Effects of Insulin Pump Versus Multiple Daily Injections of Insulin on Glycemic and Metabolic Control in Type 1 Diabetic Patients Transitioned to the Adult Center: the Management and Technology for Transition Study (METRO)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in mean amplitude glucose excursions (MAGE
研究概览
简要总结
The transition from the Pediatric clinic to the adult care is a challenging period for young adults with type 1 diabetes, due to the high risk of poor glycemic control. Achieving the glycemic target without hypoglycemia and/or large glucose excursions is of paramount importance for type 1 diabetic patients, who have high variability of daily glucose levels . Both insulin pump therapy and multiple daily injections of insulin are recommended strategy to achieve glycemic control in type 1 diabetes; however, no studies investigated the effects of insulin pump vs insulin injections on glycol-metabolic outcomes in the transition phase. The aim of this study was to evaluate the effects of continuous subcutaneous insulin infusion (CSII) therapy, as compared with multiple daily injections of insulin (MDI), on glycemic and metabolic control, in young type 1 diabetic patients transitioned to the adult diabetes care.
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
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •T1DM for at least 12 months
- •persistent HbA1c levels ≥ 7.5% (58 mmol/mol) despite optimized education therapy,
- •recurrent severe hypoglycemic episodes or high glucose variability
- •willingness to wear the insulin pump
排除标准
- •previous use of insulin pump
- •pregnancy or planning to become pregnant in the next 2 years,
- •lack of ability to use the study devices
- •history of severe chronic diseases
- •recent or concomitant use of corticosteroids
- •drug or alcohol abuse
- •psychiatric complaints that interfere with the correct use of the devices
研究组 & 干预措施
Insulin pump
Insulin Pump with rapid acting insulin analog lispro
干预措施: Insulin pump (Device)
Insulin injections
Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection at bed-time of basal insulin glargine or degludec
干预措施: Insulin injections (Drug)
结局指标
主要结局
Change in mean amplitude glucose excursions (MAGE
时间窗: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in glucose variability measured as mean amplitude of glucose excursions (MAGE).
HbA1c change
时间窗: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in HbA1c levels
Change in glucose variability
时间窗: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in time in the euglycemic range, defined as the minutes per day spent in glucose levels ranging between 70-180 mg/dL
Change in coefficient of variation (CV)
时间窗: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in glucose variability measured as coefficient of variation (CV).
Change in standard deviation (SD) of mean glucose levels
时间窗: Baseline, 6 months, 12 months, 24 months
Within and between groups difference in glucose variability measured as standard deviation (SD) of mean glucose levels
次要结局
- Occurrence of hypoglycemic events(Through study completion, an average of 1 year)
- Change in weight(Baseline, 12 months, 24 months)
- Total daily insulin doses/Kg(Baseline, 12 months, 24 months)
- Change in lipid profile(Baseline, 12 months, 24 months)
- Diabetes treatment satisfaction(Baseline, 12 months, 24 months)
研究者
Katherine Esposito
Full Professor of Endocrinology and Metabolism, Head of Diabetes Unit
University of Campania "Luigi Vanvitelli"