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임상시험 NCT05076292은(는) 제1형 당뇨병, 저혈당증에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes 22 운동 예방
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임상시험 NCT05076292은(는) 제1형 당뇨병, 저혈당증에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2021년 11월 23일에 시작되어 22명의 참여자와 함께 진행되었습니다. Steno Diabetes Center Copenhagen이(가) 진행한 이 연구는 2023년 8월 8일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2023년 12월 5일에 갱신되었습니다.
간단한 개요
The primary aim of the study is to compare the efficacy of single-administration low-dose glucagon and split-administration low-dose glucagon to placebo for prevention of exercise-induced hypoglycemia in people with type 1 diabetes using insulin pumps and multiple daily injections (MDI).
The secondary aim is to compare the accuracy of three continuous glucose monitors (CGM) during and after exercise in inpatient and...
더 보기상세한 설명
A randomized, single-blinded, placebo-controlled three-arm cross-over study will be conducted to assess the study objectives. 22 participants with type 1 diabetes will complete three study visits in random order. At every visit the participants will exercise for 60 min receiving different low doses of glucagon before or before and after exercise compared with placebo.
During the visits and in an outpatient period th...
더 보기공식 제목
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
질환명
제1형 당뇨병저혈당증기타 연구 식별자
- 78618
- 2021-001342-34 (EudraCT 번호)
NCT 번호
실제 연구 시작일
2021-11-23
최신 업데이트 게시
2023-12-05
예상 연구 완료일
2023-08-08
계획된 등록 인원
22
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
Type 1 Diabetes
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
주요 목적
예방
설계 할당
무작위배정
중재 모델
교차 설계
맹검 (마스킹)
단일맹검
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적150 ug glucagon before exercise 150 ug glucagon will be administered subcutaneously just before exercise and placebo will be administered after exercise. | GlucaGen 150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
실험적2*75 ug glucagon before exercise and after exercise 75 ug glucagon will be administered subcutaneously just before exercise and another 75 ug of glucagon will be administered immediately after exercise. | GlucaGen 150 ug or 75\*2 ug glucagon will be administered subcutaneously to the participants before and after exercise. |
활성 대조군Saline as placebo Saline as placebo will be administered in the same amount as glucagon before and after exercise. | 식염수 Saline will be used as placebo before and after exercise. |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Incidence rate of hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Percentage of time below range (PG < 3.9) | From 0-180 minutes post-intervention | |
Percentage of time in range (PG ≥ 3.9 mmol/l and ≤ 10.0 mmol/l) | From 0-180 minutes post-intervention | |
Time (min) to hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention | |
Change in plasma glucose levels | From 0-180 minutes post-intervention | |
Incidence rate of hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention | |
Nadir plasma glucose concentration | From 0-180 minutes post-intervention | |
Peak plasma glucose concentration | From 0-180 minutes post-intervention | |
Incremental peak in plasma glucose concentration | From 0-180 minutes post-intervention | |
Mean plasma glucose concentration | From 0-180 minutes post-intervention | |
Plasma glucose Area Under the Curve (AUC) | From 0 to 180 min post-intervention | |
Percentage of time in hyperglycemia (PG > 10 mmol/l) | From 0-180 minutes post-intervention | |
Change in visual analogue scale (VAS) for nausea, headache, stomachache, injection site pain and palpitations from intervention (tintervention = 0) to 180 min post-intervention | From 0-180 minutes post-intervention | |
Mean absolute relative difference (MARD) during the 60-minutes exercise session (using SMBG as the reference value) | During exercise | |
MARD during the three-day outpatient period (using the 5 daily SMBG as the reference value) | During the three-day outpatient period | |
MARD during the three-hour inpatient study visit (using YSI as reference value) | During exercise | |
Rate-of change (ROC) accuracy (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period | |
Point accuracy with the Clarke Error Grid Analysis (CEGA) (using SMBG and YSI as the reference value) | During exercise and during the three-day outpatient period |
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Age ≥ 18
- T1D ≥ 2 years
- Use of insulin pump or MDI therapy for ≥ 6 months
- Current use of insulin aspart
- HbA1c ≤ 70mmol/mol (8.5%)
- Body mass index (BMI) ≤ 30 kg/m2
- Performs exercise ≥1 time per week
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period and within 30 days prior to study start
- Professional athletes or highly active individuals ( ≥ 5 hours of exercise per week)
- Known or suspected allergies to glucagon or related products
- History of hypersensitivity or allergic reaction to glucagon or lactose
- Allergy to the patch of the CGM devices
- Patients with pheochromocytoma, insulinoma or gastroparesis
- Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (methods are considered adequate for study enrollment for females: an intrauterine device, hormonal contraception (birth control pills, implant, patch, vaginal ring or injection), a single partner who is sterile or infertile, or sexual abstinence. Contraception is required throughout the study duration. Sterilized or postmenopausal women (>12 months since last period) are not required to use contraception)
- Inability to understand the individual information and to give informed consent
- Current participation in another clinical trial that, in the judgment of the investigator, will compromise the results of the study or the safety of the subject
- Concomitant medical or psychological conditions identified through review of medical history, physical examination and clinical laboratory analysis that, according to the investigator's assessment, makes the individual unsuitable for study participation
Steno Diabetes Center Copenhagen연락처 정보가 없습니다.
1 1개국에 임상시험 장소
Sissel Banner Lundemose, Gentofte Municipality, 2820, Denmark