Closing the Loop in Adolescents During Non-compliance Behaviours

Type 1 Diabetes Clinical Trial

Official title:

An Open-label, Single-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy and Safety of 24-hour Closed-loop Glucose Control in Comparison With Conventional Subcutaneous Insulin Pump Treatment Simulating Non-compliant Behaviours in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629277
• Other study ID #: DAN03
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2011
• Last updated: June 26, 2012
• Start date: July 2011
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: University of Cambridge
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Closed-loop
Subcutaneous insulin delivery will be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings
• standard insulin pump
Subcutaneous insulin delivery will be administered according the standard insulin pump settings

Locations

Country	Name	City	State
United Kingdom	Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital	Cambridge

Sponsors (2)

Lead Sponsor	Collaborator
University of Cambridge	Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary efficacy outcome measure	The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9-10.0mmol/L) between 19:00 on Day 1 and 18:00 on Day 2 (23 hours), as obtained with closed-loop insulin delivery as compared with conventional insulin pump therapy.	24 hours	No
Secondary	Secondary efficacy outcome measure	Secondary outcomes will include: Time spent with plasma glucose concentration above the target range (>10mmol/L) between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).; Time spent with plasma glucose concentration below the target range (<3.9mmol/L) between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).; Total and basal insulin delivery between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).; CGM glucose levels between 19:00 on Day 1 and 18:00 on Day 2 (23 hours).; Overnight plasma glucose levels between 24:00 on Day 1 and 08:00 on Day 2 (8 hours)	24 hours	No