Status:
NOT_YET_RECRUITING
Effect of CGM on Glucose Control in Non-insulin-treated Patients with Type 2 Diabetes Mellitus
Lead Sponsor:
Sinocare
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
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 remain...
Eligibility Criteria
Inclusion
- (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
- (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
Key Trial Info
Start Date :
October 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT06587438
Start Date
October 15 2024
End Date
March 31 2026
Last Update
September 19 2024
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