Effect of CGM on Glucose Control in Non-insulin-treated Patients With Type 2 Diabetes Mellitus

Effects of COntinuous Glucose moNitoring Versus Usual Care on glycEmic Control in Non-insulin-tReated Adults With Type 2 Diabetes：a Multi-center Randomized Controlled Trial

The clinical value of CGM for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. The primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (CGM) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.

Inclusion Criteria:

• (1)Subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender
• (2)Patients diagnosed with type 2 diabetes
• (3)Prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapy maintained for more than 3 months, 7.5%≤HbA1c≤10%
• (4)Subjects voluntarily sign an informed consent form

Exclusion Criteria:

• (1)Patients treated with insulin within 3 months prior to screening
• (2)Currently or have used a CGM device within 3 months prior to enrollment
• (3)Serious skin disease at the sensor placement site, allergy to tape or adhesives
• (4)Pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study
• (5)Those who are participating or will participate in other clinical trials
• (6)Those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders