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

Not Applicable

Completed

• Conditions: Topic: Diabetes Research Network, Medicines for Children Research Network; Subtopic: Type 1 , All Diagnoses; Disease: All Diseases, Device studies; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN11496419
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust (UK)

Brief Summary

1. 2016 results in https://www.ncbi.nlm.nih.gov/pubmed/27837162 (added 21/01/2019)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-30
• Study Completion: 2014-09-01
• Last Update Posted: 2 September 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified