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| Name | Class |
|---|---|
| Insel Gruppe AG, University Hospital Bern | OTHER |
| DCB Research AG | OTHER |
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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.
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with type 1 or type 2 diabetes mellitus on an insulin therapy or with non-insulin antidiabetic medication.
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| Name | Affiliation | Role |
|---|---|---|
| Markus Laimer, Prof.Dr.med. | Inselspital | Principal Investigator |
| Lilian Witthauer, Prof.Dr. | University of Bern | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University and University Hospital Bern | Bern | 3010 | Switzerland |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D007003 | Hypoglycemia |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |