Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)

Stuart Little; Thomas Chadwick; Pratik Choudhary; Cath Brennand; Julia Stickland; Shalleen Barendse; Tolulope Olateju; Lalantha Leelarathna; Emma Walkinshaw; Horng K Tan; Sally M Marshall; Reena M Thomas; Simon Heller; Mark Evans; David Kerr; Daniel Flanagan; Jane Speight; James Am Shaw

doi:10.1186/1472-6823-12-33

Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)

Stuart Little, Thomas Chadwick, Pratik Choudhary, Cath Brennand, Julia Stickland, Shalleen Barendse, Tolulope Olateju, Lalantha Leelarathna, Emma Walkinshaw, Horng K Tan, Sally M Marshall, Reena M Thomas, Simon Heller, Mark Evans, David Kerr, Daniel Flanagan, Jane Speight, James Am Shaw

Newcastle University

Research output: Contribution to journal › Article › peer-review

Abstract

UNLABELLED:

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.

TRIAL REGISTRATION: ISRCTN52164803 Eudract No: 2009-015396-27.

Original language	English
Pages (from-to)	33
Journal	BMC Endocrine Disorders
Volume	12
DOIs	https://doi.org/10.1186/1472-6823-12-33
Publication status	Published - 13 Dec 2012

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10.1186/1472-6823-12-33

Cite this

Little, S., Chadwick, T., Choudhary, P., Brennand, C., Stickland, J., Barendse, S., Olateju, T., Leelarathna, L., Walkinshaw, E., Tan, H. K., Marshall, S. M., Thomas, R. M., Heller, S., Evans, M., Kerr, D., Flanagan, D., Speight, J., & Shaw, J. A. (2012). Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial). BMC Endocrine Disorders, 12, 33. https://doi.org/10.1186/1472-6823-12-33

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title = "Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)",

abstract = "UNLABELLED: 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.TRIAL REGISTRATION: ISRCTN52164803 Eudract No: 2009-015396-27.",

author = "Stuart Little and Thomas Chadwick and Pratik Choudhary and Cath Brennand and Julia Stickland and Shalleen Barendse and Tolulope Olateju and Lalantha Leelarathna and Emma Walkinshaw and Tan, {Horng K} and Marshall, {Sally M} and Thomas, {Reena M} and Simon Heller and Mark Evans and David Kerr and Daniel Flanagan and Jane Speight and Shaw, {James Am}",

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Little, S, Chadwick, T, Choudhary, P, Brennand, C, Stickland, J, Barendse, S, Olateju, T, Leelarathna, L, Walkinshaw, E, Tan, HK, Marshall, SM, Thomas, RM, Heller, S, Evans, M, Kerr, D, Flanagan, D, Speight, J & Shaw, JA 2012, 'Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)', BMC Endocrine Disorders, vol. 12, pp. 33. https://doi.org/10.1186/1472-6823-12-33

TY - JOUR

T1 - Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)

AU - Little, Stuart

AU - Chadwick, Thomas

AU - Choudhary, Pratik

AU - Brennand, Cath

AU - Stickland, Julia

AU - Barendse, Shalleen

AU - Olateju, Tolulope

AU - Leelarathna, Lalantha

AU - Walkinshaw, Emma

AU - Tan, Horng K

AU - Marshall, Sally M

AU - Thomas, Reena M

AU - Heller, Simon

AU - Evans, Mark

AU - Kerr, David

AU - Flanagan, Daniel

AU - Speight, Jane

AU - Shaw, James Am

PY - 2012/12/13

Y1 - 2012/12/13

N2 - UNLABELLED: 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.TRIAL REGISTRATION: ISRCTN52164803 Eudract No: 2009-015396-27.

AB - UNLABELLED: 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.TRIAL REGISTRATION: ISRCTN52164803 Eudract No: 2009-015396-27.

U2 - 10.1186/1472-6823-12-33

DO - 10.1186/1472-6823-12-33

M3 - Article

C2 - 23237320

SN - 1472-6823

VL - 12

SP - 33

JO - BMC Endocrine Disorders

JF - BMC Endocrine Disorders

ER -

Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia (the Hypo COMPaSS trial)

Abstract

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