None listed
Conditions
Brief summary
This is a randomized cross over trial. Patients with type 1 diabetes will have their glucose levels controlled by either a closed loop (artificial pancreas) system, or sensor augmented pump therapy with low glucose suspend. During closed loop patients will still use the bolus function of their pump for meals. The study will start in hospital for 2 days and nights, and then the participants will continue in the home for a further 5 days. Then, after a washout for at least a week, they will cross over to the opposite intervention for a further 7 day period. Our primary outcomes are the ammount of time spent euglycaemic (3.9 - 10mmol/L), and hypoglycaemic events (<3.3mmol/L). We will recruit 14 participants.
Interventions
Closed loop insulin therapy (or artificial pancreas), compromising of a Medtronic Paradigm Veo insulin pump with continuous glucose sensor, an Android-based smartphone with the closed loop algorithm software, and a translator that translates messages between the phone and insulin pump. An insulin pump is an external device, which is already used by thousands of patients in the community. There is a small cannula placed subcutaneously through which the insulin is infused - and is attached to the insulin pump by plastic tubing. No anaesthetic is required. The infusion site lasts three days, before needing to be changed to a new site. The continous glucose sensor is a small plastic cannula inserted into the subcutaneous tissue - which then connects to an external transmitting device which communicates to the insulin pump via radiofrequency. A glucose sensor lasts a maximum of 6 days, and does not require an anaesthetic for insertion. Participants will spend this first 48 - 72 hours in hospital learning how to use the technology, before going home and completing a full 7 days. While at home patient will upload their insulin pump daily, and we will use remote monitoring of the smartphone for constant monitoring and checking of adherance. There will be a washout of at least 7 days between treatments.
Sponsors
Study design
Eligibility
Inclusion criteria
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 criteria
Pregnancy Any alcoholic or substance abuse Undergoing treatment for psychological illness