BMC Endocrine Disorders (Dec 2012)

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 Tolulope,
  • Leelarathna Lalantha,
  • Walkinshaw Emma,
  • Tan Horng K,
  • Marshall Sally M,
  • Thomas Reena M,
  • Heller Simon,
  • Evans Mark,
  • Kerr David,
  • Flanagan Daniel,
  • Speight Jane,
  • Shaw James AM

DOI
https://doi.org/10.1186/1472-6823-12-33
Journal volume & issue
Vol. 12, no. 1
p. 33

Abstract

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Abstract 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