Comparison of the Efficacy of Rapid-acting Aspart and Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels
An Open-label, Double-blind, Randomized, Two-way, Cross-over Pilot Study to Provide Preliminary Evidence of the Efficacy of Rapid-acting Aspart Compared to Faster Acting Aspart Within the Context of Single-hormone Closed-loop Strategy at Regulating Postprandial Glucose Levels in 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.
The objective of this pilot study is to inform both the decision whether to conduct a confirmatory study and the design of the larger confirmatory trial. In addition, we want to estimate postprandial glucose levels parameters and confidence interval in an 11-hour in-patient study with standardized conditions in adults with type 1 diabetes, estimate the size and direction of the treatment effect.
Faster insulin Aspart (FiAsp) will provide preliminary evidence of efficacy to regulate postprandial glucose levels compared to rapid-acting Aspart in adults with type 1 diabetes using insulin pump therapy.
연구 개요
상태
정황
연구 유형
단계
- 2 단계
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 6 months.
- HbA1c ≤ 12%.
Exclusion Criteria:
- Using a patch-pump (e.g. Omnipod)
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
- Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Ongoing or planned pregnancy.
- Breastfeeding.
- Severe hypoglycemic episode within two weeks of screening.
- Current use of glucocorticoid medication (except low stable dose and inhaled stable treatment).
- Known or suspected allergy to the trial products or meal contents.
- Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
- Failure to comply with team's recommendations (e.g. not willing to eat meals/snacks, 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: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Rapid-acting Aspart
Rapid-acting Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
|
활성 비교기: Faster insulin Aspart
Faster insulin Aspart will be used to regulate glucose levels
|
The participant's insulin pump will be used to infuse insulin
The Dexcom G4 Platinum will be used to measure glucose levels
Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations. At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits. Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Change in plasma glucose levels 1 hour after the meal
기간: 1 hour
|
1 hour
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Area under the curve of plasma glucose levels for the 1-hour period following the meal.
기간: 1 hour
|
1 hour
|
|
Area under the curve of plasma glucose levels for the 2-hour period following the meal.
기간: 2 hours
|
2 hours
|
|
Plasma glucose level 1 hour after the meal.
기간: 1 hour
|
1 hour
|
|
Plasma glucose level 2 hours after the meal.
기간: 2 hours
|
2 hours
|
|
Glycemic peak in the 3 hours following the meal.
기간: 3 hours
|
3 hours
|
|
Change in plasma glucose levels 2 hours after the meal.
기간: 2 hours
|
2 hours
|
|
Peak time of glucose levels over the 4 hours following the meal.
기간: 4 hours
|
4 hours
|
|
Number of hypoglycemic events less than 4.0 mmol/L over the 4 hours following the meal.
기간: 4 hours
|
4 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 7.8 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 7.8 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels between 3.9 and 10 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels between 3.9 and 10 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.9 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.9 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 3.3 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 3.3 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels below 2.8 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels below 2.8 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 10 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 10 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 13.9 mmol/L
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 13.9 mmol/L
기간: 11 hours
|
11 hours
|
|
Percentage of time of plasma glucose levels above 16.7 mmol/L.
기간: 11 hours
|
11 hours
|
|
Percentage of time of sensor glucose levels above 16.7 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.9 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.9 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 3.3 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 3.3 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels below 2.8 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels below 2.8 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 10.0 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 10.0 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 13.9 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 13.9 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of plasma glucose levels above 16.7 mmol/L.
기간: 11 hours
|
11 hours
|
|
Area under the curve of sensor glucose levels above 16.7 mmol/L.
기간: 11 hours
|
11 hours
|
|
Standard deviation of plasma glucose levels.
기간: 11 hours
|
11 hours
|
|
Standard deviation of sensor glucose levels.
기간: 11 hours
|
11 hours
|
|
Coefficient of variance of plasma glucose levels.
기간: 11 hours
|
11 hours
|
|
Coefficient of variance of sensor glucose levels.
기간: 11 hours
|
11 hours
|
|
Total insulin delivery.
기간: 11 hours
|
11 hours
|
|
Mean plasma glucose level.
기간: 11 hours
|
11 hours
|
|
Mean sensor glucose level.
기간: 11 hours
|
11 hours
|
|
Mean plasma insulin concentration.
기간: 11 hours
|
11 hours
|
|
Number of hypoglycemic events less than 3.3 mmol/L (>20 minutes).
기간: 11 hours
|
11 hours
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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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