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Comparison of optimised MDI versus pumps with or without sensors in severe hypoglycaemia (the Hypo COMPaSS trial)

Little, Stuart, Chadwick, Thomas, Choudhary, Pratik, Brennand, Cath, Stickland, Julia, Barendse, Shalleen, Olateju, Toululope, Leelarathna, Lalantha, Walkinshaw, Emma, Horng, K. Tan, Marshall, Sally M., Thomas, Reena M., Heller, Simon, Evans, Mark, Kerr, David, Flanagan, Daniel, Speight, Jane and Shaw, James A. M. 2012, Comparison of optimised MDI versus pumps with or without sensors in severe hypoglycaemia (the Hypo COMPaSS trial), BMC endocrine disorders, vol. 12, no. 33, pp. 1-14.

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Title Comparison of optimised MDI versus pumps with or without sensors in severe hypoglycaemia (the Hypo COMPaSS trial)
Author(s) Little, Stuart
Chadwick, Thomas
Choudhary, Pratik
Brennand, Cath
Stickland, Julia
Barendse, Shalleen
Olateju, Toululope
Leelarathna, Lalantha
Walkinshaw, Emma
Horng, K. Tan
Marshall, Sally M.
Thomas, Reena M.
Heller, Simon
Evans, Mark
Kerr, David
Flanagan, Daniel
Speight, Jane
Shaw, James A. M.
Journal name BMC endocrine disorders
Volume number 12
Issue number 33
Start page 1
End page 14
Total pages 14
Publisher BioMedCentral
Place of publication London, England
Publication date 2012-12
ISSN 1472-6823
Summary Background
Severe hypoglycaemia (SH) is one of the most feared complications of type 1 diabetes (T1DM) with a reported prevalence of nearly 40%. In randomized trials of Multiple Daily Injections (MDI) and Continuous Subcutaneous Insulin Infusion (CSII) therapy there is a possible benefit of CSII in reducing SH. However few trials have used basal insulin analogues as the basal insulin in the MDI group and individuals with established SH have often been excluded from prospective studies. In published studies investigating the effect of Real Time Continuous Glucose Monitoring (RT-CGM) benefit in terms of reduced SH has not yet been demonstrated. The primary objective of this study is to elucidate whether in people with T1DM complicated by impaired awareness of hypoglycaemia (IAH), rigorous prevention of biochemical hypoglycaemia using optimized existing self-management technology and educational support will restore awareness and reduce risk of recurrent SH.

Methods/design
This is a multicentre prospective RCT comparing hypoglycaemia avoidance with optimized MDI and CSII with or without RT-CGM in a 2×2 factorial design in people with type 1 diabetes who have IAH. The primary outcome measure for this study is the difference in IAH (Gold score) at 24 weeks. Secondary outcomes include biomedical measures such as HbA1c, SH incidence, blinded CGM analysis, self monitored blood glucose (SMBG) and response to hypoglycaemia in gold standard clamp studies. Psychosocial measures including well-being and quality of life will also be assessed using several validated and novel measures. Analysis will be on an intention-to-treat basis.

Discussion
Most existing RCTs using this study’s interventions have been powered for change in HbA1c rather than IAH or SH. This trial will demonstrate whether IAH can be reversed and SH prevented in people with T1DM in even those at highest risk by using optimized conventional management and existing technology.
Language eng
Field of Research 170106 Health, Clinical and Counselling Psychology
111712 Health Promotion
111714 Mental Health
Socio Economic Objective 920104 Diabetes
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2012, BioMedCentral
Persistent URL http://hdl.handle.net/10536/DRO/DU:30051824

Document type: Journal Article
Collections: School of Psychology
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Every reasonable effort has been made to ensure that permission has been obtained for items included in DRO. If you believe that your rights have been infringed by this repository, please contact drosupport@deakin.edu.au.