Efficacy of a Digital Diabetes Logbook for People With Type 1, Type 2, and Gestational Diabetes: Results From a Multicenter, Open-Label, Parallel-Group, Randomized Controlled Trial.

BACKGROUND: In a randomized controlled trial, the efficacy of a digital diabetes diary regarding a reduction of diabetes distress was evaluated. METHODS: A randomized controlled trial with a 12-week follow-up was conducted in 41 study sites across Germany. Key eligibility criteria were a diagnosis of type 1, type 2, or gestational diabetes and regular self-monitoring of blood glucose. Participants were randomly assigned (2:1 ratio) to either use the digital diabetes logbook (mySugr PRO), or to the control group without app use. The primary outcome was the reduction in diabetes distress at the 12-week follow-up. All analyses were based on the intention-to-treat population with all randomized participants. The trial was registered at the German Register for Clinical Studies (DRKS00022923). RESULTS: Between February 11, 2021, and June 24, 2022, 424 participants (50% female, 50% male) were included, with 282 being randomized to the intervention group (66.5%) and 142 to the control group (33.5%). A total of 397 participants completed the trial (drop-out rate: 6.4%). The median reduction in diabetes distress was 2.41 (interquartile range [IQR]: -2.50 to 8.11) in the intervention group and 1.25 (IQR: -5.00 to 7.50) in the control group. The model-based adjusted between-group difference was significant (-2.20, IQR: -4.02 to -0.38, P = .0182) favoring the intervention group. There were 27 adverse events, 17 (6.0%) in the intervention group, and 10 (7.0%) in the control group. CONCLUSIONS: The efficacy of the digital diabetes logbook was demonstrated regarding improvements in mental health in people with type 1, type 2, and gestational diabetes.

Person-reported outcomes in diabetes care: What are they and why are they so important?

In this review, we aim to show how person-reported outcomes (PROs) and person-reported experiences (PREs) can significantly contribute to the way diabetes care is delivered, the involvement of people with diabetes in diabetes care, and the collaboration between health care professionals and people with diabetes. This review focuses on the definition and measurement of PROs and PREs, the importance of PROs and PREs for person-centred diabetes care, and integrating the perspectives of people with diabetes in the evaluation of medical, psychological and technological interventions. PROs have been increasingly accepted by Health Technology Assessment bodies and are therefore valued in the context of reimbursement decisions and consequently by regulators and other health care stakeholders for the allocation of health care resources. Furthermore, the review identified current challenges to the assessment and use of PROs and PREs in clinical care and research. These challenges relate to the combination of questionnaires and ecological momentary assessment for measuring PROs and PREs, lack of consensus on a core outcome set, limited sensitivity to change within many measures and insufficient standardization of what can be considered a minimal clinically important difference. Another issue that has not been sufficiently addressed is the involvement of people with diabetes in the design and development of measures to assess PROs and PREs.

Relationship Between Lipohypertrophy, Glycemic Control, and Insulin Dosing: A Systematic Meta-Analysis.

Background: Lipohypertrophy is a common complication in patients with diabetes receiving insulin therapy. There is a lack of consensus regarding how much lipohypertrophy affects diabetes management. Our study aimed to assess the potential correlation between lipohypertrophy and glycemic control, as well as insulin dosing in patients with diabetes. Methods: We performed a systematic review followed by a meta-analysis to collect data about glycemic control and insulin dosing in diabetic patients with and without lipohypertrophy. To identify relevant studies published in English, we searched medical databases (MEDLINE/PubMed, Embase, and CENTRAL) from 1990 to January 20, 2023. An additional hand-search of references was performed to retrieve publications not indexed in medical databases. Results of meta-analyses were presented either as prevalence odds ratios (pORs) or mean differences (MDs) with 95% confidence intervals (95% CIs). This study was registered on PROSPERO (CRD42023393103). Results: Of the 5540 records and 240 full-text articles screened, 37 studies fulfilled the prespecified inclusion criteria. Performed meta-analyses showed that patients with lipohypertrophy compared with those without lipohypertrophy were more likely to experience unexplained hypoglycemia (pOR [95% CI] = 6.98 [3.30-14.77]), overall hypoglycemia (pOR [95% CI] = 6.65 [1.37-32.36]), and glycemic variability (pOR [95% CI] = 5.24 [2.68-10.23]). Patients with lipohypertrophy also had higher HbA1c (MD [95% CI] = 0.55 [0.23-0.87] %), and increased daily insulin consumption (MD [95% CI] = 7.68 IU [5.31-10.06]). Conclusions: These results suggest that overall glycemic control is worse in patients with lipohypertrophy than in those without this condition.

