The RADAR Study - Wearable-Based Dysglycemia Detection and Warning in Diabetes
NCT ID: NCT04689685
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2021-02-19
2022-03-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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Wearing smartwatch and continous glucose sensor
Patients will be wearing a smartwatch and a continuous glucose meter (CGM) over a maximum duration of 3 months in an outpatient setting.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Diabetes mellitus treated with multiple daily insulin injections (MDI) or continuous subcutaneous insulin infusion (CSII)
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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ETH Zurich
OTHER
University of St.Gallen
OTHER
Insel Gruppe AG, University Hospital Bern
OTHER
Responsible Party
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Principal Investigators
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Christoph Stettler, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University of Bern
Locations
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Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism
Bern, , Switzerland
Countries
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References
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Lehmann V, Foll S, Maritsch M, van Weenen E, Kraus M, Lagger S, Odermatt K, Albrecht C, Fleisch E, Zueger T, Wortmann F, Stettler C. Noninvasive Hypoglycemia Detection in People With Diabetes Using Smartwatch Data. Diabetes Care. 2023 May 1;46(5):993-997. doi: 10.2337/dc22-2290.
Other Identifiers
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RADAR
Identifier Type: -
Identifier Source: org_study_id
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