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.

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.

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.

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.

Patients' Experience of New Technologies and Digitalization in Diabetes Care in Germany.

BACKGROUND: Little is little known about how people with diabetes experience advancing digitization and new technologies in diabetes. RESEARCH QUESTION: What are the attitudes of people with diabetes (or, in the case of children with diabetes, their parents) toward digitization and advancing technology in diabetology? What significant advantages and disadvantages do they see, and how do they assess current developments of digitization in diabetology (eg, hybrid closed-loop systems, do-It-Yourself (DIY) closed-loop systems, data protection, and data donation)? MATERIAL AND METHOD: 3,427 people with diabetes (47.7% female, 65.6% type 1 diabetes (T1D), 25.5% type 2 diabetes (T2D), 8.1% parents of children with diabetes; 0.8% other type of diabetes, age 49.2 ± 19.3 years) were interviewed with an online survey. RESULTS: Overall, survey participants had a very positive attitude toward digitization (82.6%) and considered the potential for optimizing diabetology through digitization to be very high (78.8%). The highest rated advantages of digitization were "greater personal responsibility and self-determination in therapy" (80.0%), "better quality of treatment" (80.0%), and "better communication with the doctor/diabetes team" (77.3%), while the highest rated disadvantages were the "error-proneness of digital applications" (35.9%), the "risk of misuse of patient data" (32.3%) and the "fear that digitization will replace the doctor in many cases" (31.1%). The possibility of evaluating and analyzing glucose data by means of software, and AID systems, and the possibility of improving the interoperability of the various applications are currently rated as the most significant topics. CONCLUSIONS: The vast majority of people with diabetes are very positive about new technologies in diabetology and expect that it will improve and simplify their diabetes therapy and reduce the burdens associated with diabetes. In particular, people with type 1 diabetes have high expectations for AID systems, viewing them as a kind of "technical cure" for their diabetes.

Level of Digitalization in Germany: Results of the Diabetes Digitalization and Technology (D.U.T) Report 2020.

BACKGROUND: New diagnostic and therapeutic technologies are increasingly changing the treatment of people with diabetes (PWD), along with increased usage of digital tools. To date, however, there is little data to which level and how diabetologists and PWD implement digitalization. Also, not much is known about the view of diabetologists on the current status and future developments in this respect. METHOD: In an online survey, diabetologists working in clinics and practices across Germany provided responses regarding their view on digitalization and the adoption of new technologies in diabetology to 56 questions. These comments reflect the opinion of several experts about the current importance and use of specific digital/technological topics. RESULTS: Overall, 326 diabetologists took part in the survey. They reported a positive attitude (75.8%) toward new technologies and digitalization, and they see more advantages rather than disadvantages. Younger age of the diabetologists was significantly associated with a more positive attitude (r = -0.176; P < .01), and there was no gender effect (P = .738). On average, in each practice, 5.5% of PWD are using an insulin pump for therapy, 4.8% a real-time continuous glucose monitoring system, 16.9% an intermittent scanning continuous glucose monitoring system, and 0.3% an automated insulin delivery (AID) system. With respect to digitalization, the three most important current topics are software for glucose data analysis (average rank on a scale from one to six, with one being the most important: 2.4), compatibility with other systems (2.9), and AID systems (3.8)). CONCLUSIONS: This survey, which is going to be repeated annually, showed that the diabetologists who participated predominantly have a positive attitude toward new technologies and digital applications and were aware of the associated advantages. However, perceived disadvantages need to be addressed to enable wider adoption of new technologies and digital solutions.

Perceived Benefits and Barriers Regarding CSII Treatment: Development and Psychometric Evaluation of the Insulin Pump Attitudes Questionnaire (IPA-Questionnaire).

BACKGROUND: Continuous subcutaneous insulin infusion is the most advanced and demanding form of insulin therapy. Various positive and negative expectations, attitudes and experiences can occur, influencing adherence to and efficacy of continuous subcutaneous insulin infusion therapy. A new questionnaire was developed to systematically assess perceived benefits, perceived barriers and handling of continuous subcutaneous insulin infusion therapy. METHODS: The Insulin Pump Attitude Questionnaire was tested in two samples (n=265/452) comprising pump users and non-pump users. Reliability was assessed using Cronbach's Alpha estimation. Exploratory and confirmatory factor analyses were conducted to establish the factorial structure. Correlations with other questionnaires as well as group differences between pump users and non-pump users were used to assess validity. RESULTS: Exploratory factor analysis revealed 26 items comprising six subscales: "Glycaemic Control", "Flexibility", "Impaired Body Image", "Technology Dependency", "Ease Of Use" and "Functionality". Confirmatory factor analysis confirmed this factor structure. The IPA sum score correlated significantly with diabetes distress (r=-0.30), self-efficacy (r=0.22), diabetes empowerment (r=0.36), psychological well-being (r=0.16) and treatment dissatisfaction (r=-0.24), supporting criterion validity with small to medium effect sizes. Furthermore, the IPA was able to differentiate between pump users and non-pump users with higher scores for pump users regarding "Glycaemic Control", "Flexibility", "Ease of use" and "Functionality" and lower scores for pump users regarding "Impaired Body Image" and "Technology Dependency". CONCLUSIONS: The Insulin Pump Attitude Questionnaire is a reliable and valid new instrument to assess attitudes towards continuous subcutaneous insulin infusion. With six scales, the Insulin Pump Attitude Questionnaire provides a comprehensive analysis of possible benefits, barriers, and handling problems of continuous subcutaneous insulin infusion therapy. In clinical practice, the Insulin Pump Attitude Questionnaire might be used to address the different attitudes in pump users but also in people considering continuous subcutaneous insulin infusion therapy.

Risk factors and prevention strategies for diabetic ketoacidosis in people with established type 1 diabetes.

Diabetic ketoacidosis (DKA) is a serious acute complication of type 1 diabetes, which is receiving more attention given the increased DKA risk associated with SGLT inhibitors. Sociodemographic and modifiable risk factors were identified with strong evidence for an increased risk of DKA, including socioeconomic disadvantage, adolescent age (13-25 years), female sex, high HbA1c, previous DKA, and psychiatric comorbidities (eg, eating disorders and depression). Possible prevention strategies, which include the identification of people at risk based on non-modifiable sociodemographic risk factors, are proposed. As a second risk mitigation strategy, structured diabetes self-management education that addresses modifiable risk factors can be used. Evidence has found that structured education leads to reduced DKA rates. Knowledge of these risk factors and potent risk mitigation strategies are important to identify subgroups of people with an elevated DKA risk. This knowledge should also be used when adjunct therapy options with an increased DKA risk are considered. Prevention of DKA in people with type 1 diabetes is an important clinical task, which should also be addressed when SGLT inhibitors are part of therapy.