[Cognition and depression in older people with diabetes]. / Kognition und Depression bei älteren Menschen mit Diabetes.

Cognitive dysfunction, dementia and depression are typical comorbidities of diabetes and are more common in older people with diabetes than in the general population. Both comorbid diseases have a substantial impact on the therapy of diabetes and lead to a reduction of the functional level in everyday life, the quality of life and are associated with increased mortality. This article summarizes the most important results on the etiology of cognitive dysfunction and depression and their consequences for clinical practice.

Explaining improvement in diabetes distress: a longitudinal analysis of the predictive relevance of resilience and acceptance in people with type 1 diabetes.

AIMS: To analyze if midterm improvement in diabetes distress can be explained by resilience, diabetes acceptance, and patient characteristics. METHODS: N = 179 adults with type 1 diabetes were enrolled during their stay at a tertiary diabetes center (monocentric enrolment) and followed up over three months in a prospective, observational study ('DIA-LINK1'). Improvement in diabetes distress was assessed as reduction in the Problem Areas in Diabetes Scale score from baseline to follow-up. Resilience (Resilience Scale-13), acceptance (Diabetes Acceptance Scale), and patient characteristics were analyzed as predictors of improvement in diabetes distress using hierarchical multiple regression. RESULTS: Greater reductions in diabetes distress were significantly explained by lower diabetes acceptance at baseline (ß = -0.34, p < 0.01), while resilience, diabetes complications, and other person-related variables were not significantly related to changes in diabetes distress (all p > 0.05). When change in diabetes acceptance from baseline to follow-up was added to the model, improved diabetes distress was explained by increasing diabetes acceptance (ß = 0.41, p < 0.01) and a shorter duration of diabetes (ß = -0.18, p = 0.03), while baseline diabetes acceptance was no longer significantly associated (ß = -0.14, p > 0.05). CONCLUSIONS: Diabetes acceptance is inversely related to diabetes distress, and increasing acceptance explained greater improvement in diabetes distress. These findings suggest that increasing diabetes acceptance may facilitate the reduction of diabetes distress. Treatment approaches targeting acceptance might be useful for the mental healthcare of people with type 1 diabetes and clinically elevated diabetes distress.

More Frequent Use of Glucose Alarms Is Associated with Continuous Glucose Monitoring-Specific Diabetes Education: Findings from the Dia·Link Diabetes Panel.

The associations of continuous glucose monitoring (CGM)-specific diabetes education with real-world utilization of glucose alerts and alarms were assessed in current CGM-users with type 1 or type 2 diabetes. A cross-sectional online survey was conducted in Germany assessing utilization (use and responses) of different alerts and alarms. Ordinal logistic regression analyses were conducted to analyze associations between utilization and participation in CGM-specific education. Data from 453 participants were analyzed (86.2% type 1 diabetes). Participants who received CGM-specific education were more likely to regularly use low-glucose alerts (odds ratio [OR] = 5.43, P < 0.001), low-glucose alarms (OR = 2.03, P = 0.027), and rate of change alerts (OR = 4.20, P = 0.009), and were more likely to immediately react to low-glucose alerts (OR = 5.23, P < 0.001) and rate of change alerts (OR = 3.75, P = 0.018). CGM-specific education has the potential to increase utilization of and response to alerts and alarms. This may help to implement more preventive elements regarding glucose management in everyday life.

Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach): multicentre, open-label, parallel, randomised controlled trial.

Background: The majority of people with type 2 diabetes who require insulin therapy use only basal insulin in combination with other anti-diabetic agents. We tested whether using a smartphone application to titrate insulin could improve glycaemic control in people with type 2 diabetes who use basal insulin. Methods: This was a 12-week, multicentre, open-label, parallel, randomised controlled trial conducted in 36 diabetes practices in Germany. Eligible participants had type 2 diabetes, a BMI ≥25.0 kg/m2, were on basal insulin therapy or were initiating basal insulin therapy, and had suboptimal glycaemic control (HbA1c >7.5%; 58.5 mmol/mol). Block randomisation with 1:1 allocation was performed centrally. Participants in the intervention group titrated their basal insulin dose using a smartphone application (My Dose Coach) for 12 weeks. Control group participants titrated their basal insulin dose according to a written titration chart. The primary outcome was the baseline-adjusted change in HbA1c at 12 weeks. The intention-to-treat analysis included all randomised participants. Results: Between 13 July 2021 and 21 March 2022, 251 study participants were randomly assigned (control group: n = 123; intervention group: n = 128), and 236 completed the follow-up phase (control group: n = 119; intervention group: n = 117). Regarding the HbA1c a model-based adjusted between-group difference of -0.31% (95% CI: 0.01%-0.69%; p = 0.0388) in favour of the intervention group was observed. There were 30 adverse events reported: 16 in the control group, 14 in the intervention group. Of these, 15 adverse events were serious. No event was considered to be related to the investigational device. Interpretation: Study results suggest that utilizing this digital health smartphone application for basal insulin titration may have resulted in a comparatively greater reduction in HbA1c levels among individuals with type 2 diabetes, as compared to basal insulin titration guided by a written titration schedule. No negative effect on safety outcomes was observed. Funding: Sanofi-Aventis Deutschland GmbH.

Counting the Minutes: Perceived Diabetes Mental Load and its Associations With Technology Use and Mental Disorders.

Little is known about mental load in people with diabetes and associations with demographic, clinical, and treatment characteristics, such as the use of diabetes technologies. To explore perceived mental load, 503 adults with diabetes answered the one-item survey "How much time (in minutes) would you spontaneously estimate that you spend each day thinking about your diabetes?" Mental load estimations varied widely within the sample and between subgroups. Perceived mental load was higher in type 1 diabetes than in type 2 diabetes, higher in women than in men and increased with treatment intensity (ie, insulin therapy, technology use) and the number of mental disorders. Further research may explore associations with diabetes-related distress and determine whether (perceived) mental load has relevance in technology use.

European Survey on Adult People With Type 1 Diabetes and Their Caregivers: Insights Into Perceptions of Technology.

BACKGROUND: Type 1 diabetes (T1D) is a complex condition requiring constant monitoring and self-management. The landscape of diabetes management is evolving with the development of new technologies. This survey aimed to gain insight into the perceptions and experiences of people with T1D (PWD) and their caregivers on the use of technology in diabetes care, and identify future needs for T1D management. METHODS: PWD and caregivers (≥18 years) living in five European countries (France, Germany, Italy, Spain, and the United Kingdom) completed an online survey. Data were collected during July and August 2021. RESULTS: Responders included 458 PWD and 54 caregivers. More than 60% of PWD perceived devices/digital tools for diabetes management as useful and 63% reported that access to monitoring device data made their life easier. Nearly half of participants hoped for new devices and/or digital tools. While approximately one-third of all PWD had used teleconsultation, perceptions and usage varied significantly between countries and by age (both P < .0001), with the lowest use in Germany (20%) and the highest in Spain (48%). The proportions of PWD contributing to diabetes care costs varied by device and were highest for smart insulin pen users at 83% compared with 44% for insulin pen users and 37% for insulin pump users. One-quarter (24%) of PWD and 15% of caregivers felt they lacked knowledge about devices/digital tools for T1D. CONCLUSIONS: Most PWD and caregivers had positive perceptions and experiences of new technologies/digital solutions for diabetes management, although improved support and structured education for devices/digital tools are still required.

