sing Continuous Glucose Monitoring and contextual data to increase insight in glucose patterns for individuals with type 2 diabetes.
- Conditions
- sugartype 2 diabetes mellitus10018424
- Registration Number
- NL-OMON49104
- Lead Sponsor
- TNO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
* Aged < 80 years
* BMI 25 * 40 kg/m2, with preference for < 35 kg/m2; BMI 20-25 kg/m2 is also
allowed if aged 60-80 years
* Diagnosed with type 2 diabetes mellitus
* Insulin naïve
* Using either lifestyle and/or metformin for managing their diabetes
* Able to answer questionnaires in Dutch
* 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
* Insufficient motivation to be in the study
* Unavailability for more than 2 weeks in a row during the study period
* A condition that would need an MRI in the upcoming 6 months
* 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method