None listed
Conditions
Brief summary
This study will compare the new insulin pump with predictive low glucose suspend feature with current pump therapy with the aim to reduce the time spent hypoglycaemic.
Interventions
The intervention involves continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and predictive low glucose suspend feature (Medtronic Minimed 640G) for six months duration. Continuous glucose monitoring will involve insertion of a sensor just under the skin that sends continuous glucose readings back to the insulin pump. This pump has the added feature of Predictive Low Glucose Suspend function. If a low glucose level is predicted to be reached in 30 minute
The intervention involves continuous subcutaneous insulin infusion with real-time continuous glucose monitoring system and predictive low glucose suspend feature (Medtronic Minimed 640G) for six months duration. Continuous glucose monitoring will involve insertion of a sensor just under the skin that sends continuous glucose readings back to the insulin pump. This pump has the added feature of Predictive Low Glucose Suspend function. If a low glucose level is predicted to be reached in 30 minutes and the patient does not respond to the alarm, the pump will suspend insulin infusion for 2 hours. Both the pump and glucose sensor system will be worn for the entire 6 months.
Sponsors
Professor Timothy Jones
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
8 Years to 20 Years
Healthy volunteers
No
Inclusion criteria
1) Age: 8-20yrs at Princess Margaret Hospital, Perth and John Hunter Children's Hospital, Newcastle; Age 8-18yrs at Westmead Children's Hospital, Sydney, Women and Children's Hospital,Adelaide and RCH, Melbourne 2) T1DM for >1 year 3) On insulin pump therapy for >6 months 4) HbA1c < 10.0%
Exclusion criteria
1) Medical conditions predisposing to hypoglycaemia other than diabetes 2) Oral glycaemic medications 3) Inability or refusal to meet protocol requirements 4 ) Pregnancy
Outcome results
None listed