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.
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.