Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

Diabetes Clinical Trial

— Moonwalk  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609175
• Other study ID #: Moonwalk Pilot
• Status: Recruiting
• Start date: February 14, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Bern
• Contact: Witthauer Lilian, Prof.Dr.
• Phone: +41 31 664 22 77
• Email: lilian.witthauer[@]med.unibe.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Hyperglycemia
• Hypoglycemia

Locations

Country	Name	City	State
Switzerland	Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University and University Hospital Bern	Bern

Sponsors (3)

Lead Sponsor	Collaborator
University of Bern	DCB Research AG, Insel Gruppe AG, University Hospital Bern

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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