Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep (NCT05609175) | Clinical Trial Compass
CompletedNot Applicable
Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep
Switzerland37 participantsStarted 2023-02-14
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 apne…
What they're measuring
1
Area under the receiver operator characteristics curve (AUROC) in detecting nocturnal level 1 hypoglycemia based on motion data obtained by radar signals
Timeframe: For the entire wear time of the diagnostic continuous glucose monitor (CGM), up to 10 days