Status:
COMPLETED
FASter Insulin in Closed-loop Technology in Children
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
Cambridge University Hospitals NHS Foundation Trust
Oxford University Hospitals NHS Trust
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
The main objective of this study is to determine whether 24/7 hybrid closed-loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is superior to 24/7 hybrid closed-...
Detailed Description
Purpose of clinical trial: To compare hybrid closed-loop applying faster insulin aspart to hybrid closed-loop applying standard insulin aspart over 8 weeks. Study objectives: The study objective is...
Eligibility Criteria
Inclusion
- Age between 2 and 6 years (inclusive)
- Type 1 diabetes as defined by WHO for at least 6 months \[WHO definition: 'The aetiological type named type 1 encompasses the majority of cases which are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not include those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).'\]
- Insulin pump user (with or without continuous glucose monitoring or flash glucose monitoring system) for at least 3 months, with parent/guardian good knowledge of insulin self-adjustment as judged by the investigator
- Treated with U-100 rapid or ultra-rapid acting insulin analogue
- Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- Able to wear glucose sensor
- Able to wear closed-loop system 24/7
- The parent/guardian is willing to follow study specific instructions
- The parent/guardian is proficient in English
Exclusion
- 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
- Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment
- Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids
- Known or suspected allergy to insulin
- Parent/guardian's lack of reliable telephone facility for contact
- Parent/guardian's severe visual impairment
- Parent/guardian's severe hearing impairment
- Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement
- Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located in parts of the body which could potentially be used for localisation of the glucose sensor)
Key Trial Info
Start Date :
March 12 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT04759144
Start Date
March 12 2021
End Date
December 1 2022
Last Update
March 14 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Department of Paediatrics
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
2
Wellcome Trust-MRC Institute of Metabolic Science University of Cambridge
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