In a 6-month, 24-site German RCT of 320 non-insulin-treated adults with type 2 diabetes (HbA1c 7–11%, BMI ≥25), pairing the digital therapeutic glucura with intermittent CGM reduced HbA1c by 8.7 mmol/mol (0.80 percentage points) versus 3.3 mmol/mol (0.30 pp) for CGM plus a control app alone — an adjusted between-group difference of −5 mmol/mol (p=0.00003). The intervention group also lost more weight (4.11% vs 1.79%), and was roughly 3.4-fold more likely to reach HbA1c <7.0% and 6.6-fold more likely to reach <6.5%. Mental health and diabetes distress improved significantly too.
These are clinically meaningful numbers. A 0.5 percentage-point HbA1c advantage over an active comparator in a well-powered RCT is the kind of effect most oral add-on agents are compared against, making this app's performance genuinely notable. The finding also clarifies something important: CGM alone, without behavioural scaffolding, produces modest glycaemic benefit in non-insulin users — the device's value appears contingent on how data are acted upon. That aligns with prior CGM evidence in this population.
Key limitations: the trial was open-label (unavoidable with apps), funded by the app developer (Perfood Laboratories), and conducted exclusively in Germany, which may limit generalisability. Six months is also insufficient to assess durability or hard cardiovascular outcomes. Still, for clinicians and patients seeking structured, scalable lifestyle support beyond glucose monitoring, this RCT offers the most rigorous evidence to date that a well-designed digital therapeutic can substantially amplify CGM's benefit.