Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

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.

Inclusion Criteria:Informed consent as documented by signatureAge ≥ 18 yearsPatients at the outpatient clinics or from a referring diabetologist with a diagnostic CGM according to best medical practicePatients with diabetes mellitus on an insulin therapy or with non-insulin antidiabetic medication with the potential to induce hypoglycemiaHbA1c value between 6% and 10% (inclusive) within 6 months prior to inclusionExclusion Criteria:Wearables cannot be attached around the wrist of the patientKnown allergies to components of the wearablesFemale 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-blockersDrug or alcohol abuseInability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participantPhysical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigatorAny illness or use of medications that could affect sleep patterns (including sleep apnea)Dependency from the sponsor or the clinical investigatorParticipation in another investigation with an investigational drug or a pre-market medical device within the 30 days preceding and during the present investigation