Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

NCT ID: NCT05609175

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 37 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2024-09-26

Brief Summary

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.

Conditions

Diabetes; Hypoglycemia; Hyperglycemia

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role: collaborator

DCB Research AG

OTHER

Sponsor Role: collaborator

University of Bern

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Laimer, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Inselspital

Lilian Witthauer, Prof.Dr.

Role: STUDY_DIRECTOR

University of Bern

Locations

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University and University Hospital Bern

Bern, , Switzerland

Countries

Switzerland

Other Identifiers

Moonwalk Pilot

Identifier Type: -

Identifier Source: org_study_id