DRKS00032537
Recruiting
未知
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 - Metabolic III
Perfood GmbH0 sites650 target enrollmentOctober 19, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- E11
- Sponsor
- Perfood GmbH
- Enrollment
- 650
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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