Clinical trial NCT05609175: Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep
Official title: Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep - The Moonwalk Pilot-Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypoglycemia
Hyperglycemia
Lead sponsor: University of Bern
Sponsor class: OTHER
Collaborators: name: Insel Gruppe AG, University Hospital Bern
name: DCB Research AG
First posted: 2022-11-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area under the receiver operator characteristics curve (AUROC) in detecting nocturnal level 1 hypoglycemia based on motion data obtained by radar signals
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor (CGM), up to 10 days
Secondary outcomes:
measure: Correlation coefficient between nocturnal glucose levels and motion
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Correlation coefficient between nocturnal glucose levels and motion
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Correlation coefficient between nocturnal glucose levels and physiological data
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Correlation coefficient between nocturnal glucose levels and physiological data and radar data
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Time spent in euglycemia
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Time spent below 3.9 mmol/L
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Time spent below 3.0 mmol/L
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Time spent above 10.0 mmol/L
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Time spent above 13.9 mmol/L
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Course of nocturnal glucose levels
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Course of nocturnal motion according to thermal camera measurements
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Course of nocturnal hypoglycemia symptoms according to thermal camera measurements and/or physiological data
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Glucose level at start of hyperglycemia symptoms
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: Glucose level at start of hypoglycemia symptoms
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: AUROC in detecting nocturnal hyperglycemia based on motion data (radar signals)
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: AUROC in detecting nocturnal level 2 hypoglycemia based on motion data
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: AUROC in detecting nocturnal hyperglycemia, nocturnal level 1 and level 2 hypoglycemia based on motion data, physiological data, and Artificial Intelligence
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: AUROC in classifying nocturnal dysglycemia symptoms based on motion data, physiological data, and Artificial Intelligence
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
measure: AUROC in classifying motion patterns according to thermal camera measurements based on motion data, physiological data, and Artificial Intelligence
timeFrame: For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital Bern, University and University Hospital Bern
Study officials:
affiliation: Inselspital
name: Markus Laimer, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Lilian Witthauer, Prof.Dr.
role: STUDY_DIRECTOR
References: