Post-Market Clinical Follow-Up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in Patients With Type 1 and Type 2 Diabetes Mellitus

NCT ID: NCT07122180

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-06-04
• Study Completion Date: 2026-01-31

Brief Summary

Post market Clinical follow-up of the CT3 Series Continuous Glucose Monitoring System: A 14-Day Observational Study Assessing Accuracy, Safety, and Glucose Control in patients with Type 1 and Type 2 Diabetes Mellitus

Detailed Description

To re-assess the benefits of CT3 series CGM and the risks of skin abnormalities, hypoglycaemia, hyperglycaemia so as to improve CT3 series CGM continuously.

Conditions

Diabetes Mellitus

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

CT3 Series Continuous Glucose Monitoring System:

The CT3 Series CGM System is a real-time, continuous glucose monitoring device indicated for the management of diabetes in adults (age≥18 years). Interpretation of the CT3 Series CGM System results should be based on the glucose trends and several sequential readings over time. The CT3 Series CGM System also aids in the detection of episodes of hyperglycaemia and hypoglycaemia. It is intended for single-patient use. It is intended to replace fingerstick blood glucose testing for diabetes treatment decisions unless otherwise indicated

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 1.Patients diagnosed with type 1 or 2 diabetes mellitus. 2.People aged 18 years or older, regardless of gender. 3.Those who sign informed consent to participate in this study voluntarily. 4.The patient had good compliance and could complete this whole clinical investigation.

Exclusion Criteria

• 1.Those who have broken, scarred, red, swollen, or infected skin on the upper arms or abdomen.

2.Those who are allergic to alcohol disinfectants or medical adhesive tapes. 3.Those who have hematologic diseases that affect coagulation function or have been diagnosed with a bleeding tendency.

4.Those who have anemia or abnormal hematocrit. 5.Pregnant and lactating women. 6.Psychiatric abnormalities, cognitive and communication disorders, or highly stressed and uncooperative.

7.Those with subcutaneous edema at the wearing site. 8. Those who plan to undergo magnetic resonance imaging (MRI), computed tomography (CT), or X-ray examination within 14 days of wearing.

9. Those who have participated in clinical trials of drugs or devices within 1 month.

10.Those who are considered by the investigator to be inappropriate to participate in this PMCF study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MDCECRO LLC

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Paula Stradiņa klīniskā universitātes slimnīca

Riga, Rīga, Latvia

Countries

Latvia

Other Identifiers

Yuw-CGM-20250306

Identifier Type: -

Identifier Source: org_study_id