Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06587438

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Hospital, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinocare iCan I3 CGM

Device

Real-time Continuous glucose monitoring

Sinocare jinzhi+Blood glucose meter

Device

Self-monitoring of blood glucose

Primary outcomes

  1. HbA1c

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

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

Secondary outcomes

  1. HbA1c & CGM

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

    • Proportion of participants in each group achieving HbA1c < 7.0% at Week 24.
    • Proportion of participants in each group achieving a reduction in HbA1c of ≥0.5% from baseline at Week 24.
    • Change from baseline in Time in Range (TIR, %) defined as blood glucose within 3.9-10 mmol/L at Week 24, between the two groups.
    • Change from baseline in Time in Target Range (TITR, %) defined as blood glucose within 3.9-7.8 mmol/L at Week 24, between the two groups.
    • Change from baseline in Time Above Range (TAR, %) defined as blood glucose >10 mmol/L at Week 24, between the two groups.
    • Change from baseline in Time Below Range (TBR, %) defined as blood glucose <3.9 mmol/L at Week 24, between the two groups.
    • Change from baseline in Mean Sensor Glucose (MSG, mmol/L) at Week 24, between the two groups.
    • Change from baseline in Coefficient of Variation (CV, %) at Week 24, between the two groups.

Other outcomes

  1. Exploratory Endpoints

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

    • Other CGM Endpoints
    • Difference in baseline change of Time Above Range (TAR, %, >13.9 mmol/L) at Week 24 between groups.
    • Difference in baseline change of Time Below Range (TBR, %, <3.0 mmol/L) at Week 24 between groups.
    • Difference in baseline change of Glycemic Management Index (GMI, %) at Week 24 between groups.
    • Diabetes Complication Endpoints
    • Difference in baseline change of urinary albumin-to-creatinine ratio (UACR) at Week 12 and Week 24 between groups.
    • Change from baseline in fundus photography at Week 24 between groups.
    • HbA1c Endpoints
    • Change from baseline in HbA1c at Week 48 between groups.
    • Proportion of participants with HbA1c < 7.0% at Week 48.
    • Change from baseline in TIR, TITR, TAR>10, TBR<3.9, MSG and CV at Week 48, between the two groups

Sponsors and collaborators

Lead sponsor

Sinocare

Industry

Registry information

Official study title

Effects of COntinuous Glucose moNitoring Versus Usual Care on glycEmic Control in Non-insulin-tReated Adults With Type 2 Diabetes：a Multi-center Randomized Controlled Trial

Acronym: CONVERT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.