Effect of Closed Loop Glucose Control on Exercise-Associated Hypoglycemia (ePID-03)
2017年11月9日 更新者:Medtronic Diabetes
The purpose of the study is to compare the glycemic control during and following aerobic exercise using either an open or closed-loop insulin delivery system.
研究概览
详细说明
This is an open-label, single-center, randomized crossover study evaluating the performance of a closed-loop insulin delivery system using a subcutaneous glucose sensor and an external insulin pump and comparing it to an open-loop delivery system during aerobic exercise.
Subject participation will be for a maximum of 16 weeks including an outpatient study (up to 6 days) and two inpatient studies (one closed-loop; the other open-loop).
The closed- and open-loop visit consists of approximately 67 hours over 4 days and 3 nights.
研究类型
介入性
注册 (实际的)
13
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Connecticut
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New Haven、Connecticut、美国、06519
- Yale Pediatrics Diabetes Research
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
12年 至 30年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Male and female subjects between 12-30 years of age.
- Subjects must weigh at least 50 kg to accommodate phlebotomy.
- Previously diagnosed Type 1 Diabetes Mellitus
- Diabetes duration at least 1 year.
- Currently treating their diabetes with an insulin pump.
- A1C of ≤ 9.0 % at time of enrollment.
- Willing to have an intravenous (IV) line inserted for frequent blood sampling and infusion of glucose if needed.
- Willing to wear two (2) subcutaneous glucose sensors and two (2) transmitters simultaneously during closed-loop portion of the study.
- Be in good general health without other acute or chronic illnesses except treated hypothyroidism or celiac disease and asthma not requiring glucocorticoid use.
- Able to tolerate a 75-minute exercise period of moderate intensity.
- Speak and understand English.
- Subject and parent (if minor) must be able to comprehend and sign the informed consent form and other study documents.
Exclusion Criteria:
- Pregnancy (urine pregnancy test) or lactation, if female.
- Subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening, or which might confound the collection or interpretation of the study data.
- Subject has a cardiac pacemaker or similar device that may be sensitive to radio frequency telemetry.
Subject using any of the following medications:
- glucocorticoids
- cyclosporine
- L-asparaginase
- niacin
- protease inhibitors
- anti-psychotics
- GnRH agonists
- beta-blockers
- calcium channel blockers
- immunosuppressants
- over-the-counter medications that may effect glucose metabolism.
Subject has any of the following conditions
- insulin allergy
- severe insulin resistance
- exercise-induced asthma
- musculoskeletal problems that may impact ability to complete exercise protocol
- substance abuse
- skin ulcers or poor wound healing
- bleeding disorders
- chronic infections
- eating disorders
- give a history of or are predisposed to major stress
- any other major organ system disease.
- Subject has experienced two (2) or more severe hypoglycemic events -seizures/coma requiring assistance in the past six (6) months.
- Subject has any other condition that in the investigator's opinion warrants exclusion from the study or precludes him/her from completing the protocol.
- Subjects using dietary supplements within 14 days of study enrollment
- Subject is currently enrolled in another study.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:交叉作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Closed Loop (CL) Phase
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Insulin pump controlled by closed loop unit and algorithm
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无干预:Standard of Care (OL) Phase
Standard of Care (OL) Phase or Open Loop Phase
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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 |
---|---|---|
Plasma Glucose (PG) Response to Exercise
大体时间:Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
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PG at start of exercise minus the subsequent PG nadir
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Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
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Incidence of Hypoglycemia Immediately Following Exercise
大体时间:Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
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Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL.
Maximum tally of hypoglycemic events within any 30 minute period is 1.
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Begins at end of exercise, at or after 16:15 on the in-patient visit day randomly assigned each subject for exercise; ends at 22:00 of same day. Median period: 333 minutes (min), interquartile range (IQR): 28 min, range: 262 to 344 min.
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Incidence of Nocturnal Hypoglycemia Following Exercise
大体时间:Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
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Tally of episodes where either plasma glucose (PG) < 60 mg/dL, or supplemental glucose was administered to prevent imminent PG < 60 mg/dL.
Maximum tally of hypoglycemic events within any 30 minute period is 1.
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Begins at 22:00 on the in-patient visit day randomly assigned each subject for exercise; ends at 6:00 of the subsequent day. Period was 480 minutes (min) for all subjects, both study phases.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Peak Post-prandial Plasma Glucose (PG)
大体时间:Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
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For each subject and study phase, the six peak PG following each of the six meals were determined.
The median of these six peaks became the one peak post-prandial PG value representing each subject and study phase.
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Union of 6 meal periods (3 per day on study days 2 & 3). A meal period runs from meal start to start of next meal, or 22:00 for 3rd meal of the day. Union of 6 periods median: 1666 minutes (min), interquartile range (IQR): 15 min, range: 1638 to 1680 min.
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Nadir Plasma Glucose (PG) Immediately Following Exercise
大体时间:Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
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The PG nadir observed following the start of exercise
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Begins at start of exercise, at or after 15:00 on the in-patient visit day randomly assigned each subject for exercise; ends at start of the subsequent meal. Median period: 121 minutes (min), interquartile range (IQR): 15 min, range: 93 to 133 min.
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Overnight Nadir Plasma Glucose (PG)
大体时间:Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
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For each subject and study phase, the overnight nadir PG for each of two nights were determined.
The mean of these two nadirs became the one nadir overnight PG value representing each subject and study phase.
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Union of the two 8-hour overnight periods beginning at 22:00 on in-patient visit days 2 & 3, ending at 6:00 on the subsequent day. The union of the two periods was 960 minutes (min) for all subjects, both study phases.
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Percentage of Time Plasma Glucose (PG) is Within the Euglycemic Range.
大体时间:Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
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For each subject and arm, the percentage of the PG curve such that 70 <= PG curve <= 180 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
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Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
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Percentage of Time Plasma Glucose (PG) is Above the Euglycemic Range.
大体时间:Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
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For each subject and study phase, the percentage of the PG curve > 180 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
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Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
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Percentage of Time Plasma Glucose (PG) is Below the Euglycemic Range.
大体时间:Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
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For each subject and study phase, the percentage of the PG curve < 70 mg/dL.
Linear interpolations furnished the data between the actual sampled PG to address potential sample influence bias arising from non-uniform sampling intervals.
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Begins at 6:00 of in-patient visit day 2 and ends at 6:00 of day 4; 48 hours total.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Stuart Weinzimer, MD、Yale University
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2009年1月1日
初级完成 (实际的)
2010年11月1日
研究完成 (实际的)
2010年11月1日
研究注册日期
首次提交
2009年1月26日
首先提交符合 QC 标准的
2009年1月26日
首次发布 (估计)
2009年1月28日
研究记录更新
最后更新发布 (实际的)
2017年12月12日
上次提交的符合 QC 标准的更新
2017年11月9日
最后验证
2017年11月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
1 型糖尿病的临床试验
Closed Loop的临床试验
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University of CambridgeCambridge University Hospitals NHS Foundation Trust完全的
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University of TurkuAcademy of Finland; Juho Vainio Foundation; Ministry of Education and Culture, Finland完全的
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Liverpool John Moores UniversityAlder Hey Children's NHS Foundation Trust招聘中
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Nemocnice Břeclav, p.o.未知
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University Health Network, TorontoUniversity of Toronto完全的