Over-the-Counter Glucose Monitoring for Type 2 Diabetes

(T2D INSIGHT Trial)

This trial explores whether using an over-the-counter glucose monitor every 30 or 90 days helps manage blood sugar levels in people with type 2 diabetes who do not use insulin. The researchers aim to determine if this method effectively lowers A1C levels and improves time spent within target blood sugar ranges compared to usual care. Participants will use a glucose monitor called Dexcom Stelo® at different intervals and provide feedback on its ease of use. This trial suits those diagnosed with type 2 diabetes who do not currently use insulin, have consistent medication regimens, and can use the Dexcom Stelo® app on their cell phone. As an unphased trial, this study offers an opportunity to contribute to innovative diabetes management strategies without the constraints of traditional trial phases.

The trial requires that you have a stable medication regimen for at least 30 days before joining and that you do not change your medications before randomization unless there are safety concerns. So, you should not stop taking your current medications unless advised by the study team for safety reasons.

Research has shown that over-the-counter continuous glucose monitors (CGMs), such as the Dexcom Stelo Glucose Biosensor, have received FDA approval for adults not using insulin. This approval confirms their safety and effectiveness. These devices track blood sugar levels by measuring the sugar in the fluid beneath the skin.

Studies have found that CGMs are generally easy to use and well-tolerated. They are based on highly accurate devices commonly used by people with diabetes. Some users might experience minor skin irritation at the application site, but serious side effects are rare.

Researchers are excited about over-the-counter continuous glucose monitoring (CGM) for Type 2 diabetes because it offers a more accessible and convenient way for individuals to keep track of their blood sugar levels. Unlike traditional glucose monitoring methods that often require pricking your finger multiple times a day, this approach uses a sensor to continuously monitor glucose levels, reducing the need for frequent fingersticks. Additionally, the 30-day and 90-day periodic monitoring options allow for flexible use, potentially improving adherence and overall management of the condition. This could lead to better long-term health outcomes as patients gain more consistent insights into their glucose levels and can make timely adjustments to their lifestyle and medication.

This trial will compare the use of periodic, over-the-counter continuous glucose monitoring (CGM) every 30 days with every 90 days for six months. Studies have shown that CGM can help people with type 2 diabetes better control their blood sugar. Research indicates that CGM can lower HbA1c, a measure of average blood sugar levels over time, by about 0.31% to 0.32%. This reduction means people can maintain lower average blood sugar levels, which benefits long-term health. Additionally, CGM increases the time people keep their blood sugar within a healthy range, reducing both high and low blood sugar episodes. This evidence suggests that regular CGM use could help people manage type 2 diabetes more effectively.⁶⁷⁸⁹¹⁰