Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- peak postprandial plasma glucose (PPG) level in mg/dl
研究概览
简要总结
Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels with low risk of hypoglycemia.
Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.
详细描述
Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia; hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and inaccurate for some patient, with an estimation error of around 20% in adults demonstrating only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the wide variability using ICRs suggests it should be improved upon.
However, there have been only a few randomized control studies that investigated the efficacy and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin. Therefore, we conducted a one-month randomized control trial to investigate the efficacy and safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .
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 27 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with type 1 diabetes (T1DM )for at least one year
- •patients aged 12-27 years
- •patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6 months before the study
- •patients with minimum daily insulin requirement of more than 8 units
- •patients willingness and ability to adhere to the study protocol, access to the internet and a computer system that met requirements for uploading the study pump data.
排除标准
- •patients with any microvascular or macrovascular complications
- •pregnancy, lactation
- •patients who had a point-of-care screening HbA1c >10.0% (86 mmol/mol)
- •patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the last 6 months prior to recruitment
- •patients with recurrent DKA (more than 2 episodes in the previous 6 months).
- •patients with any chronic medical condition, current use of medications (other than insulin) that are known to affect blood glucose level.
- •patients who had prior adverse reactions to the adjunctive agent
研究组 & 干预措施
Dipeptidyl peptidase-4 inhibitors
Dipeptidyl peptidase-4 inhibitors with Iftar meal
干预措施: Dipeptidyl peptidase-4 inhibitors (Drug)
结局指标
主要结局
peak postprandial plasma glucose (PPG) level in mg/dl
时间窗: 4 weeks
peak postprandial plasma glucose (PPG) level in mg/dl
次要结局
- Time in range %(4 weeks)
研究者
Nancy Samir Elbarbary
Prof. of Pediatrics
Ain Shams University