Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

NCT05609175 | Completed

• 1 other identifier: Moonwalk Pilot
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes; Hypoglycemia; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Correlation coefficient between nocturnal glucose levels and motion

  For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days

• Correlation coefficient between nocturnal glucose levels and motion

  For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days

• Correlation coefficient between nocturnal glucose levels and physiological data

  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

  For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days

• Time spent in euglycemia

  For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead
• Insel Gruppe AG, University Hospital Bern: collaborator
• DCB Research AG: collaborator

Study Sites (1)

Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University and University Hospital Bern

Bern, 3010, Switzerland

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypoglycemia; Hyperglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Markus Laimer, Prof.Dr.med.

  Inselspital

  PRINCIPAL INVESTIGATOR

• Lilian Witthauer, Prof.Dr.

  University of Bern

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 8, 2022
• Study Start: February 14, 2023
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Locations

CH (1)