Development of minimally invasive methodology for diabetyping to personalise treatment to realise remission and reversal of type 2 diabetes.

Recruiting

Conditions: sugar
Type 2 diabetes mellitus
10018424

Registration Number: NL-OMON53345

Lead Sponsor: TNO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 57

Inclusion Criteria

- - Diagnosed with (pre)diabetes type 2;
o BMI >=27 kg/m2, including a heterogenous group of people with
overweight/prediabetes (without glucose lowering medication), and/or type 2
diabetes with or without glucose lowering medication.
- Aged 40 years or older
- Able and willing to sign the informed consent form
- Willing to comply with all study procedures

Exclusion Criteria

- Type 1 diabetes
- Latent Autoimmune Diabetes (LADA)
- Skin allergy, eczema or known sensitivity for adhesives
- History of bariatric weight loss surgery
- Planned (bariatric) surgery during the 3 weeks monitoring period with the CGM
- Active cancer or chemotherapy or radiation within 2 years prior to
participation
- A condition that would need an MRI during the 3 weeks monitoring period with
the CGM
- Planned holiday during the 3 week GCM monitoring period
- (Night)shiftworkers
- Pregnancy and lactation
- Chronic medical condition, treatment, or medication other than diabetes that
may affect glucose metabolism (HIV diagnosis, use of steroids or
immunosuppressive drugs, etc.)
- 4 or more alcoholic drinks per day on a regular basis or use of recreational
drugs

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The objective of this study is to develop and evaluate algorithms predicting<br /><br>the different diabetypes and the underlying indices (diabetyping) with<br /><br>minimally invasive technology based on capillary sampling using and multi-day<br /><br>CGM with OGTT.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary objective is to develop and evaluate minimally invasive<br /><br>diabetyping technology with algorithms based on capillary sampling, venous<br /><br>blood sampling and multi-day CGM upon a standardized snack under real-world<br /><br>conditions. </p><br>