A Pilot Study of the Effect of Continuous Subcutaneous Insulin Infusion in Adolescents With Newly-diagnosed Type 1 Diabetes on Insulin Resistance, Beta-cell Function and the Honeymoon Period.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Beta Cell Function
研究概览
简要总结
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The study evaluates how these modes of therapy affect insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing).
详细描述
Within 4 weeks after diagnosis of type 1 diabetes, 10 subjects (pubertal males, 12-17 years old) will be randomized to either receive multiple daily injection (MDI) using Lantus insulin, or continuous subcutaneous insulin infusion (CSII; pump therapy). The proposed protocol compares the changes in diabetes control between pump therapy and MDI treatment groups. More importantly, however, the study evaluates how these modes of therapy may affect the honeymoon period and glycemic control, specifically focusing on changes in insulin sensitivity (measured by the euglycemic-hyperinsulinemic clamp studies and adiponectin concentration changes) and beta cell function (measured by mixed meal tolerance testing). Demonstrating that pump therapy at the time of diagnosis of type 1 diabetes prolongs the honeymoon phase by improving insulin sensitivity and beta cell function may have important therapeutic implications that could influence the standard of care in pediatric diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient between the age of 12 and 17 years inclusive at time of entry into study (i.e., after their 12th but before their 18th birthday)
- •Type 1 diabetes mellitus for no more than 10 days
- •pubertal (Tanner stage 2 or above)
- •The patient and parents or guardians should be able to do simple math calculations (necessary for pump management)
- •Parent or legal guardian must give signed informed consent
排除标准
- •No other chronic medical conditions (well-controlled thyroid disease is OK, and mild asthma is OK if the patient is not on chronic inhaled or oral daily corticosteroids)
- •Exceptional psychological stress, more than expected for circumstances of having the new diagnosis of diabetes
- •Inability or unwillingness to comply with requirements of the protocol
研究组 & 干预措施
Multiple daily injections (MDI)
Use of MDI (basal bolus therapy with glargine)
干预措施: Multiple daily injections using insulin glargine + rapid acting analog (Drug)
Pump therapy (CSII)
Use of pump therapy
干预措施: Insulin pump therapy (Device)
结局指标
主要结局
Beta Cell Function
时间窗: 24 months
Beta cell function as assessed by peak c-peptide using mixed meal tolerance testing
Insulin Sensitivity
时间窗: 24 months
Insulin sensitivity - glucose infusion rate (GIR) obtained from hyperinsulinemic-euglycemic clamp. Higher GIR reflects higher insulin sensitivity, lower GIR reflects lower insulin sensitivity.
次要结局
- Hemoglobin A1c(24 months)
- Percent Body Fat(24 months)
研究者
Larry A. Fox, MD
Pediatric Endocrinologist
Nemours Children's Clinic