NCT06764069 Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor
| NCT ID | NCT06764069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Glucotrack |
| Condition | Diabetes Mellitus |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-12-13 |
| Primary Completion | 2025-02-04 |
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
The goal of this early first in man clinical trial is to evaluate the safety of an implantable continuous blood glucose monitoring system in participants with Diabetes Mellitus. Safety will be assessed by looking at the absence of procedure or device related adverse events. Additionally, the surgical procedure and device performance will be evaluated. Key Research Questions: 1. Were there any adverse events associated with the insertion of the Sensor Lead? 2. Did Participants experience any device-related adverse events from the Sensor Lead insertion through the 96-hour observation period and subsequent removal of the Sensor Lead? 3. How effectively did the device capture data during the 96-hour wear period?
Eligibility Criteria
Inclusion Criteria: 1. Age 21 to 75 years old inclusive 2. Generally, in good health, as determined by the investigator 3. Clinical diagnosis or type 1 or type 2 diabetes as determined via medical records or source documentation by an individual qualified to make a medical diagnosis 4. Intensive Insulin Therapy - 3 plus injections/day (MDI) or Continuous Subcutaneous Insulin Infusion (CSII) 5. HbA1c \<9.0 % in the last 3 months. 6. Study subject has adequate venous access as assessed by investigator or appropriate staff. 7. Willing to comply with study procedures and be admitted to hospital for up to 5 days. 8. Willing to perform up to 7 blood glucose (fingerstick) measurements a day using provided blood glucose meters and strips 9. Willing to wear subcutaneous continuous wear glucose sensor for the duration of the study 10. Willing to always carry study provided Android Phone during study 11. Access to internet for required periodic uploads of study device data 12. BMI in the range
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.