Health care effects and medical benefits of a smartphone-based diabetes self-management application: study protocol for a randomized controlled trial.

BACKGROUND: Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. METHODS/DESIGN: This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. DISCUSSION: To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act. TRIAL REGISTRATION: German Clinical Trial Register DRKS00022923 . Registered on 22 October 2020.

Trends in diabetes self-management education: where are we coming from and where are we going? A narrative review.

AIMS: To summarize the history, development and efficacy of diabetes self-management education on glycaemic control and mental health in adults and children or adolescents with type 1 diabetes and people with type 2 diabetes. A further aim was to review the status of implementation of diabetes self-management education into routine care and outline current gaps in implementation and research. METHODS: We searched PubMed and Google scholar for German- and English-language articles regarding diabetes self-management education, glycaemic control and mental health, and restricted this search to meta-analyses. RESULTS: Diabetes education has evolved from a compliance- and knowledge-oriented approach to an empowerment- and self-management-oriented approach. Diabetes self-management education seems to have a greater impact on glycaemic outcomes than on mental health outcomes, but the latter are rarely assessed. Technological development and digitalization can provide chances and challenges for diabetes self-management education. Digital solutions show promising results and great potential for improving the efficacy of diabetes self-management education further and providing ongoing support. The implementation of diabetes self-management education into routine clinical care frequently remains a challenge. CONCLUSION: Diabetes self-management education has been acknowledged as an essential part of diabetes therapy; however, current gaps regarding the efficacy of diabetes self-management education on mental health, and the need for education on the use of diabetes technology, are future avenues for research.

The effect of an education programme (MEDIAS 2 BSC) of non-intensive insulin treatment regimens for people with Type 2 diabetes: a randomized, multi-centre trial.

AIMS: A self-management oriented education programme (MEDIAS 2 BSC) for people with Type 2 diabetes who are on a non-intensive insulin treatment regimen was developed. In a randomized, multi-centre trial, the effect of MEDIAS 2 BSC was compared with an established education programme that acted as a control group. METHODS: The primary outcome was the impact of MEDIAS 2 BSC on glycaemic control. Secondary outcomes included the incidence of severe hypoglycaemia, hypoglycaemia unawareness, diabetes-related distress, diabetes knowledge, quality of life and self-care behaviour. RESULTS: In total, 182 participants were randomized to the control group or MEDIAS 2 BSC [median age 64.0 (interquartile range 58.0-68.5) vs. 63.5 (57.0-70.0) years; HbA1c 62.8 ± 12.7 mmol/mol vs. 63.7 ± 14.0 mmol/mol; 7.9% ± 1.2% vs. 8.0% ± 1.3%]. After a 6-month follow-up, there was a mean decrease in HbA1c of 3.5 mmol/mol (0.32%) in the control group and 6.7 mmol/mol (0.61%) in MEDIAS 2 BSC. After adjusting for baseline differences and study centre, the mean difference between the groups was -3.3 mmol/mol [95% confidence interval (CI) -0.54 to -5.90 mmol/mol] [-0.30% (95% CI -0.05 to -0.54)] in favour of MEDIAS 2 BSC (P = 0.018). There were no increases in severe hypoglycaemia or hypoglycaemia unawareness. The education programmes had no significant effects on psychosocial outcome variables. CONCLUSION: MEDIAS 2 BSC was more effective in lowering HbA1c than the control condition. MEDIAS 2 BSC is a safe educational tool that improves glycaemic control without increasing the risk for hypoglycaemia. (Clinical Trials Registry No; NCT 02748239).

How to assess diabetes distress: comparison of the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS).