Assessing fear of complications in people with type 1 and type 2 diabetes with the Fear of Diabetes Complications Questionnaire.

OBJECTIVE: Fear of diabetes complications (FDC) is a common source of emotional distress in people with diabetes across types and treatments and may affect health outcomes. To assess FDC, the Fear of Diabetes Complications Questionnaire (FDCQ) was developed. This study evaluates the FDCQ's German version in people with type 1 diabetes (T1D) and type 2 diabetes (T2D). METHOD: A German version of the FDCQ was developed and administered as part of four different studies sampling people with T1D and T2D. Measurement properties were evaluated across studies using factor analyses, reliability estimates, and associations of the measure within a network of variables. A cutoff criterion for elevated FDC was derived. A short form scale was also developed. RESULTS: High reliability and validity were supported. FDC as measured by the FDCQ was independently associated with higher diabetes distress and depressive symptoms. A cut-off score for elevated FDC was set at ≥30 in the 15-item FDCQ. Elevated FDCQ scores were detected in 36% of participants in secondary diabetes care and up to 46% of those in tertiary care. CONCLUSIONS: FDC is prevalent in people with T1D and T2D and associated with diabetes distress and depressive symptoms. The FDCQ is a reliable and valid tool for assessing FDC in research and practice. It may help identify persons in need of tailored education and care and monitor effects following treatment. (PsycInfo Database Record (c) 2023 APA, all rights reserved).

Assessing Barriers and Adherence to Insulin Injection Technique in People With Diabetes: Development and Validation of New Assessment Tools.

BACKGROUND: The correct injection technique is crucial for people with insulin therapy. However, barriers to insulin injections exist, which can lead to problems with injections. In addition, injection behavior may deviate from recommendations leading to lower adherence to the correct injection technique. We developed two scales to assess barriers and adherence to the correct technique. METHODS: Two item pools were created to assess barriers to insulin injections (barriers scale) and adherence to the correct technique (adherence scale). In an evaluation study, participants completed the two newly created scales, as well as other questionnaires used for criterion validity. Exploratory factor analysis, correlational analysis, and receiver operating characteristics analysis were computed to analyze the validity of the scales. RESULTS: A total of 313 people with type 1 and type 2 diabetes using an insulin pen for insulin injections participated. For the barriers scale, 12 items were selected achieving a reliability of 0.74. The factor analysis revealed three factors namely emotional, cognitive, and behavioral barriers. For the adherence scale, nine items were selected achieving a reliability of 0.78. Both scales showed significant associations with diabetes self-management, diabetes distress, diabetes acceptance, and diabetes empowerment. Receiver operating characteristics analysis showed significant area under the curves for both scales in classifying people with current skin irritations. CONCLUSIONS: Reliability and validity of the two scales assessing barriers and adherence to insulin injection technique were demonstrated. The two scales can be used in clinical practice to identify persons in need of education in insulin injection technique.

The WHO-5 well-being questionnaire in type 1 diabetes: screening for depression in pediatric and young adult subjects.

