Diabetes is a lifelong health condition that affects many people around the world. People with diabetes need to check their blood sugar levels regularly to manage their health. The usual way to do this is checking the sugar in blood from a finger prick, several times a day, which can be painful and bothersome. This method also only gives a limited view of blood sugar levels, which could lead to missing important changes.

The Kenya Diabetes and Information Centre and FIND is exploring a better way to monitor blood sugar levels using a device called a continuous glucose monitor (CGM). CGMs are small devices that can measure blood sugar levels continuously over a week or two. They use a tiny needle inserted into the arm or abdomen, so people can avoid frequent finger pricks. CGMs provide a detailed view of blood sugar levels throughout the day, helping people make better decisions about their treatment and lifestyle.

In some places, CGMs are widely available and covered by healthcare systems, but in low-income countries like Kenya, they are not commonly used because of its cost and limited access. Little is known about how effective, practical, and affordable CGMs are in these countries. We want to find out if using CGMs sometimes (intermittently) could still be beneficial for people who cannot use them all the time due to cost.

To do this, we are conducting a study that will follow up three groups; one group using CGMs all the time, one using CGMs sometimes, and a control group receiving standard diabetes care without CGMs.

The main goal is to see how CGMs affect blood sugar management compared to standard care. We will also look at other factors, such as how stable blood sugar levels are, how often people need to go to the hospital for diabetes-related issues, and how CGMs impact the quality of life for those using them and their caregivers. Additionally, we will seek to know if healthcare providers and patients find CGMs acceptable and feasible for regular use.

By the end of the study, we hope to understand if CGMs can be a helpful tool for managing diabetes in Kenya and similar places with limited resources. This knowledge could improve diabetes care and make life better for people living with type 1 diabetes in these areas.

Title:

Use of Continuous glucose monitoring devices among Type 1 diabetes patients followed up in  CDiC clinics in Machakos, Nairobi and Kiambu Counties in Kenya: A three-arm pragmatic study on effectiveness, feasibility, acceptability, and cost.

Background:

Diabetes mellitus is a significant health concern, and self-monitoring of blood glucose (SMBG) can be challenging for individuals with diabetes. Continuous glucose monitoring (CGM) devices offer a minimally invasive and continuous glucose measurement solution. However, their effectiveness, feasibility, acceptability, and cost in low- and middle-income countries (LMICs) remain uncertain.

Objectives:

This study aims to evaluate the impact of continuous and intermittent CGM use compared to standard of care in type 1 diabetes patients in Kenya. Secondary objectives include assessing glucose stability, diabetes-related complications, quality of life, acceptability, and feasibility. Additionally, Haemoglobin A1C (HbA1c) measurement methods will be compared.

Methods:

A three-arm pragmatic randomized controlled study will be conducted in three sites within the Changing Diabetes in Children program in Kenya. Arm 1 will use CGM continuously, Arm 2 will use CGM intermittently (two weeks every three months), and Arm 3 will receive standard of care. The study population includes individuals with type 1 diabetes attending DMI Centre, Machakos and Kiambu Level five Referral Hospitals. Recipients of care, caregivers, and healthcare providers will participate in the study.

Outcomes:

The primary outcomes include changes in HbA1c levels for each arm. Secondary outcomes comprise glucose concentration variability, clinic visits, hospitalizations due to diabetes complications, quality of life, and cost. Exploratory outcomes will compare HbA1c measurements from point-of-care testing devices and venous blood tests.

Study Duration:

November 2023 to January 2025.

Summary Budget:

USD 129,990.

Conclusion:

This three-arm pragmatic study will provide critical insights into the effectiveness, feasibility, acceptability, and cost of continuous and intermittent CGM use in managing type 1 diabetes in Kenya. The findings will inform clinical models for integrating CGMs into diabetes management, particularly in LMICs, and contribute to improving diabetes care and outcomes.