E11
Conditions
Interventions
Group 1: Intervention: Intended use of the digital, personalised, low-glycaemic lifestyle programme glucura for 2 x 90 days in addition to standard therapy as defined in the DMP Diabetes mellitus.
Gro
Sponsors
Perfood GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Patients with T2DM (m/f/d) aged 18 years and older according to the ICD-10 code E11.-. - Participation that receive standard care as defined in the DMP Diabetes mellitus, 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c after 180 days | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in weight (relative) after 180 days - Change in quality of life (SF-36, MCS) after 180 days - Change in self-management (PAID) after 180 days - Change in depressive symptoms (PHQ-9) after 180 days Additional exploratory endpoints: - Change in quality of life (SF-36, PCS) after 180 days - Responder proportion: proportion of patients with HbA1c in target range (< 7 %) at 90 and 180 days compared to baseline - Potential for remission: proportion of patients with HbA1c < 6.5 % at 90 and 180 days - Change in HbA1c after 90 days - Change in weight (relative) after 90 days - Change in quality of life (SF-36, PCS and MCS) after 90 days - Change in self-management (PAID) after 90 days - Change in depressive symptoms (PHQ-9) after 90 days - Change in weight (absolute) after 90 and 180 days - Change in BMI (absolute) after 90 and 180 days - Change in abdominal circumference after 90 and 180 days - Change in blood pressure (absolute, if available) at 90 and 180 days - Change in serum lipids (if any, absolute): Triglycerides, HDL, LDL, total cholesterol at 3 and 6 months - Change in cardiovascular risk (SCORE2-Diabetes(1)) after 90 and 180 days - Change in diabetes-specific medication after 90 and 180 days - Product use after 90 and 180 days - Change in CGM data after 2nd use of glucura compared to 1st use of glucura (for example time-in-range) and intervention group in comparison to control group | — |
Countries
Germany
Contacts
Public ContactGuido Freckmann
Institut für Diabetes-Technologie, Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm
Outcome results
None listed