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
- Registration Number
- NCT07122180
- Lead Sponsor
- MDCECRO LLC
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 72
- 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.
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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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 14 days 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Paula Stradiņa klīniskā universitātes slimnīca
🇱🇻Riga, Latvia
Paula Stradiņa klīniskā universitātes slimnīca🇱🇻Riga, Latvia