Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Mali
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
This study aimed to evaluate the impact on blood glucose control and quality of life in children and youth with type 1 diabetes in Mali by switching the insulin regimen from human insulin via needle and syringe, to long-acting biosimilar insulin glargine delivered by reusable pens combined with short-acting insulin via needle and syringe.
详细描述
Analog insulins are widely used in middle- and high-income countries. However, use of analog insulin remains limited in lower-income countries due to their increased cost and lack of access, and human insulin remains the mainstay of treatment in these settings.
Long-acting (basal) analog insulin such as glargine have the benefit of a longer duration (up to 24 hours) and a minimal peak action, and generally, only one injection per day is required. Although glargine insulin has been shown to reduce the risk of overnight hypoglycemia, consistent improvement in blood glucose control (measured by HbA1c) when compared to human insulin has not been shown, and its impact on quality of life is also inconclusive. Furthermore, these studies have all been done in highly resourced countries.
Life for a Child (LFAC) has been providing diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to Santé Diabète in Mali since 2008. In 2021, LFAC commenced supplying Basaglar (glargine) insulin with insulin pen devices (HumaPen Ergo ll). This provided a unique opportunity to investigate the effect of introducing glargine (Basaglar) insulin in the low-resource setting of Mali, one of the world's poorest countries.
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
- — 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(i) diagnosed with T1D in accordance with World Health Organization criteria
- •(ii) duration of T1D ≥12 months at time of enrolment
- •(iii) aged <25 years at time of enrolment
- •(iv) current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
- •(vi) willing to regularly self-monitor blood glucose (SMBG) levels ≥2 times a day with a blood glucose meter and strips
- •(vii) live in or within one hour's travelling distance of Bamako
排除标准
- •(i) Previous use of analog insulin
研究组 & 干预措施
Intervention
Switched to once daily injection of biosimilar insulin glargine via reusable pen and three mealtime bolus insulin injections of short-acting human insulin via needle and syringe
干预措施: biosimilar insulin glargine (Drug)
结局指标
主要结局
HbA1c
时间窗: Baseline, 3-, 6-, 9- and 12-month follow-up visits
HbA1c was measured at each study time point using point of care testing via a Siemens DCA calibrated to international standards (DCA Vantage™ Analyzer (Siemens Healthcare Diagnostics, Tarrytown NY, US)). For HbA1c readings \>14% (\>130 mmol/mol), the maximum reading of this analyser, HbA1c was recorded as 14% (130 mmol/mol).
次要结局
- Episodes of diabetic ketoacidosis(Baseline, 3-, 6-, 9- and 12-month follow-up visits)
- Episodes of severe hypoglycaemia(Baseline, 3-, 6-, 9- and 12-month follow-up visits)
- Diabetes Quality of Life in Youth - Short Form(Baseline, 6- and 12-month follow-up visits)
- Participant self-reported satisfaction (intervention arm only)(12-month follow-up visit)
- Feedback from local HCPs on implementation of the study intervention(At 12 months)