Prevention of nocturnal hypoglycaemia with closed-loop insulin delivery in children and adolescents with type 1 diabetes (T1D)
| ISRCTN | ISRCTN18155883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18155883 |
| Secondary identifying numbers | REC Ref. 06/Q0108/350 |
- Submission date
- 03/06/2009
- Registration date
- 02/07/2009
- Last edited
- 27/04/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Dunger
Scientific
Scientific
Department of Paediatrics
Box 116, Level 8 Addenbrooke's Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| dbd25@cam.ac.uk |
Study information
| Study design | Phase II randomised controlled interventional crossover group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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) |
| Study acronym | APCam (Artificial Pancreas project at Cambridge) |
| Study objectives | 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. |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | Type 1 diabetes |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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. |
| Overall study start date | 12/04/2007 |
| Completion date | 23/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 17 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 12/04/2007 |
| Date of final enrolment | 23/09/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Paediatrics
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Sponsor information
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge (UK)
Hospital/treatment centre
Hospital/treatment centre
Box 277
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 OQQ
United Kingdom
| stephen.kelleher@addenbrookes.nhs.uk | |
| Website | http://www.cuh.org.uk/addenbrookes/addenbrookes_index.html |
"ROR" |
https://ror.org/04v54gj93 |
Funders
Funder type
Charity
Juvenile Diabetes Research Foundation (UK) (ref: 22-2006-1113; 22-2007-1801)
No information available
European Foundation for Study of Diabetes (Germany)
No information available
Medical Research Council (MRC) (UK) - Centre for Obesity and Related metabolic Diseases (CORD)
No information available
National Institute for Health Research (NIHR) (UK) - Cambridge Biomedical Research Centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 27/02/2010 | Yes | No | |
| Results article | results | 01/02/2011 | Yes | No |
