None listed
Conditions
Brief summary
Glucose sensor technology has been evolving with an ultimate goal of achieving a level of accuracy required to replace finger prick glucose testing, together with a level of reliability for use in an artificial pancreas. While there have been recent advances in glucose sensing technology, further improvements relating to sensor accuracy and reliability are required. A glucose sensor based on a novel technology platform has been developed. Studies in animals and humans during development of this sensor have shown positive results, and this will be the first study in humans to formally compare the novel glucose sensor to a glucose sensor based on the traditional sensing platform.
Interventions
This study evaluates the performance of a novel glucose sensor incorporating simple and orthogonal redundancy in people with type 1 diabetes. Currently available glucose sensors measure interstitial fluid glucose levels via electrochemical sensing. Sensor redundancy involves multiple sensing elements incorporated into a single sensor, thereby providing backup in case one element fails. Simple redundancy involves multiple sensing elements employing the same technology, while orthogonal redundancy
This study evaluates the performance of a novel glucose sensor incorporating simple and orthogonal redundancy in people with type 1 diabetes. Currently available glucose sensors measure interstitial fluid glucose levels via electrochemical sensing. Sensor redundancy involves multiple sensing elements incorporated into a single sensor, thereby providing backup in case one element fails. Simple redundancy involves multiple sensing elements employing the same technology, while orthogonal redundancy involves multiple elements employing different technologies which have distinct failure modes. Each participant will concurrently wear two glucose sensors for one week: 1) the investigational orthogonally redundant sensor (ORS) incorporating optical plus redundant electrochemical glucose sensing, and 2) an electrochemical comparator sensor (ECS) with simple redundancy. Each sensor will be inserted subcutaneously into the abdomen using a dedicated sensor inserter in the clinical trials centre (CTC), a procedure which takes less than 5 minutes. Each sensor will be attached to a recorder which captures sensor-related information, and this data will be uploaded at the conclusion of the study. Glucose data from the study devices will not be available to the participants and will not impact upon decisions relating to their care. Immediately following sensor insertion venous samples will be collected for reference blood glucose measurement at standardised 15-30 minute intervals for 3 hours. After 72 +/- 4 hours of sensor wear, participants will return to the CTC and consume a standardised meal. Venous samples will be collected for reference blood glucose measurement at 15 minute intervals from 1 hour prior to the test meal until 3 hours post-meal. Between visits to the CTC, participants will be instructed to undertake finger prick capillary blood glucose measurements at least 6-8 times per day (pre-meals and 2 hours post-meals) which will be recorded by the glucose meter. Following 168 +/- 4 hours of sensor wear, both the ORS and ECS will be removed in the CTC.
Sponsors
St Vincent's Hospital Melbourne
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 70 Years
Healthy volunteers
No
Inclusion criteria
Clinical diagnosis of type 1 diabetes, insulin treatment for diabetes, experience with glucose sensor use.
Exclusion criteria
Pregnant, planned pregnancy within study period, inability to tolerate tape adhesive in the area of device placement, adverse skin condition in the area of device placement.
Outcome results
None listed