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Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

Sponsored by University of Bern

About this trial

Last updated 2 years ago

Study ID

Moonwalk Pilot

Status

Recruiting

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended a year ago

What is this trial 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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting