Preferences of people with diabetes for diabetes care in Germany: a discrete choice experiment.

OBJECTIVES: The objective of this study is to elicit health care preferences of people with diabetes and identify classes of people with different preferences. METHODS: A discrete choice experiment was conducted among people with diabetes in Germany comprising attributes of role division in daily diabetes care planning, type of lifestyle education, support for correct medication intake, consultation frequency, emotional support, and time spent on self-management. A conditional logit model and a latent class model were used to elicit preferences toward diabetes care and analyze preference heterogeneity. RESULTS: A total of 76 people with diabetes, recruited in two specialized diabetes care centers in Germany (mean age 51.9 years, 37.3% women, 49.1% type 2 diabetes mellitus, 50.9% type 1 diabetes mellitus), completed the discrete choice experiment. The most important attributes were consultation frequency, division in daily diabetes care planning, and correct medication intake. The latent class model detected preference heterogeneity by identifying two latent classes which differ mainly with respect to lifestyle education and medication intake. CONCLUSION: While the majority of people with diabetes showed preferences in line with current health care provision in Germany, a relevant subgroup wished to strengthen lifestyle education and medication intake support with an aid or website.

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.

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.

The Effect of Prandial Insulin Applied for Fat Protein Units on Postprandial Glucose Excursions in Type 1 Diabetes Patients with Insulin Pump Therapy: Results of a Randomized, Controlled, Cross-Over Study.

OBJECTIVE: This randomized cross-over study aimed to compare different algorithms for calculating prandial insulin considering the fat and protein content of a standardized meal in type 1 diabetes patients using insulin pump therapy (CSII). METHODS: Twenty-six patients received a standardized evening meal for three consecutive days using different algorithms for insulin dose adjustment: A) exclusive consideration of carbohydrate content without considering fat-protein content, B) high-dose algorithm considering additional insulin for fat protein units (FPUs) with the same factor as for carbohydrates, and C) low-dose algorithm considering additional insulin for FPUs with half the factor as for carbohydrates. The primary outcome was the proportion of interstitial glucose values in the target range (≥ 70 to ≤ 180 mg/dl) during the post-prandial 12-hour follow-up period. Secondary outcomes were the occurrence of hypo- and hyperglycemic episodes and the coverage with carbohydrates for treatment of hypoglycemia. RESULTS: The percentage of glucose values in the target range was significantly higher when fat-protein content was not considered, whereas, in the hyperglycemic range, it did not differ significantly among the three groups. The percentage of hypoglycemic glucose values were the highest in the groups considering fat-protein content and lowest in the group not considering FPUs with no significant difference between the two groups in terms of FPUs. CONCLUSIONS: In adult type 1 diabetes patients using CSII, it is not recommended to consider a high fat and protein content in the diet when calculating prandial insulin dosage with the selected algorithms, as this increases the risk of hypoglycemia disproportionately.

Perceived Usefulness of Continuous Glucose Monitoring Devices at the Workplace: Secondary Analysis of Data From a Qualitative Study.

BACKGROUND: Previous research suggests that psychosocial working conditions may detrimentally affect diabetes self-management behavior at work, including self-monitoring of glucose levels. We aimed to better understand the potential usefulness of continuous glucose monitoring devices at the workplace according to employees with diabetes. METHODS: We carried out secondary analyses of data from a qualitative study, which sought to explore potential barriers to and solutions for effective diabetes self-management at work. Interviews were carried out in face-to-face contact or by telephone and were transcribed and content-analyzed using MaxQDA. The used topic guide did not specifically inquire after continuous glucose monitoring devices, but views on the suitability of those devices at the workplace repeatedly emerged from the interviews. Data from 25 employed adults with diabetes mellitus type 1 or type 2 on insulin therapy were included. RESULTS: The major perceived improvements associated with the use of continuous glucose monitoring devices pertained to their time-saving application that allowed for an increased frequency of glucose level assessments and for socially covert glucose measurement. The socially less noticeable way of monitoring glucose level was specifically perceived as beneficial, as employees with diabetes believed their illness would thereby attract less attention. Fewer or shorter interruptions as well as the reliability of integrated alarm systems were perceived to increase concentration at work and workability. CONCLUSIONS: Continuous glucose monitoring devices were perceived to facilitate glucose management at the workplace, which may exert positive effects on compliance as well as functioning at work. Further research would be of interest to statistically confirm our findings in occupational samples.

Psychosocial working conditions and diabetes self-management at work: A qualitative study.

AIMS: We conducted a qualitative study to expand our current understanding of the potential link between psychosocial working conditions and diabetes self-management at work. METHODS: Thirty employed adults with diabetes mellitus living in Germany (n = 19 with type 1, n = 11 with type 2, 57% female, aged 24-64 years) were recruited. Using a topic guide, we carried out in-depth interviews in face-to-face contact or by telephone. Interviews were transcribed and content-analyzed using MaxQDA. RESULTS: Psychosocial working conditions perceived to detrimentally affect self-management activities included, amongst others, a high workload, poor job control, unhygienic working environments, the requirement to work under high or fluctuating temperature, perceived social norms at the workplace, and the attitude to prioritize work-related demands as opposed to diabetes-related demands. The types of self-management activities considered to be adversely affected related to glucose monitoring, insulin injections, dietary control, the ability to recognize hypoglycemia and health care use. CONCLUSIONS: Various types of occupational psychosocial factors may determine diabetes self-management practices at the workplace. Quantitative studies are needed to confirm our observations. Subsequently, interventions could be developed and evaluated to improve opportunities to adequately engage into diabetes self-management at work.

