Mobile health (mHealth) solutions such as diabetes self-management apps improve glycated hemoglobin, particularly those that provide a feedback loop between patient and health care provider. mHealth apps that incorporate behaviorally designed interventions can improve patient access to diabetes self-management education and ongoing support. The mySugr mobile app was designed to support patients in their diabetes self-management. Most studies of mHealth apps were conducted under controlled conditions and did not elucidate the nuances of patient perceptions and utilization of these apps in everyday life. In this article, we discuss findings from real-world observations of changes in glycemic control and patient satisfaction associated with the use of the mySugr mHealth app.

Background Diabetes self-management is a mainstay of diabetes care, but the implementation of self-management regimens into daily life is complex and often results in discouragement and distress. Modern approaches such as smartphone-based self-management applications are therefore needed to support people with diabetes. Since reimbursability would increase the availability of such digital applications to people with diabetes, we designed a study that meets all scientific and methodological requirements set by the German Digital Healthcare Act to allow reimbursement for a specific application (mySugr PRO). Here, we report the protocol of this study that aims at evaluating the efficacy of the digital self-management application with regard to patient-reported outcomes and medical benefits. Methods/design This multicenter, open-label, randomized, parallel-group, controlled trial will evaluate the health care effects and medical benefits of mySugr PRO. A total of 466 people with diabetes will be randomly allocated (2:1 randomization) to the interventional group (n = 311) that will use the digital self-management application during the 12-week study period or the control group (n = 155; no usage of the application). Baseline and follow-up examinations will assess diabetes distress as the primary endpoint as well as empowerment, HbA1c, blood glucose data, self-management, general well-being, and treatment satisfaction as secondary endpoints. Statistical analyses will use an intention-to-treat procedure (using multiple imputation for missing values) as well as a per-protocol approach for sensitivity analysis. Discussion To the best of our knowledge, this study will be one of the largest diabetes-specific evaluations of a digital health application supporting people with diabetes in their diabetes self-management that follow the requirements of the German Digital Healthcare Act. Trial registration German Clinical Trial Register DRKS00022923. Registered on 22 October 2020.

Objective: The mySugr App is the most widespread mobile health application in the diabetes industry, reaching 1.5M patients in 62 countries. mySugr’s Integrated Diabetes Management solution, the mySugr bundle, introduces unlimited test strip delivery and Certified Diabetes Educator-led coaching. In a previous retrospective study we looked at real world changes in blood glucose (BG) in a U.S. population of mySugr Bundle users. In this follow-up study we extended the observation period of intervention to further analyse the course of effect seen before. Method: We analyzed changes in BG control (mean±SD, tests in range (TIR), estimated A1c (eA1c)) and frequency of testing. Participants monitored BG ≥3 times/day during the observation period. Data from the first 2 weeks of use (t0), 8 weeks before (t1), 8 weeks after (t2) and 8 to 16 weeks after (t3) initiation of Bundle usage were aggregated and statistically compared using two-sided t-tests. Results: Study participants were 61 users; 59% with type 1 diabetes, 32.8% with type 2 diabetes, 6.6% with LADA and 1.6% with unreported diabetes type. Baseline BG was 152.0±56.0 mg/dl, eA1c 6.9% and TIR 65%. Significant (p<0.05) improvements were observed in mean BG (-11,8 mg/dl), standard deviation (-5,48 mg/dl), TIR (+6.8%), readings above target (-7.2%) and eA1c (-0.41%) between t0 and t3. A significant improvement was also observed in monitoring frequency (+21.4%) between t1 and t3. Conclusion: Our previous study suggested use of the mySugr Bundle triggered positive changes of glucose control at 8 weeks post intervention. We were now able to show a sustainable improvement in BG control over an extended time period of 16 weeks, indicating the potential benefits of mobile interventions that combine complementary treatment strategies for therapy adherence over longer time periods. Given that improvements were observed in well-controlled patients, findings support further studies in a wider study population range. Disclosure H. Mayer: Employee; Self; mySugr. R.P. Bankosegger: Employee; Self; mySugr. J. Kober: Employee; Self; mySugr.

The digital diabetes logbook mySugr is designed to help people with diabetes manage their diabetes and to reduce burden of diabetes management. To test the efficacy of the app, a randomized controlled trial (RCT) was conducted. The RCT was designed as a multi-center, open-label, parallel study with a 3-month follow-up in Germany. Participants were randomized to either using the mySugr app or to the treatment-as-usual control group in a 2:1 ratio. Primary outcome was change in diabetes distress using the Problem Areas in Diabetes (PAID) questionnaire. Based on the power analysis, the recruitment goal was 396 participants, anticipating 15% drop-out it was planned to recruit 466 participants. Robust regression was used to analyze the data with follow-up scores as dependent variable, group as independent variable and controlled for respective baseline scores. Primary analysis was based on the intention-to-treat population with jump-to-reference approach for multiple imputation of missing data. A total of 424 people with diabetes were randomized, 282 to the intervention and 142 to the control group (12.5% type 1 diabetes, 68.2% type 2 diabetes, 18.9% gestational diabetes, age: 51.7±15.2 years, 50% female, diabetes duration: 9.5±10.8 years, A1c: 7.1±1.5%, PAID: 21.6±17.4); 397 completed the 3-month follow-up. Intention-to-treat analysis revealed a significant between-group difference in the primary outcome (p = 0.0182). PAID scores at follow-up in the mySugr group were significantly lower than in the control group (Δ -2.20, 95% CI: -4.02 to -0.38). This was corroborated by the per-protocol analysis (Δ -2.43, 95% CI: -4.49 to -0.37, p = 0.0211). Recruitment was successful and could be stopped earlier due to the very low drop-out rate (6.4%). Use of mySugr led to a significant improvement in diabetes distress after 3 months compared to the treatment-as-usual control group. Thus, the efficacy of mySugr regarding the reduction of diabetes distress could be demonstrated in the RCT. Disclosure D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. S.Silbermann: Employee; Roche Diabetes Care. J.Kober: Employee; mySugr. K.Finke-groene: None. T.Roos: None. I.Vesper: None. V.L.Schaefer: Employee; Roche Diabetes Care. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. Funding Roche Diabetes Care GmbH (DC000097)