Assessment of the Efficacy of Closed-loop Insulin Therapy (Artificial Pancreas) on the Control of Type 1 Diabetes in Prepubertal Child in Free-life: Comparison Between Nocturnal and 24-hour Use on 18 Weeks, Followed by an Extension on 18 Weeks
试验速览
- 阶段
- 不适用
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data
研究概览
简要总结
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).
详细描述
The study is a randomized trial preceded by a run-in period and followed by a non-randomized study extension. After 3 weeks of outpatient use of study pump (1 week) and study pump+CGM (2weeks) as run-in period, patient and parents will be admitted for 4-hour training to closed-loop (AP) mode. Following randomization (1:1), patient will be allocated to '24-hour' use of AP or 'dinner and overnight AP mode/day time pump and CGM use' for the next 18-week period. A hotline phone number will be given to the patient and parents so that they can contact the study staff as needed. A logbook will be provided to collect details about hypoglycemic and hyperglycemic episodes, physical activity and noticeable events. Phone calls will be scheduled between investigator and patient+parents 48 hours, 1 week and 2 weeks after AP mode initiation. Potential misbehaviors will be corrected and all questions answered. If needed, AP parameters may be revised and reconfigured. Hospital visits will be scheduled 6, 12 and 18 weeks after AP mode initiation for the same purposes, plus HbA1c measurement at week 12 and 18. At 18-week visit, a study extension for a further 18-week period will be initiated. AP mode that will be prescribed to all patients will depend from an independent DSMB decision based upon study safety data collected after 6 and 12 weeks from the first 30 included patients. Visits will occur at week 27 (safety follow-up) and 36 (final visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment of diabetes by insulin pump since > 6 months
- •HbA1c level < 10%
排除标准
- •Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- •Any associated chronic disease or therapy (except insulin) affecting glucose metabolism
结局指标
主要结局
Percent of time spent in the 70-180 mg/dl glucose range assessed on daily CGM data
时间窗: 18 weeks
% time blood glucose in 70-180 mg/dl range
次要结局
- Percent of time spent in the 70-140 mg/dl glucose range assessed on daily CGM data(18 and 36 weeks)
- HbA1c level measured at week 12, 18, 27 and 36(12,18, 27 and 36 weeks)
- Percent of time spent with glucose level < 70, 60 and 50 mg/dl, assessed on daily CGM data(18 and 36 weeks)
- Mean glucose level assessed on daily CGM data(18 and 36 weeks)
- Percent of time with AP functional, discriminating between each component failure modes(18 and 36 weeks)
- Percent of time spent with glucose level > 180 and 300 mg/dl, assessed on daily CGM data(18 and 36 weeks)
- Number of needed interventions by the patients or care providers to treat hypoglycemia(18 and 36 weeks)
- Score of the Artificial Pancreas Acceptance Questionnaire(18 and 36 weeks)