Evaluating the Impact of Introducing Basaglar, a Long-acting Analog Insulin, on Clinical and Quality of Life Outcomes in Youth with Diabetes in Bangladesh
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Mean and median HbA1c (% and mmol/mol)
研究概览
简要总结
This study aimed to determine the effect of introducing Basaglar and insulin pen injection devices on clinical and quality of life (QOL) parameters in children and young adults with type 1 diabetes in Bangladesh
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) provides diabetes supplies (insulin, syringes, meters and strips for blood glucose self-monitoring), diabetes-related education, mentoring and technical support to the team managing youth with type 1 diabetes (T1D) managed at the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM) Hospital in Dhaka, Bangladesh. In 2022, 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 Bangladesh.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with type 1 diabetes (T1D). Diabetes was diagnosed in accordance with World Health Organization (WHO) criteria. Determination of diabetes type was made by the local investigators according to available clinical features and history: T1D was diagnosed upon abrupt onset of typical symptoms of diabetes with insulin required from diagnosis, and no acanthosis nigricans. They were usually non-obese.
- •Duration of T1D at enrolment >12 months
- •Aged 10-25 years (inclusive) at time of enrolment
- •Current insulin regimen consisting of Humulin NPH® and R, or pre-mixed insulin (30/70 R/NPH), with no prior use of analogue insulin
- •Attending Life for a Child, BIRDEM Hospital, Dhaka for their usual diabetes care
排除标准
- •Previous use of analog insulin
研究组 & 干预措施
Introduction of Basaglar to insulin treatment regimen
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
Mean and median HbA1c (% and mmol/mol)
时间窗: Baseline, 3-, 6-, 9- and 12-month follow-up visits
HbA1c was measured at each study time point using the Minicap Sebia Autoanalyzer with venous blood
次要结局
- Proportion of participants experiencing episodes of diabetic ketoacidosis(Baseline, 3-, 6-, 9- and 12-month follow-up visits)
- Proportion of participants experiencing episodes of severe hypoglycaemia(Baseline, 3-, 6-, 9- and 12-month follow-up visits)
- Diabetes Quality of Life for Youth scale - Short Form (DQOLY-SF)(Baseline, 6- and 12-month follow-up visits)
- Participant self-reported satisfaction(12-month follow-up visit)