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Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep | Clinical Trials | Clareo Health

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Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep - The Moonwalk Pilot-Study

NCT05609175•University of Bern

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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)
+2 more criteria

Locations (1)

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

Bern, Switzerland

Key Dates

Start Date

February 14, 2023

Primary Completion Date

September 26, 2024

Completion Date

September 26, 2024

Last Updated

October 18, 2024

Enrollment

ACTUAL participants

Conditions

DiabetesHypoglycemiaHyperglycemia

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 18, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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