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Prevention of nocturnal hypoglycaemia with closed-loop insulin delivery in children and adolescents with type 1 diabetes (T1D)
ISRCTN ISRCTN18155883
DOI 10.1186/ISRCTN18155883
ClinicalTrials.gov identifier
EudraCT number
Public title Prevention of nocturnal hypoglycaemia with closed-loop insulin delivery in children and adolescents with type 1 diabetes (T1D)
Scientific title Three randomised studies to assess closed-loop overnight glucose control as compared to standard pump therapy, copying with variable evening intake and afternoon exercise in youngsters with type 1 diabetes (T1D)
Acronym APCam (Artificial Pancreas project at Cambridge)
Serial number at source REC Ref. 06/Q0108/350
Study hypothesis Closed loop systems can reduce risk of nocturnal hypoglycaemia in children and adolescents with type 1 diabetes (T1D) even after variable evening meal intake and differing exercise patterns.
Lay summary
Ethics approval Cambridge Local Ethics Committee approved on the 8th December 2006 (ref: 06/Q0108/350). The last substantive approval was granted on the 20th December 2007.
Study design Phase II randomised controlled interventional crossover group trial
Countries of recruitment United Kingdom
Disease/condition/study domain Type 1 diabetes
Participants - inclusion criteria 1. Young subjects stratified into age for each of the three trials:
1.1. Trial 1: Aged 5 to 18 years, either sex
1.2. Trial 2: Aged 12 to 18 years, either sex
1.3. Trial 3: Aged Post-pubertal to 18 years, either sex
2. Type 1 diabetes for at least 6 months or confirmed C-peptide negative
Participants - exclusion criteria 1. Any other physical or psychological disease or medication likely to interfere with the normal conduct of the study and interpretation of the study results
2. Experienced recurrent severe hypoglycaemic unawareness
3. Clinical significant nephropathy, neuropathy or proliferative retinopathy
Anticipated start date 12/04/2007
Anticipated end date 23/09/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 17
Interventions The three studies will take place as follows:

1. Comparison of closed loop system with standard CSII (APCam01):
In random fashion, twelve subjects aged 5 to 18 years were treated by overnight closed-loop or CSII on two separate occasions at the Clinical Research Facility 1 to 3 weeks apart. On both study occasions, the subjects consumed a self-selected meal (87 +/- 23g carbohydrates) at 18:00 accompanied by prandial insulin (9 +/- 5U) calculated according to subject's insulin-to-carbohydrate ratio. The meals were identical on both study nights. Closed-loop control was applied between 20:00 and 08:00 the next day. On the CSII night, the subject's standard insulin pump settings were applied.

2. Evaluation of the effects of a variable-content large evening meal (APCam02):
Six subjects participating in APCam01, aged 12 to 18 years, were recruited for APCam02. They were studied on two further occasions 1 to 4 weeks apart. On each occasion at 18:00, the subjects consumed either a rapidly or slowly absorbed large meal selected from a list of standardised meals differing in glycaemic load (113 +/- 29 versus 40 +/- 8; rapid versus slow, P = 0.001, paired t-test) but matched for carbohydrates (129 +/- 34 versus 129 +/- 34 g; P = NS). The carbohydrate amount corresponded to the largest meal eaten over the three preceding months. Prandial insulin doses were comparable (17 +/- 6 versus 17 +/- 7 U) and were calculated according to subject's insulin-to-carbohydrate ratio. Closed-loop was performed from 18:30 to 08:00 the next day.

3. Effects of moderate-intensity evening exercise (APCam03):
Nine post-pubertal subjects aged 12 to 18 years were studied on two occasions 1 to 5 weeks apart; four subjects participated previously in APCam01. One week before the first study occasion, a ramped treadmill protocol was used to estimate the peak VO2 as an indicator of the maximum oxygen uptake 15.

Subsequently, subjects were studied after identical exercise protocols using closed-loop or CSII. On each occasion at 16:00, subjects consumed a light meal chosen from a list of standardised snacks (45 +/- 13 g carbohydrates) accompanied by prandial bolus calculated from subject's insulin-to-carbohydrate ratio. The subjects exercised at 55% VO2max on treadmill from 18:00 until 18:45 with a 5-minute rest at 18:20. Closed-loop was then performed overnight between 20:00 and 08:00. On the CSII night, subject's standard insulin pump settings were applied.
Primary outcome measure(s) Overnight glucose control including the assessment of variability and frequency of hypoglycaemic events.

Measured from the start of the closed-loop (20:00 or 18:30) until 08:00 the next day, and from 00:00 until 08:00 the day after.
Secondary outcome measure(s) 1. The time spent in A+B and E+F Grades of the glycaemic control grading scheme
2. The total overnight insulin dose
3. Endocrine effects of exercise on growth hormone (GH), insulin-like growth factor 1 (IGF-1), insulin-like growth factor binding protein 1 (IGFBP-1) and counter-regulatory hormones

Measured from the start of the closed-loop (20:00 or 18:30) until 08:00 the next day, and from 00:00 until 08:00 the day after.
Sources of funding 1. Juvenile Diabetes Research Foundation (UK) (ref: 22-2006-1113; 22-2007-1801)
2. European Foundation for Study of Diabetes (Germany)
3. Medical Research Council (MRC) (UK) - Centre for Obesity and Related metabolic Diseases (CORD)
4. National Institute for Health Research (NIHR) (UK) - Cambridge Biomedical Research Centre
Trial website
Publications 1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20138357
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21216859
Contact name Prof  David  Dunger
  Address Department of Paediatrics
Box 116, Level 8 Addenbrooke's Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 0QQ
  Country United Kingdom
  Email dbd25@cam.ac.uk
Sponsor Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (UK)
  Address Box 277
Addenbrooke's Hospital
Hills Road
  City/town Cambridge
  Zip/Postcode CB2 OQQ
  Country United Kingdom
  Email stephen.kelleher@addenbrookes.nhs.uk
  Sponsor website: http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html
Date applied 03/06/2009
Last edited 27/04/2011
Date ISRCTN assigned 02/07/2009
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