Inpatient Safety and Feasibility Evaluation of the Zone-MPC Control Algorithm Integrated Into the APS APP
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Percent time in glucose range 70-180 mg/dL
研究概览
简要总结
This clinical trial is a safety and feasibility study to assess the performance of artificial pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring System (HMS) algorithms embedded into the APS APP platform.
详细描述
The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years old at a single clinical site (Sansum Diabetes Research Institute), who will complete a 48-hour closed-loop (CL) session in an observed CRC environment with medical staff present. During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session while supervised by medical staff. The AP system used consists of an insulin pump, a CGM sensor, and a phone app (the Artificial Pancreas System [APS] phone app).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 and ≤ 75 years at the time of screening.
- •Clinical diagnosis of type 1 diabetes for at least one year.
- •Has been using an insulin pump for at least 6 months at the time of screening.
- •HbA1c < 10.5%.
- •Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- •Willing to perform at least 7 fingerstick blood glucose tests a day.
- •If using Apidra (insulin glulisine) at home and planning to use the Tandem t:AP pump for the closed-loop session, willing to switch to Novolog or Humalog for the closed-loop session.
- •Willing to refrain from taking acetaminophen products for the duration of the clinical trial.
- •Willing to abide by the study protocol and use study-provided devices, including the Omnipod OR Tandem Pump, Dexcom CGM, glucometer, ketone meter and APS APP on the study phone device.
排除标准
- •Pregnancy
- •One or more episodes of hypoglycemia requiring an emergency room visit or hospitalization in the past 6 months.
- •One or more episodes of hyperglycemia requiring an emergency room visit or hospitalization in the past 6 months.
- •Known unstable cardiac disease or untreated cardiac disease, as revealed by history or physical examination.
- •Dermatological conditions that would preclude wearing a CGM sensor or Pod/infusion site.
- •One or more seizures in the past year.
- •Any condition that could interfere with participating in the trial, based on investigator judgment.
- •Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
研究组 & 干预措施
Artificial Pancreas App
After completing a 1 week open-loop run in period, subjects will use the APS APP for a 48-hour period in an observed transitional environment.
干预措施: Artificial Pancreas App (Device)
结局指标
主要结局
Percent time in glucose range 70-180 mg/dL
时间窗: 48 hours
Time in target glucose range overall
次要结局
- Percent time glucose > 180 mg/dL(48 hours)
- Percent time in glucose range 80-140 mg/dL overnight(48 hours)
- Percent time in glucose range 70-150 mg/dl postprandial within 5 hours following meals(48 hours)
- Percent time glucose > 250 mg/dL(48 Hours)
- Percent time glucose < 70 mg/dL(48 hours)
- Percent time glucose < 54 mg/dL(48 hours)
- Connectivity Analysis (Number of Connection Errors Between devices)(48 Hours)