E11
Conditions
Interventions
Group 1: Healthy, young adults will wear a continuous glucose monitoring (CGM) system for 14 consecutive days to participate in nine methods under standardized conditions that will elicit a glucose re
Sponsors
Heinrich-Heine Universität Düsseldorf
Eligibility
Sex/Gender
All
Age
18 Years to 40 Years
Inclusion criteria
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
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glucose response to each of the seven challenges - 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] This metric is described with mean ± standard deviation of all participants as a descriptive measure for each individual challenge | — |
Secondary
| Measure | Time frame |
|---|---|
| Description of the curve after each challenge: - Extreme glucose value (minimum or maximum) [mg/dL] - Time until extreme value is reached [minutes] - Time until basal value is reached again [minutes] - Amplitude of the deflection (subtraction of basal value from extreme value) [mg/dL] CGM metrics according to international consensus - Percent of time in target range (70-180 mg/dL) - Percent of time below target range ( 180mg/dL) - Mean value of all glucose values - Glycemic variability: * Coefficient of variation [%CV] * Mean amplitude of glycemic excursions [mg/dL] - Number of hypoglycemic events 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)) | — |
Countries
Germany
Contacts
Public ContactFlorian Kinny
Institut für Klinische Pharmazie und Pharmakotherapie, Heinrich-Heine Universität Düsseldorf
Outcome results
None listed