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

NCT07122180 | Enrolling By Invitation

• 1 other identifier: Yuw-CGM-20250306
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

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

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• This PMCF study (Version V2.0) uses a strong evaluation plan, with methods and timing carefully matched to the study's rules. It includes 72 patients

  The Continuous Glucose Monitoring (CGM) is done for 14 days for each person. During this time, glucose readings are collected every three minutes in real-time Self-Monitoring of Blood Glucose (SMBG) involves using fingerstick tests to check glucose levels. Important measurements-like Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and error grid analysis-are taken at specific times, including at the beginning and on certain follow-up days. These timings help collect key data to check how well the device works in the short term and how it affects glucose control over the full monitoring period.

  14 days

Interventions

CT3 Series Continuous Glucose Monitoring System: DEVICE

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with type 1 or 2 diabetes mellitus

You may qualify if:

• 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.

You may not qualify if:

• Those who have broken, scarred, red, swollen, or infected skin on the upper arms or abdomen.
• 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.
• Those who have anemia or abnormal hematocrit. 5.Pregnant and lactating women. 6.Psychiatric abnormalities, cognitive and communication disorders, or highly stressed and uncooperative.
• 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.
• \. Those who have participated in clinical trials of drugs or devices within 1 month.
• Those who are considered by the investigator to be inappropriate to participate in this PMCF study.

Sponsors & Collaborators

• MDCECRO LLC: lead

Study Sites (1)

Paula Stradiņa klīniskā universitātes slimnīca

Riga, Rīga, LV1002, Latvia

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2025
• First Posted: August 14, 2025
• Study Start: June 4, 2025
• Primary Completion: September 17, 2025
• Study Completion: January 31, 2026
• Last Updated: August 22, 2025

Record last verified: 2025-08

Locations

LA (1)