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A parallel randomised controlled trial of the Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised self-care (HARPdoc)

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Stephanie A Amiel, Laura Potts, Kimberley Goldsmith, Peter Jacob, Emma L Smith, Linda Gonder-Frederick, Simon Heller, Elena Toschi, Augustin Brooks, Dulmini Kariyawasam, Pratik Choudhary, Marietta Stadler, Helen Rogers, Mike Kendall, Nick Sevdalis, Ioannis Bakolis, Nicole de Zoysa

Original languageEnglish
Article number2229
Pages (from-to)2229
JournalNature Communications
Volume13
Issue number1
DOIs
Published28 Apr 2022

Bibliographical note

Funding Information: We wish to acknowledge the input of Sheffield diabetes nurse and HARPdoc educator, Valerie Gordon, who passed away during the course of the study. The study was performed by the HARPdoc Trial study group, members of which are listed in the supplementary material, Table . The authors are grateful to the research teams in each of the sites. We thank in particular Mustabshira Qayyum, the study manager; Sean Haywood, the study data manager; Karolina Bogdanowicz, who managed the set-up of the trial and Shrey Choudhary for additional data input. We acknowledge the valuable input of the members of the PPI group, Lis Warren, Vicky Ruzala, Arthur Durrant and Melanie Stephenson Gray; Elizabeth Ryan for the first draft of the statistical analysis plan and Dominic Stringer, who acted as the unblinded statistician and Elka Giemza and her team on the King’s College Hospital NIHR Clinical Research Facility and the staff of the King’s College London Clinical Trials Unit. We would also like to thank Prof. Amanda Adler (chair), Dr. Stephen Sharp and Dr. Mark Evans of our Data Monitoring Committee; Prof. James Shaw (chair) and Prof. Irene Stratton of our Trial Management Group and Prof Nick Oliver, Dr. Lalantha Leelarathna, Dr. J Miranda Rosenthal, Dr. Ahmed Iqbar, Dr. David Hopkins, Dr. Yee Cheah and Dr. Diarmuid Smith for adjudication of severe hypoglycaemia episodes. This project was funded by the Juvenile Diabetes Research Foundation Project Grant no 4-SRA-2017-266-M-N, Chief Investigator Professor Amiel, and made to King’s College London. Additional support was provided by the UK’s National Institute of Health Research (NIHR) through the South London Collaboration for Leadership in Applied Health Research and Care South London (CLAHRC), now the Applied Research Collaboration (ARC) at King’s College Hospital NHS Foundation Trust, London, UK. I.B. is supported by the NIHR Maudsley BRC and I.B. and by the CLAHRC. M.S is supported by a National Institute for Health Research (NIHR) Clinician Scientist fellowship (CS-2017-17-023). This paper thus represents independent research part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London and the ARC. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The study was sponsored jointly by King’s College London (Professor Rezavi, susan.dickson@ kcl. ac. uk) and King’s College Hospital NHS Foundation Trust, (Research & Innovation Office, kch- tr. research@ nhs. net). Funding Information: We wish to acknowledge the input of Sheffield diabetes nurse and HARPdoc educator, Valerie Gordon, who passed away during the course of the study. The study was performed by the HARPdoc Trial study group, members of which are listed in the supplementary material, Table?S10. The authors are grateful to the research teams in each of the sites. We thank in particular Mustabshira Qayyum, the study manager; Sean Haywood, the study data manager; Karolina Bogdanowicz, who managed the set-up of the trial and Shrey Choudhary for additional data input. We acknowledge the valuable input of the members of the PPI group, Lis Warren, Vicky Ruzala, Arthur Durrant and Melanie Stephenson Gray; Elizabeth Ryan for the first draft of the statistical analysis plan and Dominic Stringer, who acted as the unblinded statistician and Elka Giemza and her team on the King?s College Hospital NIHR Clinical Research Facility and the staff of the King?s College London Clinical Trials Unit. We would also like to thank Prof. Amanda Adler (chair), Dr. Stephen Sharp and Dr. Mark Evans of our Data Monitoring Committee; Prof. James Shaw (chair) and Prof. Irene Stratton of our Trial Management Group and Prof Nick Oliver, Dr. Lalantha Leelarathna, Dr. J Miranda Rosenthal, Dr. Ahmed Iqbar, Dr. David Hopkins, Dr. Yee Cheah and Dr. Diarmuid Smith for adjudication of severe hypoglycaemia episodes. This project was funded by the Juvenile Diabetes Research Foundation Project Grant no 4-SRA-2017-266-M-N, Chief Investigator Professor Amiel, and made to King?s College London. Additional support was provided by the UK?s National Institute of Health Research (NIHR) through the South London Collaboration for Leadership in Applied Health Research and Care South London (CLAHRC), now the Applied Research Collaboration (ARC) at King?s College Hospital NHS Foundation Trust, London, UK. I.B. is supported by the NIHR Maudsley BRC and I.B. and by the CLAHRC. M.S is supported by a National Institute for Health Research (NIHR) Clinician Scientist fellowship (CS-2017-17-023). This paper thus represents independent research part funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King?s College London and the ARC. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care. The study was sponsored jointly by King?s College London (Professor Rezavi, susan.dickson@ kcl. ac. uk) and King?s College Hospital NHS Foundation Trust, (Research & Innovation Office, kch- tr. research@ nhs. net). Publisher Copyright: © 2022, The Author(s).

