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

Sinocare

Status: Not yet enrolling

Conditions: Diabetes Mellitus

Treatments: Device: Sinocare iCan I3 CGM; Device: Sinocare jinzhi+Blood glucose meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT06587438

SN-CGM-PO-001

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Real-time Continuous glucose monitor

Experimental group

Description:

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

Treatment:

Device: Sinocare iCan I3 CGM

Self-monitoring of blood glucose

Active Comparator group

Description:

Using SMBG for usual care only.

Treatment:

Device: Sinocare jinzhi+Blood glucose meter