NCT05609175已完成不适用
Investigating the Relationship Between Nocturnal Glucose Levels and Motion During Sleep - The Moonwalk Pilot-Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Area under the receiver operator characteristics curve (AUROC) in detecting nocturnal level 1 hypoglycemia based on motion data obtained by radar signals
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Area under the receiver operator characteristics curve (AUROC) in detecting nocturnal level 1 hypoglycemia based on motion data obtained by radar signals
时间窗: 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
次要结局
- 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)
- Time spent below 3.9 mmol/L(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
- Time spent below 3.0 mmol/L(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(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
- Time spent above 10.0 mmol/L(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
- Time spent above 13.9 mmol/L(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
- Course of nocturnal glucose levels(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
- Course of nocturnal motion according to thermal camera measurements(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(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(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
- Glucose level at start of hypoglycemia symptoms(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)(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(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(For the entire wear time of the diagnostic continuous glucose monitor, up to 10 days)
研究者
研究点 (1)
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