Controlled Insulin Delivery: Combining Technology With Treatment
2021년 3월 18일 업데이트: Sansum Diabetes Research Institute
Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations.
This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.
연구 개요
상세 설명
The goal of the JDRF Artificial Pancreas Project is to produce an autonomous artificial pancreas that can safely and effectively regulate glycemia in people with type 1 diabetes mellitus.
In our work, this fully automated closed-loop system combines a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin infusion (CSII) pump with a sophisticated control algorithm.
This is a proof-of-concept study to demonstrate that the controller could bring the patient back to a relatively normal glucose concentration after an unannounced meal and from mild hyperglycemia.
Once the system is initiated, all insulin delivery is calculated automatically.
There was no outside intervention either by the subject or medical personnel.
An artificial pancreas system that aims at replicating normal beta-cell function by using the subcutaneous-subcutaneous (sc-sc) route needs to address inherent delays in both glucose sensing and insulin delivery.
Our strategic approach is that a closed-loop system should operate safely without any knowledge of meals or other disturbances.
We have developed the Artificial Pancreas System (APS©) and used it to clinically evaluate a control strategy that allows efficient glycemic control without any a priori meal information.
The Artificial Pancreas device uses the Artificial Pancreas System (APS©) platform with the OmniPod insulin pump, the DexCom SEVEN PLUS CGM and a multi-parametric model predictive control algorithm (mpMPC) with an insulin-on-board (IOB) safety constraint.
연구 유형
중재적
등록 (실제)
19
단계
- 초기 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
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
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- Willing to sign the consent form
- Type 1 diabetes for at least 1 year prior to the study
- Using continuous subcutaneous insulin infusion pump
- Above 21 years of age
- Willing to follow the study requirements
Exclusion Criteria:
- Allergy to the sensor or to one of its components
- Psychiatric disorders
- Reported diabetic ketoacidosis within last 3 months
- Abnormal liver function (Transaminase > 2 times the upper limit of normal)
- Heart failure
- Any carcinogenic disease
- Any other chronic abnormality
- Unwilling to perform or to follow the research protocol
- Participation in any other study concurrent with the proposed study
- Creatinine concentration above the upper limit of normal for age and sex
- Active coronary artery disease
- Active gastroparesis
- History of uncontrolled seizures
- Pregnancy
- Untreated adrenal insufficiency
- Hypokalemia
- Uncontrolled thyroid disease.
- Condition, which in the opinion of the investigator, would interfere with patient safety
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 |
|---|---|
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실험적: Closed-loop control system
The objective of this study is to automate glucose control in subjects with type 1 diabetes using a computer control algorithm in a controlled in-clinic research setting. The controller will be evaluated under two conditions:
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Subjects will arrive fasting at 7am unless needed for hypoglycemia (glucose < 70 mg/dL) and no extra bolus insulin after 3am. An IV catheter will be inserted for blood samples and for IV administration of glucose if necessary. Blood samples will be analyzed for glucose by YSI 2300Stat every 30 minutes. Breakfast consisting of 25g of CHO will be eaten at 7:30 am and the subject will bolus for this amount of CHO. The controller is switched "on" on the down slope of the meal response, and the subject is brought to a basal steady-state by the controller. Target blood glucose is 110 ± 30-mg/dL. After approximately 3 hours a small lunch will be eaten consisting of 25g of CHO (unannounced meal challenge). The subject will be monitored until blood glucose returns to euglycemia.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Restoration of Euglycemia
기간: 12 hours
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The primary endpoint of this pilot study is successful restoration of euglycemia from the two perturbed conditions using closed loop control with minimal hypo- and hyperglycemia exposure.
The first condition involves restoration of euglycemia when the subject is in a hyperglycemic state.
The second condition involves restoration of euglycemia following consumption of a meal containing 25g CHO with no insulin bolus.
The patients will be followed for the duration of the 12 hour study.
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12 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Average percent-of-time-in-range (80 - 180 mg/dL)
기간: 12 hours
|
All reported blood glucose values per both CGM and YSI ware analyzed for average percent-of-time-in-range (80 - 180 mg/dL).
The participants will be followed for the duration of the 12 hour study.
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12 hours
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Lois Jovanovic, M.D., Sansum Diabetes Research Institute
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
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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
2008년 7월 1일
기본 완료 (실제)
2010년 1월 1일
연구 완료 (실제)
2010년 1월 1일
연구 등록 날짜
최초 제출
2011년 11월 15일
QC 기준을 충족하는 최초 제출
2011년 11월 30일
처음 게시됨 (추정)
2011년 12월 2일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 3월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 3월 18일
마지막으로 확인됨
2021년 3월 1일
추가 정보
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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