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

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ClinicalTrials.gov Identifier: NCT00989898
Recruitment Status : Completed
First Posted : October 6, 2009
Last Update Posted : June 25, 2012
Sponsor:
Collaborator:
Cambridge University Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Dr Roman Hovorka, University of Cambridge

Tracking Information
First Submitted Date  ICMJE October 5, 2009
First Posted Date  ICMJE October 6, 2009
Last Update Posted Date June 25, 2012
Study Start Date  ICMJE February 2009
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00989898 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Closed-loops at Dinner
    Automated closed-loop control starts at 18:00
    Intervention: Other: Automated closed-loop insulin delivery
  • Active Comparator: Closed-loop at Bedtime
    Automated closed-loop control starts at 21:00
    Intervention: Other: Automated closed-loop insulin delivery
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 5, 2009)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00989898
Other Study ID Numbers  ICMJE CI/2008/0036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Roman Hovorka, University of Cambridge
Study Sponsor  ICMJE University of Cambridge
Collaborators  ICMJE Cambridge University Hospitals NHS Foundation Trust
Investigators  ICMJE
Principal Investigator: David B Dunger, Professor in Paediatrics University of Cambridge
PRS Account University of Cambridge
Verification Date June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP