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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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

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: 24 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jian Zhou, Prof.

CONTACT

[email protected]

86-21-64369181

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

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.

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