NCT00361608撤回不适用
Monitoring of Nocturnal Hypoglycemia Using EarlySense Monitoring Device
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
研究概览
简要总结
This study observes the continuous measurement of breathing patterns, heart rate, restlessness, and tremor in sleep using the EarlySense ES 16 device as a tool in the management of hypoglycemia in pediatric type I diabetes patients.
详细描述
The study patients are children, 12-18 years old, suffering from type I diabetes. Each patient will participate in the trial for 30 days.
During this period of time the patients' breathing patterns, heart rate, restlessness and tremor in sleep will be measured by the EarlySense device which is put in the patient's bed. These measured values will be compared to:
- glucose values measured by a "Guardian RT" device - an approved device for CBGM - Continuous Blood Glucose Measurement;
- glucose levels tested by SBGM -Self Blood Glucose Measurement.
These comparisons will show whether the EarlySense device is applicable in predicting hypoglycemia events in type I diabetes patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 12-18 years
- •Diagnosis of type I diabetes for at least a year
- •Home close to participating center
- •Guardian able and willing to cooperate with the trial for at least 1 month and prepared to sign the Informed Consent Form.
排除标准
- •Recent (within 3 months) admission to emergency room or intensive care unit (ICU) due to any condition unrelated directly to diabetes.
- •Any other pre-existing medical pathology unrelated to diabetes.
- •Inability of the patient or his guardian to use the Guardian RT.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Prediction and Prevention of Nocturnal Hypoglycemia in Persons With Type 1 Diabetes Using Machine Learning TechniquesType1diabetesHypoglycemiaNCT03711656Hospital Clinic of Barcelona10
招募中
不适用
Early Detection of noctUrnal hypoglyCemiA in TypE 2 Diabetes Using Pulse Rate Variability Measured by a Smartwatch(EDUCATED-Smartwatch)HypodlycemiaNCT05636007Sun Yat-sen University150
Unknown
4 期
Real-Time Continuous Glucose Monitoring in Pre-School Children With Type-1 Diabetes MellitusDiabetes MellitusNCT01016457Sheba Medical Center15
撤回
不适用
EarlySense Monitoring Device Evaluation on COPD, CHF and Pneumonia PatientsCOPD PatientsNCT00361426EarlySense Ltd.
已完成
不适用
Role of CGMS Usage in Predicting Risk for HypoglycemiaType 2 Diabetes MellitusHypoglycemiaNCT03481530University of Minnesota41