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)

• DOI: 10.1038/s41467-022-29488-x
• Publication Date: 2022-04-28T10:04:48Z
• Authors: Stephanie A. Amiel; Laura Potts; Kimberley Goldsmith; Peter Jacob; Emma L. Smith; Linda Gonder-Fred...; Simon Heller; Elena Toschi; Augustin Brooks; Dulmini Kariyawasam; Pratik Choudhary; Marietta Stadler; Helen Rogers; Mike Kendall; Nick Sevdalis; Ioannis Bakolis; Nicole de Zoysa
• Keywords: Psychoeducation; Depression

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