Use of Continuous Glucose Monitoring Devices Among People Living With Type 1 Diabetes in South Africa

Summary

Diabetes mellitus (diabetes) is a chronic condition that represents a major public health and clinical concern. Self-monitoring of blood glucose (SMBG) is a critical part of the care of individuals with diabetes. SMBG entails capillary fingerstick blood glucose testing multiple times per day. Many people with diabetes find this testing painful and cumbersome, often resulting in poor compliance to a glucose self-monitoring schedule. Furthermore, SMBG only provides limited visibility on daily and nightly glucose profiles, meaning that hypo- and hyperglycaemic episodes can be missed or detected with delay. The use of minimally invasive continuous glucose monitoring devices (CGMs) in diabetes management circumvents these challenges as CGMs measure glucose every few minutes over a period of 1-2 weeks through a sensor with a fine needle that is inserted once into a user's arm or abdomen. This enables periodic glucose measurement without repeat finger pricks and provides the user with a detailed glucose profile over the entire wear time of the sensor, thus enabling better adjustment of therapy or behaviour.

In populations where CGMs are accessible to people with diabetes as standard of care and without additional cost, many people with type 1 diabetes have switched from SMBG via fingerstick to the use of CGMs permanently, using the devices continuously. This is rarely possibly for people with type 1 diabetes in the public sector in LMICs as CGMs are not provided as standard of care. Little data on effectiveness, feasibility, acceptability, and cost of the use of CGMs in LMIC populations is available to inform clinical models for the integration of CGMs into diabetes management. Furthermore, it has not been investigated if intermittent, as opposed to continuous use of CGMs provides clinical benefit. Intermittent use could be beneficial for people with diabetes who do not have the means to pay for continuous use of CGMs.

This study aims to evaluate the effectiveness, feasibility, acceptability, and cost of intermittent and continuous use of CGM among people with type 1 diabetes in South Africa.

Conditions

• Type 1 Diabetes

Interventions

DEVICE

Continuous glucose monitor

Continuous Glucose Monitoring (CGM) is a technology used to measure glucose levels in people with diabetes. Unlike traditional finger prick self-monitoring of blood glucose (SMBG), CGM devices provide continuous and real-time glucose readings throughout the day and night. CGM systems consist of a small sensor that is inserted under the skin to measure glucose levels in the interstitial fluid, a transmitter that sends the glucose data to a receiver or smartphone, which shows the glucose readings. The sensor measures glucose levels automatically at regular intervals, eliminating the need for frequent finger pricks. CGM devices can track glucose trends, identify high or low glucose levels, and provide alerts for hypo- or hyperglycemia. This can help individuals make more informed decisions regarding their diabetes management, such as adjusting insulin doses, dietary choices, or physical activity levels.

Sponsors & Collaborators

• The Leona M. and Harry B. Helmsley Charitable Trust

  collaborator OTHER

• University of Pretoria

  collaborator OTHER

• University of Cape Town

  collaborator OTHER

• Foundation for Innovative New Diagnostics, Switzerland

  lead OTHER

Principal Investigators

• Beatrice Vetter · Find

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

4 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-09-11

Primary Completion

2025-07-31

Completion

2025-07-31

Countries

• South Africa

Study Locations