Pharmacy Diabetes Screening Trial: protocol for a pragmatic cluster-randomised controlled trial to compare three screening methods for undiagnosed type 2 diabetes in Australian community pharmacy

Abstract

IntroductionWith the rising prevalence of type 2 diabetes in Australia, screening and earlier diagnosis is needed to provide opportunities to intervene with evidence-based lifestyle and treatment options to reduce the individual, social and economic impact of the disease. The objectives of the Pharmacy Diabetes Screening Trial are to compare the clinical effectiveness and cost-effectiveness of three screening models for type 2 diabetes in a previously undiagnosed population.Methods and analysisThe Pharmacy Diabetes Screening Trial is a pragmatic cluster randomised controlled trial to be conducted in 363 community pharmacies across metropolitan, regional and remote areas of Australia, randomly allocated by geographical clusters to one of three groups, each with 121 pharmacies and 10 304 screening participants. The three groups are: group A: risk assessment using a validated tool (AUSDRISK); group B: AUSDRISK assessment followed by point-of-care glycated haemoglobin testing; and group C: AUSDRISK assessment followed by point-of-care blood glucose testing. The primary clinical outcome measure is the proportion of newly diagnosed cases of type 2 diabetes. Primary outcome comparisons will be conducted using the Cochran-Mantel-Haenszel test to account for clustering. The secondary clinical outcomes measures are the proportion of those who (1) are referred to the general practitioner (GP), (2) take up referral to the GP, (3) are diagnosed with pre-diabetes, that is, impaired glucose tolerance or impaired fasting glucose and (4) are newly diagnosed with either diabetes or pre-diabetes. The economic outcome measure is the average cost (direct and indirect) per confirmed new case of diagnosed type 2 diabetes based on the incremental net trial-based costs of service delivery and the associated incremental longer term health benefits from a health funder perspective.Ethics and disseminationThe protocol has been approved by the Human Research Ethics Committees at University of Sydney and Deakin University. Results will be available on the Sixth Community Pharmacy Agreement website and will be published in peer reviewed journals.Trial registration number ACTRN12616001240437; Pre-results.

The Role of Hemoglobin A1C in Diabetes Screening and Diabetic Retinopathy

“…Since A1C only picked up 25.90% of undiagnosed diabetic adult participants diagnosed using FPG and/or 2hPG, substantial amount, 74.10%, of undiagnosed adult participants would be missed using A1C alone. Our observations are consistent with previous reports of low sensitivity of the current A1C cutoff [ 7 , 16 ]. Thus, it is a significant public health and clinical issue by missing diagnosis of diabetes exclusively based on A1C.…”

“…Despite ADA stating that DM may be diagnosed by FPG, 2hPG, and A1C with no preference [ 14 ], A1C has become widely used in various clinical and research settings, such as defining the prevalence of DM [ 15 , 16 ]. Although the low sensitivity of A1C in diagnosis of DM has been noted [ 8 ], the factors that may affect the performance of A1C in the diagnosis has not been well described.…”

Opportunistic screening for type 2 diabetes in community pharmacies. Results from a region-wide experience in Italy

“…Few experiences of pharmacy-based opportunistic screening for diabetes have been published in different countries such as Australia [14], Switzerland [15], Spain [16,17], each of them based on different questionnaires and scorecards. All of them reported that pharmacies, also thanks to their high accessibility, are an appropriate setting for screening for diabetes, as well as for other risk factors for cardiovascular diseases [18,19].…”

Building Toward a Population-Based Approach to Diabetes Screening and Prevention for US Adults

“…Some recent evidence suggests that using POC A1c analyzers for diabetes screening in primary care clinics may increase identification of prediabetes and diabetes compared to usual care [50]. Expansion of POC devices for diabetes screening in dental offices, pharmacies, and community-based settings are promising, but require clear instructions about follow-up procedures and linkage to clinical care for those who require repeat testing or treatment [51,52]. The endorsement of ambulatory blood pressure measurement in the USPSTF hypertension screening guideline suggests the potential for a similar community-based approach in diabetes screening [53•, 54].…”