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Closed Loop Glucose Control in a Simulated ICU Setting

2026년 6월 9일 업데이트: Ideal Medical Technologies

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

6

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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:

    1. Are 18-70 years of age, inclusive.
    2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
    3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 3 months.
    4. Use insulin injections at home for glucose control.
    5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.

    6. Have a hemoglobin in the range for sex:

      1. Females: 7-15.5 grams/dL.
      2. Males: 7-17.5 grams/dl.
    7. Have adequate venous access sites in upper extremities.
    8. Body weight between 40 - 150 kg.

Exclusion Criteria:

  1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
  2. Have a known hypersensitivity to any of the components of study treatment.
  3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
  4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
  5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.

  6. Have a clinically significant history or presence of any of the following conditions:

    1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
    2. Has an estimated GFR <30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
    3. Have congestive heart failure greater than class 1 on the NYHA classification system.
    4. Have a history of seizures.
    5. Have a history of cerebrovascular accident.
    6. Have a history of ischemic heart disease.

  7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:

    1. Pregnant.
    2. Refuse to agree to a pregnancy test at the time of enrollment.
    3. Have a positive urine pregnancy test at the time of enrollment.
  8. Have a positive Influenza or COVID test within 14 days of visit 3.
  9. Have any viral lower respiratory related symptoms (e.g., cough, chest tightness, respiratory distress) in the 14-day period prior to visit 3.
  10. Have a known unprotected Influenza or COVID exposure in the 14-day period prior to visit 3.
  11. 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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 퓨전 폐쇄 루프 포도당 제어 시스템 안전 연구
모든 피험자는 퓨전 폐쇄 루프 포도당 제어 시스템으로 최대 24 시간 동안 치료됩니다.
장치: FUSION 폐쇄 루프 포도당 제어 시스템
FUSION 시스템은 피험자의 포도당을 100-140 mg/dL 범위로 조절하는 데 사용됩니다. 데이터는 최대 24시간 동안 또는 연구 세션의 조기 종료 시 수집됩니다.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Safety Measure
기간: 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
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Percent of All Glucose Values Within Glucose Range <54 mg/dL
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Ideal Medical Technologies

협력자

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Emory University

수사관

  • 연구 책임자: Leon M DeJournett, MD, Ideal Medical Technologies
  • 수석 연구원: Francisco Pasquel, MD, MPH, Emory School of Medicine

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 12월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2026년 6월 9일

QC 기준을 충족하는 최초 제출

2026년 6월 9일

처음 게시됨 (실제)

2026년 6월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 12일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 9일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2025P013846
  • 5R44DK133084-02 (미국 NIH 보조금/계약)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

예

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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