Randomized Trial of the RIGHTEST iFree 2 CGM System for Glycemic Control in Adults With Diabetes Mellitus

Brief Summary

The goal of this clinical trial is to find out whether using a real-time continuous glucose monitoring (CGM) system can improve daily blood sugar control compared with usual self-monitoring of blood glucose (SMBG; finger-stick testing) in people with diabetes who are treated with insulin. This study will include adults with type 1 or type 2 diabetes who have less-than-ideal blood sugar control while using insulin. The main questions it aims to answer are: * Does CGM-guided diabetes management lead to a larger decrease in HbA1c from baseline to about 6 months than SMBG-guided management? * Does CGM use increase the time that glucose stays in the target range and reduce low blood sugar episodes, without causing new safety problems? Researchers will compare two groups. One group will use the RIGHTEST iFree 2 CGM system together with a smartphone app to view glucose data in real time. The other group will use standard finger-stick blood glucose monitoring with an approved blood glucose meter as their main tool for checking glucose. Both groups will continue to receive routine diabetes care from their usual health-care providers. Participants will take part in regular clinic visits over approximately 6 months. At these visits, study staff will review glucose records, adjust diabetes treatment if needed, and collect information such as HbA1c and other blood tests, device data, and questionnaires about quality of life and diabetes-related distress. Safety information and any device problems will also be recorded. The results will help determine whether CGM can be used as a routine tool to improve long-term blood sugar control in people with diabetes.