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Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes

2014년 10월 18일 업데이트: Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal

An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and Adults With Type 1 Diabetes

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).

연구 유형

중재적

등록 (실제)

28

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 캐나다
    • Ontario
      • Toronto, Ontario, 캐나다
        • Mount Sinai Hospital
    • Quebec
      • Montreal, Quebec, 캐나다
        • Institut de Recherches Cliniques de Montreal
      • Montreal, Quebec, 캐나다
        • Montreal Children Hospital

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

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Males and females aged ≥ 12 years of old.
  • Body mass index < 35
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 4 months.
  • HbA1c < 12%.
  • At least two visits with an endocrinology team in the past 1 year.

Exclusion Criteria:

  • Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
  • Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
  • Failure to comply with team's recommendations.

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: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Conventional insulin pump therapry
Subjects will use conventional pump therapy to regulate their glucose levels.
다른: Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
다른: Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
활성 비교기: Single-hormone closed-loop system
Variable subcutaneous insulin infusion rate will be used to regulate glucose levels. Insulin Aspart (Novorapid) will be infused using a subcutaneous infusion pump. The glucose level as measured by the real time sensor will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer-generated recommendations of infusion rates.
다른: Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
다른: Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
활성 비교기: Dual-hormone closed-loop system
Insulin Aspart (Novorapid) and glucagon (Paladin) will be infused using two separate subcutaneous infusion pumps. The glucose levels as measured by the real time sensor will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated-recommendation delivery levels.
다른: Carbohydrate-rich meal
At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
다른: Exercise
Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Percentage of time in target range
기간: 8 hours
Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range. Target range is defined to be between 4.0 to 8.0 mmol/L
8 hours

2차 결과 측정

결과 측정
측정값 설명
기간
Percentage of time in target range for each night separately
기간: 8 hours
Percentage of time for which glucose levels are in target range for each night separately. Target range is defined to be between 4.0 and 8.0 mmol/L.
8 hours
Percentage of time in target range for the pooled data
기간: 8 hours
Percentage of time for which glucose levels are in target range for the pooled data. Target range is defined to be between 4.0 to 8.0 mmol/L.
8 hours
Percentage of time spent below 4.0 mmol/L
기간: 8 hours
Percentage of time for which glucose levels are below 4.0 mmol/L.
8 hours
Percentage of time spent below 3.3 mmol/L
기간: 8 hours
Percentage of time for which glucose levels are spent below 3.3 mmol/L.
8 hours
Area under the curve for glucose levels below 4.0 mmol/L
기간: 8 hours
8 hours
Area under the curve for glucose levels below 3.3 mmol/L
기간: 8 hours
8 hours
Percentage of time spent above 8.0 mmol/L
기간: 8 hours
Percentage of time for which glucose levels are above 8.0 mmol/L
8 hours
Percentage of time spent above 10.0 mmol/L
기간: 8 hours
Percentage of time for which glucose levels are above 10.0 mmol/L.
8 hours
Area under the curve for glucose levels spent above 8.0 mmol/L
기간: 8 hours
8 hours
Area under the curve for glucose levels spent above 10.0 mmol/L
기간: 8 hours
8 hours
Mean glucose levels
기간: 8 hours
8 hours
Standard deviation of glucose levels
기간: 8 hours
Standard deviation of glucose levels as a measure of glucose variability.
8 hours
Total insulin delivery
기간: 8 hours
8 hours
Number of subjects experiencing at least one hypoglycemic event requiring treatment
기간: 8 hours
8 hours
Number of hypoglycemic events requiring treatment
기간: 8 hours
8 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Institut de Recherches Cliniques de Montreal

협력자

McGill University
Mount Sinai Hospital, New York
Montreal Children's Hospital of the MUHC

수사관

  • 수석 연구원: Bruce Perkins, Mount Sinai Hospital

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

2013년 7월 1일

기본 완료 (실제)

2014년 9월 1일

연구 완료 (실제)

2014년 9월 1일

연구 등록 날짜

최초 제출

2013년 7월 12일

QC 기준을 충족하는 최초 제출

2013년 7월 17일

처음 게시됨 (추정)

2013년 7월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (추정)

2014년 10월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2014년 10월 18일

마지막으로 확인됨

2014년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • CLASS-04

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. .

제1형 당뇨병에 대한 임상 시험

Carbohydrate-rich meal에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Kosovo

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다