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Completed

NCT Number: NCT00989898

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

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.

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Key information

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wellcome Trust Clinical Research Facility, Addenbrooke's Hospital

Cambridge, Cambridgeshire, CB20QQ, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Automated closed-loop insulin delivery

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.

Other names: Automated CL

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).

    Time frame: midnight to 8:00 am

Sponsors and collaborators

Lead sponsor

University of Cambridge

Other

Collaborators

  • Cambridge University Hospitals NHS Foundation Trust

Registry information

Official study 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

Acronym: APCam05

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 6, 2009
Registry last updated
Jun 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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