Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT

Andrew Healey; Tayana Soukup; Nick Sevdalis; Ioannis Bakolis; Samantha Cross; Simon R Heller; Augustin Brooks; Dulmini Kariyawasam; Elena Toschi; Linda Gonder-Frederick; Marietta Stadler; Helen Rogers; Kimberley Goldsmith; Pratik Choudhary; Nicole de Zoysa; Stephanie A Amiel; HARPdoc RCT Study Group

doi:10.1111/dme.15304

Cost-effectiveness of a Novel Hypoglycaemia Programme: The 'HARPdoc vs BGAT' RCT

Diabet Med. 2024 Jun;41(6):e15304. doi: 10.1111/dme.15304. Epub 2024 Feb 29.

Authors

Andrew Healey¹, Tayana Soukup¹, Nick Sevdalis¹, Ioannis Bakolis^{1

2}, Samantha Cross^{1

2}, Simon R Heller³, Augustin Brooks⁴, Dulmini Kariyawasam^{5

6}, Elena Toschi⁷, Linda Gonder-Frederick⁸, Marietta Stadler⁹, Helen Rogers¹⁰, Kimberley Goldsmith², Pratik Choudhary^{9

11}, Nicole de Zoysa¹⁰, Stephanie A Amiel^{9

10}; HARPdoc RCT Study Group

Affiliations

¹ Centre for Implementation Science, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
² Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.
³ Department of Oncology and Metabolism, University of Sheffield, Sheffield, UK.
⁴ University Hospitals Dorset NHS Foundation Trust, Bournemouth, UK.
⁵ Department of Diabetes and Endocrinology, Guy's and St Thomas' NHS Foundation Trust, London, UK.
⁶ Guy's and St Thomas' NHS Foundation Trust, London, UK.
⁷ Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts, USA.
⁸ Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, USA.
⁹ Department of Diabetes, School of Cardiovascular and Metabolic Medicine & Sciences, King's College, London, UK.
¹⁰ Department of Diabetes, King's College Hospital NHS Foundation Trust, London, UK.
¹¹ Leicester Diabetes Centre, University of Leicester, Leicester, UK.

PMID: 38421806
DOI: 10.1111/dme.15304

Abstract

Aims: To assess the cost-effectiveness of HARPdoc (Hypoglycaemia Awareness Restoration Programme for adults with type 1 diabetes and problematic hypoglycaemia despite optimised care), focussed upon cognitions and motivation, versus BGAT (Blood Glucose Awareness Training), focussed on behaviours and education, as adjunctive treatments for treatment-resistant problematic hypoglycaemia in type 1 diabetes, in a randomised controlled trial.

Methods: Eligible adults were randomised to either intervention. Quality of life (QoL, measured using EQ-5D-5L); cost of utilisation of health services (using the adult services utilization schedule, AD-SUS) and of programme implementation and curriculum delivery were measured. A cost-utility analysis was undertaken using quality-adjusted life years (QALYs) as a measure of trial participant outcome and cost-effectiveness was evaluated with reference to the incremental net benefit (INB) of HARPdoc compared to BGAT.

Results: Over 24 months mean total cost per participant was £194 lower for HARPdoc compared to BGAT (95% CI: -£2498 to £1942). HARPdoc was associated with a mean incremental gain of 0.067 QALYs/participant over 24 months post-randomisation: an equivalent gain of 24 days in full health. The mean INB of HARPdoc compared to BGAT over 24 months was positive: £1521/participant, indicating comparative cost-effectiveness, with an 85% probability of correctly inferring an INB > 0.

Conclusions: Addressing health cognitions in people with treatment-resistant hypoglycaemia achieved cost-effectiveness compared to an alternative approach through improved QoL and reduced need for medical services, including hospital admissions. Compared to BGAT, HARPdoc offers a cost-effective adjunct to educational and technological solutions for problematic hypoglycaemia.

Keywords: cost‐effectiveness; health economics; hypoglycaemia; quality of life; randomised controlled trial; service utilization; type 1 diabetes.

Publication types

Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Blood Glucose / metabolism
Cost-Benefit Analysis*
Diabetes Mellitus, Type 1* / economics
Diabetes Mellitus, Type 1* / therapy
Female
Humans
Hypoglycemia* / economics
Hypoglycemia* / therapy
Hypoglycemic Agents / economics
Hypoglycemic Agents / therapeutic use
Male
Middle Aged
Patient Education as Topic / economics
Quality of Life*
Quality-Adjusted Life Years*

Substances

Blood Glucose
Hypoglycemic Agents

Grants and funding

4-SRA-2017-255-M-N/JDRF/Juvenile Diabetes Research Foundation/United States