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DiabetesMoonwalkNCT05609175

Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep

An observational study of Diabetes and Hypoglycemia, run by University of Bern at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Hypoglycemia, Hyperglycemia
How many people
37 participants
Where
1 siteSwitzerland
Study dates
14 Feb 2023to 26 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

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

    Bern, 3010

Other trials in Switzerland

About this study

Official title: 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.

Medical subject headings
Diabetes Mellitus, Hypoglycemia, Hyperglycemia

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

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

Secondary outcomes (19)

  1. 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

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

  2. 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

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

  3. 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.

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

  4. 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

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

  5. 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.

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

  6. Time spent below 3.9 mmol/L

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

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

  7. Time spent below 3.0 mmol/L

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

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

  8. Time spent above 10.0 mmol/L

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

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

  9. Time spent above 13.9 mmol/L

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

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

  10. Course of nocturnal glucose levels

    Glucose will be measured with a CGM in mmol/L

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

  11. Course of nocturnal motion according to thermal camera measurements

    Glucose will be measured with a CGM and thermal camera measurements

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

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

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

  13. Glucose level at start of hyperglycemia symptoms

    Measured by CGM

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

  14. Glucose level at start of hypoglycemia symptoms

    Measured by CGM

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

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

    Glucose > 10.0 mmol/L

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

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

    Glucose < 3 mmol/L

    Motion data extracted from radar signals

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

  17. 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

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

  18. 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

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

  19. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start14 Feb 2023
  3. Primary completion26 Sep 2024
  4. Study completion26 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05609175
Sponsor's protocol ID
Moonwalk Pilot
Acronym
Moonwalk
Status last verified
Oct 2024
First submitted
1 Nov 2022
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes and Hypoglycemia, run by University of Bern at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609175.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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