Healthy participants
Conditions
Interventions
Group 1: Healthy participants: Up to two-week observation phase with continuous measurement of blood glucose levels (CGM sensor) and recording of sensor data via non-invasive wearables / smartwatches
Sponsors
Universitätsklinikum Schleswig-Holstein
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Use of an Android or iOS smartphone. • Sufficient knowledge of German to understand the study documents. • Submission of the signed declaration of consent.
Exclusion criteria
Exclusion criteria: • Pregnancy, breastfeeding. • Presence of a non-medically controlled chronic disease requiring treatment, including cancer. • Known HbA1c = 11, fasting plasma glucose level = 270 mg/dl, hypertension level 4 (systolic blood pressure (SBP) = 180, diastolic blood pressure (DBP) = 110). • Relevant food allergies or intolerances. • Eating/body schema disorder (bulimia nervosa, etc.). • In individual cases, the study director must check whether an existing illness and/or medication intake leads to exclusion from the study. • Indications that exclude the wearing of a continuous glucose sensor: Allergies or skin reactions to adhesives of the sensor, severe circulatory disorders, intake of high doses of paracetamol or vitamin C. • Alcohol or drug addiction. • Failure to provide informed consent; unwillingness or inability to comply with the study protocol or study-related procedures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility check using further wearables (adherence, variability of the devices, data availability, data quality, measurement accuracy of the methods, capacity check / availability, comprehensibility of the study documents, comprehensibility and user-friendliness of the devices, support options from the manufacturer, challenges in recruiting / addressing the study participants, initial data on the effect size for further biometrics) and parameters in order to later investigate the relationship between the postprandial blood glucose response and digital signatures (wearables) as part of a follow-up study. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Assessment of the measurement accuracy and quantitative dynamics of sensor data. • Investigation of whether results from earlier pilot studies can also be reproduced with other sensor systems. • Differentiation and validation between high-end wearables for scientific studies (Empatica) and life-style fitness wristbands and clarification of the question of whether correlations between continuously measured sensor and blood glucose data can also be achieved with other commercially available fitness wristbands. • Investigation of whether a prediction of metabolic types and/or meals can be achieved by integrative analysis of sensor data and metabolomics. • Gender-specific analysis of the data. | — |
Countries
Germany
Contacts
Public ContactFranziska Schmelter
Universitätsklinikum Schleswig-Holstein
Outcome results
None listed