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

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus
• Interventions: Device: Sinocare iCan I3 CGM; Device: Sinocare jinzhi+Blood glucose meter

• Registration Number: NCT06587438
• Lead Sponsor: Sinocare

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-04
• Last Update Submitted: 2024-09-04
• Study First Posted: 2024-09-09
• Last Update Posted: 2024-09-09
• Study Start: 2024-10-15
• Primary Completion: 2025-09-30
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Real-time Continuous glucose monitor	Sinocare iCan I3 CGM	In the first two weeks of every four-week period, rt-CGM is used to monitor blood glucose levels, while in the latter two weeks, SBMG is employed for usual care
Self-monitoring of blood glucose	Sinocare jinzhi+Blood glucose meter	Using SMBG for usual care only.

Primary Outcome Measures

Name	Time	Method
HbA1c	24 weeks	Between group differences (CGM and SMBG) for the change in HbA1c (from Central Lab) from baseline to week 24.