AIMS: To compare the properties of the two most commonly used assessment tools for diabetes distress, the Problem Areas in Diabetes Scale (PAID) and the Diabetes Distress Scale (DDS), in order to discriminate their psychometric capabilities and functions. METHODS: Six hundred and twenty-eight people with diabetes (67% Type 1, 33% Type 2) were cross-sectionally assessed with the PAID, the DDS and further self-report scales regarding coping, quality of life, depressive symptoms and self-care, and medical data were gained. We analysed the PAID and DDS for areas of contentual/psychometric divergence in assessing diabetes distress and compared their associations with criteria of interest. RESULTS: Content analysis: The PAID covers a greater variety of emotional concerns and shows a stronger focus on food-related problems and complications. The DDS is more reflective of physician-related distress and problems concerning diabetes self-management. Psychometric analysis: Exploratory factor analyses revealed four-factor structures of both scales, explaining 60% (PAID) and 67% (DDS) of variance. Confirmatory factor analyses confirmed that single-factor and four-factor models fit the data. Total scales proved high and subscales mostly satisfactory reliability. Associations with criteria of interest: The PAID was significantly more strongly associated with dysfunctional coping styles, quality of life and depressive symptoms. The DDS showed significantly stronger associations with diabetes self-care and metabolic outcomes. CONCLUSION: Our results support both PAID and DDS as good self-report measures of diabetes distress. The observed contentual/psychometric differences suggest that a justified choice with regard to the intended clinical or scientific purpose can improve the acquisition of the required data.

Longitudinal relationship of diabetes-related distress and depressive symptoms: analysing incidence and persistence.

AIM: To investigate the longitudinal bi-directionality of diabetes-related distress and depressive symptoms. METHODS: A total of 509 patients receiving intensified insulin therapy completed the Centre for Epidemiological Studies Depression scale questionnaire for the assessment of depressive symptoms as well as the Problem Areas in Diabetes questionnaire for the assessment of diabetes-related distress at baseline and at 6-month follow-up. Separate logistic and linear regression analyses for incidence and persistence were performed with demographic (age, gender, BMI) and medical (diabetes type, HbA1c , diabetes duration, late complications) control variables. RESULTS: Diabetes-related distress at baseline increased the risk of the incidence of elevated depressive symptoms by 2.56-fold (odds ratio 2.56; 95% CI 1.15-5.72; P = 0.02) when controlling for demographic and medical variables. In addition, diabetes-related distress at baseline doubled the chance of the persistence of elevated depressive symptoms (odds ratio 2.04, 95% CI 1.04-3.99; P = 0.04) when controlling for demographic and medical variables. The chance of having persistent elevated diabetes-related distress was increased 5.94-fold (odds ratio 5.94, 95% CI 2.60-13.59; P < 0.0001) when elevated depressive symptoms were present at baseline. None of the medical variables had an influence on incidence or persistence. CONCLUSIONS: Diabetes-related distress was identified as a risk factor for the incidence and persistence of depressive symptoms. Reducing diabetes-related distress could help to prevent the development of elevated depressive symptoms. Furthermore, depressive symptoms were identified as an amplifier for diabetes-related distress. Diabetes-related distress and depressive symptoms were independent risk factors for each other and should be monitored in routine care to disentangle their influence.

Assessment of diabetes acceptance can help identify patients with ineffective diabetes self-care and poor diabetes control.

AIMS: To estimate the associations between insufficient diabetes acceptance and relevant diabetes outcomes. METHODS: A total of 320 patients completed questionnaires on diabetes non-acceptance (the Acceptance and Action Diabetes Questionnaire), diabetes distress (the Problem Areas in Diabetes Scale), depressive mood (the Center for Epidemiologic Studies Depression Scale), coping with illness (the Freiburg Questionnaire of Coping with Illness), self-care activities (the Summary of Diabetes Self-Care Activities Measure) and quality of life (the Short Form-36 Health Questionnaire). A six-item version of the Acceptance and Action Diabetes Questionnaire showing good reliability and validity was established, and the associations between insufficient acceptance and clinical outcomes were estimated. RESULTS: Higher diabetes non-acceptance correlated significantly with less active coping (-0.37), reduced self-care (-0.43) and higher HbA1c levels (0.31), higher diabetes distress (0.53) and more depressive symptoms (0.36). Correlations of diabetes non-acceptance with diabetes self-care/glycaemic control were significantly higher than were those of depressive mood or diabetes distress with these criteria. CONCLUSIONS: Low diabetes acceptance is associated with impaired self-care and glycaemic control. Assessment of diabetes acceptance may facilitate the detection of patients at high risk and may present an essential target for treatments to improve diabetes control that is more relevant than elevated depressive mood or diabetes distress.

