Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes

NCT ID: NCT00989898

Last Updated: 2012-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-12-31

Brief Summary

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.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Closed-loops at Dinner

Automated closed-loop control starts at 18:00

Group Type: ACTIVE_COMPARATOR

Automated closed-loop insulin delivery

Intervention Type: OTHER

Insulin infusion rates via the insulin pump will be dictated by a computer-based control algorithm according to the CGM glucose readings and automatically adjusted on the pump.

Closed-loop at Bedtime

Automated closed-loop control starts at 21:00

Group Type: ACTIVE_COMPARATOR

Automated closed-loop insulin delivery

Intervention Type: OTHER

Insulin infusion rates via the insulin pump will be dictated by a computer-based control algorithm according to the CGM glucose readings and automatically adjusted on the pump.

Interventions

Automated closed-loop insulin delivery

Insulin infusion rates via the insulin pump will be dictated by a computer-based control algorithm according to the CGM glucose readings and automatically adjusted on the pump.

Intervention Type: OTHER

Other Intervention Names

Automated CL

Eligibility Criteria

Inclusion Criteria

• Signed informed consent obtained before study-related activities. Study-related activities are any procedure that would not have been performed during standard medical care.
• The subject is between 6 and 18 years of age (inclusive).
• The subject has type 1 diabetes, as defined by WHO for at least 6 months or confirmed C-peptide negative.
• The subject will have been on insulin pump for at least 3 months

Exclusion Criteria

• Non-type 1 diabetes mellitus including those secondary to chronic disease
• Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
• Taking medication likely to interfere with interpretation of the results
• Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator).
• Known or suspected allergy against insulin.
• Patients with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: lead

Responsible Party

Dr Roman Hovorka

Principal Research Associate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David B Dunger, Professor in Paediatrics

Role: PRINCIPAL_INVESTIGATOR

University of Cambridge

Locations

Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Cambridge, Cambridgeshire, United Kingdom

Countries

United Kingdom

References

Hovorka R, Acerini CL, Allen J, Chassin LJ, Larsen AM, De Palma A, Wilinska ME, Dunger DB: Overnight sc-sc closed-loop control improves glucose control and reduces risk of hypoglycaemia in children and adolescents with type 1 diabetes. Diabetes 57:A22, 2008

Reference Type: BACKGROUND

Hovorka R, Acerini CL, Allen J, Chassin LJ, Larsen AF, Mundt D, De Palma A, Wilinska ME, Dunger DB: Good overnight closed-loop glucose control in children and adolescents with type 1 diabetes following ingestion of large, rapidly and slowly absorbed evening meal. Diabetologia 51:S81-181, 2008

Reference Type: BACKGROUND

D. Elleri, C.L. Acerini, J.M. Allen, L.J. Chassin, U. Ekelund, A.M.F. Larsen, M. Nodale, M.E. Wilinska, D.B. Dunger & R. Hovorka Afternoon exercise and overnight closed-loop (cl)insulin delivery in adolescents with type 1 diabetes(t1d). Pediatric Diabetes (2009) 10 (Suppl.11): 20

Reference Type: BACKGROUND

Related Links

http://jdrf.org

Juvenile Diabetes Research Foundation

Other Identifiers

CI/2008/0036

Identifier Type: -

Identifier Source: org_study_id