Bhana Sindeep, Naidoo Poobalan, Pillay Somasundram, Variava Ebrahim, Naidoo Kiolan, Rohitlall Neeresh, Sekhuthe Lauren, Pauly Bruno
Chris Hani Baragwanath Hospital Complex, Johannesburg, South Africa.
King Edward VIII Hospital, Durban, South Africa.
JMIR Res Protoc. 2023 Feb 13;12:e44308. doi: 10.2196/44308.
Type 1 diabetes mellitus (T1DM) is less common than type 2 diabetes mellitus but is increasing in frequency in South Africa. It tends to affect younger individuals, and upon diagnosis, exogenous insulin is essential for survival. In South Africa, the health care system is divided into private and public health care systems. The private system is well resourced, whereas the public sector, which treats more than 80% of the population, has minimal resources. There are currently no studies in South Africa, and Africa at large, that have evaluated the immediate and long-term costs of managing people living with T1DM in the public sector.
The primary objective was to quantify the cost of health care resource utilization over a 12-month period in patients with controlled and uncontrolled T1DM in the public health care sector. In addition, we will project costs for 5, 10, and 25 years and determine if there are cost differences in managing subsets of patients who achieve glycemic control (hemoglobin A [HbA] <7%) and those who do not.
The study was performed in accordance with Good Epidemiological Practice. Ethical clearance and institutional permissions were acquired. Clinical data were collected from 2 tertiary hospitals in South Africa. Patients with T1DM, who provided written informed consent, and who satisfied the inclusion criteria were enrolled in the study. Data collection included demographic and clinical characteristics, acute and chronic complications, hospital admissions, and so on. We plan to perform a cost-effectiveness analysis to quantify the costs of health care utilization in the preceding 12 months. In addition, we will estimate projected costs over the next 10 years, assuming that study participants maintain their current HbA level. The cost-effectiveness analysis will be modeled using the IQVIA CORE Diabetes Model. The primary outcome measures are incremental quality-adjusted life years, incremental costs, incremental cost-effectiveness ratios, and incremental life years.
Ethical clearance and institutional approval were obtained (reference number 200407). Enrollment began on February 9, 2021, and was completed on August 24, 2021, with 224 participants. A database lock was performed on October 29, 2021. The statistical analysis and clinical study report were completed in January 2022.
At present, there are no data assessing the short- and long-term costs of managing patients with T1DM in the South African public sector. It is hoped that the findings of this study will help policy makers optimally use limited resources to reduce morbidity and mortality in people living with T1DM.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR1-10.2196/44308.
1型糖尿病（T1DM）不如2型糖尿病常见，但在南非其发病率正在上升。它往往影响较年轻的个体，确诊后，外源性胰岛素对生存至关重要。在南非，医疗保健系统分为私立和公立医疗保健系统。私立系统资源充足，而负责治疗超过80%人口的公共部门资源极少。目前在南非乃至整个非洲，尚无研究评估在公共部门管理T1DM患者的直接和长期成本。
主要目的是量化公共医疗保健部门中T1DM控制良好和控制不佳的患者在12个月期间的医疗资源利用成本。此外，我们将预测5年、10年和25年的成本，并确定在管理血糖控制良好（糖化血红蛋白[HbA]<7%）和血糖控制不佳的患者亚组方面是否存在成本差异。
本研究按照良好流行病学实践进行。获得了伦理批准和机构许可。从南非的2家三级医院收集临床数据。符合纳入标准并提供书面知情同意书的T1DM患者被纳入研究。数据收集包括人口统计学和临床特征、急慢性并发症、住院情况等。我们计划进行成本效益分析，以量化前12个月的医疗利用成本。此外，假设研究参与者维持其当前的HbA水平，我们将估计未来10年的预测成本。成本效益分析将使用IQVIA核心糖尿病模型进行建模。主要结局指标为增量质量调整生命年、增量成本、增量成本效益比和增量生命年。
获得了伦理批准和机构批准（参考编号200407）。于2021年2月9日开始招募，2021年8月24日完成，共有224名参与者。2021年10月29日进行了数据库锁定。统计分析和临床研究报告于2022年1月完成。
目前，尚无数据评估南非公共部门管理T1DM患者的短期和长期成本。希望本研究结果将有助于政策制定者优化利用有限资源，以降低T1DM患者的发病率和死亡率。
国际注册报告标识符（IRRID）：RR1-10.2196/44308。
