An open-label, single-centre, randomised, 2-period cross-over study to assess the efficacy and safety of a novel automated overnight closed-loop glucose control system on day 1 of continuous glucose monitoring sensor insertion in comparison to day 3 to 4 after sensor insertion in children and adolescents with type 1 diabetes
| ISRCTN | ISRCTN11496419 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11496419 |
| ClinicalTrials.gov (NCT) | NCT02129868 |
| Protocol serial number | 16002 |
| Sponsor | Cambridge University Hospitals NHS Foundation Trust (UK) |
| Funder | Juvenile Diabetes Research Foundation Limited (JDRF) (UK) |
- Submission date
- 30/01/2014
- Registration date
- 30/01/2014
- Last edited
- 09/08/2019
- 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
| 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 | An open-label, single-centre, randomised, 2-period cross-over study to assess the efficacy and safety of a novel automated overnight closed-loop glucose control system on day 1 of continuous glucose monitoring sensor insertion in comparison to day 3 to 4 after sensor insertion in children and adolescents with type 1 diabetes |
| Study acronym | Automated closed-loop in children and adolescents with T1D |
| Study objectives | An openlabel, singlecentre, randomised, 2period crossover study to assess the efficacy and safety of a novel automated overnight closedloop glucose control system on day 1 of continuous glucose monitoring sensor insertion in comparison to day 3 to 4 after sensor insertion in children and adolescents with type 1 diabetes. |
| Ethics approval(s) | ref: 13/WM/0498 |
| Health condition(s) or problem(s) studied | Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: All Diseases, Device studies |
| Intervention | Primary Intervention, Sensor insertion for the Continuous Glucose monitor (CGM) |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary Outcome; Timepoint(s): The primary outcome measure is time spent with plasma glucose concentration in the target range (3.9 |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/2014 |
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 | 12 |
| Key inclusion criteria | 1. Between the ages of 6 and 18 years 2. Have Type 1 diabetes, as defined by WHO criteria for at least 1 year or is confirmed Cpeptide negative 3. Be an insulin pump user for at least 3 months, with a good knowledge of insulin dose adjustment 4. HbA1c between below 11 % based on analysis from central laboratory 5. Literate in English 6. Willing to undertake all study related activities |
| Key exclusion criteria | 1. Nontype 1 diabetes mellitus including those secondary to chronic disease 2. Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results 3. Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, nonselective betablockers and MAO inhibitors 4. Known or suspected allergy against insulin 5. Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator 6. Patient is pregnant, or breast feeding during the period of the study 7. Total daily insulin dose = 2 Units/kg/day 8. Total daily insulin dose < 10 Units/day 9. Severe visual impairment 10. Severe hearing impairment 11. Subjects using implanted internal pacemaker |
| Date of first enrolment | 01/01/2014 |
| Date of final enrolment | 01/09/2014 |
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 | 01/05/2017 | 21/01/2019 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
09/08/2019: ClinicalTrials.gov number added.
21/01/2019: Publication reference added
22/02/2017: No publications found in PubMed, verifying study status with principal investigator.
