Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin
2021年11月4日 更新者：Yale University
Reducing the Risk of Metabolic Decompensation in Adolescents With Poorly Controlled Type 1 Diabetes by Supervised School Administration of Insulin Degludec
This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.
研究概览
详细说明
This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6 mmol/L at the start of the school week following weekend/holiday breaks in subjects who have been randomized to receive daily injections of I-deg or I-glar.
Hypothesis: β-hydroxybutyrate levels will be lower in the morning of the first day of the school week in subjects receiving I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays.
To remove variability due to potential non-compliance during the school week, this study will utilize our routine clinical practice of supervised insulin administration and monitoring of blood glucose and ketones during the school day.
研究类型
介入性
注册 (实际的)
32
阶段
- 第一阶段早期
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、06511
- Yale University
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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
8年 至 18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:
- Clinical diagnosis of T1D, diagnosed at least 12 months prior to enrollment
- HbA1c ≥8.5%9 and <14% on enrollment
- Taking no medications known to affect blood glucose levels other than insulin.
- Ability to provide participant written informed consent if age 18 years, or parental written informed consent and participant assent if participant is < age 18 before any trial-related activities
- Current regimen includes insulin detemir or I-glar, as long acting insulin
- Willingness to use either I-glar or I-deg pens as basal insulin, and have school personnel supervise administration
- Willingness to have school personnel supervise fasting blood β-hydroxybutyrate levels first thing in the morning at the beginning and end of each school week
- Willingness to have school personnel supervise fasting blood glucose checks daily in the morning on school days, and eat breakfast after the fasting check
Exclusion Criteria:
- Female participants who are pregnant, breast-feeding or planning on becoming pregnant
- Participant (and parent if age <18) unable to read, write, and speak English.
- Adolescents who are home schooled or no longer attending secondary school
- Participant's school is unable to provide personnel to supervise injections of long-acting insulin or measurement blood glucose and β-hydroxybutyrate levels
- Known or suspected allergy to trial medication(s), excipients, or related products.
- Contraindications to study medications, including hypersensitivity to I-deg or one of its excipients, hypersensitivity to I-glar or one of its excipients, and administration of either during episodes of hypoglycaemia
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：治疗
- 分配：随机化
- 介入模型：并行分配
- 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：subjects receiving insulin degludec
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin degludec injections.
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Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose
其他名称：
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有源比较器：Subjects receiving insulin glargine
Youth aged 8-18 years with T1D whose diabetes is poorly-controlled (A1c ≥8.5%) will receive insulin glargine injections.
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Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose
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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Lower beta hydroxybutyrate levels
大体时间：4 months
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Will test the the hypothesis that β-hydroxybutyrate levels will be lower in the morning (≥0.6 mmol/L) of the first day of the school week in subjects receiving I-deg, since the long half-life of I-deg will compensate for missed insulin doses over the weekend/holidays.
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4 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Control of HbA1c levels
大体时间：4 months
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Test the hypothesis that the longer duration of action of I-deg will lead to improvements in glycemic control measured by HbA1c (a secondary aim) and fasting glucose.
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4 months
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Measure of beta hydroxybutyrate levels between the 2 groups.
大体时间：4 months
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Test the differences in frequency of elevated β-hydroxybutyrate levels when receiving supervised injections of basal insulin versus when not receiving supervised injections between the I-deg and I-glar groups
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4 months
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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：William Tamborlane, PhD、MED School of Medicine
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 (实际的)
2017年10月1日
初级完成 (实际的)
2021年6月7日
研究完成 (实际的)
2021年6月7日
研究注册日期
首次提交
2018年1月9日
首先提交符合 QC 标准的
2018年1月9日
首次发布 (实际的)
2018年1月17日
研究记录更新
最后更新发布 (实际的)
2021年11月5日
上次提交的符合 QC 标准的更新
2021年11月4日
最后验证
2021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
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Laval University尚未招聘糖尿病，Mellitus，1 型
Insulin Degludec的临床试验
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The United Bio-Technology (Hengqin) Co., Ltd.尚未招聘
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Gan and Lee Pharmaceuticals, USAProfil Institut für Stoffwechselforschung GmbH招聘中
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Jiangsu HengRui Medicine Co., Ltd.主动，不招人