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.

Roles and competencies of the clinical psychologist in adult diabetes care-A consensus report.

AIMS: Psychological care is recognised as an integral part of quality diabetes care. We set out to describe the roles and competencies of the clinical psychologist as a member of the multidisciplinary adult diabetes care team, focused on secondary care. METHODS: The authors are clinically experienced psychologists involved in adult diabetes care, from Australia, Europe and North America, and active members of the international psychosocial aspects of diabetes study group. Consensus was reached as a group on the roles and competencies of the clinical psychologist working in adult diabetes secondary care, building both on expert opinion and a selective review and discussion of the literature on psychological care in diabetes, clinical guidelines and competency frameworks. RESULTS: The clinical psychologist fulfils multiple roles: (1) as a clinician (psychological assessment and therapy), (2) as advisor to the healthcare team (training, consulting), (3) as a communicator and promotor of person-centred care initiatives and (4) as a researcher. Four competencies that are key to successfully fulfilling the above-mentioned roles in a diabetes setting are as follows: (a) specialised knowledge, (b) teamwork and advice, (c) assessment, (d) psychotherapy (referred to as STAP framework). CONCLUSIONS: The roles and competencies of clinical psychologists working in diabetes extend beyond the requirements of most university and post-graduate curricula. There is a need for a comprehensive, accredited specialist post-graduate training for clinical psychologists working in diabetes care, building on the proposed STAP framework. This calls for a collaborative effort involving diabetes organisations, clinical psychology societies and diabetes psychology interest groups.

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.

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.

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.

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.

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).

Evidence and Diabetes Technology: A Catch-22?

Diabetes technology is a dynamically evolving field. Sometimes the pace of evaluation of new diabetes technologies does not keep pace with its dynamic development. This leads to a dilemma: either the evaluation lags behind the developing technologies or diabetes technologies are used without sufficient evaluation. This situation is known as the Catch 22 dilemma. The aim of this paper is a discussion of ideas for a timely assessment, taking account of the speed of technological development and the need for evidence and safety improvement.

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.

PHQ-9, CES-D, health insurance data-who is identified with depression? A Population-based study in persons with diabetes.

AIMS: Several instruments are used to identify depression among patients with diabetes and have been compared for their test criteria, but, not for the overlaps and differences, for example, in the sociodemographic and clinical characteristics of the individuals identified with different instruments. METHODS: We conducted a cross-sectional survey among a random sample of a statutory health insurance (SHI) (n = 1,579) with diabetes and linked it with longitudinal SHI data. Depression symptoms were identified using either the Centre for Epidemiological Studies Depression (CES-D) scale or the Patient Health Questionnaire-9 (PHQ-9), and a depressive disorder was identified with a diagnosis in SHI data, resulting in 8 possible groups. Groups were compared using a multinomial logistic model. RESULTS: In total 33·0% of our analysis sample were identified with depression by at least one method. 5·0% were identified with depression by all methods. Multinomial logistic analysis showed that identification through SHI data only compared to the group with no depression was associated with gender (women). Identification through at least SHI data was associated with taking antidepressants and previous depression. Health related quality of life, especially the mental summary score was associated with depression but not when identified through SHI data only. CONCLUSION: The methods overlapped less than expected. We did not find a clear pattern between methods used and characteristics of individuals identified. However, we found first indications that the choice of method is related to specific underlying characteristics in the identified population. These findings need to be confirmed by further studies with larger study samples.

Assessing attitudes towards insulin pump therapy in adults with type 1 diabetes: Italian validation of the Insulin Pump Attitudes Questionnaire (IT-IPA questionnaire).

AIMS: The aim of the study was to adapt the German version of the insulin pump therapy (IPA) questionnaire to Italian (IT-IPA) and to evaluate its psychometric properties in adults with type 1 diabetes. METHODS: We conducted a cross-sectional study, data were collected through an online survey. In addition to IT-IPA, questionnaires evaluating depression, anxiety, diabetes distress, self-efficacy, and treatment satisfaction were administered. The six factors identified in the IPA German version were assessed using confirmatory factor analysis; psychometric testing included construct validity and internal consistency. RESULTS: The online survey was compiled by 182 individuals with type 1 diabetes: 45.6% continuous subcutaneous insulin infusion (CSII) users and 54.4% multiple daily insulin injection users. The six-factor model had a very good fit in our sample. The internal consistency was acceptable (Cronbach's α = 0.75; 95% IC [0.65-0.81]). Diabetes treatment satisfaction was positively correlated with a positive attitude towards CSII therapy (Spearman's rho = 0.31; p < 0.01), less Technology Dependency, higher Ease of Use, and less Impaired Body Image. Furthermore, less Technology Dependency was associated with lower diabetes distress and depressive symptoms. CONCLUSIONS: The IT-IPA is a valid and reliable questionnaire evaluating attitudes towards insulin pump therapy. The questionnaire can be used for clinical practice during consultations for shared decision-making to CSII therapy.

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.

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.

Diabetes-related distress and associated factors among adults with diabetes in Germany: Results of the nationwide study "Disease knowledge and information needs - Diabetes mellitus 2017".

