CGM-HYPE: Continuous glucose monitoring in healthy young people under standardized conditions

Not Applicable

Recruiting

Conditions: E11
Type 2 diabetes mellitus

Registration Number: DRKS00032821

Lead Sponsor: Heinrich-Heine Universität Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 10

Inclusion Criteria

Body mass index (BMI) > 18.5 & < 30 kg/m^2
- Waist circumference (men < 94 cm, women < 80 cm)
- Healthy according to own information (absence of heart or metabolic diseases, no intake of corresponding medication)
- Fasting blood glucose < 100 mg/dL
- Blood glucose value < 140 mg/dL after two hours from the start of an oral glucose tolerance test (2h-OGTT)
- possession of a mobile device and willingness to use it during the study
- Voluntary consent to participate in the interventional data collection
- Voluntary consent to data protection for the interventional data collection

Exclusion Criteria

- Lack of declaration of consent to participate in this investigation
- Absence of declaration of consent to data protection
- Diagnosis of diabetes mellitus type I or II (self-reported)
- Eating or thyroid dysfunction
- Allergies to food or patch allergies
- Cognitive or physical limitations
- Smoker:in
- Pregnant or breastfeeding
- Intake of > 500 mg vitamin C per day
- Taking metabolic drugs (e.g. antihypertensive drugs, antidiabetics, insulin, immunomodulatory drugs, etc.)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glucose response to each of the seven challenges<br>- AUC (area under the curve) for each individual challenge in a time window of four hours after the start of the challenge [(mg/dL)*minutes] <br>This metric is described with mean ± standard deviation of all participants as a descriptive measure for each individual challenge

Secondary Outcome Measures

Name	Time	Method
Description of the curve after each challenge:<br>- Extreme glucose value (minimum or maximum) [mg/dL]<br>- Time until extreme value is reached [minutes]<br>- Time until basal value is reached again [minutes]<br>- Amplitude of the deflection (subtraction of basal value from extreme value) [mg/dL]<br><br>CGM metrics according to international consensus<br>- Percent of time in target range (70-180 mg/dL)<br>- Percent of time below target range (< 70mg/dL)<br>- Percent of time above the target range (> 180mg/dL)<br>- Mean value of all glucose values<br>- Glycemic variability:<br> * Coefficient of variation [%CV]<br> * Mean amplitude of glycemic excursions [mg/dL]<br>- Number of hypoglycemic events<br><br>After the 14 days, the participants are asked once about their satisfaction with the system and their quality of life using the questionnaire (The World Health Organization- Five Well-Being Index (WHO-5))