Real-world patient-reported rates of non-severe hypoglycaemic events in Germany.

AIMS: Hypoglycaemia is a common side effect of insulin therapy in diabetes patients, with negative physical and emotional impacts. Despite this, there are few studies investigating the frequency of non-severe hypoglycaemic events from the perspective of patients in the real-world setting. We investigated self-reported NSHE frequency and levels of hypoglycaemia awareness in Germany. METHODS: Respondents > 15 years with Type 1 or insulin-treated Type 2 diabetes (receiving basal only, basal-bolus or other insulin regimens) were recruited using online panels to complete ≤ 4 questionnaires. Questionnaires collected demographics, non-severe hypoglycaemic event rates and patient-reported level of hypoglycaemia awareness. Non-severe hypoglycaemic event rates are reported as respondent-week records and calculated using data from all respondents completing at least one questionnaire. RESULTS: A total of 1,771 respondent-week records were obtained from 614 participants. Mean non-severe hypoglycaemic event rates per respondent-week were 1.6 for Type 1 and 0.6-0.8 for Type 2, with estimated annual rates of 83 and 31-42 respectively. Two-thirds of Type 1 (65%) and Type 2 (61-72%) respondents reported impaired levels of awareness or unawareness of hypoglycaemic events (inability or impaired ability to recognise the symptoms of hypoglycaemia). Respon­dents' self-reported hypoglycaemia-awareness was significantly associated with the proportion of asymptomatic non-severe hypoglycaemic events; respondents classified as being unaware of hypoglycaemia had a higher proportion of asymptomatic non-severe hypoglycaemic events than aware respondents. CONCLUSION: Non-severe hypoglycaemic events are common in people with Type 1 or insulin-treated Type 2 diabetes in the real-world setting in Germany but may still be underestimated due to an inability to recognise the symptoms of hypoglycaemia.

Oral glucose tolerance test and HbA1c for diagnosis of diabetes in patients undergoing coronary angiography: [corrected] the Silent Diabetes Study.

AIMS/HYPOTHESIS: The primary aim of this study was to compare the results of HbA(1c) measurements with those of an OGTT for early diagnosis of 'silent diabetes' in patients with coronary artery disease (CAD) undergoing angiography without prediagnosed diabetes. A secondary aim was to investigate the correlation between the extent of CAD and the glycaemic status of the patient. METHODS: Data from 1,015 patients admitted for acute (n = 149) or elective (n = 866) coronary angiography were analysed. Patients with known diabetes were excluded from the study. Using the OGTT results, patients were classified as having normal glucose tolerance (NGT), impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or diabetes. According to the results of the HbA(1c) measurements, patients were classified into three groups: normal (HbA(1c) <5.7% [<39 mmol/mol]), borderline (HbA(1c) 5.7-6.4% [39-47 mmol/mol]) and diabetes (HbA(1c) ≥6.5% [≥48 mmol/mol]). RESULTS: Based on the OGTT, 513 patients (51%) were classified with NGT, 10 (1%) with IFG, 349 (34%) with IGT and 149 (14%) were diagnosed with diabetes. According to HbA(1c) measurements, 588 patients (58%) were classified as normal, 385 (38%) as borderline and 42 (4%) were diagnosed with diabetes. The proportion of patients with IGT and diabetes increased with the extent of CAD (IGT ρ = 0.14, p < 0.001, diabetes ρ = 0.09, p = 0.01). No differences in HbA(1c) were seen among the groups with different extents of CAD (p = 0.652). CONCLUSIONS/INTERPRETATION: An OGTT should be performed routinely for diagnosis of diabetes in patients with CAD undergoing coronary angiography, since HbA(1c) measurement alone appears to miss a substantial proportion of patients with silent diabetes. A limitation of the study is that the OGTT was not performed before the angiography.

