sing Continuous Glucose Monitoring and contextual data to increase insight in glucose patterns for individuals with type 2 diabetes

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 40

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

•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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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). <br>

Secondary Outcome Measures

Name	Time	Method
<br>1.Daily food and drink intake<br>2.Wellbeing<br>3.Physical Activity: heart rate, type of exercise, onset and duration of exercise, and energy expenditure<br>4.Sleep: sleep duration, sleep onset, awakening time, and sleep quality <br>5.Anthropometric measurements: weight (kg), BMI (kg/m2), waist and hip circumference (cm), waist/hip ratio and blood pressure (mmHg) <br>6.Oral glucose tolerance test (OGTT): both glucose and insulin levels will be measured using a venous blood sample. <br>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)<br>