Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus
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.
Interventions
DEVICECT3 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
Sponsors
MDCECRO LLC
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Latvia
Outcome results
None listed