Diabetes Mellitus Clinical Trial
Official title:
An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of a Novel Automated Overnight Closed-loop Glucose Control System on Day 1 of Continuous Glucose Monitoring Sensor Insertion in Comparison to Day 3 to 4 After Sensor Insertion in Children and Adolescents With Type 1 Diabetes
People with type 1 diabetes need regular insulin injections or continuous delivery of
insulin using a pump. Keeping blood sugars in the normal range is known to reduce long term
complications. However, achieving treatment goals can be very difficult due to the risk of
low glucose levels (hypoglycaemia). One solution is to use a system where the amount of
insulin injected closely matches the blood sugar levels on a continuous basis. This can be
achieved by what is known as a "closed loop system" where a small glucose sensor placed
under the skin communicates with a computer containing an algorithm that drives a
subcutaneous insulin pump. Previous studies conducted under carefully controlled clinical
research facility environment, in Cambridge, United Kingdom, as well as several other
centres have shown that closed-loop glucose control is superior to usual insulin pump
therapy. The next logical step in the development pathway is to test closed loop systems in
the home environment. An essential requirement for conducting closed-loop studies outside
clinical research facility is an automated system where wireless data transmission takes
place between the glucose sensor and insulin pump.
The purpose of the present study is to evaluate the efficacy and safety of automated
overnight closed-loop, in children and adolescents with type 1 diabetes, using a novel
system which has greatest potential for use in the home setting. The study will take place
at a clinical research facility on two occasions, using a standardised protocol. The
performance of the closed-loop system will be evaluated on day 1 of continuous glucose
monitoring (CGM) sensor life as compared to on days 3 to 4 of sensor life. Data and
experience gained from this study will be used for further refinements and development of
the system for future home use.
The main objective of the current study is to evaluate the efficacy, safety and
utility/reliability of a novel automated overnight closed-loop glucose control system in
children and adolescents with type 1 diabetes. This will inform the future development of
closed-loop systems in children and adolescents aged 6 to 18 years with type 1 diabetes.
This is an open-label, randomised, 2-period cross-over study, using the Medtronic Android
closed loop platform or similar, comparing the safety and efficacy of overnight closed loop
glucose control on day 1 compared with day 3 to 4 of CGM sensor life. Participants will be
randomised to undergo two overnight studies in a clinical research facility, during which
glucose levels will be controlled by the computer-based closed-loop algorithm on day 1 of
CGM sensor insertion or day 3 to 4 after sensor insertion.
A total of 16 children and adolescents with T1D between 6 and 18 years of age will be
recruited through the Outpatient Diabetes Clinic in the Department of Paediatrics,
Addenbrooke's Hospital and Paediatric Diabetes Centres in London, Norwich, and Ipswich, to
allow for 12 available for assessment. All participants will be on insulin pump treatment
with a good knowledge of insulin dose adjustments. The study will take place at the Wellcome
Trust Clinical Research Facility (WTCRF), Cambridge. Participants will be admitted at the
clinical research facility in the evening and stay until the following morning. During the
two closed-loop visits, automated closed-loop glucose control with wireless data
transmission will be performed. A Model-Predictive-Control algorithm will determine the
insulin infusion rate based on interstitial glucose measured by a continuous subcutaneous
glucose monitoring (CGM) system. Intravenous sampling for glucose and insulin levels will
also be carried out on both study visits for post hoc validation of glucose sensor data and
for future modelling purposes.
The primary efficacy endpoint is the time spent in the target plasma glucose range from 3.9
to 8 mmol/L. Safety evaluation is focused on the frequency and duration of episodes of
hypoglycaemia.
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