None listed
Conditions
Brief summary
Achieving optimal glucose control in type 1 diabetes requires frequent monitoring of glucose which can be burdensome for many patients. The most common methods for self-monitoring glucose involve frequent "finger-pricking" or continuous glucose monitors inserted under the skin which last up to 1-2 weeks and require at least daily calibration with finger-pricks. This study aims to collect glucose information from the implanted sensor to optimise sensor signal processing and improve sensor performance. This investigational device is an implantable long-term glucose sensor that measures an individual's glucose levels continuously and sends data to a receiver outside the body. Following implantation, the sensor requires no user interaction, and the receiver only needs to be kept close by. The only maintenance required of the receiver is battery changes and data downloading.
Interventions
The purpose of this research study is to collect data that can help to answer questions about the performance and safety of a new iteration of the surgically implanted Model 100 continuous glucose sensor. Trial participants will be randomized into two groups to evaluate performance. Sensors for the two groups will have been manufactured in the identical manner, with the sensor treatment (Dexamethasone with or without PEGylation) to be the only variation.
12 participants are expected to be enro
The purpose of this research study is to collect data that can help to answer questions about the performance and safety of a new iteration of the surgically implanted Model 100 continuous glucose sensor. Trial participants will be randomized into two groups to evaluate performance. Sensors for the two groups will have been manufactured in the identical manner, with the sensor treatment (Dexamethasone with or without PEGylation) to be the only variation. 12 participants are expected to be enrolled in this study and the sensor will be implanted subcutaneously (just below the skin) into the participant’s lower abdominal area and remain there for a minimum of four and a half months and up to eight months, after which it will be removed. The implant of the sensor requires a small incision in the lower abdomen which is placed as a minor surgical operation, usually achieved under local anaesthesia with some intravenous sedation in under 30 minutes. At the end of the study, another minor surgical operation using the same technique is required to remove the sensor. Throughout the course of the trial, device properties and safety assessments will be made to determine device function and performance. Participants will attend the trials centre 1, 7 and 14 days after device implant for ~30mins, and then at monthly intervals for ~6 hours to undergo meal testing and blood sampling. Blood samples taken during thee monthly visits will assess device safety and determine if the protocol will be terminated at 4.5months, or up to 8 months. Participants will be required to test their blood glucose daily by fingerprick between 4-8 times per day, and fill out a diary each week to monitor adherence to the study interventions. The study diary will be reviewed, and devices downloaded at each trial visit.
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus for at least 5 years * HbA1c <10% * BMI < 35kg/m2
Exclusion criteria
* Serious chronic illness * Use of paracetamol during the trial * c-peptide <150pmol/L
Outcome results
None listed