Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Hypoglycemia, Hyperglycemia

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the receiver operator characteristics curve (AUROC) in detecting nocturnal level 1 hypoglycemia based on motion data obtained by radar signals | Level 1: glucose < 3.9 mmol/L Motion data obtained from radar signals | For the entire wear time of the diagnostic continuous glucose monitor (CGM), up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation coefficient between nocturnal glucose levels and motion | Nocturnal glucose will be measured with a CGM and motion will be measured with the radar signal as average dispersion index across all range bins in the range-doppler map | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Correlation coefficient between nocturnal glucose levels and motion | Nocturnal glucose will be measured with a CGM and motion will be measured with the radar signal as the average of detected points in the 3D point cloud from the radar sensor | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Correlation coefficient between nocturnal glucose levels and physiological data | Nocturnal glucose will be measured with a CGM and physiological data, i.e., heart rate, heart rate variability, respiratory rate, will be gathered from smartwatches. | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Correlation coefficient between nocturnal glucose levels and physiological data and radar data | Nocturnal glucose will be measured with a CGM and physiological data, i.e., heart rate, heart rate variability, respiratory rate, will be gathered from smartwatches. Motion will be measured with the radar signal as the average dispersion index across all range bins in the range-doppler map or the average of detected points in the 3D point cloud from the radar sensor | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Time spent in euglycemia | Glucose will be measured with a CGM. Euglycemia is defined as 4.0 - 10.0 mmol/L. The time will be illustrated as percent of CGM measurements within this range. | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Time spent below 3.9 mmol/L | Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements. | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Time spent below 3.0 mmol/L | Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements. | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Time spent above 10.0 mmol/L | Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements. | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Time spent above 13.9 mmol/L | Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements. | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Course of nocturnal glucose levels | Glucose will be measured with a CGM in mmol/L | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Course of nocturnal motion according to thermal camera measurements | Glucose will be measured with a CGM and thermal camera measurements | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Course of nocturnal hypoglycemia symptoms according to thermal camera measurements and/or physiological data |  | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Glucose level at start of hyperglycemia symptoms | Measured by CGM | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| Glucose level at start of hypoglycemia symptoms | Measured by CGM | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| AUROC in detecting nocturnal hyperglycemia based on motion data (radar signals) | Glucose > 10.0 mmol/L | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| AUROC in detecting nocturnal level 2 hypoglycemia based on motion data | Glucose < 3 mmol/L Motion data extracted from radar signals | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| AUROC in detecting nocturnal hyperglycemia, nocturnal level 1 and level 2 hypoglycemia based on motion data, physiological data, and Artificial Intelligence | Level 1: glucose < 3.9 mmol/L Level 2: glucose < 3 mmol/L motion data extracted from radar signals | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| AUROC in classifying nocturnal dysglycemia symptoms based on motion data, physiological data, and Artificial Intelligence | Dysglycemia: <4.0 and >10.0 mmol/L Motion data extracted from radar signals | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days | 
| AUROC in classifying motion patterns according to thermal camera measurements based on motion data, physiological data, and Artificial Intelligence | Motion data extracted from radar signals | For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days |