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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 healthcare 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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: N.H. has received fees for Advisory Board Participation from Abbott. He also received fees for lectures from Berlin Chemie, Sanofi, and Novo Nordisk. He also reports research support from Sanofi, Berlin Chemie, Roche, and mySugr. D.E. has received fees for Advisory Board participation from Dexcom, Roche Diabetes Care, mySugr, and Medtronic. He also received fees for lectures from Dexcom and Berlin-Chemie AG. K.F.G has no conflict of interest. T.R has no conflict of interest. G.F. is general manager of the Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm (IfDT, Ulm, Germany), which carries out clinical studies on the evaluation of BG meters and medical devices for diabetes therapy on its own initiative and on behalf of various companies. G.F./IfDT has received grants, speakers’ honoraria, or consulting fees from Abbott, Agamatrix, Ascensia, Berlin-Chemie, Beurer, Boydsens, CRF Health, Dexcom, i-SENS, LifeScan, Lilly, Metronom Health, Medtronic, Menarini, mySugr, Novo Nordisk, PharmaSens, Roche, Sanofi, Sensile, and Ypsomed. B.K. reports grants from AstraZeneca, Berlin-Chemie, Roche Diabetes Care, Abbott Diabetes Care, AstraZeneca, Dexcom, and Ypsomed, and personal fees from Berlin-Chemie, Roche Diabetes Care, Novo Nordisk, Medtronic, Ascensia Diabetes Care, Abbott Diabetes Care, and Eli Lilly.

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., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: DE reports Advisory Board member fees from mySugr, Dexcom Germany, and Roche Diabetes Care as well as honoraria for lectures from Berlin-Chemie AG, Sanofi-Aventis, Dexcom Germany, and Roche Diabetes Care. NH reports Advisory Board member fees from Abbott Diabetes Care and Insulet as well as honoraria for lectures from Berlin-Chemie AG, Becton Dickenson, Sanofi Germany, Roche Diabetes Care, and Dexcom Germany. TR reports honoraria for lectures from Berlin-Chemie AG. JK is an employee of mySugr. VS is an employee of Roche Diabetes Care Deutschland. TH reports consulting fees from Eli Lilly, NovoNordisk, Sanofi, Boehringer Ingelheim, and Abbott Diabetes Care as well as honoraria for lectures from Abbott Diabetes Care, Sanofi, and Eli Lilly. RZ reports consulting fees from Roche Diabetes Care and mySugr as well as honoraria for lectures from Roche Diabetes Care, Dexcom, VitalAire, NovoNordisk, and Abbott Diabetes Care. He participated in data safety monitoring boards or advisory boards of Roche Diabetes Care, mySugr, Dexcom, NovoNordisk, and Eli Lilly. LH reports consulting fees from Roche Diabetes Care, Lifecare, Medtronic, Spiden, Embecta, Dexcom, Onetwenty, Perfood, Boydsense, Pharmasense, Unomedical and Sinocare. CR is an employee of Roche Diabetes Care. EB is an employee of mySugr. BK reports Advisory Board member fees from Abbott Diabetes Care, Embecta, Roche Diabetes Care, Novo Nordisk, Berlin-Chemie AG and Dexcom Germany as well as honoraria for lectures from Sanofi Germany, Novo Nordisk, Abbott Diabetes Care, Roche Diabetes Care, Berlin-Chemie AG, Embecta, Dexcom, and Feen. In addition, he reports support for travel and fees for scientific meetings from Sanofi, Roche Diabetes Care and Berlin-Chemie AG as well as unpaid obligations as workshop leader and member of working groups of the German Diabetes Association. SS is an employee of Roche Diabetes Care. The remaining authors have nothing to disclose.