NCT06587438

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus

Timeline
5mo left

Started Jan 2025

Typical duration for not_applicable diabetes-mellitus

Geographic Reach
1 country

6 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Jan 2025Dec 2026

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2026

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 24, 2026

Expected
Last Updated

August 6, 2026

Status Verified

July 1, 2026

Enrollment Period

1.2 years

First QC Date

September 4, 2024

Last Update Submit

August 3, 2026

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.

    From enrollment to the end of the 24-week intervention period.

Secondary Outcomes (1)

  • HbA1c & CGM

    From enrollment to the end of the 24-week intervention period.

Other Outcomes (1)

  • Exploratory Endpoints

    From enrollment to the end of the 24-week intervention period.

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 CGMDEVICE

Real-time Continuous glucose monitoring

Real-time Continuous glucose monitor
Sinocare jinzhi+Blood glucose meterDEVICE

Self-monitoring of blood glucose

Self-monitoring of blood glucose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

The Eighth Affiliated Hospital of Southern Medical University

Shunde, Guangdong, China

Location

Renmin Hospital of Wuhan University （Hubei General Hospital）

Wuhan, Hubei, 430060, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

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

January 17, 2025

Primary Completion

March 14, 2026

Study Completion (Estimated)

December 24, 2026

Last Updated

August 6, 2026

Record last verified: 2026-07

Locations

CN(6)