Evaluation of the Digital Health Application glucura in the treatment of Diabetes mellitus Type 2.A randomized controlled trial over a period of 6 months

Not Applicable

Recruiting

• Conditions: E11; Type 2 diabetes mellitus

• Registration Number: DRKS00032537
• Lead Sponsor: Perfood GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-19
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 650

Inclusion Criteria

Patients with T2DM (m/f/d) aged 18 years and older according to the ICD-10 code E11.-.
- Participation in DMP T2DM, for at least 3 months before inclusion
- HbA1c = 7.0 % (53 mmol/mol) and = 11,0 % (96,7 mmol/mol) at last routine clinical examination
- Body mass index (BMI) = 25 kg/m²
- Weight stable over the last 3 months (± 5 %)
- Diabetes-specific medication stable over the last 3 months
- Digital literacy to adequately use a smartphone and willingness to make lifestyle changes according to the given dietary recommendations

Exclusion Criteria

- Current treatment with insulin
- Bariatric surgery in the past
- Existing or planned treatment with steroids during the intervention phase (topical, inhaled application and long-term use at low doses is not an exclusion criterion). The decisive factor is that the HbA1c value must not be influenced by this.
- Pregnancy and breastfeeding (according to patient information)
- Current or planned participation in another interventional clinical trial
- Past use of the investigational product glucura
- Current participation in a therapeutically effective program
or use of a DiGA for weight reduction (does not apply to grade III obesity - see below for explanation) / use of another DiGA for diabetes management
- Severe impairment (including mental or psychological impairment) that would hinder participation in the study according to the investigator's opinion and compromise the data integrity of the study
- Lack of capacity to give informed consent

In patients with grade III obesity (BMI = 40 kg/m2), adequate obesity therapy is permitted in parallel, but must have been stable for at least three months at the time of inclusion.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in HbA1c after 180 days