Type 2 diabetes
Conditions
Interventions
Several interventions are introduced to induce a glucose response. These interventions will take a total of 4 days of which 3 are week days and 1 is a weekend day.
The following interventions are per
Sponsors
TNO
Eligibility
Inclusion criteria
Inclusion criteria: • BMI 25 – 40 kg/m2, with preference for < 35 kg/m2 • Diagnosed with type 2 diabetes mellitus • Insulin naïve • Using either lifestyle and/or metformin for managing their diabetes • In possession of a Smartphone running on a recent version of iOS or Android • Able and willing to sign the informed consent form • Willing to comply with all study procedures
Exclusion criteria
Exclusion criteria: • Insufficient motivation to be in the study • Unavailability for more than 2 weeks in a row during the study period • History of bariatric weight loss surgery • Planned (bariatric) surgery in the upcoming 6 months • Active cancer or chemotherapy or radiation within 2 years prior to participation • Chronic medical condition, treatment, or medication other than diabetes that may affect glucose metabolism (HIV diagnosis, use of steroids or immunosuppressive drugs, etc.) • Chronic anaemia (haemoglobin of 6.2 mmol/l or less) • Use of antibiotics or fertility treatments within 3 months prior to participation • Pregnancy or a pregnancy wish • 4 or more alcoholic drinks per day on a regular basis or use of recreational drugs • Skin allergy, eczema or known sensitivity for plasters • Coeliac or Crohns’ disease • Food allergies or intolerances including, gluten, wheat, egg, (pea)nuts, celery, sesame, soy, cacao, glutamate, legumes, coriander, maize, (shell)fish, chicken, beef, pork, lamb, sulphites, lupine, milk and lactose
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter in this study consists of continuous measured glucose values (mmol/l) measured over a period of 180 days with the use of a CE approved continuous glucose sensor (Dexcom G6). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Daily food and drink intake 2. Wellbeing 3. Physical Activity: heart rate, type of exercise, onset and duration of exercise, and energy expenditure 4. Sleep: sleep duration, sleep onset, awakening time, and sleep quality 5. Anthropometric measurements: weight (kg), BMI (kg/m2), waist and hip circumference (cm), waist/hip ratio and blood pressure (mmHg) 6. Oral glucose tolerance test (OGTT): both glucose and insulin levels will be measured using a venous blood sample. 7. Clinical chemistry: average glucose levels (HbA1c), c-peptide, lipid profile (total cholesterol, HDL, LDL, triglycerides, free fatty acids) and C-reactive protein (CRP in mg/l) | — |
Contacts
Public ContactIris de Hoogh
TNO
Outcome results
None listed