Improving Access to HbA1c Measurement in Sub-Saharan Africa
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,349
- 试验地点
- 9
- 主要终点
- one year change in glycated haemoglobin (HbA1c)
研究概览
简要总结
Glycated haemoglobin (HbA1c) is the best surrogate of average blood glucose control in diabetic patients. Large-scale studies in the USA and UK have demonstrated that lowering HbA1c significantly reduces diabetes complications. Moreover, immediate feedback of HbA1c measurement to patients improves control. However, HbA1c is unavailable in most parts of Africa, a continent with one of the highest burden of diabetes. To translate these evidences, the investigators will provide affordable access to HbA1c measurement and relevant education in 2 African countries aiming significant improvement of diabetes control. The investigators will develop with local health authorities, training and cost-recovery scheme for long-term sustainability.
详细描述
The objective is to determine whether the introduction of routine affordable HbA1c determination with immediate feedback to patients and relevant education in an underserved population without any further intervention on drug supply would significantly improve diabetes control. As this will be an after-versus-before type study, each patient will be his own control.
Study setting The study will be undertaken in 10 existing diabetes care centre in two countries, including 4 regional centers in Guinea, a West African country of 10 millions inhabitants, and 6 regional centers in Cameroon, a Central African country of 18 million inhabitants.
The health districts covered in Guinea are Conakry, Labe, Kankan and Boke each being situated in a different ecological and cultural areas. In Cameroon, the health districts covered are Biyem Assi in Yaoundé, Garoua, Limbe, Ebolowa, Bamenda, Bafoussam also covering the 4 ecological zone of Cameroon.
All these health districts have existing diabetes care centre with trained personnel run in public hospital with prices and medicine affordable to most of the population covered. However, none of these centers have an HbA1c machine, and diabetes control is mainly evaluated using blood glucose, most often fasting.
Target population The aim is to provide the service to all patients followed in the selected centers at low cost however the first eligible 1000 patients will be included in the formal intervention free of charge.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diabetes mellitus irrespective of type
- •Patients who have been followed regularly for at least one year prior to inclusion in the target health facilities
- •Adult age (18 years and over)
排除标准
- •Individuals planning to migrate from study sites within one year
- •Any intercurrent acute illness
- •Enrollment in any other concomitant intervention study
结局指标
主要结局
one year change in glycated haemoglobin (HbA1c)
时间窗: Baseline and 12 months
Baseline to 12 months individual change in HbA1c level
次要结局
- One-year change in proportion of patients reaching HbA1c targets(Baseline and 12 months)
- One-year change in urinary albumin excretion(Baseline and 12 months)
研究者
Sobngwi Eugene
Senior Lecturer and Consultant Physician
Yaounde Central Hospital