The purpose of the KidsAP project is to assess the ability of the artificial pancreas to improve glucose control in the most vulnerable population with type 1 diabetes, children aged 1 to 7 years. In the main KidsAP02 study, half of the participants will be treated by the personalised artificial pancreas and the other half by the state-of-the-art predictive low glucose management pump therapy (control comparator). Each treatment will last 12 months.
The KidsAP objective is to compare the biomedical, psychological and health economics effectiveness of two insulin delivery systems in young children aged 1 to 7 years with type 1 diabetes. The insulin delivery systems are:
Closed Loop (Artificial Pancreas) insulin delivery (novel investigational personalised algorithmic insulin delivery below and above preset insulin amounts to avoid hypo and hyperglycaemia
Predictive low glucose management insulin pump therapy (state-of-the-art comparator)
|Primary Objective||Time spent in target glucose range 3.9 to 10mmol/l (70 to 180 mg/dl)|
1. To redefine the recruitment pathways to optimise recruitment to the outcome trial
2. To open contingency sites if recruitment targets are not met in the feasibility pilot
3. To pilot regulatory submissions to national regulatory bodies for approval of closed loop insulin delivery system in children
|Primary Objective||Central Laboratory glycated haemoglobin (HbA1c) at 12 months (end of study)|
|Key Secondary Objectives||Biomedical: Severe hypoglycaemia, nocturnal hypoglycaemia, glycaemic control (3 monthly HbA1c & CGM data), glucose variability, insulin dose, BMI SDS
Utility: usage and reliability measures
Psychosocial: Parents/guardians’ perception in terms of lifestyle change, diabetes management and fear of hypoglycaemia will be assessed using validated questionnaires (Diabetes Technology, Hypoglycaemia Fear Survey, Quality of Life, Diabetes Burden) and semi-structured qualitative interviews conducted with parents/guardians to assess the use of and engagement with closed loop systems and changes in these aspects over time; health professionals will also be interviewed.
Cost-effectiveness analysis: We will examine costs & outcomes. Costs will include those relating to diabetes (complications and management). An incremental cost-effectiveness ratio (ICER) and cost-effectiveness acceptability curve will be estimated based on total treatment costs and QALYs. Also, the estimation of the time alive and free of complications and the lifetime costs will be possible due to the model. The sensitivity analysis will examine the robustness of the ICER.
Analyses: Intention to treat (ITT), with secondary per protocol analysis
Work Package 1 – Project Management
WP1 will address project coordination and management. The main objectives are to coordinate, manage and monitor the project, to ensure swift and smooth decision making, communication within the consortium and towards the Commission and to report to the Commission. It will foster collaboration between the Participants and ensure compliance with EC requirements.
Work Package 2 – Pilot Study
WP2 will perform a feasibility trial to pilot the study setup and to address the specific needs of the studied population by comparing closed loop insulin delivery using standard strength insulin and diluted insulin over 3 weeks. The results will feed into the design of the main study.
Work Package 3 – Main Study
WP3 covers studying the application of the closed loop system at home, under daily life conditions in very young children with type 1 diabetes over a 12 month period.
To this goal, a randomised, multicentre trial will be designed and executed comparing the use of the closed loop system to state-of-the-art predictive low glucose management insulin pump therapy. As determined by the pilot feasibility study, either full strength or diluted insulin will be used.
The aim is to show effectiveness, safety and usability of the closed loop insulin delivery system, as well as its impact on children/family centred outcomes.
Work Package 4 – Data Management and Analysis
WP4 will integrate project specific data types in cooperation with all participants to ensure highest quality standards for clinical trial data management and subsequent data analysis.
- provide a database for all KidsAP participants to share and access data and data analysis results as well as track progress
- Manage all KidsAP data according to data safety and security regulations
- Perform data analysis using state-of-the-art techniques to ensure maximum use of all gathered data
Work Package 5 – Health Economic Evaluation
The objective of WP5 is health economic analysis of the artificial pancreas (closed loop) versus conventional insulin pump therapy using a health economic simulation model: the IMS CORE DIABETES MODEL (CDM)
Work Package 6 – Dissemination and exploitation
WP6 encompasses various dissemination and exploitation activities, all focused to ensure effective and wide impact and visibility on different levels but also to avoid any overlap of efforts with similar research projects. All project results will be distributed to end users and external stakeholders to ensure maximal exploitation even after the end of KidsAP. WP6 will set up the framework to implement and execute the project’s dissemination and exploitation strategy, with the following objectives:
- consider the commercial exploitation of study results
- disseminate all scientific and technological results throughout the project to the scientific/technical/medical community
- publically dissemination KidsAP’s progress and results to diabetes patients and patient organisations
- design and implement an effective exploitation strategy
Work Package 7 – Ethics requirements
The objective is to ensure compliance with the “ethics requirements” set out within the work package.
The ambitious objectives of KidsAP require a strong and coherent management structure to support the progress of the project. The schematic to the right shows how the organisational bodies interact in the project.