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A single-site feasibility randomised controlled trial comparing ‘my hypo compass’ short pyscho-educational intervention with standard care alone in individuals with type 1 diabetes and impaired awareness of hypoglycaemia

Lookup NU author(s): Dr Ayat Bashir, Dr Anneliese Flatt, Gez Richell, Professor James ShawORCiD

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© 2024 The Author(s). Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK. Aims: The HypoCOMPaSS multi-centre trial achieved improvement in hypoglycaemia awareness and 20-fold reduction in severe hypoglycaemia (SH) in a cohort with long-standing type 1 diabetes (T1D). All participants received ‘my hypo compass’ (MHC) brief structured psycho-educational intervention in addition to optimisation of insulin delivery/glucose monitoring. In this 24-week, prospective, single-centre feasibility RCT, we piloted MHC as a sole intervention in comparison to standard clinical care alone (CON). Methods: Participants with T1D and impaired hypoglycaemia awareness (IAH) (Clarke score ≥4) were recruited. MHC comprised a group/individual 1–2 h face-to-face session followed by a telephone call and second face-to-face session at 4 weeks. Outcome measures at 24 weeks were compared with baseline. Results: Fifty-two individuals provided consent for screening with 39 fulfilling eligibility criteria. Fifteen withdrew before any study intervention. Twenty-four adults with (mean ± SD) T1D duration 41.0 ± 15.1 years commenced/completed the study (100% visit attendance); 12 randomised to MHC and 12 to CON. All had IAH at baseline and at 24 weeks. Annualised SH rate following MHC was 3.8 ± 19.0 (24 weeks) versus 12.6 ± 3.5 (Baseline) and in CON group 2.0 ± 19.0 (24 weeks) versus 4.6 ± 11.5 (Baseline). ‘Immediate Action’ for and ‘Worry’ about hyperglycaemia measured by the Hyperglycaemia Avoidance Scale appeared lower following MHC. Participants attended all study visits and reflected positively on the MHC intervention. Conclusions: Feasibility of MHC implementation without additional intervention has been demonstrated. MHC education was associated with positive changes in attitudes and behaviours with the potential to reduce SH risk. MHC provides a validated, simple, well-received programme to fulfil the educational component within RCTs targeting problematic hypoglycaemia and as part of holistic clinical care.

Publication metadata

Author(s): Bashir A, Flatt AJ, Richell G, Shaw JAM

Publication type: Article

Publication status: Published

Journal: Diabetic Medicine

Year: 2024

Volume: 41

Issue: 9

Print publication date: 01/09/2024

Online publication date: 26/06/2024

Acceptance date: 09/06/2024

Date deposited: 15/07/2024

ISSN (print): 0742-3071

ISSN (electronic): 1464-5491

Publisher: John Wiley and Sons Inc.

URL: https://doi.org/10.1111/dme.15389

DOI: 10.1111/dme.15389

Data Access Statement: The data that support the findings of this study are available from the corresponding author upon reasonable request.

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