Investigation of the effectiveness of the digital intervention glykio for improving lifestyle and self-management in patients with type 2 diabetes mellitus (T2DM) after three months' use
- Conditions
- E11Type 2 diabetes mellitus
- Registration Number
- DRKS00032134
- Lead Sponsor
- mementor DE GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 76
medically diagnosed T2DM according to ICD-10 (E11)
-historical HbA1c value =7.0% - =11.0%, not older than 3 months
-stable diabetes medication in the last three months
-Internet access and computer/smartphone which are compatible with glykio
-Ability to speak and read the German language
-patients are able to participate fully in the clinical trial and comply with the requirements for participation
-Patient with home health care assisting with blood glucose monitoring or insulin administration
-current or planned pregnancy during the study; breastfeeding women -steroid therapy within the last three months (not an exclusion criterion if used topically or inhaled less than five times per week)
-cognitive impairment
-alcohol and/or drug abuse (within the last six months)
-uncontrolled hypertension (=200 mmHg at baseline)
-participation in another clinical trial
-current or recent (within the last six months) use of glycio
-current or recent (within the last six months) participation in a lifestyle intervention programme (e.g. exercise or diet programme)
-Patients using an insulin pump
-Staff of mementor or other institution involved in the conduct/organisation/coordination/funding of the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is the average long-term blood glucose (HbA1c), which is measured by taking a blood sample at study inclusion (t0) and 12 weeks after the start of the intervention (t1).
- Secondary Outcome Measures
Name Time Method