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

Last updated: September 4, 2024
Sponsor: Sinocare
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes And Hypertension

Treatment

Sinocare iCan I3 CGM

Sinocare jinzhi+Blood glucose meter

Clinical Study ID

NCT06587438
SN-CGM-PO-001
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • (1)Subjects aged ≥18 years at screening (based on the day of signing the informedconsent form) and of any gender

  • (2)Patients diagnosed with type 2 diabetes

  • (3)Prior to the screening, glycemic control was suboptimal with diet, exercisecontrol, and oral medication or glucagon-like peptide-1RA (GLP-1RA) therapymaintained for more than 3 months, 7.5%≤HbA1c≤10%

  • (4)Subjects voluntarily sign an informed consent form

Exclusion

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, orthose 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 thisclinical trial, such as: ①those who have a history of eye trauma or other diagnosedeye diseases resulting in visual impairment, etc.; ②those who are unwilling orunable to fully understand or cooperate due to speech disorders; ③those who sufferfrom mental disorders

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Sinocare iCan I3 CGM
Phase:
Study Start date:
October 15, 2024
Estimated Completion Date:
March 31, 2026