A Pilot Study to Evaluate the Safety of Terbutaline in Children With Type 1 Diabetes
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 6
- 主要终点
- Safety of bedtime administration of the epinephrine simulating β2 adrenergic agonist terbutaline to reduce the incidence of nocturnal hypoglycemia without compromising glycemic control in youth with type 1 diabetes (T1D).
研究概览
简要总结
The purpose of the study is to gain experience with the use of terbutaline in children with T1D and to determine that there is not a frequent serious, unexpected, uncontrollable effect on short-term glycemic control. Some information also will be obtained with regard to whether terbutaline, in the dosing being used in the study, is sufficiently well tolerated to expect that adherence will be satisfactory in a large randomized trial. In addition, this pilot study will provide data on the accuracy of a continuous glucose monitor during terbutaline use to verify that the drug does not impact on sensor function.
详细描述
Approximately 10 children will be recruited from five centers in the United States to participate in this study. The data collected in this pilot study will be used to determine whether to proceed to a randomized trial using the dose of terbutaline being used in the pilot study or the need for additional pilot testing with a lower dose of terbutaline.
Beginning the Study
When a chid enters the study, the following will be done:
- After eligibility is determined, informed consent and assent are obtained from the parent/guardian and subject.
- An unblinded CGM will be used and blood ketones will be checked each morning by the subject for at least one week. Subjects may be asked to wear an Actiwatch monitor each night.
- Terbutaline will be initiated during a CRC admission and continued following the CRC stay for 21-28 days.
• Subjects weighing between 25 and 45 kg will be treated with a nightly oral dose of 2.5 mg and subjects who weigh more than 45 kg will be treated with 3.75 mg. 4. The CRC admission will last approximately 18-20 hours and include the following:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
- •Age 12.0 years to less than 18.0 years
- •HbA1c <8.0%
- •Use of basal: bolus insulin therapy with either an insulin pump or glargine with MDI of a short-acting insulin for at least 6 months (approximately 5 pump and 5 MDI users will be enrolled)
- •Availability of home computer to download the CGM
- •For females: not currently pregnant, negative pregnancy test, and not intending to become pregnant during the next 3 months
- •Parent/guardian and subject understand the study protocol and agree to comply with it
- •Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject if required by IRB
排除标准
- •Severe hypoglycemic event (seizure or coma) or diabetic ketoacidosis in the past 6 months
- •Cardiac disease, including prolonged QT interval on EKG or pathologic arrhythmia
- •An EKG will be done either prior to the CRC admission or during the CRC admission prior to the first dose of terbutaline
- •Treatment for hypertension or blood pressure exceeding the 90th percentile for age and height
- •Current treatment for a seizure disorder
- •Asthma if treated with systemic or inhaled corticosteroids in the last 6 months or with a beta adrenergic agonist more than once a month
- •Cystic fibrosis
- •Use of MAO inhibitors, tricyclic antidepressants, or beta blockers
- •Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
- •Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian).
- •Medical condition that in the judgment of the investigator might interfere with the completion of the protocol
研究组 & 干预措施
1
干预措施: Terbutaline (Drug)
结局指标
主要结局
Safety of bedtime administration of the epinephrine simulating β2 adrenergic agonist terbutaline to reduce the incidence of nocturnal hypoglycemia without compromising glycemic control in youth with type 1 diabetes (T1D).
时间窗: 1 month
次要结局
未报告次要终点