TrialPath
Recruiting

Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor

NCT06764069 · Glucotrack
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
Early Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor in Adults with Diabetes Mellitus
About this study
Eligible Participants will be inserted with the Sensor Lead of the investigational continuous blood glucose monitoring device and stay in the hospital for a 96-hour observation period. Glucose measurements, medications and food will be tracked throughout the 96-hour Observation period. Two 3-hour frequent sample tests (sampling every 15-min for glucose measurement) will occur during the 96-hour Observation period. After approximately 96-hours is complete the participant will have the Sensor Lead removed and will be discharged after an hour observation post removal. A final follow-up visit will occur approximately 1-week post sensor removal to check on the removal site and formally exit that participant from the study. All safety events will be recorded.
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 18-35 kg/m2 13. Has the ability to understand and comply with protocol procedures and to provide informed consent (i.e., proficient in both verbal and written communication in English or from a translator (Portuguese to English). Exclusion Criteria: 1. Currently taking Acetaminophen and unable to switch to another anti-inflammatory or pain reliever 2. Currently being treated with an anticoagulation agent 3. History of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or blood clotting disorder that in the opinion of the Investigator would compromise safety of the study subject. 4. Currently using one of the following non-insulin glucose-lowering agent, SGLT2 and Insulin Secretagogues 5. Female study subject of childbearing potential and has a positive pregnancy screening test 6. Female study subject of childbearing potential who is planning to become pregnant or not using adequate method of contraception deemed reliable by Investigator 7. 1 of more episodes of hypoglycemia or diabetic ketoacidosis (DKA) in the last 6 months requiring care in a medical facility or assistance from another individual to treat. 8. Study subject has a hematocrit (Hct) lower than the normal reference range 9. Known cardiovascular disease considered to be clinically relevant by the investigator 10. Currently undergoing treatment with: * Systemic oral or intravenous corticosteroids (current or within the last 8 weeks from screening), * Thyroid hormones, unless use has been stable during the past 3 months 11. Significant history of any of the following, that in the opinion of the investigator would compromise safety or successful study participation: * Alcoholism * Drug abuse 12. Significant acute or chronic illness, that in the opinion of the investigator might interfere with safety or integrity of study results 13. Current participation in another clinical drug or device study 14. Study subject may not be on the research staff of those performing this study.
Study design
Enrollment target: 10 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-12-13
Estimated completion: 2025-02-28
Last updated: 2025-01-08
Interventions
Device: Sensor Lead
Primary outcomes
  • Primary outcome: study device safety as evidence by absence of serious procedure or device related adverse event(s). (From enrollment through 7-days (+/-3 days) post Sensor Lead removal.)
Sponsor
Glucotrack · industry
Contacts & investigators
ContactSandra L Martha · contact · smartha@glucotrack.com · 6198892412
All locations (1)
Instituto do Coração (InCor) |Recruiting
São Paulo, Brazil, Brazil
Feasibility Study to Evaluate an Intravascular Blood Continuous Glucose Sensor · TrialPath