Comparative Efficacy of a Two Daily Mixed Insulin Injection Versus a Basal-bolus Scheme With Human Insulin in a Limited Resources Setting: a Multicenter Randomized Controlled Crossover Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 3
- 主要终点
- To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin
研究概览
简要总结
The goal of this clinical trial is to compare glycemic control and variability between children and adolescents with type 1 diabetes treated by a two daily injection of premixed human insulin (Humulin 30/70) and those who have a basal bolus scheme (Humulin N + Humulin R) in a resources limited setting.
The main question it aims to answer is: what is the effectiveness of premixed human insulin on glycemic control? Ten participants will be randomized initially to premix insulin human isophane suspension and insulin human injection (Humulin 30/70) twice daily, and 10 persons to insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals. At the end of the initial 16-wk treatment (period 1), all patients will be crossed over to the alternate treatment arm for an additional 16 wk (period 2). Insulin doses will be adjusted weekly by the clinical site according to a prespecified insulin intensification algorithm to achieve target fasting [<110 mg/dl (6.1 mmol/liter)], bedtime [<130 mg/dl (7.2 mmol/liter)], and premeal [<110 mg/dl (6.1 mmol/liter)] glucose levels until HbA1c was below 7.0%.
Subjects will receive training on the FreeStyle Libre CGMS System, electronic hand-held personal digital assistant (e-diary), and self-monitoring of blood glucose (SMBG), including recording glucose, insulin doses, and symptoms of hypo- or hyperglycemia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female 5 - 18 years of age
- •Be diagnosed for at least 1 year at the date of inclusion.
- •Have been regular at consultations during the last 12 years preceding inclusion (at least 3 visits)
- •Willing and able to inject insulin human isophane and multi-day dosing of rapid acting human insulin.
- •Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study
- •Have (patient or guardian) a minimum 4 years primary school level
- •Have (patient or guardian) a connected cellphone that can install the free FreeStyle link application and use connected messaging app
排除标准
- •pregnant or lactating females
- •opposition to participating in the study
- •residing outside the towns where the care centers are located
- •Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
研究组 & 干预措施
Humulin N plus Humulin R
10 subjects will receive insulin human isophane suspension (Humulin N) twice daily plus regular human insulin (Humulin R) before meals
干预措施: Humulin N plus Humulin R (Drug)
Premix human isophane suspension plus insulin human injection
10 subjects will receive premix insulin human isophane suspension and insulin human injection twice daily
干预措施: premix insulin human isophane suspension and insulin human (Drug)
结局指标
主要结局
To compare improvements from baseline in patient HbA1c when aggressively treated with insulin human isophane plus rapid acting human insulin vs treatment with Premix human insulin
时间窗: 12 months
次要结局
- frequency of hypo events (throughout the trial)(8 months)
- correlation between patient QoL and glucose variability as measured by CGMS (baseline, week 16 and week 32)(8 months)
- Quality of life score (baseline, week 32) (Using the Pediatric Quality of Life Inventory, 3.2 Diabetes module.)(8 months)
研究者
Yempabou Sagna
Principal Investigator
Université NAZI BONI