Rationale and protocol for the Assessment of Impact of Real-time Continuous Glucose Monitoring on people presenting with severe hypoglycaemia (AIR-CGM) study
File(s)
Published version
Author(s)
Avari, Parizad
Ramli, Rozana
Reddy, Monika
Oliver, Nick
Fothergill, Rachael
Type
Journal Article
Abstract
Background: Severe hypoglycaemia carries a significant risk of morbidity and mortality for people with type 1 diabetes. Economic costs are also high, estimated at approximately £13 million annually in England, UK. Continuous glucose monitoring (CGM) has been shown to reduce hypoglycaemia and associated fear, improve overall glycaemia and quality of life, and is cost-effective. Despite effective pathways in place with high levels of resource utilization, it has been reported there are low levels of follow-up, therapy change and specialist intervention after severe hypoglycaemia. This study is designed to assess the impact of providing real-time CGM to people with type 1 diabetes, who have had a recent episode of severe hypoglycaemia (within 72hours), compared to standard care.
Methods/Design: Fifty-five participants with type 1 diabetes and a recent episode of severe hypoglycaemia, who are CGM naïve, will be recruited to the study. Participants will be randomised to CGM or standard care. The primary outcome is percentage time spent in hypoglycaemia (<3.0mmol/L, 55mg/dL). Secondary outcomes include other measures of hypoglycaemia, time in euglycaemia, overall glucose status and patient reported qualitative measures.
Discussion: This study assesses the impact of providing continuous glucose monitoring at the outset in individuals at highest risk of hypoglycaemia. Changing demand means that novel approaches need to be taken to healthcare provision. This study has the potential to shape future national standards.
Methods/Design: Fifty-five participants with type 1 diabetes and a recent episode of severe hypoglycaemia, who are CGM naïve, will be recruited to the study. Participants will be randomised to CGM or standard care. The primary outcome is percentage time spent in hypoglycaemia (<3.0mmol/L, 55mg/dL). Secondary outcomes include other measures of hypoglycaemia, time in euglycaemia, overall glucose status and patient reported qualitative measures.
Discussion: This study assesses the impact of providing continuous glucose monitoring at the outset in individuals at highest risk of hypoglycaemia. Changing demand means that novel approaches need to be taken to healthcare provision. This study has the potential to shape future national standards.
Date Issued
2019-10-26
Date Acceptance
2019-10-09
Citation
BMC Endocrine Disorders, 2019, 19 (1)
ISSN
1472-6823
Publisher
BioMed Central
Journal / Book Title
BMC Endocrine Disorders
Volume
19
Issue
1
Copyright Statement
© 2019 The Author(s). This article is distributed under the terms of the Creative Commons Attribution 4.0
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and
reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to
the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver
(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Sponsor
DexCom Inc.
Grant Number
IIS-2016-031
Subjects
Continuous glucose monitoring
Severe hypoglycaemia
Type 1 diabetes
1103 Clinical Sciences
Endocrinology & Metabolism
Publication Status
Published
Date Publish Online
2019-10-26