None listed
Conditions
Brief summary
This study will evaluate the accuracy of an experimental CGM measuring glucose continuously in the immediate vicinity of subcutaneous insulin delivery in people with type 1 diabetes (T1D) on insulin pump therapy. Glucose sensory accuracy will be measured over a 7 days period, along with device survival and tolerability over the same period. Accuracy of the device will be tested in both a free living state, as well as over three seperate mixed meal challenges in order to test the device accuracy over a range of glucose levels.
Interventions
The study participants will have an experimental combined insulin cannula and glucose sensor (SynerG) delivering insulin via an insulin pump. The device will be inserted subcutaneously and will deliver the insulin via the commercially available Medtronic 780G or Tandem T-Slim insulin pump which is also inserted into the participant. The overall system is therefore the SynerG (combined cannula and glucose sensor) with the commercially available insulin pump, and there is no control device. The sy
The study participants will have an experimental combined insulin cannula and glucose sensor (SynerG) delivering insulin via an insulin pump. The device will be inserted subcutaneously and will deliver the insulin via the commercially available Medtronic 780G or Tandem T-Slim insulin pump which is also inserted into the participant. The overall system is therefore the SynerG (combined cannula and glucose sensor) with the commercially available insulin pump, and there is no control device. The system will be inserted by the study staff, and used on the participant's usual insulin delivery settings. The participants may use Basal-IQ (Tandem) or the fully open-loop system (Tandem or Medtronic). The participants will also have a Dexcom G6 Continuous Glucose Monitor (CGM) system inserted. The study period will involve a 7 day period of wearing the SynerG device with the Medtronic 780G or Tandem T-Slim insulin pump. The participants will wear the devices for 24 hours a day, for 7 days. Data from the insulin pumps will be able to used to assess for adherence to the devices. There will be three mixed meal tests throughout the 7 day period on days 1,4 and 7, with free living days in between. The mixed meal test will last over 4-5 hours with 15 minutely interval blood sampling. The mixed meal test will involve 30-60g carbohydrates + 10g protein + 10g fat with the goal of accumulating glucose values in the hypoglycaemic, euglycaemic and hyperglycaemic ranges. Experimental device CGM data will be collected throughout the seven days. Experimental device CGM accuracy will be compared with reference Yellow Springs Instruments (YSI) blood glucose level (BGL) as well as commercially available Dexcom G6 CGM readings.
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
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. T1D, of at least 6 months duration. 2. Age 18-75 3. Insulin pump usage at the time of screening and for at least 3 months prior to screening 4. HbA1c between 5.8 and 10% 5. Willingness and ability to follow all study procedures and to attend all clinic visits.
Exclusion criteria
1. Skin reactions and infections. 2. History of recurrent infusion site failure. 3. Any other major medical or psychiatric condition which in the opinion of the investigator would preclude safe implementation of the protocol. 4. Vulnerable population ie. Children/neonates, Pregnant women, cognitively impaired adults, prisoners.
Outcome results
None listed