New RCT: diabetes DTx matched drug-like A1C reduction using CGM-driven lifestyle coaching; now eyeing U.S./UK roll-out

Perfood today announced positive results from a multicenter, randomized controlled trial evaluating glucura, its digital therapeutic for type 2 diabetes.

LUBECK, GERMANY, November 5, 2025 /EINPresswire.com/ -- Perfood today announced positive results from “Metabolic III” (DRKS00032537), a multicenter, randomized controlled trial in Germany evaluating glucura, the company’s prescription digital therapeutic (DTx) for type 2 diabetes. The study enrolled 320 adults with type 2 diabetes who were already receiving standard of care under the German Disease Management Program (DMP) and compared 6 months of glucura plus continuous glucose monitoring (CGM) with CGM alone.

Key findings:
• Mean HbA1c reduction of –0.80 percentage points at 6 months in the glucura + CGM group
• Clinically meaningful group difference of –0.46 percentage points vs. CGM alone
• 54.8% of patients reached guideline target <7.0%, 27.0% reached <6.5% (remission-range for many)
• 40.5% achieved >5% weight loss
• Digital, lifestyle-first model designed to reduce burden on physicians and extend care capacity

“These data show that glucura delivers an effect size that, in many patients, is in the range we typically expect from diabetes medication – but achieved through a structured, app-based lifestyle intervention powered by CGM data,” said Dr. med. Dr. rer. nat. Torsten Schröder, Medical Director of the study and Chief Medical Officer at Perfood. “Because it is digital, glucura can be delivered repeatedly and at scale, without adding workload for already overburdened diabetes and primary care practices.”

U.S. and UK relevance
Germany is currently the most advanced market for prescription digital therapeutics through its DiGA fast-track, where statutory health insurers reimburse digital apps such as glucura in full. Perfood is now evaluating an international roll-out, including the UK and U.S., to bring the CGM-driven, lifestyle-first model to systems struggling with care capacity, rising GLP-1 costs, and large prediabetes/type 2 diabetes populations. Because the trial tested glucura on top of real-world standard of care and CGM, the data are relevant to payers and integrated delivery networks considering digital adjuncts to existing diabetes pathways.

“Health systems in the U.S. and UK are looking for scalable ways to help people with type 2 diabetes improve control before intensifying drugs – and to support people who are already on medication,” said Dominik Burziwoda-von Papen, Managing Director, Perfood. “glucura gives clinicians a reimbursable, data-driven lifestyle intervention that aligns with guideline care and can be deployed remotely. These RCT data give us the evidence base we need to talk to international partners.”

Study details
• Study name: Metabolic III
• Register: DRKS00032537
• Design: Multicenter, randomized, controlled, parallel-group trial
• Population: 320 adults with type 2 diabetes, all on standard DMP care
• Duration: 6 months
• Intervention arm (n=158): CGM + glucura (app-based, personalized lifestyle program)
• Control arm (n=162): CGM alone
• Primary endpoint: Change in HbA1c at 6 months
• Secondary endpoints: Weight, BMI, quality of life, mental health, diabetes self-management / self-efficacy

Primary endpoint – HbA1c (A1C):
• Intervention (CGM + glucura): –0.80 percentage points
• Control (CGM): –0.30 percentage points
• Between-group difference: –0.46 percentage points (favors glucura)

Treatment targets achieved (intervention arm):
• 54.8% reached HbA1c <7.0%
• 27.0% reached HbA1c <6.5% (remission-indicative range for many patients)

Weight and metabolic improvements:
• 40.5% of participants in the glucura group lost >5% of body weight in 6 months
• Mean relative weight reduction in the intervention group: –4.11%
• Control: –1.79%

About glucura
glucura is a prescription digital health application (DiGA) for the non-pharmacological treatment of type 2 diabetes. In Germany, it can be prescribed as a first-line, guideline-conform lifestyle intervention and in parallel with drug therapy to intensify metabolic control. All German statutory health insurers currently reimburse glucura in full. The application combines CGM integration, nutrition tracking, personalized meal recommendations based on glucose data, SMART goals and behavioral training, and educational modules tailored to metabolic health.

About Perfood
Perfood, headquartered in Lübeck, Germany, develops data-driven digital therapeutics that personalize nutrition and lifestyle to improve metabolic diseases. The company leverages CGM, behavioral science, and AI-supported analytics to deliver scalable, reimbursable interventions. Perfood is expanding partnerships to make glucura available outside Germany, including in the UK and the United States.

D Burziwoda-von Papen
Perfood
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