Measurement of psychological adjustment to diabetes with the diabetes acceptance scale.

AIMS: To develop a psychometric measure of diabetes acceptance. METHODS: An item pool was developed and pilot-tested using a sample of 220 people with diabetes; item selection resulted in the 20-item 'Diabetes Acceptance Scale (DAS)'. 606 people with diabetes were then cross-sectionally assessed with the DAS to evaluate its reliability, validity and clinical utility; concurrent measurements included diabetes-related coping (FQCI), diabetes distress (PAID-5), depressive symptoms (PHQ-9), quality of life (EQ-5D), self-management (DSMQ), glycaemic control (HbA1c) and complications. RESULTS: Internal reliability was high (Cronbach's α = 0.96). Factorial and criterion-related results supported validity. Higher diabetes acceptance scores correlated with more functional coping styles, lower distress and depression levels, higher treatment adherence, better glycaemic control and better quality of life (all P < .001). Persons with low diabetes acceptance (22% of the sample) were four times more likely to have HbA1c values over 9.0% (75 mmol/mol), two times more likely to be diagnosed with long-term complications and each over two times more likely to have had episodes of severe hypoglycaemia and ketoacidosis in the past year; the prevalence of major depression in this group was fivefold increased (all P < .05). CONCLUSIONS: The DAS is a reliable and valid tool to measure diabetes acceptance. It may help identify patients with significant problems of accepting diabetes, a putative high-risk group in need of tailored care and support.

Depression is linked to hyperglycaemia via suboptimal diabetes self-management: A cross-sectional mediation analysis.

OBJECTIVE: To analyse if the association between depressive symptoms and hyperglycaemia is mediated by diabetes self-management. METHODS: 430 people with diabetes (57.7% type 1, 42.3% type 2) were cross-sectionally assessed using validated self-report scales for depressive symptoms (Center for Epidemiologic Studies Depression Scale (CES-D)) and diabetes self-management (Diabetes Self-Management Questionnaire (DSMQ)); HbA1c was analysed simultaneously in a central laboratory. Structural equation modelling was used to test if the association between depressive symptoms and hyperglycaemia (HbA1c) was mediated by suboptimal self-management in people with type 1 and type 2 diabetes. RESULTS: The hypothesised model of depressive symptoms, diabetes self-management and hyperglycaemia fit the data well for both diabetes types (SRMR≤0.04, TLI≥0.99, CFI>0.99, RMSEA≤0.02 for both models). In both the type 1 and type 2 diabetes group, higher depressive symptoms were associated with lower self-management (P<0.001) and lower self-management was associated with higher HbA1c (P<0.001). Results indicated that the association between depressive symptoms and hyperglycaemia was significantly mediated by suboptimal diabetes self-management in both type 1 and type 2 diabetes patients (P<0.001). Significant direct associations between depressive symptoms and hyperglycaemia, not mediated by self-management, could not be observed. CONCLUSIONS: This study provides good evidence supporting that depression is linked to hyperglycaemia via suboptimal diabetes self-management in both major diabetes types.

Effect of local heating on postprandial blood glucose excursions using the InsuPad device: results of an outpatient crossover study.

The InsuPad is a medical device to accelerate insulin resorption by applying local heat at the insulin injection site. This crossover study examined the impact of the InsuPad use on postprandial glucose excursions under daily life conditions. In 1 study phase, diabetic patients used the InsuPad when injecting bolus insulin before breakfast and dinner and measured their blood glucose 5 times daily (before breakfast, lunch, and dinner and after breakfast and dinner). In the other study phase, blood glucose measurements were maintained without using the InsuPad. The order of the study phases was randomized. Twenty patients with a high insulin demand took part (30% type 1 diabetes, age 53.7 ± 8.9 years, diabetes duration 14.9 ± 7.4 years; HbA1c 8.3 ± 0.8%; total daily insulin demand 0.97 ± 0.32 IU per kg). Postprandial glucose excursion was reduced by 15.4 mg/dl (95% CI 9.7-21.2 mg/dl; P = .011) after breakfast and dinner if InsuPad was used. The mean blood glucose was lower by 8.8 mg/dl (95% CI 0:3-18:0 mg/dl; P = .099) when using the InsuPad. Safety parameters and the percentage of hypoglycemic (< 60 mg/dl) or hyperglycemic (> 300 mg/dl) blood glucose measurements were not negatively affected by InsuPad use (hypoglycemic values 1.4% vs 1.5%, P = .961; hyperglycemic values 2.6% vs 4.0%, P = .098). Local heating of the insulin injection site by use of the InsuPad device is an effective and safe method to reduce postprandial blood glucose excursions under daily life conditions without negative side effects on the occurrence of low or high blood glucose values.