A clinical trial has demonstrated that Roche's digital health application mySugr Pro effectively reduces diabetes-related emotional distress, offering a promising digital solution for comprehensive diabetes management.
The randomized study, presented at the EASD meeting by Dr. Dominic Ehrmann from the FIDAM diabetes research institute in Germany, evaluated nearly 400 patients with type 1, type 2, and gestational diabetes. The trial specifically assessed the impact of the digital diabetes logbook on diabetes distress - an emotional burden affecting approximately 35% of diabetes patients.
Understanding Diabetes Distress
Diabetes distress manifests as feelings of hopelessness, discouragement, and exhaustion related to managing diabetes and its treatment demands. While not inherently pathological, elevated levels of distress can significantly impact patient outcomes, leading to increased risk of depression, diminished quality of life, and compromised blood glucose control.
Clinical Trial Design and Outcomes
The 12-week study measured diabetes distress using the standardized PAID questionnaire as its primary endpoint. Participants were required to perform daily blood glucose measurements and record them in the app. The mySugr Pro group showed a clinically meaningful reduction of 3.6 points on the PAID scale, while the control group experienced a slight increase (p=0.0182).
Secondary Findings and Glycemic Control
While overall secondary endpoints, including HbA1c levels, did not show significant improvements across the entire study population, a subgroup analysis of type 1 and type 2 diabetes patients revealed promising trends:
- 2.2 times higher likelihood of achieving target HbA1c levels of 6.5% or lower
- Reduced frequency of extreme blood sugar fluctuations
- Evidence of improved glycemic control
Exceptional Patient Engagement
The trial demonstrated remarkable user engagement metrics:
- 93% adherence rate for daily app usage
- Unusually low dropout rate of 6.4% for a digital intervention study
- High overall patient satisfaction
Digital Health Application Landscape in Germany
The study results position mySugr Pro favorably for potential inclusion in Germany's digital health application (DiGA) framework. Currently, Germany has 55 prescribable digital health products, with five specifically targeting metabolic diseases. Recent data shows:
- Over 200,000 DiGA prescriptions in the first nine months of 2022
- 164,000 prescriptions redeemed (80% redemption rate)
- €15 million spent on diabetes-related apps
- Total DiGA spending reached €55 million since implementation
The mySugr app, acquired by Roche in 2017, has become central to the company's diabetes management ecosystem, complementing its Accu-Chek blood glucose testing portfolio. The positive trial results suggest that digital interventions can play a meaningful role in addressing both the emotional and clinical aspects of diabetes care.
