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
Status
Type
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the participation requirements?
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