Automated Overnight Closed-loop Glucose Control in Young People With Type 1 Diabetes
APCam05
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
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2009
CompletedFirst Posted
Study publicly available on registry
October 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 25, 2012
June 1, 2012
2.2 years
October 5, 2009
June 22, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
midnight to 8:00 am
Study Arms (2)
Closed-loops at Dinner
ACTIVE COMPARATORAutomated closed-loop control starts at 18:00
Closed-loop at Bedtime
ACTIVE COMPARATORAutomated closed-loop control starts at 21:00
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB20QQ, United Kingdom
Related Publications (3)
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
BACKGROUNDHovorka 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
BACKGROUNDD. 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
BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David B Dunger, Professor in Paediatrics
University of Cambridge
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Research Associate
Study Record Dates
First Submitted
October 5, 2009
First Posted
October 6, 2009
Study Start
February 1, 2009
Primary Completion
May 1, 2011
Study Completion
December 1, 2011
Last Updated
June 25, 2012
Record last verified: 2012-06