Feasibility Evaluation of an Artificial Pancreas With an Enhanced Model Predictive Control (eMPC) Controller and a Health Monitoring System (HMS) With a Glucose Prediction Trust Index
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
研究概览
简要总结
The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.
详细描述
This is a feasibility study of an artificial pancreas (AP) system with our previously validated target eMPC and HMS algorithms, with the addition of a trust index of the predicted glucose value integrated into the portable Artificial Pancreas System (pAPS). The system will be evaluated on up to 20 subjects, with the goal of 10 subjects completing a 48-hour closed-loop session at one clinical site (William Sansum Diabetes Center). During the session subjects will bolus for all meals and snacks and perform a 45-minute walking session.
The purpose of this pilot study is to establish that closed-loop insulin delivery with a target enchanted model predictive control (eMPC)/Health Monitoring System (HMS) algorithms with a trust index of the predicted glucose value is safe and effective, to analyze and learn to improve upon the accuracy of the predicted glucose values, and to collect efficacy data to inform a future larger study.
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%, as performed by point of care or central laboratory testing. A1c will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- •Serum creatinine of < 2.0 mg/dL. Serum creatinine will be assessed at the screening visit, or if already completed within 2 months of the screening visit, the prior lab value may be used in lieu of repeating this assessment.
- •Bolus for all meals and snacks that contain ≥ 5 grams of carbohydrate.
- •Willing to perform at least 7 fingerstick blood glucose tests a day.
- •Willing to refrain from taking acetaminophen products for the duration of the clinical trial. If acetaminophen is taken, subject is to avoid making any insulin dosing decisions based on CGM for at least 12 hours.
- •Willing to abide by the study protocol and use study-provided devices, including the Omnipod, Dexcom CGM, glucometer, ketone meter and pAPS tablet.
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.
- •One or more seizures in the past year.
- •Screening A1c ≥ 10% or serum creatinine ≥ 2.0 mg/dL.
- •Any condition that could interfere with participating in the trial, based on investigator judgment.
- •Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals), defined as using any of these medications within 30 days of the screening visit or during the study.
- •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
The artificial pancreas device will employ its enhanced Model Predictive Control (MPC) algorithm with a target glucose level of 110 mg/dL with a trust index for MPC-predicted glucose values, weighing future glucose predictions and only acting on predictions with higher weight in the trust index. The Health Monitoring System algorithm uses the same CGM data as the MPC control algorithm but utilizes a separate algorithm for trending and predictions of future glucose values. Using a redundant and independent algorithm is an important safety feature of the overall AP device.
干预措施: Artificial Pancreas Device (Device)
结局指标
主要结局
Percent time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM).
时间窗: 48 hours
The primary endpoint for this pilot study will be time within the target glucose range of 70-180 mg/dl overall as assessed by continuous glucose monitoring (CGM), during closed-loop use, determining if the combination of eMPC and the assessment of trust index can provide safe and effective glucose control.
次要结局
- Percent time within the target glucose range of 70-140 mg/dl during closed-loop use.(48 hours)
- Standard Deviation and Coefficient of Variation of glucose values(48 hours)
- Insulin Doses Given(48 hours)
- Number of treatments given for hypoglycemia (defined as carbohydrates given for treatment of a documented or suspected low blood sugar), during the 48 hours of closed-loop use.(48 hours)
- Failure analysis of the devices/connectivity issues that may occur (# disconnects and device restarts).(48 hours)
- Assessment of the trust index predictions vs. standard eMPC glucose predictions.(48 hours)
- Frequency of hypoglycemia during closed-loop use.(48 hours)
- Frequency of hyperglycemia during closed-loop use.(48 hours)
- Percent time glucose is within range 70-150 mg/dl postprandial within 5 hours following meals, during closed-loop use.(48 hours)
- Markers of hypo- and hyperglycemia(48 hours)
- Number of alerts given by the HMS to prevent hypoglycemia(48 hours)
研究者
Jordan Pinsker
Research Physician
Sansum Diabetes Research Institute