A European evidence-based guideline for the prevention of type 2 diabetes.

BACKGROUND: The prevalence and socioeconomic burden of type 2 diabetes (T2DM) and associated co-morbidities are rising worldwide. AIMS: This guideline provides evidence-based recommendations for preventing T2DM. METHODS: A European multidisciplinary consortium systematically reviewed the evidence on the effectiveness of screening and interventions for T2DM prevention using SIGN criteria. RESULTS: Obesity and sedentary lifestyle are the main modifiable risk factors. Age and ethnicity are non-modifiable risk factors. Case-finding should follow a step-wise procedure using risk questionnaires and oral glucose tolerance testing. Persons with impaired glucose tolerance and/or fasting glucose are at high-risk and should be prioritized for intensive intervention. Interventions supporting lifestyle changes delay the onset of T2DM in high-risk adults (number-needed-to-treat: 6.4 over 1.8-4.6 years). These should be supported by inter-sectoral strategies that create health promoting environments. Sustained body weight reduction by >or= 5 % lowers risk. Currently metformin, acarbose and orlistat can be considered as second-line prevention options. The population approach should use organized measures to raise awareness and change lifestyle with specific approaches for adolescents, minorities and disadvantaged people. Interventions promoting lifestyle changes are more effective if they target both diet and physical activity, mobilize social support, involve the planned use of established behaviour change techniques, and provide frequent contacts. Cost-effectiveness analysis should take a societal perspective. CONCLUSIONS: Prevention using lifestyle modifications in high-risk individuals is cost-effective and should be embedded in evaluated models of care. Effective prevention plans are predicated upon sustained government initiatives comprising advocacy, community support, fiscal and legislative changes, private sector engagement and continuous media communication.

Quality indicators for the prevention of type 2 diabetes in Europe--IMAGE.

BACKGROUND: The marked increase of type 2 diabetes necessitates active development and implementation of efficient prevention programs. A European level action has been taken by launching the IMAGE project to unify and improve the various prevention management concepts, which currently exist within the EU. This report describes the background and the methods used in the development of the IMAGE project quality indicators for diabetes primary prevention programs. It is targeted to the persons responsible for diabetes prevention at different levels of the health care systems. METHODS: Development of the quality indicators was conducted by a group of specialists representing different professional groups from several European countries. Indicators and measurement recommendations were produced by the expert group in consensus meetings and further developed by combining evidence and expert opinion. RESULTS: The quality indicators were developed for different prevention strategies: population level prevention strategy, screening for high risk, and high risk prevention strategy. Totally, 22 quality indicators were generated. They constitute the minimum level of quality assurance recommended for diabetes prevention programs. In addition, 20 scientific evaluation indicators with measurement standards were produced. These micro level indicators describe measurements, which should be used if evaluation, reporting, and scientific analysis are planned. CONCLUSIONS: We hope that these quality tools together with the IMAGE guidelines will provide a useful tool for improving the quality of diabetes prevention in Europe and make different prevention approaches comparable.

Short-term effects on patient satisfaction of continuous glucose monitoring with the GlucoDay with real-time and retrospective access to glucose values: a crossover study.

BACKGROUND: This randomized crossover trial examines the effect of continuous glucose monitoring (CGM) with real-time access (RTA) to glucose data versus CGM with a retrospective analysis (RA) of glucose data regarding satisfaction with CGM and other patient-reported outcomes. METHODS: Participants used the CGM device (GlucoDay, Menarini Diagnostics, Florence, Italy) twice. In one study phase, patients were allowed RTA to, and in the other phase RA of, current glucose values. The order of these two conditions was randomized. At baseline and after the first and second trials, subjects completed questionnaires (Continuous Glucose Monitoring Satisfaction Scale) about perceived satisfaction with CGM. They also completed the Problem Areas in Diabetes Questionnaire, a state anxiety scale (State-Trait Anxiety Inventory), and a depression scale (Center of Epidemiological Studies-Depression Scale). RESULTS: Fifty patients with type 1 diabetes (41.7 +/- 12.3 years old, diabetes duration of 14.75 +/- 11.9 years, 48% female, hemoglobin A1c 8.1 +/- 1.5%, years of education 10.3 +/- 2.1 years) participated in this study. At baseline patients perceived CGM as rather advantageous, but after RA and RTA the perceived benefits were reduced (baseline, 101.0 +/- 16.0; RA, 95.7 +/- 20.2; RTA, 93.6 +/- 22.8; P < 0.01). However, there was no significant difference between RA and RTA. Also, there was no significant effect on diabetes-related distress or state anxiety, but a positive effect on depression scores. CONCLUSIONS: There was no specific, significant, negative or positive effect of RA versus RTA on satisfaction with CGM. Exposing patients with type 1 diabetes to their current glucose values does not seem to have a specific negative impact on the appraisal of CGM or more generic patient-reported outcomes.

Effect of experimentally induced hypoglycemia and different insulin levels on feelings of hunger in type 1 diabetic patients.

INTRODUCTION: This study investigates the impacts of experimentally induced hypoglycemia and different insulin infusion rates on feelings of hunger. METHODS: Blood glucose and insulin levels were manipulated by hyperinsulinemic glucose clamp technique. Participants were 16 patients with type 1 diabetes (age 36.2+/-11.7 yrs, diabetes duration 9.0+/-6.3 yrs, HbA1c 8.2+/-2.0%). One group (n=8) received moderate, constant insulin infusion (0.8 microU/kg/min), whereas the insulin infusion was doubled in the other group (1.6 microU/kg/min). Blood glucose was lowered stepwise from euglycemia (5.6 mmol/l) to moderate hypoglycemia (2.5 mmol/l). RESULTS: As expected, there was a significant effect of hypoglycemia on feelings of hunger (F (3, 42)=41.7, p<0.01). But during high insulin infusion, feelings of hunger were significantly less intense than during moderate insulin infusion (F (1, 14)=7.2, p=0.02). CONCLUSION: Peripheral insulin levels seem to be associated with the intensity of feelings of hunger.

Association of glucose levels and glucose variability with mood in type 1 diabetic patients.

AIMS/HYPOTHESIS: The aim of this study was to investigate the association of glucose levels and variability of glucose, assessed by continuous glucose monitoring, with mood in type 1 diabetic patients. MATERIALS AND METHODS: Thirty-six type 1 diabetic patients (77.8% male, age: 31.1 +/- 10.0 years; disease duration: 14.7 +/- 7.1 years, BMI: 26.7 +/- 5.1 kg/m2, HbA1c 8.4 +/-1.8%, 27.8% with continuous subcutaneous insulin infusion [CSII] therapy) used a continuous glucose monitoring system for 48.8 h. During this time the patients rated their current mood states 14.6 times on average, using the University of Wales Institute of Science and Technology Mood Adjective Checklist and hand-held computers. RESULTS: Sensor performance was satisfactory, with a mean absolute difference from reference laboratory glucose measurement of 13.7%. Current glucose values were significantly associated with ratings of 'tension' (z = 2.40), 'hedonic tone' (z = -2.63) and 'energetic arousal' (z = -2.09). 'Anger' (z = 1.64) was not significantly associated with glucose values. The glucose AUC during the 60 min prior to the mood rating showed similar associations. The two parameters of glucose variability-coefficient of variation and absolute glucose change during the 60 min prior to the mood ratings-did not show any significant association with the mood ratings. The magnitude of association was significantly higher for glucose level than for glucose variability in the scales 'tension' and 'hedonic tone'. CONCLUSIONS/INTERPRETATION: High glucose values had a negative impact on mood; positive mood ratings decreased, whereas negative mood ratings increased. The association between mood and glucose variability seemed to be less important than that between glucose level and mood.

