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)

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 and Nicole Zoysa
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Stephanie A. Amiel: King’s College London
Laura Potts: Institute of Psychiatry, Psychology and Neuroscience, King’s College London
Kimberley Goldsmith: Institute of Psychiatry, Psychology and Neuroscience, King’s College London
Peter Jacob: King’s College London
Emma L. Smith: King’s College Hospital NHS Foundation Trust
Linda Gonder-Frederick: University of Virginia School of Medicine
Simon Heller: University of Sheffield
Elena Toschi: Harvard Medical School
Augustin Brooks: University Hospitals Dorset NHS Foundation Trust
Dulmini Kariyawasam: Guy’s and St Thomas’ Hospital NHS Foundation Trust
Pratik Choudhary: King’s College London
Marietta Stadler: King’s College London
Helen Rogers: King’s College Hospital NHS Foundation Trust
Mike Kendall: King’s College London
Nick Sevdalis: King’s College London
Ioannis Bakolis: Institute of Psychiatry, Psychology and Neuroscience, King’s College London
Nicole Zoysa: King’s College Hospital NHS Foundation Trust

Nature Communications, 2022, vol. 13, issue 1, 1-15

Abstract: 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.

Date: 2022
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DOI: 10.1038/s41467-022-29488-x

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