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

Launched by MDCECRO LLC · Aug 13, 2025

Keywords

ClinConnect Summary

This is a post-market, observational study looking at how well the CT3 Series Continuous Glucose Monitoring (CGM) system works in adults with diabetes (both Type 1 and Type 2). About 72 participants will wear the CT3 CGM for 14 days to collect glucose data every few minutes, with occasional fingerstick glucose checks for comparison. Researchers will evaluate the device’s accuracy, safety (including skin irritation), and whether using CGM helps people manage their glucose during the 14-day period. The main measurements include how much time glucose stays in the target range, and how often it is high or low, along with some error analyses.

Eligibility is for adults 18 to 80 years old with Type 1 or Type 2 diabetes who can give informed consent and reliably complete the study. People with skin problems at the wear site, allergies to adhesives or disinfectants, certain blood disorders, pregnancy, or plans for MRI/CT in the near term are typically not eligible. The study is taking place at Paula Stradiņa Cliniskā universitātes slimnīca in Riga, Latvia, and enrollment is by invitation. Results are not yet available, and the study is expected to wrap up in early 2026.

Gender

ALL

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.