Actively Recruiting
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor
Led by Glucotrack · Updated on 2025-01-08
10
Participants Needed
1
Research Sites
11 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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?
CONDITIONS
Official Title
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 21 to 75 years old inclusive
- Generally in good health as determined by the investigator
- Clinical diagnosis of type 1 or type 2 diabetes verified by medical records
- Using intensive insulin therapy with 3 or more injections per day or continuous insulin infusion
- HbA1c less than 9.0% within the last 3 months
- Adequate venous access as assessed by medical staff
- Willing to comply with study procedures and be admitted to hospital for up to 5 days
- Willing to perform up to 7 blood glucose fingerstick tests daily using provided meters and strips
- Willing to wear a subcutaneous continuous glucose sensor during the study
- Willing to always carry a study-provided Android phone during the study
- Access to internet for periodic uploads of study device data
- Body mass index between 18 and 35 kg/m2
- Able to understand and comply with study procedures and provide informed consent in English or via translator
You will not qualify if you...
- Currently taking acetaminophen and unable to switch to another anti-inflammatory or pain reliever
- Currently treated with anticoagulation medication
- History of deep vein thrombosis, pulmonary embolism, or blood clotting disorder that may affect safety
- Currently using non-insulin glucose-lowering agents SGLT2 or insulin secretagogues
- Female of childbearing potential with a positive pregnancy test
- Female of childbearing potential planning pregnancy or not using reliable contraception
- One or more episodes of hypoglycemia or diabetic ketoacidosis requiring medical care or assistance in the last 6 months
- Hematocrit lower than normal reference range
- Known clinically relevant cardiovascular disease
- Current or recent use of systemic corticosteroids or unstable thyroid hormone treatment
- History of alcoholism or drug abuse that may affect safety or study participation
- Significant acute or chronic illness that may interfere with safety or study results
- Currently participating in another clinical drug or device study
- Study staff members performing this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Instituto do Coração (InCor) |
São Paulo, Brazil, Brazil, 05403-000
Actively Recruiting
Research Team
S
Sandra L Martha
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here