What is Continuous Glucose Monitoring (CGM)?
Diabetes is often undiagnosed or inadequately treated, with people unable to access the essential medicines and devices they need. Over the next 25 years, diabetes prevalence is expected to increase globally, with the greatest increase expected in middle-income countries.
Controlling diabetes requires management of glucose levels in people living with diabetes. Accurate measurement of glycaemic levels enables many people to self-manage to avoid the dire consequences of uncontrolled disease. One way that the call for action can be realised, is through enabling greater access to accurate, affordable, quality diagnostic tools for the self-management of diabetes.
Self-monitoring has become a vital part of the solution for many people living with type 1 diabetes and for certain individuals living with type 2 diabetes. Along with self-monitoring blood glucose test systems (SMBGs), which require fingerstick-collected capillary blood, alternatives to testing, such as continuous glucose monitoring systems (CGMs), are enabling the individual to better achieve glycaemic targets with less inconvenience.
CGM stands for Continuous Glucose Monitoring. A CGM system essentially tracks glucose levels 24/7, every few minutes, through a tiny sensor placed either on your abdomen or arm, using an automatic inserter. The sensor measures your interstitial glucose level, which is the glucose level found in the fluid that surrounds the cells.
Continuous Glucose Monitoring (CGM) is a technology that provides real-time, continuous data on blood glucose levels, eliminating the need for frequent finger pricks. A small sensor is inserted under the skin, usually on the abdomen or arm, and it measures interstitial fluid, which closely reflects blood glucose levels.
How accurate is your CGM? What doctors and patients must know before choosing a device.
Diabetes management is evolving, with Continuous Glucose Monitoring (CGM) playing a pivotal role in improving patient outcomes. However, not all CGM devices are created equal.
The technology landscape is evolving quickly, and now CGMs can be linked with appropriate software and other hardware to automatically deliver appropriate doses of insulin. Standalone software applications are also providing the person with diabetes with improved self-management support.
In South Africa, the South African Health Products Regulatory Authority (SAHPRA) oversees the regulatory framework for market authorization of Continuous Glucose Monitoring (CGM) devices, ensuring safety, quality, and efficacy. This framework aligns with international standards, global harmonisation, emphasizing product quality, safety, and efficacy for both domestic innovation and
global market access.
CGM devices are classified as medical devices, and registration with SAHPRA is required before market authorization. Further SAHPRA has a system in place for post-market surveillance, which involves monitoring devices once they are in the market ensuring their safety and efficacy continue to meet global standards. Approvals of these devices from the EU and US are recognised in various manners to expedite market access in many jurisdictions, regardless of a jurisdiction’s economic status.
Countries as diverse as Australia, Ghana, Malaysia, Switzerland and South Africa all use reliance mechanisms that include the recognition of Conformité Européenne (CE) mark (EU approval) or Food and Drug Administration (FDA) authorisation.
Yet, with multiple CGM options available, how do healthcare professionals make the right choice?
A medical practitioner Dr Reyna Daya- Specialist Physician and Legal Expert on Health law Elsabe Klinck discussed the ethical implications of device selection.
Dr Daya highlighted the importance of patient education, saying “It’s crucial for individuals considering CGM technology to be well-informed about the available options, their accuracy, and potential benefits and risks”. Diabetics need to manage their diabetes levels to prevent cardiac, kidney, liver, and gallbladder problems. A person with diabetes can reduce the risk of cardiovascular and circulatory problems by managing blood sugar levels, with continuous glucose monitoring.
Self-monitoring enables people living with diabetes to achieve appropriate metabolic control, avoiding hypoglycaemia and reducing the likelihood of developing long term complications of hyperglycaemia, such as blindness or renal failure. CGMs further facilitate diabetes care in such a way as to maximise user care whilst minimising discomfort.
Thanks to the adoption of CGM in diabetes treatment, hypoglycaemia can be successfully mitigated both improving individuals’ quality of life and reducing the shortcoming of dangerous short-term complications. It is equally important to eat a well-balanced diet loaded with fresh fruits, vegetables, whole grains, pulses, and lentils. Avoid junk, spicy, oily, and canned food.
Be sure to take medication as recommended by your health care provider, check blood sugar levels at home. The general recommendation for HbA1c testing is every 3-6 months, with adjustments based on individual needs and treatment goals. If your HbA1c levels are stable and meet treatment goals, testing every 6 months may be sufficient. However, more frequent testing (e.g., every 3 months) may be necessary if your treatment plan is changing, or if you are having trouble managing your blood sugar levels.
A continuous glucose monitoring system monitors glucose levels in more or less real time. CGMs that measure glucose levels continuously and send results automatically to a display unit, providing the user with automated alarms and alerts at specific glucose levels and/or for changing glucose levels.
In high income countries, the market for continuous glucose monitoring systems is growing. Although the uptake of these devices has been limited in low-income settings, this is not the case in many middle-income settings, where their use is gaining in popularity, especially as they become more simple, robust, and affordable. There is strong consensus that the use of CGMs reduces hypoglycaemic risk and increases the amount of time a person with diabetes can stay in the target glucose range.
Continuous glucose monitoring technologies, when applied appropriately, can improve the lives and health of people with diabetes; however, there remains inequity as to who benefits from these technological innovations.
Author: Wanda J Bruce