualitative semi-structured interviews were undertaken with Australian HCPs to obtain insight into their beliefs and practices relating to SMBG in patients with NITT2DM. The perceptions about the value of monitoring, why and how HCPs form these views, and the ways they use the results were examined. Moreover, the type and source of the education and training of HCPs were identified. Results: A qualitative approach thematic analysis of the data resulted in key insights from 25 interviews with diabetes educators, pharmacists, endocrinologists, general practitioners, dietitians and primary care nurses. Seven main themes emerged from the analysis: (1) The perceived value of SMBG in people with diabetes varies within and between health professional groups; (2) The information patients receive about SMBG is limited; (3) SMBG is not a benign activity and can have negative consequences; (4) The health care professionals most likely to use the results in a purposeful manner are diabetes educators and dietitians; (5) the capacity to provide specialised training to patients is limited; (6) Professional training does not address SMBG; and (7) HCPs want impartial information about SMBG. Conclusions: This thesis demonstrated that the views of HCPs are varied and largely based on inconsistent information, training as well as the influence of marketing, and other key stakeholder groups. The consequences of these actions have implications for the health care system, provider and patients. Inconsistent recommendations to patients contribute to adverse health care outcomes and rising health care costs. These findings provide an empirical basis to inform educational and policy interventions to help ensure that training and recommendations regarding SMBG are standardised and evidence-based.

博士
國立臺灣大學
護理學研究所
105
Background: Self-monitoring of blood glucose plays a core role in diabetes treatment and has been strongly recommended for use by patients with diabetes who are undergoing insulin treatment. However, clinical utilization remains low. The primary purpose of this study was to examine the degree of adherence to self-monitoring of blood glucose by patients with type 2 diabetes who were undergoing insulin treatment, assess predictive factors, and investigate the relationship between self-monitoring and glycemic control. Methods: This study featured a cross-sectional design and primarily examined patients with type 2 diabetes who had received insulin treatment continuously for over 6 months. Subjects were recruited from the endocrinology departments of medical centers and regional hospitals located in central Taiwan. Structured questionnaires were used to collect research data from April 2017 to May 2017 and a total of 101 effective samples were obtained. Results: The average degree of patient adherence to the self-monitoring of blood glucose was 45%, with only 26.7% of the patients demonstrating a degree of self-monitoring 80%. The most recent glycosylated hemoglobin levels measured by the research subjects were between 5.0% and 15.6%, with an average value of 8.45% (SD = 1.84). Multiple regression analysis showed that variables such as self-efficacy, consequences and treatment control of illness representation could predict the degree of adherence to self-monitoring of blood glucose. After adjustment, the overall model was able to explain 57.9% of variance, with self-efficacy demonstrating the greatest degree of explained variance. In addition, adherence to self-monitoring of blood glucose was negatively correlated with glycosylated hemoglobin (r = −0.34, p ＜ .01), indicating the moderating effect of the social support from professional healthcare providers on the relationship between adherence to the self-monitoring of blood glucose and glycosylated hemoglobin. Conclusions: Adherence to the self-monitoring of blood glucose exhibited a negative correlation with glycosylated hemoglobin. As self-efficacy is a crucial predictor for self-monitoring of blood glucose, in the future, greater encouragement of patient self-efficacy to perform blood glucose monitoring will assist patients in developing self-care capabilities. Furthermore, social support from professional healthcare providers can regulate the relationship between adherence to the self-monitoring of blood glucose and glycosylated hemoglobin. Professional healthcare providers should proactively discuss monitoring results and records with patients to improve self-care capabilities based on the results of blood glucose monitoring and facilitate glycemic control.

碩士
慈濟大學
護理學系碩士班
101
This study was conducted based on the transtheoretical model (known as TTM). Through telephone counseling and health education brochure, the researcher intervened both the subjects’ cognition of self-monitoring of blood glucose (known as SMBG) and the conditions of subjects’ behavioral changes. The researcher applied randomized clinical trial (known as RCT) as the research method. The study subjects were adult patients of a diabetes outpatient clinic at a hospital in Hualien County; those patients were recruited in a project known as Diabetes Shared Care. The researcher adopted the pretest-posttest design as the experimental design of this study. Participants were randomly assigned to telephone counseling (n=37), health education brochure (n=35) and control (n=35) groups, respectively by using random numbers table. Participants of the telephone counseling group were provided telephone counseling services on the first, sixth and twelfth weeks; TTM processes of change was applied during the process of telephone counseling. Participants of the health education brochure group were given a modified version of the SMBG booklet and were advised how to use it. A posttest was conducted twelve weeks after the study started. A posttest on the group of comparison was conducted on the twelfth week after the study started as well. All data were collected within the period of July 2012 and September 2012. After all of the collected data were coded, statistical results were analyzed by using SPSS 17.0. The study results pointed out that both demographic variables and disease attributes had a high level of homogeneity among subjects of all three groups. As regards subjects of the SMBG cognition group, the statistical results indicated that the cognition variance of health education brochure group was significantly higher than both the group of telephone counseling and the group of comparison (p<.05); the study results also proved that the health education brochure could effectively promote subjects’ cognition of SMBG. As the stage of behavioral changes, the findings gained from regular monitoring showed an 11.40% increase in the health brochure education group and a 10.80% increase in the comparison group (p<.05); nevertheless, the number of patients did not change significantly along with the intervention done by telephone counseling. Furthermore, on the topic of the behavioral scale of the SMBG group, subjects of the telephone counseling group showed a better performance of SMBG. The study results suggested providing appropriate health education brochures for SMBG patients could effectively promote SMBG patients’ cognition as well as their action of self-monitoring. The study findings also suggested that the correlation between telephone counseling and strategies of behavioral changes could be further studied by future researchers.