Closing the Loop in Adults With Type 1 Diabetes - Alcohol Consumption (ANGELA02)
Randomised, Two-Period Crossover Study to Assess the Efficacy of Overnight Computer-based Glucose Control Compared With Conventional Pump Therapy Following the Consumption of Alcohol in Adults With Type 1 Diabetes
연구 개요
상세 설명
People with type 1 diabetes need regular insulin injections or continuous delivery of insulin using an insulin pump. Keeping blood sugars in the normal range is known to reduce the risk of long term complications involving the eyes, kidneys and heart. However, achieving treatment goals can be very difficult as the tighter we try to control blood glucose levels, the greater the risk of the person developing episodes of low glucose levels (hypoglycaemia). One solution is using a system where the amount of insulin injected closely matches the blood sugar levels on a continuous basis. This can be achieved by what is known as a "closed loop system" where a small glucose sensor placed under the skin communicates with a computer containing an algorithm that drives a subcutaneous insulin pump. This system is being developed in Cambridge and is undergoing trials in children and adults with type 1 diabetes. Results thus far show that the system is very effective at preventing hypoglycaemia and maintaining blood glucose levels in target range.
We plan to test the closed loop in various challenging conditions faced by patients in daily life. One of these is the consumption of alcohol, which can give rise to delayed hypoglycaemia in patients with diabetes. The studies will be done in a clinical research facility under supervised conditions. Subjects will attend for two study nights where they will receive a specific volume of alcohol with an evening meal. On one night this will be followed by closed loop algorithm control of their insulin overnight. On the other (control) night subjects will remain on their usual pump therapy regime overnight.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Cambridge, 영국, CB2 0QQ
- Addenbrooke's Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative
- On insulin pump therapy for at least 3 months
Exclusion Criteria:
- Non-type 1 diabetes mellitus
- Any physical/psychological disease likely to interfere with the study
- Taking medication likely to interfere with interpretation of results
- Known/suspected allergy against insulin
- Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator
- Unstable blood glucose control, including recurrent severe hypoglycaemia as judged by the investigator
- Current pregnancy/breastfeeding
- Total daily insulin dose > 1.4 IU/kg
- HbA1C > 10% within the last 3 months
- Unable/unwilling to consume the necessary quantity of alcohol stated in the study protocol
공부 계획
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 |
|---|---|
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실험적: Closed loop (algorithm)
Subcutaneous delivery of Novorapid insulin, dose calculated by computer-driven control algorithm, based on continuous glucose sensor readings
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Novorapid 인슐린의 피하 전달, 연속 포도당 센서 판독값을 기반으로 제어 알고리즘에 의해 계산된 용량
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위약 비교기: Open loop
Subcutaneous delivery of Novorapid insulin according to usual pump regime
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일반적인 펌프 요법에 따른 Novorapid 인슐린의 피하 전달
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of plasma glucose values in target (3.9-8.0 mmol/L)
기간: 2200-1200hr
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2200-1200hr
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Percentage of CGM (continuous glucose monitoring) values in target (3.9-8.0 mmol/L)
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values in target (3.9-8.0 mmol/L)
기간: 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values below 3.9 mmol/L
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values above 8.0 mmol/L
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Average plasma and CGM glucose
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Average plasma insulin concentration
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Total dose of insulin administered
기간: 2200-1200hrs
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2200-1200hrs
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Low blood glucose index (LBGI) score
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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High blood glucose index (HBGI) score
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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Percentage of plasma glucose and CGM values below 3.0 mmol/L
기간: 2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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2200-1200; 0000-0400; 0400-0800; 0800-1200; 0300-1200hrs
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공동 작업자 및 조사자
수사관
- 수석 연구원: Mark L Evans, MD FRCP, University of Cambridge, UK
- 연구 책임자: Roman Hovorka, PhD, University of Cambridge, UK
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 (추정)
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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