https://orcid.org/0000-0002-8561-898X
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Abstract
Purpose
To investigate the glycated albumin (GA) introduction implications, as an add-on strategy to traditional glycemic control (Hb1Ac and fasting plasma glucose – FPG) instruments, considering insulin-naïve individuals with type 2 diabetes mellitus (T2DM), treated with oral therapies.
Methods
A Health Technology Assessment was conducted in Italy, as a multi-dimensional approach useful to validate any innovative technology. The HTA dimensions, derived from the EUnetHTA Core Model, were deployed by means of literature evidence, health economics tools and qualitative questionnaires, filled-in by 15 professionals.
Results
Literature stated that the GA introduction could lead to a higher number of individuals achieving therapeutic success after 3 months of therapy (97.0% vs 71.6% without GA). From an economic point of view, considering a projection of 1,955,447 T2DM insulin-naïve individuals, potentially treated with oral therapy, GA introduction would imply fewer individuals requiring a therapy switch (−89.44%), with a 1.06% in costs reduction, on annual basis, thus being also the preferable solution from a cost-effectiveness perspective (cost-effectiveness value: 237.74 vs 325.53). According to experts opinions, lower perceptions on GA emerged with regard to equity aspects (0.13 vs 0.72, p-value>0.05), whereas it would improve both individuals (2.17 vs 1.33, p-value=0.000) and caregivers quality of life (1.50 vs 0.83, p-value=0.000). Even if in the short term, GA required additional investments in training courses (−0.80 vs 0.10, p-value = 0.036), in the long run, GA could become the preferable technology (0.30 vs 0.01, p-value=0.018) from an organisational perspective.
Conclusion
Adding GA to traditional glycaemic control instruments could improve the clinical pathway of individuals with T2DM, leading to economic and organisational advantages for both hospitals and National Healthcare Systems.
Abbreviations
BIA, budget impact analysis; CEA, cost-effectiveness analysis; CEV, cost-effectiveness value; DM, diabetes mellitus; Hb1Ac, glycated haemoglobin; HTA, Health Technology Assessment; IVD, In vitro diagnostic; GA, glycated albumin; FPG, fasting plasma glucose; NHS, National Health Service; T2, type 2; T2DM, type 2 diabetes mellitus.
Data Sharing Statement
Data will be available upon reasonable request.
Ethics Approval and Informed Consent
Not applicable, since the research activity investigated only the standard clinical pathway devoted to any T2DM individuals, without collecting human and sensible data. Furthermore, besides the process mapping approach used for the definition of the standard clinical practice, clinicians’ perceptions were collected according to a qualitative questionnaire. All the clinicians involved voluntary completed the questionnaire, whose perceptions were analyzed using aggregated methods, in accordance with the “EU Regulation n. 679 of 04.05.2016”.
Consent for Publication
All the clinicians involved were aware that the present research activity had as main aim the publication of the results, and they gave their consent in disseminating their perceptions, in an aggregated and anonymous manner, in accordance with the “EU Regulation n. 679 of 04.05.2016”.
Acknowledgments
The Authors would like to thank all the professionals involved, for their valuable support to complete the qualitative and quantitative questionnaires, leading to the success of the present research activity.
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
Dr Antonio Nicolucci reports grants from Astra Zeneca, grants from AlfaSigma, grants from Sanofi, grants from Medtronic, grants from Eli Lilly, grants from Novo Nordisk, grants from Pikdare, grants from Shionogi, grants from SOBI, outside the submitted work. Dr Emanuela Foglia reports non-financial support from Instrumentation Laboratories - Werfen, personal fees from Instrumentation Laboratories - Werfen, outside the submitted work. The authors declare that they have no other conflicts of interest in connection with the submitted article.