Closed Loop Glucose Control in a Simulated ICU Setting
Demonstration of an Expert Rule-Based Automated Insulin Delivery (AID) System for People With Type 1 and Type 2 Diabetes
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
The persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg/dL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.
研究概览
详细说明
Tight glucose control in the intensive care unit (ICU) setting is difficult to achieve. The investigators hypothesize that a closed loop glucose control system that is rule-based 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.
This Earl Feasibility Study will test the ability of a prototype rule-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 a safety 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 rule-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 algorithms of the FUSION systems rule-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).
The average of the two CGM's, that is used by the FUSION system for glucose control, will be used for statistical analysis.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Leon M DeJournett, MD
- 电话号码：1-828-337-9960
- 邮箱：leondej@idealmedtech.com
研究联系人备份
- 姓名：Jeremy DeJournett, EE
- 电话号码：1-828-545-9110
- 邮箱：jeremy@idealmedtech.com
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:
- 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 3 months.
- Use insulin injections at home for glucose control.
- Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
Have a hemoglobin in the range for sex:
- Females: 7-15.5 grams/dL.
- Males: 7-17.5 grams/dl.
- Have adequate venous access sites in upper extremities.
- Body weight between 40 - 150 kg.
Exclusion Criteria:
- 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 GFR <30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
- Have congestive heart failure greater than class 1 on the 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:
- Pregnant.
- 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 Influenza or COVID test within 14 days of visit 3.
- Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.
- Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3.
- Are currently being treated with Hydroxyurea, a medication which may cause the Dexcom G6 CGM to produce glucose readings that are higher than the actual glucose value.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：融合闭环葡萄糖控制系统安全研究
所有受试者将使用融合闭环葡萄糖控制系统进行处理长达24小时
|
FUSION 系统将用于将受试者的葡萄糖控制在 100-140 mg/dL 的范围内。
数据将收集长达 24 小时，或在研究课程提前结束时收集。
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Primary Safety Measure
大体时间：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
|
The percentage of all glucose values <70 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 up to 24 hours
|
|
Primary Efficacy Measure
大体时间：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
|
The percentage of all glucose values within the glucose range of 70-180 mg/dL
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percent of All Glucose Values Within Glucose Range <54 mg/dL
大体时间：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
|
The percentage of all glucose values that are less than 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 54-69 mg/dL
大体时间：From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.
|
The percentage of all glucose values that are within the glucose range of 54-69 mg/dL
|
From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.
|
|
Number of Hypoglycemic Events (<70 mg/dL)
大体时间：From beginning of use of the FUSION System until end of use of the FUSION System, which will be a period of time of up to 24 hours.
|
The total number of hypoglycemic events less than 70 mg/dL as measured by a continuous series of glucose values less than 70 mg/dL for at least 15 minutes duration.
|
From beginning of use of the FUSION System until 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 70-100 mg/dL
大体时间：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
|
The percentage of all glucose values within the glucose range of 70-100 mg/dL
|
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 70-140 mg/dL
大体时间：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
|
The percentage of all glucose values within the glucose range of 70-140 mg/dL
|
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 100-140 mg/dL
大体时间：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
|
The percentage of all glucose values within the glucose range of 100-140 mg/dL
|
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 >140 mg/dL
大体时间：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
|
The percentage of all glucose values greater than 140 mg/dL
|
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 >180 mg/dL
大体时间：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
|
The percentage of all glucose values that are greater than 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
大体时间：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
|
The percentage of all glucose values that are greater than 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
大体时间：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
|
The average of all measured glucose values 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
|
|
Measure of dispersion - Coefficient of Variation
大体时间：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
|
The Coefficient of variation of glucose will be calculated by dividing the standard deviation of the average glucose value by the average glucose value, then multiplying this value by 100.
|
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
|
|
Clarke Error Grid Analysis of Continuous Glucose Monitor Data
大体时间：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
|
The study data will be used to determine the percentage of the two Dexcom G6 CGM's glucose values in each zone using a Clarke error grid analysis.
