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

NCT06587438 | Not Yet Recruiting

• 1 other identifier: SN-CGM-PO-001
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

  24 weeks

Study Arms (2)

Real-time Continuous glucose monitor

EXPERIMENTAL

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

Device: Sinocare iCan I3 CGM

Self-monitoring of blood glucose

ACTIVE COMPARATOR

Using SMBG for usual care only.

Device: Sinocare jinzhi+Blood glucose meter

Interventions

Sinocare iCan I3 CGM DEVICE

Real-time Continuous glucose monitoring

Real-time Continuous glucose monitor

Sinocare jinzhi+Blood glucose meter DEVICE

Self-monitoring of blood glucose

Self-monitoring of blood glucose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Sinocare: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Jian Zhou, Prof.

CONTACT

86-21-64369181; zhoujian@sjtu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion: September 30, 2025
• Study Completion: March 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share