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

Insel Gruppe AG, University Hospital Bern

Status: Completed

Conditions: Diabetes; Diabetes Mellitus, Insulin-Dependent

Treatments: Other: Wearing smartwatch and continous glucose sensor

Study type: Observational

Funder types: Other

Identifiers

NCT04689685

RADAR

Details and patient eligibility

About

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

Full 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-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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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