Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 1 and Type 2 Diabetic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Primary Safety Outcome
研究概览
简要总结
This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting.
The type 1 and type 2 diabetic subjects in this study will have their glucose controlled to a range of 100-140 mg/dL by a novel artificial intelligence based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals during the 24 hour study period.
详细描述
Tight glucose control in the intensive care unit (ICU) setting is difficult to achieve. The investigators hypothesize that a closed loop glucose control system based on artificial intelligence (AI) will improve upon the glucose control currently achieved by the current open loop manual methods, and that this improved glucose control may improve the outcomes of critically ill patients, including those with COVID-19.
This Earl Feasibility Study will test the ability of a prototype artificial intelligence based closed loop glucose control system named FUSION, to provide safe and effective glucose control in subjects with type 1 and type 2 diabetes in a clinical research center (CRC) setting. Subjects with type 1 diabetes have been chosen as safe and effective glucose control is difficult to achieve in these subjects during meal challenges. Subjects with type 2 diabetes have been chosen as they are insulin resistant, which makes their insulin resistance profile similar to that of ICU patients. As this is the first in human study of a new medical device, the controlled environment of the CRC is preferable to the less controlled environment of an ICU setting.
The prototype FUSION system to be used in this study will consist to two Dexcom G6 continuous glucose monitors (CGM), the AI-based glucose control software run on an all-in-one medical computer, and two syringe pumps. The prototype system is housed on a medical cart. Based on the average glucose value of the two Dexcom G6 CGM's, and the rules of the FUSION systems AI-based glucose control software, the FUSION system will make rate adjustments every 5-10 minutes to the intravenous infusion rates of short acting insulin (NovoLog) and dextrose (D10NS) under its control, in an attempt to keep the subjects glucose in the range of 100-140 mg/dL. The FUSION system only requires entry of the subjects study identification number and weight in kilograms to initiate the system.
For safety reasons, the subjects will have their blood glucose independently measured every 10-60 minutes on the point of care Nova StatStrip system, throughout the 24 hour study period.
The study has halting criteria to avoid recurrent instances of severe hypoglycemia (< 54 mg/dL).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are 18-70 years of age, inclusive.
- •Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
- •Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 1 year.
- •Use insulin injections at home for glucose control and are on a stable insulin regimen without more than a 20% change in their total daily insulin dose during the previous 3 months. Their total daily insulin dose during the previous 3 months will be confirmed through a review of the subject's electronic health record, insulin prescriptions, and insulin pump settings (if applicable).
- •Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
- •Have a hemoglobin in the normal range for sex:
- •Females: 12-15.5 grams/dL.
- •Males: 13.5-17.5 grams/dl.
- •Have adequate venous access sites in upper extremities.
- •Body weight between 40 - 150 kg.
排除标准
- •Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
- •Have a known hypersensitivity to any of the components of study treatment.
- •Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
- •Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
- •Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
- •Have a clinically significant history or presence of any of the following conditions:
- •Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
- •Has an estimated glomerular filtration rate (GFR) <60 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
- •Type 2 diabetic subjects who have a C-peptide level less than 0.2 nmol/L (these subjects will be referred to their primary care doctor or endocrinologist for further work up).
- •Have congestive heart failure of class 1 or greater on the New York Heart Association (NYHA) classification system.
- •Have a history of seizures.
- •Have a history of cerebrovascular accident.
- •Have a history of ischemic heart disease.
- •For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
- •Refuse to agree to a pregnancy test at the time of enrollment.
- •Have a positive urine pregnancy test at the time of enrollment.
- •Have a positive COVID-19 test within 14 days of visit
- •Have any COVID-19 related symptoms in the 14-day period prior to visit
- •Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.
结局指标
主要结局
Primary Safety Outcome
时间窗: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours
Percent of All Glucose Values Within Glucose Range \< 70 mg/dL
Primary Efficacy Outcome
时间窗: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours
Percent of All Glucose Values Within Glucose Range 70-180 mg/dL
次要结局
- Average Glucose Value in mg/dL(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Percent Coefficient of Variation of Glucose(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Weight in Kilograms(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Body Mass Index(As measured at the start of the closed loop glucose control session)
- Total Daily Dose of Insulin in Units/Kilogram(As measured prior to the start of the closed loop glucose control session)
- Hemoglobin A1c Percentage Level(As measured within 2 weeks of the start of the closed loop glucose control session)
- C-Peptide Level in ng/mL(As measured from a blood draw taken within 2 weeks of the start of the closed loop glucose control session)
- Percent of All Glucose Values Within Glucose Range < 54 mg/dL(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Percent of All Glucose Values Within Glucose Range > 180 mg/dL(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Percent of All Glucose Values Within Glucose Range > 250 mg/dL(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Average Glucose Value in mg/dL(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Percent Coefficient of Variation of Glucose(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Weight in Kilograms(From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours)
- Body Mass Index(As measured at the start of the closed loop glucose control session)
- Total Daily Dose of Insulin in Units/Kilogram(As measured prior to the start of the closed loop glucose control session)
- Hemoglobin A1c Percentage Level(As measured within 2 weeks of the start of the closed loop glucose control session)
- C-Peptide Level in ng/mL(As measured from a blood draw taken within 2 weeks of the start of the closed loop glucose control session)