Multicentre closed-loop home study in young people with type 1 diabetes
| ISRCTN | ISRCTN24960600 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24960600 |
| Protocol serial number | 15892 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | Juvenile Diabetes Research Foundation Limited (JDRF) (UK) |
- Submission date
- 16/01/2014
- Registration date
- 16/01/2014
- Last edited
- 21/01/2019
- 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
Ms Josephine Hayes
Scientific
Scientific
Wellcome Trust-MRC Institute of Metabolic Science
Addenbrookes Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
| Phone | +44 1223 762 862 |
|---|---|
| jfh31@cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised; Interventional; Design type: Treatment |
| Secondary study design | Randomised controlled trial |
| Scientific title | Multicentre closed-loop home study in young people with type 1 diabetes |
| Study objectives | An open-label, three-centre, randomised, two-period, crossover study to assess the efficacy, safety and utility of real-time continuous subcutaneous glucose monitoring combined with overnight closed-loop glucose control in the home setting in comparison with realtime continuous subcutaneous glucose monitoring alone in children and adolescents with type 1 diabetes on subcutaneous insulin infusion pump therapy |
| Ethics approval(s) | 13/EE/0120 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: Diabetic Control, All Diseases |
| Intervention | 1. Realtime CGM + overnight CL 2. Realtime CGM alone |
| Intervention type | Other |
| Primary outcome measure(s) |
Time spent overnight in the target glucose range (3.9 to 8.0 mmol/l) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Key inclusion criteria | 1. The subject is between 6 and 18 years of age (inclusive) 2. The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed Cpeptide negative 3. The subject will have been an insulin pump user for at least 3 months, with good knowledge of insulin selfadjustment as judged by theinvestigator. 4. The subject is willing to perform regular fingerprick blood glucose monitoring, with at least 4 blood glucose measurements taken every day 5. HbA1c = 10 % based on analysis from central laboratory or equivalent 6. The subject is literate in English |
| Key exclusion criteria | 1. Known or suspected allergy against insulin 2. Nontype 1 diabetes mellitus including those secondary to chronic disease 3. Untreated celiac disease 4. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator 5. Current treatment with drugs known to interfere with glucose metabolism, eg systemic corticosteroids, nonselective betablockers and MAO inhibitors etc 6. Known or suspected allergy against insulin 7. Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 8. Total daily insulin dose = 2 IU/kg/day 9. Total daily insulin dose < 10 IU/day 10. Pregnancy, planned pregnancy, or breast feeding 11. Severe visual impairment 12. Severe hearing impairment 13. Subjects using implanted internal pacemaker |
| Date of first enrolment | 10/12/2013 |
| Date of final enrolment | 31/12/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Wellcome Trust-MRC Institute of Metabolic Science
Cambridge
CB2 0QQ
United Kingdom
CB2 0QQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 26/11/2015 | 21/01/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
21/01/2019: Publication reference added
11/05/2017: No publications found in PubMed, verifying study status with principal investigator
