임상 레이더 AI | ||
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임상시험 NCT04620967은(는) 제1형 당뇨병에 대해 미상 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Fast-Acting Insulin Aspart and Insulin Pump Settings 4상 40
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT04620967은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 제1형 당뇨병에 대해 진행되며, 4상 중재연구으로 현재 상태는 미상입니다. 연구는 2021년 2월 1일에 시작되어 40명의 참여자를 모집하고 있습니다. Kirsten Nørgaard이(가) 진행하며, 2022년 6월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2021년 2월 16일에 갱신되었습니다.
간단한 개요
To clarify the role of fast-acting insulin aspart (Fiasp) in insulin pump-treated type 1 diabetes more research is needed.
The aim of this study is twofold:
- to compare the effects of Fiasp and Iasp in adults with type 1 diabetes who are using insulin pump and CGM and who are attending a diabetes out-patient clinic with extensive expertise in insulin pump and CGM therapy.
- to determine differences in insulin pu...
공식 제목
Fast-Acting Insulin Aspart and Insulin Pump Settings: THE FAST PUMP SETTING STUDY
질환명
제1형 당뇨병기타 연구 식별자
- 2020-001158-23
- H-20022359 (기타 식별자) (Scientific Ethical Committee of the Capital Region of Denmark)
NCT 번호
실제 연구 시작일
2021-02-01
최신 업데이트 게시
2021-02-16
예상 연구 완료일
2022-06-30
계획된 등록 인원
40
연구종류
중재연구
단계/상
4상
상태
미상
키워드
Insulin pump
주요 목적
치료
설계 할당
무작위배정
중재 모델
교차 설계
맹검 (마스킹)
삼중맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적Iasp-Fiasp First period: Insulin pump with Iasp Second period: Insulin pump with Fiasp | Insulin aspart Insulin aspart (Iasp) in insulin pump Fast-acting insulin aspart Fast-acting insulin aspart (Fiasp) in insulin pump |
실험적Fiasp-Iasp First period: Insulin pump with Fiasp Second period: Insulin pump with Iasp | Insulin aspart Insulin aspart (Iasp) in insulin pump Fast-acting insulin aspart Fast-acting insulin aspart (Fiasp) in insulin pump |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Time in range | Difference in time spent with glucose values in the range 3.9-10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Mean glucose | Difference in mean glucose between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Coefficient of variation | Difference in coefficient of variation between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time below range level 1 | Difference in time spent with glucose values below 3.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time below range level 2 | Difference in time spent with glucose values below 3.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time above range level 1 | Difference in time spent with glucose values above 10.0 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Time above range level 2 | Difference in time spent with glucose values above 13.9 mmol/l between Fiasp and Iasp treatment assessed by continuous glucose monitoring | Last two weeks of the 16-week interventions |
Fructosamine | Difference in change in fructosamine between Fiasp and Iasp treatment | 16 weeks |
Total daily insulin dose | Difference between Fiasp and Iasp treatment in total daily insulin dose | Last two weeks of the 16-week interventions |
Total daily basal insulin dose | Difference between Fiasp and Iasp treatment in total daily basal insulin dose | Last two weeks of the 16-week interventions |
Total daily bolus insulin dose | Difference between Fiasp and Iasp treatment in total daily bolus insulin dose | Last two weeks of the 16-week interventions |
Severe hypoglycemia | Difference between Fiasp and Iasp treatment in number of severe hypoglycemia events | 16 weeks |
Ketoacidosis | Difference between Fiasp and Iasp treatment in number of ketoacidosis events | 16 weeks |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Type 1 diabetes for ≥ 5 years
- HbA1c 53-75 mmol/mol (7.0-9.0%)
- Insulin pump treatment for ≥ 6 months (all insulin pump makes except hybrid closed-loop systems are eligible for inclusion)
- CGM use for ≥ 6 months (all CGM makes are eligible for inclusion)
- Carbohydrate counting for all snacks and meals
- Use of the insulin pump bolus calculator for all meals and snacks
- Breast-feeding, pregnant, planning to become pregnant or of child-bearing potential and not using adequate contraceptive methods
- Gastroparesis (clinical assessment)
- Shift work
- Changing insulin needs throughout the menstrual cycle that requires different basal rate patterns
- Use of a hybrid closed-loop system
- Use of flash glucose monitoring
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
- Chronic paracetamol use
- Alcohol or drug abuse
- Severe cardiac disease or retinopathy contraindicating HbA1c below 53 mmol/mol
- Impaired renal function (eGFR< 60 ml/min/1.73 m2)
- History of local skin reactions to Fiasp and/or Iasp
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Lack of compliance with key study procedures at the discretion of the investigator
- Unacceptable adverse events at the discretion of the investigator
- Less than 40 weeks guarantee remaining on insulin pump
Kirsten Nørgaard연구 책임자
Kirsten Nørgaard, 의뢰자-연구자, Senior Consultant, Steno Diabetes Center Copenhagen
연구 대표 연락처
연락처: Signe Schmidt, MD PhD, +45 51174785, [email protected]
1 1개국에 임상시험 장소
Steno Diabetes Center Copenhagen, Gentofte Municipality, 2820, Denmark
Signe Schmidt, MD PhD, 연락처, +45 51174785, [email protected]
Ajenthen Ranjan, MD PhD, 공동연구자
Hanne-Charlotte Andersen, RN, 공동연구자
Signe Schmidt, MD PhD, 공동연구자
모집중