Status:
COMPLETED
The RADAR Study - Wearable-Based Dysglycemia Detection and Warning in Diabetes
Lead Sponsor:
Insel Gruppe AG, University Hospital Bern
Collaborating Sponsors:
ETH Zurich
University of St.Gallen
Conditions:
Diabetes Mellitus, Insulin-Dependent
Diabetes
Eligibility:
All Genders
18+ years
Brief Summary
The study RADAR aims at developing a wearable based dysglycemia detection and warning system for patients with diabetes mellitus using artificial intelligence.
Detailed Description
Prior research has investigated the general potential of data analytics and artificial intelligence to infer blood glucose levels from a variety of data sources. In this study patients with insulin-de...
Eligibility Criteria
Inclusion
- Informed consent as documented by signature
- Age ≥ 18 years
- Diabetes mellitus treated with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)
Exclusion
- Smartwatch cannot be attached around the wrist of the patient
- Known allergies to components of the Garmin smartwatch or the Dexcom G6 system
- Pregnancy, intention to become pregnant or breast feeding
- Cardiac arrhythmia (e.g. atrial flutter or fibrillation, AV-reentry tachycardia, AV-block \> grade 1)
- Pacemaker or ICD (implantable cardioverter defibrillator)
- Treatment with antiarrhythmic drugs or beta-blockers
- Drug or alcohol abuse
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
- Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
Key Trial Info
Start Date :
February 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 28 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04689685
Start Date
February 19 2021
End Date
March 28 2022
Last Update
September 14 2022
Active Locations (1)
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1
Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism
Bern, Switzerland