Documents

  • NCOMMS-21-46984A[27]

    NCOMMS_21_46984A_27_.docx, 467 KB, application/vnd.openxmlformats-officedocument.wordprocessingml.document

    Uploaded date:09 May 2022

    Version:Accepted author manuscript

King's Authors

Abstract

Impaired awareness of hypoglycaemia (IAH) is a major risk for severe hypoglycaemia in insulin treatment of type 1 diabetes (T1D). To explore the hypothesis that unhelpful health beliefs create barriers to regaining awareness, we conducted a multi-centre, randomised, parallel, two-arm trial (ClinicalTrials.gov NCT02940873) in adults with T1D and treatment-resistant IAH and severe hypoglycaemia, with blinded analysis of 12-month recall of severe hypoglycaemia at 12 and/or 24 months the primary outcome. Secondary outcomes included cognitive and emotional measures. Adults with T1D, IAH and severe hypoglycaemia despite structured education in insulin adjustment, +/- diabetes technologies, were randomised to the "Hypoglycaemia Awareness Restoration Programme despite optimised self-care" (HARPdoc, n = 49), a psychoeducation programme uniquely focussing on changing cognitive barriers to avoiding hypoglycaemia, or the evidence-based "Blood Glucose Awareness Training" (BGAT, n = 50), both delivered over six weeks. Median [IQR] severe hypoglycaemia at baseline was 5[2-12] per patient/year, 1[0-5] at 12 months and 0[0-2] at 24 months, with no superiority for HARPdoc (HARPdoc vs BGAT incident rate ratios [95% CI] 1.25[0.51, 3.09], p = 0.62 and 1.26[0.48, 3.35], p = 0.64 respectively), nor for changes in hypoglycaemia awareness scores or fear. Compared to BGAT, HARPdoc significantly reduced endorsement of unhelpful cognitions (Estimated Mean Difference for Attitudes to Awareness scores at 24 months, -2.07 [-3.37,-0.560], p = 0.01) and reduced scores for diabetes distress (-6.70[-12.50,-0.89], p = 0.02); depression (-1.86[-3.30, -0.43], p = 0.01) and anxiety (-1.89[-3.32, -0.47], p = 0.01). Despite positive impact on cognitive barriers around hypoglycaemia avoidance and on diabetes-related and general emotional distress scores, HARPdoc was not more effective than BGAT at reducing severe hypoglycaemia.

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