Status:
COMPLETED
The Artificial Pancreas in Very Young Children With T1D
Lead Sponsor:
University of Cambridge
Collaborating Sponsors:
European Commission
Cambridge University Hospitals NHS Foundation Trust
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
1-7 years
Phase:
NA
Brief Summary
The suggested clinical trial is part of the KidsAP project funded by the European Commission's Horizon 2020 Framework Programme and JDRF. It evaluates the use of the Artificial Pancreas (closed loop s...
Detailed Description
Purpose of clinical trial: To determine whether 24/7 automated hybrid closed loop will improve glucose control as measured by time within the target range compared with sensor augmented pump therapy ...
Eligibility Criteria
Inclusion
- Age between 1 and 7 years (inclusive) (Luxembourg and Austria)
- Age between 2 and 7 years (inclusive) (Germany and UK)
- 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 subject/carer good knowledge of insulin self-adjustment as judged by the investigator
- On sensor-augmented pump as standard clinical care (extension phase only)
- Treated with rapid or ultra-rapid acting insulin analogue
- Subject/carer is willing to perform regular finger-prick blood glucose monitoring, with at least 2 blood glucose measurements taken every day
- Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- Willing to wear glucose sensor
- Willing to wear closed loop system 24/7 during intervention arm
- The subject/carer is willing to follow study specific instructions
- The subject/carer is willing to upload pump and CGM data at regular intervals
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
- Use of closed loop insulin delivery within the past 2 months
- Known or suspected allergy to insulin
- Carer's lack of reliable telephone facility for contact
- Subject/carer's severe visual impairment
- Subject/carer'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)
- Sickle cell disease, haemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- Plan to receive red blood cell transfusion or erythropoietin over the course of study participation
- Subject/carer not proficient in English (UK, Germany, Austria, Luxembourg) or German (Germany, Austria, Luxembourg) or French (Luxembourg)
- Additional exclusion criteria - Germany only
- Known microvascular diabetes complications (retinopathy, renal disease, neuropathy)
- Eating disorders
- Psychiatric diseases of the parents that would possibly interfere with the ability to comply to study procedures
- Major needle phobia that would complicate to wear pump catheter and sensor
- Congenital malformations that would interfere with diabetes treatment (e.g. congenital heart malformations, lung diseases, renal malformations)
- Growth hormone deficiency
- Combined Hypopituitarism
- Down Syndrome (high risk for comorbidity with coeliac disease, autoimmune thyroiditis)
- Cancer under treatment
- Current participation in other interventional clinical trials
Key Trial Info
Start Date :
May 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2022
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT03784027
Start Date
May 1 2019
End Date
October 3 2022
Last Update
March 27 2025
Active Locations (8)
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1
Medical University of Graz Department of Pediatrics and Adolescent Medicine
Graz, Austria, A-8036
2
Medical University of Innsbruck Department of Pediatrics I
Innsbruck, Austria, A-6020
3
Medical University of Vienna Department of Pediatrics
Vienna, Austria, A-1090
4
University of Leipzig Division for Paediatric Diabetology
Leipzig, Germany, D-04103