In clinic evaluation of an "artificial pancreas" for the management of type 1 diabetes, when possible hypoglycaemia causing scenarios are simulated.
In clinic evaluation of a closed loop insulin delivery system using the Minimed 670g insulin pump, under hypoglycaemic stimuli including an over reading glucose sensor and exercise, in patients with type 1 diabetes aged 12 - 50 years old, with assessment of the incidence of hypoglycaemic events (plasma glucose level <3.5mmol/L)
Dr Martin de Bock
8 participants
Jan 27, 2015
Interventional
Conditions
Summary
This study will let us explore the safety of a closed loop for the management system that is designed for unmonitored home use. It is possible that if the system is stressed, that hypoglycaemia can still happen. For example during and after exercise, or if the glucose sensor is over reading. We will simulate these possibilites while participants are in a hospital system and are closely monitored. This will help us learn and improve the system, and educate participants in the future, when the device is used in the community.
Eligibility
Inclusion Criteria6
- Age 12-50 years with type 1 diabetes
- Duration of diabetes at least 12 months
- On insulin pump therapy for at least 6 months
- Carbohydrate counting
- Using bolus calculator function
- HbA1C<9%
Exclusion Criteria5
- Pregnancy
- Any alcoholic or substance abuse
- Undergoing treatment for psychological illness
- Any additional condition(s) that in the investigator’s opinion would warrant exclusion from the study or prevent the subject from completing the study
- Participants unable to comply with V02 max exercise testing and moderate exercise for medical or any other reason.
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Interventions
In this interventional study, we will study patients with type 1 diabetes. They will be wearing a closed loop or 'artificial pancreas' system, which consists of an insulin pump with a mathematical algorithm that adjusts insulin according to real time continuous glucose monitoring from a glucose sensor. We will use the Minimed 670g insulin pump containing the algorithm, and enlite III glucose sensor. The closed loop system will be fitted by the research team (research nurse, and doctor). The insulin pump and glucose sensor is worn as usual (external hardware, with subcutaneous infusion, and glucose sensor). The observational period will be four consecutive days and three nights and will occur in-clinic, during whcih the closed loop system is used continuously. On day 1 the participants will wear the closed loop system, and learn how to use it. On day 2 we will calibrate the glucose sensor so that it over reads the glucose value by 30% On day 3, we will continue to have the glucose sensor over read by 30% and participants will be asked to exercise by cycling on a stationary ergometer at moderate intensity (50 - 60% of VO2 max) for 45 minutes. On day 4 the glucose sensor will be changed just like in normal clinical practice, and will be recalibrated to read normally. As this study is conducted in clinic, all of the study protocol will be monitored and adhered to.
Locations(1)
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ACTRN12614001005640