None listed
Conditions
Brief summary
The single group assignment, open label, clinical trial will enroll up to 30 participants with the goal of at least 20 participants completing the yearlong study implant duration. Enrolled Participants will have the CBGM system implanted via a 20–30-minute procedure. Post procedure, after the initial 14-day post implant assessment, Participants will undergo In-Clinic visits every few months during their yearlong implant duration that include both safety and performance assessments of the CBGM System. Outside of the clinic, Participants will complete a minimum of 3 fingerpicks per day (with a study provided commercially approved BG meter and supplies, carry a study phone to collect investigational sensor data (data is blinded to the participant) and complete a study diary. Removal of the CBGM System will be similar to the implant procedure. A final 14-Day post removal visit will occur to follow-up with the participant to assess the wound. If there are not outstanding safety events or items for follow-up, this will be considered the participants final visit and they can safely exit the study.
Interventions
This human clinical trial will assess the feasibility of the Continuous Blood Glucose Monitoring (CBGM) System’s safety during long-term use as evidence by the absence of procedure and/or device related serious adverse event(s). Qualified participants who have signed informed consent will have the device implanted for up to 1-year during an outpatient procedure. They will attend clinic visits at 7-Days, 14-Days (follow-up with the procedural specialist/Investigator), 1-month, 3-months, 6-months,
This human clinical trial will assess the feasibility of the Continuous Blood Glucose Monitoring (CBGM) System’s safety during long-term use as evidence by the absence of procedure and/or device related serious adverse event(s). Qualified participants who have signed informed consent will have the device implanted for up to 1-year during an outpatient procedure. They will attend clinic visits at 7-Days, 14-Days (follow-up with the procedural specialist/Investigator), 1-month, 3-months, 6-months, 9-months, and 11-months post Continuous Blood Glucose Monitoring (CBGM) System insertion. Device removal will occur following completion of the 11-month in-clinic visit, with a follow-up / final visit to review the wound site and safely exit the Participant from the study. During post implant visits, Participants will undergo safety evaluations and a 6-hour Frequent Sample Testing (FST) session, during which venous blood samples will be collected every 15 minutes via an indwelling IV catheter and analyzed using a Nova Primary blood glucose tabletop reference analyzer (25 µL whole blood per sample). During the FST, controlled hyperglycemic and hypoglycemic challenges will be induced by adjusting the timing and/or dose of rapid-acting insulin, physical activity, and carbohydrate intake. These interventions will be individualized based on each participant’s usual insulin regimen and meal patterns and will be authorized and supervised by the endocrinology team's qualified clinical research staff. Outside of the clinic, Participants will complete up to 3 fingerpricks per day (with a study provided commercially approved Blood Glucose (BG) meter), carry a study phone to collect investigational sensor data (data is blinded to Participant), complete a study diary (to collect any safety events or medications taken, etc. in between visits), and wear a study provided commercial Continuous Glucose Monitor (CGM) sensor per approved manufacturer’s instructions for use (with minimum wear to occur at least during the time of the in-clinic visits). Removal of the investigational device will be similar to the insertion procedure. A final 14-day post removal visit will occur to follow-up with the participant to assess the sensor insertion site. If there are no outstanding adverse events or items for follow-up, this will be considered the participant’s final visit, and they can safely exit the study .
Sponsors
Glucotrack Australia PTY LTD.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 21 to 75 years old inclusive. 2. Generally, in good health, as determined by the investigator. 3. Clinical diagnosis of type 1 or type 2 diabetes for at least 3 years 4. Insulin Therapy – 3 plus injections/day or Continuous Subcutaneous Insulin Infusion (CSII) in Participants with type 1 diabetes, or with basal insulin or multi-dose insulin regimen in Participants with type 2 diabetes. 5. HbA1c < 9.0 % as reported on baseline laboratory result. 6. BMI in the range 18–32 kg/m2.
Exclusion criteria
1. Any biochemical profile, full blood examination or differential result that falls outside the laboratory’s reference range and deemed by the investigator as clinically significant or indicative of a serious chronic illness. 2. History of Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE), or blood clotting disorder that, in the opinion of the Investigator, would compromise the safety of the study Participant. 3. Female Participant of childbearing potential who has a positive pregnancy screening test or who is planning to become pregnant or not using adequate method of contraception deemed reliable by Investigator. 4. One (1) or more episodes of hypoglycemia or diabetic ketoacidosis (DKA) in the last 6 months requiring an emergency room (ER) visit or hospital admission. 5. Known cardiovascular disease that, in the opinion of the Investigator, would compromise the safety of the study Participant. 6. End Stage Renal Disease on hemodialysis. 7. Current participation in another clinical drug or device study.
Outcome results
None listed