Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes (APCam05)

This study has been completed.
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge
ClinicalTrials.gov Identifier:
NCT00989898
First received: October 5, 2009
Last updated: June 22, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Other: Automated closed-loop insulin delivery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Randomised, Two Period Cross-over Study to Assess the Feasibility, Efficacy and Safety of Automated Closed-loop Glucose Control Initiated at the Time of Dinner or Before Sleep in Children and Adolescents With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Cambridge:

Primary Outcome Measures:
  • The primary outcome measure is overnight glucose control as measured by plasma glucose concentration between midnight and 8:00 a.m. in the two Time Schedules (closed-loop control starting at 1800 or 2100). [ Time Frame: midnight to 8:00 am ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: February 2009
Study Completion Date: December 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Closed-loops at Dinner
Automated closed-loop control starts at 18:00
Other: 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.
Other Name: Automated CL
Active Comparator: Closed-loop at Bedtime
Automated closed-loop control starts at 21:00
Other: 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.
Other Name: Automated CL

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989898

Locations
United Kingdom
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom, CB20QQ
Sponsors and Collaborators
University of Cambridge
Cambridge University Hospitals NHS Foundation Trust
Investigators
Principal Investigator: David B Dunger, Professor in Paediatrics University of Cambridge
  More Information

Additional Information:
Publications:
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
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
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

Responsible Party: Dr Roman Hovorka, Principal Research Associate, University of Cambridge
ClinicalTrials.gov Identifier: NCT00989898     History of Changes
Other Study ID Numbers: CI/2008/0036
Study First Received: October 5, 2009
Last Updated: June 22, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Cambridge:
T1D, closed-loop systems, overnight hypoglycaemia

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014