E11
Conditions
Interventions
Group 1: Intervention (application of the nutritional recommendations: after a test phase in which the patients continuously measure their blood sugar and record their diet via the app, patients recei
Sponsors
Perfood GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Type 2 diabetes mellitus E11, - without insulin treatment based on at least two of the following tests: o HbA1c = 6.5% (48 mmol / mol) o Fasting plasma glucose = 126 mg / dl (7 mmol / l) o OGTT-2 hours = 200 mg / dl (11.1 mmol / l) o Occasional plasma glucose = 200 mg / dL (11.1 mmol / L) with typical diabetes-related symptoms - HbA1c = 6.5% (48 mmol / mol) at the last clinical routine check (within the last 12 months); - Treatment with one of the following options (unchanged since at least 3 months) 1. Lifestyle modification only 2. metformin 3. SGLT-2 inhibition 4. GLP-1 analogs 5. DPP4 inhibition 6. any combination of drugs from 2 to 5. - Body Mass Index (BMI)> 27 and = 40 kg / m2; - Written declaration of consent; - Good understanding of written and spoken German; - Use of an Android smartphone (version 5.1 or higher) or iOS smartphones (version 13.0 or higher); - Intellectual capacity and willingness to change Lifestyle according to the dietary recommendations
Exclusion criteria
Exclusion criteria: - Use of a Perfood GmbH product with a glucose monitoring test phase within the past 24 months; - Antibiotic treatment (systemic, longer than 1 day) within the last 3 months; - Pregnancy, breastfeeding or active desire to have children (acc. patient information); - Eating disorder, e.g. binge eating, bulimia, anorexia nervosa; - Alcohol or drug abuse; - Current and planned participation in another clinical study; - Current insulin treatment; - HbA1c = 8.5% (70 mmol / mol); - Weight change of = 5% of the initial body weight within the last 3 months; - last eGFR <30 ml / min / 1.73 m2; - Known tumor disease (exception: remission after treatment for at least 2 years); - Myocardial infarction within the last 6 months; - Severe heart failure defined as equivalent to class 3 the New York Heart Association (NYHA); - Current treatment with anti-obesity drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. relative change in body weight; 2. absolute change in HbA1c | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Absolute change in fasting glucose; 2. Absolute change in the oGTT-2-hour value; 3. HbA1c status ("normal" with HbA1c <6.5% or 48 mmol / mol); 4. Time in range: relative change in the CGM time with glucose values ??in the therapeutic target range of 70 to 180 mg / dl; 5. Relative change in insulin resistance (HOMA-IR) | — |
Countries
Germany
Contacts
Public ContactJens Aberle
Schwerpunktpraxis für Diabetes mellitus
Outcome results
None listed