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Hypoglycaemia - REdefining SOLutions for better liVEs

Deliverables

Final Statistical Analysis plan

Using the classifications and research priorities developed in other tasks: development and implementation of a Statistical Analysis Plan (SAP) to 1) examine risk factors for severe hypoglycaemia, and 2) establish the clinical consequences of hypoglycaemic events at different glucose levels. Consequences will include biomedical (e.g. acute and chronic cognitive impairment, cardiac arrhythmias and mortality), psychological (fear of hypoglycaemia, quality of life), social (limitation of employment, loss of driving license), economic (costs to the individual and society).

Improvement and validation of the in-silico model of T1D patient (related to Task 5.3.2)

We will improve the description of hypoglycaemia in the model-based framework developed at UNIPD . The new in-silico model-based framework will be validated by comparing the incidence, frequency and duration of hypoglycaemia seen in the model with data from the validation datasets.

Identification of behavioural parameters affecting hypoglycaemia occurrence and effect of their optimization (related to Task 5.3.3)

Identification of behavioural risk factors for hypoglycaemia and modelling of the potential benefit of addressing each of those risk factors.

Updated review of the evidence surrounding our proposed classification

A systematic review will be undertaken of the literature to establish the strength of the existing evidence base for the cut-off level, in terms of associated and predicted clinical consequences, and define what questions need to be answered in analysing the database sets. Definitions of hypoglycaemia will be extended to include continuous glucose monitoring data where these have been collected robustly with input from WP5.

Hypo-RESOLVE Position Paper

A position paper will be authored by the coordinator (RUMC) to inform about the project. It is aimed to be published in a high-ranked journal.

First study subject approvals package (WP5)

We will register the study on clinicaltrials.net with inclusion and exclusion criteria.

Systematic review and report on guidelines

A validated search strategy will be applied to collect the existing guidelines and documents. Completeness of the guidelines will be cross-checked with the agencies and organisations, and relevant literature will be added to the document. A consensus process of the group will be applied, and a report as deliverable will be available to all consortium members.

Summary of expert group meetings I

A multi-disciplinary expert group will be established to guide, comment and inform the analysis of clinical trial data as it is generated by the statistics groups.

External Project Website

An external project website will be developed and launched online.

Searching for OpenAIRE data...

Publications

Reducing the burden of hypoglycaemia in people with diabetes through increased understanding: design of the Hypoglycaemia REdefining SOLutions for better liVEs (Hypo‐RESOLVE) project

Author(s): B. E. Galan, R. J. McCrimmon, M. Ibberson, S. R. Heller, P. Choudhary, F. Pouwer, J. Speight, J. Carlton, T. R. Pieber, M. Rosilio, C. J. Tack, M. Müllenborn
Published in: Diabetic Medicine, Issue 37/6, 2020, Page(s) 1066-1073, ISSN 0742-3071
DOI: 10.1111/dme.14240

Modeling carbohydrate counting error in type 1 diabetes management

Author(s): Chiara Roversi, Martina Vettoretti, Simone Del Favero, Andrea Facchinetti, Giovanni Sparacino
Published in: Diabetes Technology & Therapeutics, 2020, ISSN 1520-9156
DOI: 10.1089/dia.2019.0502

Baseline Glucose Variability and Interweek Variability Affects the Time to Stability of Continuous Glucose Monitoring-Derived Glycemic Indices

Author(s): Suresh Rama Chandran, Peter Jacob, Pratik Choudhary
Published in: Diabetes Technology & Therapeutics, 2020, ISSN 1520-9156
DOI: 10.1089/dia.2020.0011