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Improving hypoglycaemia unawareness: 2-year follow up of the HypoCOMPaSS trial

Devices and technology – October 2018 digest.
Two-year follow-up of this 2×2 factorial trial of MDI vs insulin pumps and SMBG vs RT-CGM to improve hypoglycaemia unawareness.

Little SA, Speight J, Leelarathna L et al (2018) Sustained reduction in severe hypoglycemia in adults with type 1 diabetes complicated by impaired awareness of hypoglycemia: two-year follow-up in the HypoCOMPaSS randomized clinical trial. Diabetes Care 41: 1600–7

  • The original HypoCOMPaSS (Comparison of Optimised MDI versus Pumps with or without Sensors in Severe Hypoglycaemia) trial was a 6-month, 2×2 factorial randomised controlled trial, which demonstrated that improved hypoglycaemia awareness and prevention of recurrent severe hypoglycaemia (SH) was possible, without worsening overall glycaemic control, in a high-risk population of adults with long-standing type 1 diabetes.
  • Importantly, in addition to the randomisation to multiple daily injections versus insulin pump therapy, and self-monitoring of blood glucose (SMBG) versus SMBG plus real-time continuous glucose monitoring (RT-CGM), all participants received intensive support in active insulin dose adjustment, as well as education structured around the four points of the compass:
    – N: Never delay hypo treatment.
    – E: establish times of Extra risk.
    – S: recognise Subtle hypo symptoms.
    – W: be Wary about detecting and preventing nocturnal hypoglycaemia.
  • At the end of the 6-month trial, participants returned to routine clinical care. Overall, 76 of the original 96 participants (79%) were followed up to 2 years.
  • The improvements in hypoglycaemia awareness, independent of treatment modality or glucose monitoring system, were retained at 2 years compared with baseline, with improvements in three different hypo awareness scores (Gold score, 1.4 points; Clarke score, 1.7 points; HypoA-Q improved awareness score, 5.0 points).
  • Compared with the 12 months prior to study enrolment, over the 2-year follow-up, there was a 95% reduction in annualised rates of SH (0.4 vs 8.9 events per person-year), with 26% of participants having an SH event compared with 92% pre-study. Only five participants (5%) experienced two or more SH events per person-year, compared with 56 (58%) in the 12 months pre-study.
  • Mean HbA1c fell by 5 mmol/mol (0.5%) compared with baseline, and there were six diabetic ketoacidosis events over the 2-year follow-up.
  • The authors conclude that this brief educational intervention with intensive support over 6 months leads to sustained improvements in hypoglycaemia awareness in high-risk individuals, and that hypo prevention is possible without reductions in HbA1c. They stress that structured education and support should underpin any interventions targeting impaired awareness of hypoglycaemia in type 1 diabetes.

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