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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CT3 Series Continuous Glucose Monitoring System:.
- Who it may be relevant to
- Registry conditions: Diabetes Mellitus. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Latvia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Device 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 treatme
Primary outcome measures
- 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 [Time frame: 14 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Latvia · 1 center
- Paula Stradiņa klīniskā universitātes slimnīca — Riga
Identifiers
NCT: NCT07122180 · Yuw-CGM-20250306