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Italian master’s thesis uses the MESI mTABLET ABI, highlighting the significance of PAD screening of diabetics in primary care
Measurement of the ankle-brachial index in patients with Diabetes Mellitus type 2 in General Medicine
Research study authors: Flavia Fiorini (mentor Prof. Mario D’Uva), Sapienza University of Rome, Italy.
In 2022, the MESI mTABLET ABI was used in an experimental master’s thesis at the Faculty of Pharmacy and Medicine (Department of Medico-Surgical Sciences and Biotechnologies) of the Sapienza University of Rome (Sapienza Università di Roma). Postgraduate student Flavia Fiorini (under the mentorship of Prof. Mario D’Uva) used the MESI mTABLET ABI diagnostic system to research the feasibility and usefulness of measurement of ABI in type 2 diabetics at primary care level. The thesis concludes that ABI measurement could contribute to early PAD diagnosis, optimise healthcare resources and improve access to PAD treatment in Italy.
In this blog you will learn:
The background of the study
In patients with diabetes mellitus type 2 (T2DM), the likelihood of developing Peripheral Arterial Disease (PAD) is 1.5 to 4 times higher than in non-diabetics. The prevalence and extent of PAD increases with age and with the severity and duration of T2DM. The Italian Standards for the Treatment of Diabetes Mellitus 2018 (Standard Italiani per la Cura del Diabete Mellito 2018) [2] recommend annual measurement of the Ankle-Brachial Index (ABI) in all patients with diabetes regardless of the risk level. The same is recommended in the ESC/EASD Guidelines 2019. [3]
However, the measuring of ABI with the handheld Doppler probe, traditionally regarded as a more accurate method compared to others, only takes place in Italy to a limited extent – just in secondary care. This is due to the skill required, which not only limits access to the examination due to the lack of operators, but also contributes to its high cost.
On the other hand, the measurement of automated Ankle-Brachial Index only takes minutes; not only could this allow for greater accessibility, but also for higher frequency of such examinations. The aim of the thesis was to research the feasibility and usefulness of measuring (automated) ABI in patients with T2DM in general medicine (primary care). The research method employed was an experimental study.
The study was conducted between February and November 2022. It took place at various general medicine clinics and at the headquarters of UCP primary health centres (Unità di Cure Primarie) in Cisterna, southwest Italy. The patients of 7 GPs were considered, with a population of approximately 10,250 individuals. All the patients diagnosed with T2DM and without a known diagnosis of PAD were included in the study. Automated ABI was measured using the MESI mTABLET ABI – a wireless measuring device that uses the oscillometric method of plethysmography. The blood pressure measurement in the extremities and the ABI calculation are automated, and the process only takes 1 minute.
Impact of PAD
The theoretical part of the thesis sheds light on a number of impacts of PAD (and CVDs in general) on diabetics. Let us only mention a few. [1]
Cardiovascular disease (CVD) is the leading cause of death in patients with DM. In such patients, atherosclerosis develops early and rapidly due to multiple causes. Adult diabetics are twice as likely to develop ischemic heart disease compared to non-diabetic patients.
Diabetics with PAD are generally younger, have a higher body mass index (BMI), are more often neuropathic and show a higher number of cardiovascular co-morbidities compared to non-diabetics. Obstructive arterial disease in these patients progresses rapidly, usually as distal and bilateral. The arterial walls are often calcified, with obstructions more common than stenoses.
In cases of arterial lesions on the lower extremities, PAD in diabetics the most frequently affects the vessels below the knee (the tibial and peroneal arteries), is symmetrical and multi-segmental. It can also affect the collateral vessels. Arterial lesions in infrapopliteal vessels are connected with high risk of major amputations if revascularisation is not performed.
Approximately 27% of diabetic patients with PAD experience its progression in the next 5 years and 4% of them undergo major amputation surgery; approximately 20% experience a cardiovascular event (myocardial infarction, stroke).
Role of primary care
Italian diabetologist and endocrinologist associations have stressed the necessity for primary care to acquire a more active role in diabetes treatment. In a joint 2012 statement, the Association of Diabetologists (Associazione medici diabetologi, AMD), the Italian Society of Diabetology (Società italiana di diabetologia, SID) and the Italian Association of Endocrinology (Società italiana di endocrinologia, SIE) underlined the importance of strengthening the involvement and cooperation with general practitioners to ensure the best possible care for diabetic patients. In this, reimbursement for GPs to be able to prescribe innovative therapies for diabetes would be crucial. [1] [4]
Also proposed were the concepts of ‘the diabetes team’ and ‘the integrated care network’. They would require a more active role for GPs in the care of diabetic patients, also in the form of periodic ‘frailty triage’ to refer them for the most appropriate care based on their specific needs. In this, the GP would be the first point of reference for diabetics if they do not require complex, high-intensity care. However, steps in this direction still need to be implemented. [1] [4]
The results of the study
The ABI measurement was performed on 153 patients; 16 of them (10.46 %) presented an ABI value significant for PAD. In these cases, there was a significant correlation with several factors including: sedentary lifestyle (p=0.001); skin dystrophy (p=0.008); years of diabetes (>9 p=0.020); no antiplatelet in therapy (p=0.025); retinopathy (p=0.001). [1]
The aim of the study in the thesis was to show the effectiveness, usefulness and benefits of ABI measurement as a tool for early diagnosis of PAD in asymptomatic DM2 patients in primary care (general practice).
ABI represents the first-line diagnostic approach for both screening and diagnosis of PAD. It is simple to perform, non-invasive, and with high specificity and sensitivity. It is also cost-effective and easily reproducible if performed with automatic oscillometric devices.
It would therefore be advisable to implement ABI measurement as standard clinical practice in diagnostic-therapeutic care pathways (percorsi diagnostico terapeutici assistenziali, PDTA) for diabetes at all local health authorities. In this, it would be recommended for general practitioners to have their patients screened annually with ABI. This would serve several important purposes:
- to detect PAD early and prevent complications,
- to refer only patients with ABI values indicative of PAD for a subsequent Doppler. This would result in greater accessibility of the Doppler exam, cost reduction and optimised healthcare resources in Italy.