Abstract
Abstract
Aims/hypothesis
CGM is increasingly recommended for non-insulin-treated type 2 diabetes according to the ADA Standards of Care 2026. However, its clinical benefit in high-quality standard care remains limited. This study evaluated whether addition of the digital therapeutic glucura, which delivers personalised lifestyle intervention and self-management guidance, improves glycaemic outcomes beyond CGM and standard care.
Methods
The study was a 6-month, multicentre, open-label RCT conducted at 24 sites in Germany (ID: DRKS00032537). Adults (≥18 years) with non-insulin-treated type 2 diabetes (HbA
1c
53–97 mmol/mol [7.0–11.0%], BMI≥25 kg/m
2
) receiving standard care were randomly assigned (1:1) by centralised stratified block randomisation to glucura or a control app. Participants and study personnel were not masked to group assignment. Both groups used intermittent CGM every 3 months during the study. CGM sensors were not used prior to the study. The primary endpoint was the change in HbA
1c
from baseline to 6 months. Secondary outcomes included weight change and patient-centric measures.
Results
Of 327 randomised participants (intervention:
n
=165; control:
n
=162), 320 were analysed (ITT population). The standalone CGM control group improved HbA
1c
levels by 3.3 mmol/mol (0.30 percentage points); however, the intervention group showed greater reductions of 8.7 mmol/mol (0.80 percentage points) with an adjusted difference of –5 mmol/mol (−0.46 percentage points; 95% CI −7, −3 mmol/mol;
p
=0.00003). Within the intervention group, more participants achieved HbA
1c
targets (p
=0.0002; p
=0.0001). The mean weight loss was also greater in the intervention group (4.11% vs 1.79%,
p
Conclusions/interpretation
In non-insulin-treated type 2 diabetes, CGM plus standard care yielded less metabolic benefit than CGM combined with glucura. The combination of glucura and CGM also translated into improvements beyond glycaemic management.
Trial registration
German Clinical Trials Register DRKS00032537
Funding
The study was funded by Perfood Laboratories GmbH