This same calculation will be performed on the average of the two Dexcom G6 CGM systems used by the FUSION system for purposes of glucose control.
|
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
|
|
FDA integrated Continuous Glucose Monitor Standards
大体时间：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
|
The study data will be used to determine if each individual Dexcom G6 CGM system, and their average value meet FDA criteria for integrated Continuous Glucose Monitor (iCGM) accuracy for the glucose zones <70 mg/dL, 70-180 mg/dL, and >180 mg/dL.
|
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
|
|
Hemoglobin A1c Percentage Level
大体时间：As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
The subjects hemoglobin A1c measurement from a blood draw taken within 2 weeks of the start of the closed loop glucose control session
|
As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
|
C-Peptide Level
大体时间：As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
The subjects C-peptide level will be measured prior to the start of the closed loop glucose control session.
|
As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
|
|
Total Daily Dose of Insulin in Units/Kilogram
大体时间：As documented within two weeks prior to the start of the 24-hour closed loop glucose control session
|
The subjects total daily dose of insulin used prior to the start of the closed loop glucose control session was calculated by adding up all of the insulin doses used by the subjects (both short and long acting insulin) in units and dividing this value by the subjects weight in Kilograms
|
As documented within two weeks prior to the start of the 24-hour closed loop glucose control session
|
|
Weight in Kilograms
大体时间：As measured just prior to the start of the 24-hour closed loop glucose control session
|
Average weight in kilograms of the subjects
|
As measured just prior to the start of the 24-hour closed loop glucose control session
|
|
Body Mass Index
大体时间：As measured just prior to the start of the 24-hour closed loop glucose control session
|
The body mass index will be calculated by dividing the subjects weight in kilograms by the square of their height in meters
|
As measured just prior to the start of the 24-hour closed loop glucose control session
|
合作者和调查者
调查人员
- 研究主任：Leon M DeJournett, MD、Ideal Medical Technologies
- 首席研究员：Francisco Pasquel, MD, MPH、Emory School Of Medicine
出版物和有用的链接
一般刊物
- DeJournett L, DeJournett J. In Silico Testing of an Artificial-Intelligence-Based Artificial Pancreas Designed for Use in the Intensive Care Unit Setting. J Diabetes Sci Technol. 2016 Nov 1;10(6):1360-1371. doi: 10.1177/1932296816653967. Print 2016 Nov.
- DeJournett J, DeJournett L. Comparative Simulation Study of Glucose Control Methods Designed for Use in the Intensive Care Unit Setting via a Novel Controller Scoring Metric. J Diabetes Sci Technol. 2017 Nov;11(6):1207-1217. doi: 10.1177/1932296817711297. Epub 2017 Jun 22.
- DeJournett J, Nekludov M, DeJournett L, Wallin M. Performance of a closed-loop glucose control system, comprising a continuous glucose monitoring system and an AI-based controller in swine during severe hypo- and hyperglycemic provocations. J Clin Monit Comput. 2021 Apr;35(2):317-325. doi: 10.1007/s10877-020-00474-2. Epub 2020 Jan 31.
- DeJournett L. Essential elements of the native glucoregulatory system, which, if appreciated, may help improve the function of glucose controllers in the intensive care unit setting. J Diabetes Sci Technol. 2010 Jan 1;4(1):190-8. doi: 10.1177/193229681000400124.
- Sardu C, D'Onofrio N, Balestrieri ML, Barbieri M, Rizzo MR, Messina V, Maggi P, Coppola N, Paolisso G, Marfella R. Outcomes in Patients With Hyperglycemia Affected by COVID-19: Can We Do More on Glycemic Control? Diabetes Care. 2020 Jul;43(7):1408-1415. doi: 10.2337/dc20-0723. Epub 2020 May 19.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- 2025P013846
- 5R44DK133084-02 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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