Sinocare jinzhi+Blood glucose meter: Self-monitoring of blood glucose
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
HbA1c — 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.
Trial sites (6)
Facility
City
Region
Status
Beijing Hospital
Beijing
Beijing Municipality
The First Affiliated Hospital of Chongqing Medical University
Chongqing
Chongqing Municipality
The Eighth Affiliated Hospital of Southern Medical University
Shunde
Guangdong
Renmin Hospital of Wuhan University (Hubei General Hospital)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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