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

NCT ID: NCT06587438

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-15
• Study Completion Date: 2026-03-31

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.

Conditions

Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Real-time Continuous glucose monitor

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

Group Type: EXPERIMENTAL

Sinocare iCan I3 CGM

Intervention Type: DEVICE

Real-time Continuous glucose monitoring

Self-monitoring of blood glucose

Using SMBG for usual care only.

Group Type: ACTIVE_COMPARATOR

Sinocare jinzhi+Blood glucose meter

Intervention Type: DEVICE

Self-monitoring of blood glucose

Interventions

Sinocare iCan I3 CGM

Real-time Continuous glucose monitoring

Intervention Type: DEVICE

Sinocare jinzhi+Blood glucose meter

Self-monitoring of blood glucose

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sinocare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Jian Zhou, Prof.

Role: CONTACT

zhoujian@sjtu.edu.cn

86-21-64369181

Other Identifiers

SN-CGM-PO-001

Identifier Type: -

Identifier Source: org_study_id