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

Sinocare0 sites160 target enrollmentOctober 15, 2024

ConditionsDiabetes Mellitus

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Diabetes Mellitus
Sponsor: Sinocare
Enrollment: 160
Primary Endpoint: HbA1c
Status: Not yet recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

October 15, 2024

End Date

March 31, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Sinocare

Responsible Party

Sponsor

Eligibility Criteria

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