OBJECTIVES: To evaluate the WHO-5 tool in pediatric and young adult subjects with type 1 diabetes, and to analyse associations with demographic/psychological characteristics. METHODS: We included 944 patients with type 1 diabetes 9-25 years of age, documented in the Diabetes Patient Follow-up Registry between 2018 and 2021. We used ROC curve analysis to determine optimal cut-off values for the WHO-5 scores to predict psychiatric comorbidity (ICD-10-diagnoses) and analysed associations with obesity, HbA1c, therapy regimen, and lifestyle via logistic regression. All models were adjusted for age, sex, and diabetes duration. RESULTS: In the total cohort (54.8% male), the median score was 17 [Q1-Q3: 13-20]. Adjusted for age, sex, and diabetes duration, the WHO-5 scores<13 were associated with psychiatric comorbidity, especially depression and ADHD, poor metabolic control, obesity, smoking, and less physical activity. There were no significant associations with therapy regimen, hypertension, dyslipidemia, or social deprivation. In subjects with any diagnosed psychiatric disorder (prevalence 12.2%), the odds ratio for conspicuous scores was 3.28 [2.16-4.97] compared to patients without mental disorders. Using ROC analysis, the optimal cut-off to anticipate any psychiatric comorbidity in our cohort was 15, and 14 for depression. CONCLUSIONS: The WHO-5 questionnaire is a useful tool to predict depression in adolescents with type 1 diabetes. ROC analysis suggests a slightly higher cut-off for conspicuous questionnaire results compared to previous reports. Due to the high rate of deviant results, adolescents and young adults with type-1 diabetes should be screened regularly for signs of psychiatric comorbidity.

Evaluation of a Digital Health Tool for Titration of Basal Insulin in People With Type 2 Diabetes: Rationale and Design of a Randomized Controlled Trial.

BACKGROUND: Optimal insulin titration is essential in helping people with type 2 diabetes mellitus (T2DM) to achieve adequate glycemic control. Barriers of people with diabetes to implementation of titration include lack of self-efficiency and self-management skills, increased diabetes-related distress, low treatment satisfaction, poor well-being, as well as concerns about hypoglycemia and insulin overdose. My Dose Coach is a digital health tool for optimizing titration of basal insulin that combines a smartphone app for patients with T2DM and a Web portal for health care professionals. METHODS/DESIGN: This is a prospective, open-label, multicenter, randomized controlled parallel study conducted in approximately 50 centers in Germany that are specialized in the treatment of diabetes. Patients in the intervention group will use the titration app and will be registered on the Web portal by their treating physician. Control group patients will continue their current basal insulin titration without using the app. The primary outcome is the mean change in HbA1c levels at the 12-week follow-up. The secondary outcome measures include patient-reported outcomes such as diabetes-related distress, self-management, empowerment, self-efficacy, treatment satisfaction, and psychological well-being as well as fasting blood glucose values. CONCLUSION: This digital health tool has been previously implemented in several independent pilot studies. The findings from this multicenter randomized controlled trial can provide further evidence supporting the effectiveness of this tool in patients with T2DM and serve as a basis for its clinical integration. TRIAL REGISTRATION: German Register for Clinical Studies-DRKS-ID: DRKS00024861.

Reduced heart rate variability in people with type 1 diabetes and elevated diabetes distress: Results from the longitudinal observational DIA-LINK1 study.

AIMS: People with type 1 diabetes have a higher risk for cardiovascular disease (CVD). Reduced heart rate variability (HRV) is a clinical marker for CVD. In this observational study using continuous HRV measurement across 26 days, we investigated whether psychological stressors (diabetes distress, depressive symptoms) and glycaemic parameters (hypo- and hyperglycaemic exposure, glycaemic variability and HbA1c ) are associated with lower HRV in people with type 1 diabetes. METHODS: Data from the non-interventional prospective DIA-LINK1 study were analysed. At baseline, depressive symptoms and diabetes distress were assessed. Glucose values and HRV were recorded daily for 26 days using continuous glucose monitoring (CGM) and a wrist-worn health tracker respectively. Multilevel modelling with participant as nesting factor was used to analyse associations between day-to-day HRV and diabetes distress, depressive symptoms and CGM-derived parameters. RESULTS: Data from 149 participants were analysed (age: 38.3 ± 13.1 years, HbA1c : 8.6 ± 1.9%). Participants with elevated diabetes distress had a significantly lower HRV across the 26 days compared to participants without elevated distress (ß = -0.28; p = 0.004). Elevated depressive symptoms were not significantly associated with HRV (ß = -0.18; p = 0.074). Higher daily exposure to hyperglycaemia (ß = -0.44; p = 0.044), higher average exposure to hypoglycaemia (ß = -0.18; p = 0.042) and higher HbA1c (ß = -0.20; p = 0.018) were associated with reduced HRV across the 26 days. Sensitivity analysis with HRV averaged across all days corroborated these results. CONCLUSIONS: Diabetes distress is a clinically meaningful psychosocial stressor that could play a role in the cardiovascular health of people with type 1 diabetes. These findings highlight the need for integrated psychosocial care in diabetes management.

