Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep (Moonwalk)

University of Bern

Status: Completed

Conditions: Hypoglycemia; Diabetes; Hyperglycemia

Study type: Observational

Funder types: Other

Identifiers

NCT05609175

Moonwalk Pilot

Details and patient eligibility

About

In this study the investigators will explore whether the motion during sleep of people with diabetes changes as a function of the blood glucose levels. The motion will be assessed with a radar sensor, a thermal camera, and wrist worn smartwatches. Additionally, participants will answer a short daily questionnaire. Data will be collected for 10 days and analyzed at the end of the study.

Enrollment: 37 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Informed consent as documented by signature
• Age ≥ 18 years
• Patients at the outpatient clinics or from a referring diabetologist with a diagnostic CGM according to best medical practice
• Patients with diabetes mellitus on an insulin therapy or with non-insulin antidiabetic medication with the potential to induce hypoglycemia
• HbA1c value between 6% and 10% (inclusive) within 6 months prior to inclusion

Exclusion criteria

• Wearables cannot be attached around the wrist of the patient
• Known allergies to components of the wearables
• Female subjects: pregnancy, lactation period, lack of a negative urine pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use a contraception during the study (for sexually active subjects of childbearing potential)
• Known cardiac arrhythmia (e.g., atrial flutter or fibrillation, Atrioventricular-reentry tachycardia, Atrioventricular 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
• Any illness or use of medications that could affect sleep patterns (including sleep apnea)
• Dependency from the sponsor or the clinical investigator
• Participation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation