Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep (Moonwalk)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hyperglycemia; Hypoglycemia; Diabetes

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Witthauer Lilian, Prof.Dr.; Phone Number: +41 31 664 22 77; Email: lilian.witthauer@med.unibe.ch

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Recruiting
    • Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University and University Hospital Bern
    • Contact: Lilian Witthauer, Prof.Dr.; Phone Number: +41 31 664 22 77; Email: lilian.witthauer@med.unibe.ch
    • Principal Investigator: Markus Laimer, Prof.Dr.med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with type 1 or type 2 diabetes mellitus on an insulin therapy or with non-insulin antidiabetic medication.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Bern
• Collaborators: University Hospital Inselspital, Berne; DCB Research AG
• Investigators: Principal Investigator: Markus Laimer, Prof.Dr.med., Inselspital; Study Director: Lilian Witthauer, Prof.Dr., University of Bern

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2023
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: November 1, 2022
• First Submitted That Met QC Criteria: November 1, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2023
• Last Update Submitted That Met QC Criteria: May 11, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Hypoglycemia
• Other Study ID Numbers: Moonwalk Pilot

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No