试验雷达 AI | ||
|---|---|---|
临床试验 NCT05076292 针对1型糖尿病，低血糖目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
一个试验符合筛选条件
卡片视图
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes 22 运动 预防
临床试验详情主要以英语提供。然而，试验雷达 AI可以提供帮助！只需点击“试验详解”即可查看和讨论您选择的语言的试验信息。
临床试验NCT05076292是一项针对1型糖尿病，低血糖的干预性研究试验，试验状态为已完成。试验开始于2021年11月23日，共计划招募22名患者。该研究由Steno Diabetes Center Copenhagen主导，已于2023年8月8日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2023年12月5日。
简要概括
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...
显示更多详细描述
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...
显示更多官方标题
Low-dose Glucagon for Prevention of Exercise-Induced Hypoglycemia in People With Type 1 Diabetes
疾病
1型糖尿病低血糖其他研究标识符
- 78618
- 2021-001342-34 (EudraCT 编号)
NCT编号
实际开始日期
2021-11-23
最近更新发布
2023-12-05
预计完成日期
2023-08-08
计划入组人数
22
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
已完成
关键词
Type 1 Diabetes
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
Exercise
Hypoglycemia
Glucagon
Continuous Glucose Monitoring
主要目的
预防
分配方式
随机
干预模型
交叉设计
盲法
单盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性150 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. |
实验性2*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. |
阳性对照Saline as placebo Saline as placebo will be administered in the same amount as glucagon before and after exercise. | 盐水 Saline will be used as placebo before and after exercise. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Incidence rate of hypoglycemia (PG < 3.9 mmol/l) | From 0-180 minutes post-intervention |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 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 Copenhagen没有联系数据。
1 位于 1 个国家/地区的研究中心
Sissel Banner Lundemose, Gentofte Municipality, 2820, Denmark