JMIR Publications

ABSTRACT

Background:

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 diagnoses, exogenous insulin is essential for survival In South Africa, the health care system is divided into a private and public health care systems. The private system is well resourced, whereas the public sector which treats more than 80% percent 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 terms costs of managing patients with type 1 diabetes mellitus in the public sector.

Objective:

The primary objective is to quantify the cost of healthcare resource utilization over a 12-month period in controlled and uncontrolled T1DM patients in the public healthcare 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 glycaemic control (HbA1c < 7%) and those who do not.

Methods:

The study will be performed in accordance with Good Epidemiological Practice. Ethical clearance and institutional permissions will be acquired. The clinical data will be collected from two tertiary hospitals in South Africa. Patients with type 1 diabetes mellitus, written informed consent and who satisfy the inclusion criteria will enter the study. Data collection will include demographic and clinical characteristics, acute and chronic complications, hospital admissions, etc. Thereafter, we will perform a cost-effectiveness analysis to quantify the costs of health care utilisation in the preceding 12-months. In addition, we will estimate projected costs over the following 10 years, assuming that study participants maintain their current HbA1c. The cost-effectiveness analysis will be modelled using the IQVIA CORE Diabetes Model (CDM)®. The primary outcome measures are incremental quality-adjusted life years (QALYs), incremental costs, incremental cost-effectiveness ratios (ICERs), and incremental life years (LYs).

Results:

Ethical clearance and institutional approval have been obtained (reference number 200407). Enrolment began on 9th February 2021 and was completed on 24 August 2021 with 224 participants. Database lock occurred on the 29th of October 2021. The statistical analysis and clinical study report were completed in January 2022.

Conclusions:

There is no data assessing short- and long-term costs of managing patients with type 1 diabetes in the South African public sector. It is hoped that the findings of this study will help policy makers optimally utilise limited resources to reduce morbidity and mortality in people living with type 1 diabetes mellitus. Clinical Trial: Ethical clearance and institutional approval have been obtained (reference number 200407).