The RADAR Study - Wearable-Based Dysglycemia Detection and Warning in Diabetes

NCT ID: NCT04689685

Last Updated: 2022-09-14

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-19

Study Completion Date

2022-03-28

Brief Summary

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The study RADAR aims at developing a wearable based dysglycemia detection and warning system for patients with diabetes mellitus using artificial intelligence.

Detailed Description

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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-dependent diabetes mellitus will be wearing a continuous glucose meter (CGM) and a smartwatch for a maximum duration of 3 months in an outpatient setting. The gathered data will be used to develop a non-invasive and wearable based dysglycemia detection and warning system using artificial intelligence.

Conditions

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Diabetes Mellitus, Insulin-Dependent Diabetes

Study Design

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Observational Model Type

OTHER

Study Time Perspective

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ETH Zurich

OTHER

Sponsor Role collaborator

University of St.Gallen

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Switzerland

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.

Reference Type DERIVED
PMID: 36805169 (View on PubMed)

Other Identifiers

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RADAR

Identifier Type: -

Identifier Source: org_study_id

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