Effects of self-management training in Type 2 diabetes: a randomized, prospective trial.

AIMS: The efficacy of three education programmes for Type 2 diabetic patients was tested in a randomized trial. A didactic-oriented training programme (treatment A) was compared with a self-management-oriented programme delivered in group sessions (treatment B). The latter programme was compared with a more individualized approach (treatment C). METHODS: One hundred and eighty-one Type 2 diabetic patients (age 55.6 +/- 6.3 years, diabetes duration 6.6 +/- 6.2 years, HbA(1c) 7.8 +/- 1.6%, female 49.7%) took part. Efficacy was assessed 3 months (t1) after baseline (t0) and at a follow-up 15 months (t2) after baseline. RESULTS: The fall in HbA(1c) in treatment B at t1 was sustained at t2 (t0 8.1 +/- 1.8%, t1 7.3 +/- 1.7%, t2 7.4 +/- 1.9%). In treatment A, HbA(1c) was unchanged throughout (t0 7.6 +/- 1.5%, t1 7.5 +/- 1.3%, t2 7.7 +/- 1.7%; treatment A vs. treatment B; P < 0.05). With the more individualized approach of treatment C, there was a fall in HbA(1c) at t1, but this was not sustained at t2 (t0 7.8 +/- 1.6%, t1 7.1 +/- 1.3%, t2 7.6 +/- 1.6%; treatment B vs. treatment C; P = 0.73). There were also significant benefits in treatment B subjects compared with treatment A in further medical (body mass index and fasting blood glucose), psychological (control, irritability and hunger dependency of eating behaviour, and trait anxiety) and behavioural (exercise) variables. There were no significant benefits of the more individualized treatment C compared with group treatment B. No significant differences were found regarding triglyceride levels, high-density lipoprotein, diabetes-related knowledge, negative well-being, urine or blood glucose levels or foot care. CONCLUSION: Self-management training had a significantly higher medium-term efficacy than didactic diabetes education. The group sessions were more effective than a more individualized approach.

The effect of an education programme (HyPOS) to treat hypoglycaemia problems in patients with type 1 diabetes.

BACKGROUND: In a randomized, prospective multi-centre trial, the effect of a specific training programme (HyPOS) for patients with hypoglycaemia problems was compared with a control group (CG), receiving a standardized education programme aiming at avoidance of hypoglycaemia by optimization of insulin therapy. METHODS: A total of 164 type 1 diabetes patients (age 46.0 +/- 12.5 yrs, HbA(1c) 7.3 +/- 1.0%, 50% male) were randomized. Hypoglycaemia awareness was measured by the hypoglycaemia awareness questionnaire (HAQ) and by a visual analogue scale (VAS). There were no baseline differences. RESULTS: After a 6-month follow-up, hypoglycaemia awareness significantly improved in HyPOS compared to that in the CG (Delta HAQ 0.7 [95% CL 0.1-1.2], p = 0.024, Delta VAS 0.8 [95% CL 0.2 - 1.2], p = 0.015). In HyPOS, the threshold for detection of low blood glucose (Delta 0.2 mmol/L [95% CL 0.03 - 0.04], p = 0.02) and the treatment of low blood glucose (Delta 4.6 g [95% CL 1.6 - 7.6], p = 0.03) increased significantly. The number of undetected hypogylcaemic episodes (Delta - 1.4 episodes per week [95% CL 0.4-2.5], p = 0.01) and the rate of mild hypoglycaemia dropped significantly in HyPOS (Delta 2.1% [95% CL 0.5-5.3], p = 0.015). The numbers of severe (Delta 0.3 events per patient per year [95% CL - 0.04-1.0], p = 0.037) and very severe hypoglycaemic episodes (Delta 0.3 events per patient per year [95% CL - 0.1-0.7], p = 0.09) were lower in HyPOS, but these differences were not significant. CONCLUSION: Compared to the CG, HyPOS demonstrates additional benefits in terms of improving impaired hypoglycaemia awareness, reducing mild hypoglycaemia, detecting low blood glucose, and treating low blood glucose.

