- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02855307
Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes
A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes
Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.
The artificial pancreas 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. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.
The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.
연구 개요
상태
정황
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Quebec
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Montreal, Quebec, 캐나다, H2W 1R7
- Institut de Recherches Cliniques de Montreal
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- The subject will have been on insulin pump therapy for at least 3 months.
- Last (less than 3 months) HbA1c ≤ 12%.
Exclusion Criteria:
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Use of medication with an effect on heart rate (e.g. beta-blockers).
- Abnormal blood panel and/or anemia.
- Ongoing or planned pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
- Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
- Problems with venous access.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: Unannounced exercise
The target blood glucose of the algorithm will be as usual.
A pre-meal full insulin bolus will be given.
|
환자의 일반적인 속효성 인슐린 아날로그가 사용됩니다.
Dexcom G4 Platinum 포도당 센서는 포도당 수준을 측정하는 데 사용됩니다.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) 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 recommendation infusion rates.
|
활성 비교기: Announced exercise with pre-meal full bolus
The target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
|
환자의 일반적인 속효성 인슐린 아날로그가 사용됩니다.
Dexcom G4 Platinum 포도당 센서는 포도당 수준을 측정하는 데 사용됩니다.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) 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 recommendation infusion rates.
|
활성 비교기: Announced exercise with reduced insulin bolus
The target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
|
환자의 일반적인 속효성 인슐린 아날로그가 사용됩니다.
Dexcom G4 Platinum 포도당 센서는 포도당 수준을 측정하는 데 사용됩니다.
Patients will be admitted at the research clinical facility at 6:30.
The artificial pancreas intervention will start at 7:00.
A standardized breakfast will be served at 8:00.
At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max.
At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served.
Patients will be discharged after lunch consumption.
Patient's insulin pump will be used to infuse insulin.
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels.
Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump.
The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) 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 recommendation infusion rates.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Percentage of time of plasma glucose levels spent below 3.9 mmol/L
기간: From 9:30 to 11:30 (120 minutes)
|
From 9:30 to 11:30 (120 minutes)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Relative decrease in glucose levels during exercise compared to pre-breakfast levels
기간: From 8:00 to 10:50 (170 minutes)
|
Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise
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From 8:00 to 10:50 (170 minutes)
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Number of patients experiencing exercise-induced hypoglycemia requiring treatment
기간: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Decremental area under the curve from the start of the exercise
기간: From 9:30 to 11:00 (90 minutes)
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From 9:30 to 11:00 (90 minutes)
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Percentage of time of plasma glucose levels spent below 3.9 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent below 3.3 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent below 2.8 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
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Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
|
Percentage of time of plasma glucose levels spent above 10 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
|
Percentage of time of plasma glucose levels spent above 13.9 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Percentage of time of plasma glucose levels spent above 16.7 mmol/L
기간: From 9:30 to 10:30 (60 minutes)
|
From 9:30 to 10:30 (60 minutes)
|
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Mean plasma glucose levels
기간: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Standard deviation of glucose levels
기간: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Coefficient of variation of glucose levels
기간: From 8:00 to 11:30 (210 minutes)
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From 8:00 to 11:30 (210 minutes)
|
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Mean time (minutes) to the first hypoglycemic event
기간: From 9:30 to 10:30 (60 minutes)
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From 9:30 to 10:30 (60 minutes)
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
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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