Type 1 Diabetes Clinical Trial
Official title:
Open Randomised, Two Period Cross-over Study to Assess the Feasibility, Efficacy and Safety of Automated Closed-loop Glucose Control Initiated at the Time of Dinner or Before Sleep in Children and Adolescents With Type 1 Diabetes
Children and adolescents with type 1 diabetes need regular insulin injections or continuous
insulin delivery with an insulin pump in order to keep blood sugar levels normal. The
investigators know that keeping blood sugars in the normal range can prevent long term
diabetes complications involving the eyes, kidneys and heart. However, achieving treatment
goals can be very difficult as the tighter the investigators try to control blood glucose
levels, the greater the risk for the young person to develop symptoms and signs of low
glucose levels (hypoglycaemia). This is a particular problem at night. One solution is to
develop a system whereby the amount of insulin injected is very closely matched to the blood
sugar levels on a continuous basis. In a closed loop system, for example, a continuous
glucose sensor communicates with a computer algorithm which drives an insulin pump. The
investigators have been developing such a system in Cambridge over the last year with
funding from the Juvenile Diabetes Research Foundation. The investigators have found that
this system is very effective at preventing hypoglycaemia in young people with diabetes.
Until now the information from the sensor has been entered manually into the computer and
the pump settings have also been changed manually. The investigators now need to move onto
the next step which is to fully automate the system. The studies will be done in a clinical
research facility. The investigators will study the young people on two nights in order to
find out if the closed loop system started early in the evening is as effective as when it
is started later before sleep. 12 young people will be recruited from diabetes clinics in
the East Anglia region. The studies will provide further important information concerning
the safety, efficacy and utility of closed loop systems.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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