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Completed

NCT Number: NCT05609175

Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

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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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: For the entire wear time of the diagnostic continuous glucose monitor (CGM), up to 10 days

    Level 1: glucose < 3.9 mmol/L

    Motion data obtained from radar signals

Secondary outcomes

  1. Correlation coefficient between nocturnal glucose levels and motion

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

    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

  2. Correlation coefficient between nocturnal glucose levels and motion

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

    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

  3. Correlation coefficient between nocturnal glucose levels and physiological data

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

    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.

  4. Correlation coefficient between nocturnal glucose levels and physiological data and radar data

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

    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

  5. Time spent in euglycemia

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

    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.

  6. Time spent below 3.9 mmol/L

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

    Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements.

  7. Time spent below 3.0 mmol/L

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

    Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements.

  8. Time spent above 10.0 mmol/L

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

    Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements.

  9. Time spent above 13.9 mmol/L

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

    Glucose will be measured with a CGM. The time will be illustrated as percent of CGM measurements.

  10. Course of nocturnal glucose levels

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

    Glucose will be measured with a CGM in mmol/L

  11. Course of nocturnal motion according to thermal camera measurements

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

    Glucose will be measured with a CGM and thermal camera measurements

  12. Course of nocturnal hypoglycemia symptoms according to thermal camera measurements and/or physiological data

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

  13. Glucose level at start of hyperglycemia symptoms

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

    Measured by CGM

  14. Glucose level at start of hypoglycemia symptoms

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

    Measured by CGM

  15. AUROC in detecting nocturnal hyperglycemia based on motion data (radar signals)

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

    Glucose > 10.0 mmol/L

  16. AUROC in detecting nocturnal level 2 hypoglycemia based on motion data

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

    Glucose < 3 mmol/L

    Motion data extracted from radar signals

  17. AUROC in detecting nocturnal hyperglycemia, nocturnal level 1 and level 2 hypoglycemia based on motion data, physiological data, and Artificial Intelligence

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

    Level 1: glucose < 3.9 mmol/L

    Level 2: glucose < 3 mmol/L motion data extracted from radar signals

  18. AUROC in classifying nocturnal dysglycemia symptoms based on motion data, physiological data, and Artificial Intelligence

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

    Dysglycemia: <4.0 and >10.0 mmol/L

    Motion data extracted from radar signals

  19. AUROC in classifying motion patterns according to thermal camera measurements based on motion data, physiological data, and Artificial Intelligence

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

    Motion data extracted from radar signals

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Collaborators

  • DCB Research AG
  • Insel Gruppe AG, University Hospital Bern

Registry information

Official study title

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

Acronym: Moonwalk

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 8, 2022
Registry last updated
Oct 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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