BACKGROUND: Diabetes-related distress (DRD) can affect diabetes management adversely. In lack of population-based data, the frequency and determinants of DRD among adults with diabetes in Germany remain controversial. METHODS: This study included 1367 adults with diabetes who participated in a nationwide health telephone survey conducted among German adults aged 18 years and older in 2017. The short form of the Problem Areas in Diabetes (PAID-5) scale was used to assess DRD. The associations of high DRD (PAID-5 sum score ≥ 8) with socio-demographics, diabetes-related risk factors, diabetes clinical characteristics as well as quality of self-care and chronic illness care assessed by patients were tested in multivariable logistic regression models. RESULTS: The overall DRD prevalence was 15.1% (95% confidence intervals, 95% CIs, 12.5-18.0%) with no significant difference between men (14.7%, 95% CIs 11.2-19.1%) and women (15.4%, 11.9-19.8%). In multivariable analyses, DRD was significantly associated with younger age (odds ratio 0.96, 95% CIs 0.94-0.98, per year), immigration background (2.26, 1.16-4.42), current smoking (2.06, 1.14-3.70), insulin use (2.57, 1.45-4.56), and the presence of diabetes-specific complications (1.80, 1.10-2.94) or depressive symptoms (5.34, 3.24-8.81). Among those with depressive symptoms (18,4% of the study population), 38.3% also had DRD, which accounted for 7.0% (95% CIs 5.3-9.3%) of the study population. CONCLUSION: DRD is a common health problem among adults with diabetes in Germany, and highly correlates with depressive symptoms, current smoking, immigration background, and insulin use. Addressing DRD needs to become an integrative part of ambulatory diabetes care.

ACTonDiabetes: study protocol of a pragmatic randomised controlled trial for the evaluation of an acceptance and commitment-based internet-based and mobile-based intervention for adults living with type 1 or type 2 diabetes.

INTRODUCTION: Living with diabetes can be burdensome and lead to serious emotional distress and impaired mental health. Acceptance and commitment therapy (ACT) can support people facing the challenges of living with diabetes. This trial aims to evaluate the effectiveness and cost-effectiveness of the internet-based and mobile-based intervention (IMI) 'ACTonDiabetes' in reducing diabetes distress against enhanced treatment as usual (TAU+) following specialised diabetes care. METHODS AND ANALYSIS: A two-armed pragmatic randomised controlled trial will be conducted to evaluate the guided IMI ACTonDiabetes against TAU+. A total of 210 adults with type 1 or type 2 diabetes and elevated diabetes distress (Problem Areas in Diabetes ≥40) will be recruited at a specialised diabetes centre. The intervention begins 2-4 weeks after hospital discharge and takes about 7-10 weeks to complete. Assessments are performed at baseline and 5 and 10 weeks as well as 6 and 12 months after randomisation. The primary outcome is diabetes distress at a 10-week follow-up (T2). Secondary outcomes are depression (Patient Health Questionnaire-8), psychological well-being (WHO-5), quality of life (Assessment of Quality of Life-8 Dimension), Diabetes-related Self-Management Questionnaire, diabetes acceptance (Acceptance and Action Diabetes Questionnaire) and negative treatment effects (Inventory for the Assessment of Negative Effects of Psychotherapy). All statistical analyses will be performed based on the intention-to-treat principle with additional per-protocol analyses. Changes in outcomes will be evaluated using the general linear model. A health-economic evaluation will be conducted from a societal perspective. Reasons for drop-out will be systematically investigated. ETHICS AND DISSEMINATION: This clinical trial has been approved by the State Medical Chamber of Baden-Württemberg (file no. B-F-2019-010). Trial results will be submitted for publication in a peer-reviewed journal and presented at conferences. TRIAL REGISTRATION NUMBER: DRKS00016738.

Time With Diabetes Distress and Glycemia-Specific Distress: New Patient-Reported Outcome Measures for the Psychosocial Burden of Diabetes Using Ecological Momentary Assessment in an Observational Study.

OBJECTIVE: To estimate time with diabetes distress using ecological momentary assessment (EMA) in people with type 1 diabetes and analyze its associations with glycemic management based on continuous glucose monitoring (CGM). RESEARCH DESIGN AND METHODS: We used EMA to assess diabetes distress in a sample of recently hospitalized adults with type 1 diabetes once a day for 17 consecutive days in an ambulatory setting. Additionally, participants were asked daily about hypoglycemia distress (<70 mg/dL [3.9 mmol/L]), hyperglycemia distress (>180 mg/dL [10 mmol/L]), and variability distress (glucose fluctuations). Per person, the percentage of days with elevated distress was calculated (time with distress). Multilevel regression was used to analyze daily associations of distress ratings with CGM-derived parameters. EMA-derived associations between diabetes distress and glycemic outcomes were compared with questionnaire-derived associations. RESULTS: Data of 178 participants were analyzed. Participants spent a mean (SD) of days in a state of diabetes distress, 54.6 ± 26.0% in hyperglycemia distress, 45.2 ± 27.5% in variability distress, and 23.0 ± 19.3% in hypoglycemia distress. In multilevel analyses, higher daily ratings of diabetes distress were significantly associated with hyperglycemia (ß = 0.41). Results showed high between-person variability as explanation of variance of the models ranged between 22.2 and 98.8%. EMA-derived diabetes distress showed a significant association with mean glucose (r = 0.25), while questionnaire-based diabetes distress did not (r = 0.10). Prospectively, time with diabetes distress was associated with HbA1c at the 3-month follow-up (r = 0.27), while questionnaire-based distress showed no association (r = 0.11). CONCLUSIONS: Time with distress as assessed with EMA showed a comparative advantage over distress as determined by questionnaire-based assessment of diabetes distress regarding associations with glycemic management.