[Diabetes mellitus: how important is it to measure the quality of life?]. / Diabetes mellitus: Wie wichtig ist die Messung der Lebensqualität?

Maintaining the quality of life (QoL) of diabetics is a decisive outcome variable in the treatment of diabetes. It should be used as an important indicator of quality in assessing efficacy and effectiveness of therapeutic measures. QoL of diabetics is reduced compared with non-diabetics. Diabetics with impaired QoL more frequently suffer from subclinical or clinical depression, which clearly impairs the short-term and chronic prognosis of the disease. The WHO-5 questionnaire has proven valuable for measuring QoL and in screening for depression. It is a simple and valid method of assessment which is recommended in international and national guidelines.

Microdialysis-based 48-hour continuous glucose monitoring with GlucoDay: clinical performance and patients' acceptance.

BACKGROUND: This study was designed to assess clinical performance and patients' acceptance of the minimally invasive microdialysis-based continuous glucose monitoring system Gluco- Day() (Menarini Diagnostics, Florence, Italy) with a targeted monitoring time of 48 h. METHODS: An inpatient sample of 28 patients with diabetes was studied. The analysis of clinical performance was performed using mean absolute differences (MAD) (in percent), Pearson correlations, the Bland-Altman analysis, and Clarke Error Grid Analysis (EGA). GlucoDay glucose values were compared with laboratory standard blood glucose measurements (glucohexokinase assay). The patients' acceptance of the monitoring device was assessed via two self-report scales (pain during application and discomfort while wearing device). RESULTS: A mean (+/- SD) monitoring time of 45.7 +/- 3.3 h with a total of 484 paired readings could be achieved. A correlation of r (average) = 0.91 and a MAD of 19.9% indicated satisfactory to good clinical performance. Of the paired readings, 95.5% fell into the acceptable A and B zones of the EGA. Rather wide 95% limits of agreement were revealed in the Bland-Altman analysis. Whereas virtually no pain was experienced during sensor application, discomfort associated with wearing the device was rather high. All of the participants, however, stated that they would wear the device again. CONCLUSIONS: Satisfactory to good performance of the GlucoDay monitor was observed, indicating the device to be suitable for routine clinical use. In particular, however, the discomfort experienced during wearing requires further improvements in its usability.

[Eating disorders and diabetes mellitus]. / Ess-Störungen und Diabetes mellitus.

Adolescent and young women with type 1 diabetes mellitus demonstrate a more than random coincidence with bulimia nervosa. However, the prevalence of eating disorders that do not fulfil the criteria of bulimia nervosa is also raised in women of this age group yet without diabetes mellitus. The comorbidity of type 1 diabetes and an eating disorder poses a risk factor in the development of diabetic follow-up diseases. Patients with an eating disorder and type 1 diabetes are characterized by an insufficient metabolic control and the early development of diabetic complications such as a retinopathy. The binge eating disorder, according to research aspects initially a new eating disorder entity, may especially be observed in overweight and obesity. Even if a binge eating disorder in persons with a type 2 diabetes does not occur more frequently than in those metabolically healthy persons, it does depict a risk factor for an accelerated weight gain which as rule involves an increase of insulin resistance.