The Assessment Of Value For Medical Devices: A Case Study On Injection Technique Education In Insulin Delivery

Abstract

Education and product training are critical but overlooked variables in the value assessment of medical devices. By example, over 24 million insulin injections occur daily in Europe, with little knowledge on proper injection technique (IT).1 This case study illustrates the positive impact of insulin IT education on diabetes outcomes, drug consumption and healthcare costs. We conducted a literature review on diabetes IT. The impact of IT education on adherence, adverse events, insulin consumption, and glycemic control were appraised in the context of i) Proper device selection; ii) Education, application, and adherence to IT best practices; and; iii) adverse event monitoring. Potential healthcare savings from a UK NHS perspective were estimated using probabilistic patient simulations based on risk equations from the UKPDS study.2 Evidence suggests the clinical benefits of IT best practices include 1) better patient acceptability via overall preference and lower injection pain (VAS significantly less with shorter needle, sharper tips; p<0.001)3 2), associations between not rotating injection sites (poor IT practice) and increased prevalence of lipohypertrophy, >30% higher insulin consumption and worse glycaemic control4 (HbA1c 0.5% higher in patients with lipohypertrophy (p=0.003)5, and 3), lower risk of intramuscular injections with proper device selection (0.4% – 1.8% for 4 and 5mm needles)6. Another prospective non-controlled study, investigating the impact of individualized IT education including site rotation and use of short needles, in patients taking insulin for more than 4 years, identified a mean HbA1c reduction of 0.58% and reduced insulin consumption by 2 units/day within 3 months (both, p<0.05).7 Over 10 years, savings could range from £12-25 million and potential insulin savings of £5 million per 100,000 people. The value assessment of medical devices should include HCP/patient education as clinical outcomes and cost savings are material. This is exemplified vis-à-vis proper education on diabetes IT for people on insulin.