Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 第一阶段早期
联系人和位置
学习地点
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Connecticut
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New Haven、Connecticut、美国、06520
- Yale University School Of Medicine
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age 18-40 years
- clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)
- duration of T1D ≥ 1 year
- HbA1c ≤ 9 %
- Treated with CSII for at least 3 months
- Body weight > 50 kg (to accommodate phlebotomy)
- Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct
Exclusion Criteria:
- Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
- Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
- Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
- History of hypoglycemic seizure within last 3 months
- Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.
- Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy
- History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility
- Taking a medication known to affect gastric motility
- History of pancreatitis, gallstones, alcoholism or high triglyceride levels
- Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)
- Subjects unable to give consent
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Closed Loop Insulin Delivery
Each participant recruited into the study will undergo two inpatient closed loop admissions. The first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback. Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period. Participants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy. |
由闭环单元和算法控制的胰岛素泵
Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Peak Post-prandial Venous Glucose Levels
大体时间:48 hours
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peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide
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48 hours
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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the Incremental Meal-related Glucose Area Under Curve (AUC)
大体时间:5-hour post prandial period after breakfast, lunch, and dinner
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5-hour post prandial period after breakfast, lunch, and dinner
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其他结果措施
结果测量 |
大体时间 |
|---|---|
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Mean 24-hour Glucose Levels
大体时间:24- hours
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24- hours
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Mean Time to Peak Post-meal Glucose Value
大体时间:5- hour postprandial period
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5- hour postprandial period
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Mean Daytime Glucose Levels
大体时间:8a.m.-11p.m.
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8a.m.-11p.m.
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Incremental Glucagon Peak
大体时间:5 hours
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5 hours
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AUC Plasma Glucagon During MMTT
大体时间:2 hours
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2 hours
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Differences in Daily Insulin Requirements
大体时间:24 hours
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24 hours
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Prandial Insulin Delivery During Closed Loop Therapy
大体时间:Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
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Average of the 5-hour post prandial period for breakfast, lunch, dinner combined
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Mean Nocturnal Glucose Levels
大体时间:11p.m.-6a.m.
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11p.m.-6a.m.
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合作者和调查者
调查人员
- 首席研究员:Jennifer Sherr, MD, PhD、Yale University
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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