Type 1 Diabetes Clinical Trial
Official title:
An Open-label, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 36-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment in Adolescents With Type 1 Diabetes
High variability of blood sugar levels and high incidence of night-time hypoglycaemia (low
blood sugar) in young people with type 1 diabetes (T1D) make achieving the treatment goals
in this population extremely challenging.
Our ongoing research focuses on the development of a closed-loop glucose control in children
and adolescents with T1D. The three components of the closed-loop system are a continuous
glucose monitor, an insulin pump, and a computer-based algorithm. The studies performed thus
far evaluated the efficacy and safety of overnight closed-loop glucose control. The results
showed that overnight closed-loop improved control of blood glucose and prevented nocturnal
hypoglycaemia, as compared to the conventional insulin pump therapy. The next objective is
to evaluate the efficacy and safety of closed-loop insulin delivery over a prolonged time
period, including the daytime, when normal living activities occur. This will pave the way
for a more comprehensive use of closed loop systems to control glucose levels in T1D.
The present study adopts an open-label, randomised, 2-period cross-over design whereby the
safety and efficacy of closed-loop insulin therapy will be compared with the conventional
insulin pump therapy in 12 adolescents with T1D. Participants aged 12 to 18 years will be
randomised for two 36 hour studies in a clinical research facility, during which glucose
levels will be controlled by either the computer-based closed-loop algorithm (intervention
arm) or by conventional insulin pump therapy (control arm). During both studies participants
will perform normal daily activities, i.e. playing, reading, snacking and physical activity.
On both occasions, the Actiheart, a combined heart rate and movement sensor will be used to
accurately quantify each subject's individual physical activity energy expenditure during
the 36 hour study period and for 36 hours of free living during weekday.
The study is an open-label, randomised, 2-period crossover study comparing the closed-loop
insulin therapy with the conventional insulin pump therapy in 12 adolescents with type 1
diabetes.
Subjects who consented to take part in the study will attend the Clinical Research Facility
on two occasions, each lasting 36 hours. Approximately 1-3 days prior to each Study Visit, a
subcutaneous continuous glucose monitoring (CGM) device will be inserted.
On each Study Visit subjects will arrive between 17:30 and 18:00 and will stay in the
clinical research facility for two nights.
Shortly after arrival the subjects will have Actiheart monitor fitted and a cannula inserted
into a vein of one arm for blood sampling purposes. Blood sampling for plasma glucose and
plasma insulin will start at 18:30 and will be carried out at 30 minutes intervals during
the day and at 60min intervals during the night throughout the study period. Plasma glucose
measurements will be done in real time every 30min during the day and every 60min during the
night except when when plasma glucose < 3.5mmol/L or following treatment for hypoglycaemia,
when the measurements will be carried out every 15 minutes.
On Study Visit 1 the subjects will be randomised on arrival to receive either the
conventional insulin pump therapy or the closed-loop intervention. At 18:30 subjects will
perform 5 to 10 minutes exercise on a bicycle to determine the settings needed to achieve a
heart rate of 140 bpm corresponding to an exercise level at 55%60% of peak VO2. In the
closed-loop intervention arm the insulin pump therapy will be driven by the computer-based
algorithm from 19:30 until the end of the study. The basal insulin infusion rate on the
insulin pump will be adjusted manually at 15min intervals following the computer-based
algorithm advice. During the control arm, the subject will carry on with their usual insulin
pump regimen. In both groups CGM will be continued throughout the whole of the study period.
Subjects who completed Study Visit 1 will cross over to the alternative Study Visit schedule
after an interval of 1 to 6 weeks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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