Closing the Loop in Adolescents During Non-compliance Behaviours

University of Cambridge

Status and phase

Completed

Phase 2

Conditions

Type 1 Diabetes

Treatments

Device: standard insulin pump

Device: Closed-loop

Study type

Interventional

Funder types

Other

Identifiers

NCT01629277

DAN03

Details and patient eligibility

About

The ultimate goal of the investigators ongoing research is the development of a closed-loop system for insulin delivery, which can help people with type 1 diabetes (T1D) attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model-predictive algorithm', which computes the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control was evaluated both overnight and over a prolonged period of time including the day-time in children and adolescents with T1D. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy.

The objective of the current study is to test the performance of closed-loop further, by evaluating the system during common non-compliant behaviours in the administration of meal insulin doses in adolescents with T1D. This will pave the way for a more comprehensive use of closed loop systems to control glucose levels in T1D under various "real-life mimicking" common circumstances. The present study adopts an open-label, randomised, 2 period cross-over design whereby 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 24 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). On both occasions, participants will under-estimate and omit the meal-related insulin dose for the evening-meal and lunch, respectively. The study will take place at the Wellcome Trust Clinical Research Facility (WTCRF), Cambridge with participants recruited from paediatric diabetes clinics in England.

Enrollment

12 patients

Sex

All

Ages

12 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Aged 12-18 years
Type 1 diabetes diagnosed for > 1 year
Insulin pump treatment for at least 3 months
HbA1c between 8 and 12%
Subject willing to perform reduction/omission of meal insulin boluses during clinical studies

Exclusion criteria

Non-type 1 diabetes mellitus
Physical or psychological disease likely to interfere with the normal conduct of the study
Current treatment with drugs known to interfere with glucose metabolism
Known or suspected allergy against insulin
Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy
Total daily insulin dose >= 2 IU/kg/day
Pregnancy, planned pregnancy, or breast feeding