Posttraumatic stress disorder and diabetes-related outcomes in patients with type 1 diabetes.

Mental comorbidities in patients with type 1 diabetes mellitus (T1D) are common, and can have a negative impact on acute blood glucose levels and long-term metabolic control. Information on the association of T1D and comorbid posttraumatic stress disorder (PTSD) with diabetes-related outcomes is limited. The aim was to examine the associations between a clinical diagnosis of PTSD and diabetes-related outcomes in patients with T1D. Patients with T1D and comorbid documented PTSD from the DPV database (n = 179) were compared to a group with T1D without PTSD (n = 895), and compared to a group with T1D without comorbid mental disorder (n = 895) by matching demographics (age, gender, duration of diabetes, therapy and migration background) 1:5. Clinical diabetes-related outcomes {body mass index (BMI), hemoglobin A1c (hbA1c), daily insulin dose, diabetic ketoacidosis (DKA), hypoglycemia, number of hospital admissions, number of hospital days} were analyzed, stratified by age groups (≤ 25 years vs. > 25 years). Patients with comorbid PTSD aged ≤ 25 years compared with patients without PTSD or patients without mental disorders had significantly higher HbA1c (8.71 vs. 8.30 or 8.24%), higher number of hospital admissions (0.94 vs. 0.44 or 0.32 per year) and higher rates of DKA (0.10 vs. 0.02 or 0.01 events/year). Patients with comorbid PTSD aged ≤ 25 years compared with patients without PTSD had significantly higher BMI (0.85 vs. 0.59) and longer hospital stays (15.89 vs.11.58 days) than patients without PTSD. Patients with PTSD > 25 years compared with patients without PTSD or without any mental comorbidities had significantly fewer hospital admissions (0.49 vs. 0.77 or 0.69), but a longer hospital length of stay (20.35 vs. 11.58 or 1.09 days). We found that PTSD in younger patients with T1D is significantly related to diabetes outcome. In adult patients with T1D, comorbid PTSD is associated with fewer, but longer hospitalizations. Awareness of PTSD in the care of patients with T1D should be raised and psychological intervention should be provided when necessary.

The German Fast Track Toward Reimbursement of Digital Health Applications (DiGA): Opportunities and Challenges for Manufacturers, Healthcare Providers, and People With Diabetes.

BACKGROUND: Digital health applications (DiGA) supporting the management of diabetes are among the most commonly available digital health technologies. However, transparent quality assurance of DiGA and clinical proof of a positive healthcare effect is often missing, which creates skepticism of some stakeholders regarding the usage and reimbursement of these applications. METHODS: This article reviews the recently established fast-track integration of DiGA in the German reimbursement market, with emphasis on the current impact for manufacturers, healthcare providers, and people with diabetes. The German DiGA fast track is contextualised with corresponding initiatives in Europe. RESULTS: The option of a provisional prescription and reimbursement of DiGA while proving a positive healthcare effect in parallel may expedite the adoption of DiGA in Germany and beyond. However, hurdles for a permanent prescription and reimbursement of DiGA are high and only one of 12 that have achieved this status specifically addresses people with diabetes. CONCLUSION: The DiGA fast track needs to be further enhanced to cope with remaining skepticism and contribute even more to a value-based diabetes care.