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Postal methods for monitoring HbA1c in diabetes mellitus: a protocol for systematic review
Jack Colley1, Hajira Dambha-Miller2, Beth Stuart3
1Southern Health Foundation Trust, Southampton, UK.
Insights
Home-based finger-prick blood tests for HbA1c could offer a viable alternative to clinic visits for people with diabetes. This systematic review assesses the accuracy, reliability, and patient acceptance of self-collected capillary HbA1c samples.
Area of Science:
- Endocrinology and Metabolic Diseases
- Clinical Chemistry
- Health Services Research
Background:
- Diabetes affects 463 million globally, with UK patients offered annual HbA1c monitoring for glycaemic control.
- Missed reviews correlate with poorer health outcomes; pandemic saw a 77% drop in UK HbA1c monitoring.
- Investigating alternative HbA1c monitoring methods is crucial for diabetes management.
Purpose of the Study:
- To evaluate the agreement and correlation between self-collected capillary HbA1c and standard venous samples.
- To assess the reliability, repeatability, and storage effects of capillary HbA1c testing.
- To explore patient acceptability and safety of postal self-collection methods for HbA1c.
Main Methods:
- A systematic review of literature will be conducted.
- Searches will include MEDLINE, Embase, CINAHL, Web of Science, Google Scholar, and grey literature up to 2021.
- The COSMIN Risk of Bias tool will assess study quality regarding reliability and measurement error.
Main Results:
- This section is to be populated upon study completion.
- The review will synthesize findings on capillary HbA1c accuracy against venous standards.
- Data on test-retest reliability and pre-analytical variables will be analyzed.
Conclusions:
- Postal self-collection of capillary HbA1c samples may offer a practical alternative to routine venous sampling.
- Findings will inform the potential implementation of home-based HbA1c monitoring for diabetes patients.
- The review will highlight the acceptability and safety profile of patient self-collection methods.
Background:
Worldwide there are an estimated 463 million people with diabetes. In the UK people with diabetes are offered annual review, which includes monitoring of haemoglobin A1c (HbA1c). This can identify people with diabetes who are not meeting their glycaemic targets, enabling early intervention. Those who do not attend these reviews often have poorer health outcomes. During the COVID-19 pandemic, there was a 77% reduction in monitoring of HbA1c in the UK.
Aim:
It is hypothesised that people with diabetes could take finger-prick samples at home for measurement of HbA1c. This study will examine the agreement and correlation of capillary HbA1c values compared with a venous reference standard. It will explore reliability and repeatability of capillary HbA1c testing methods, as well as the direction of effect of storage variables. The study will also explore patient acceptability and safety. It will look at capillary blood methods that would be suitable for posting.
Design & Setting:
A systematic review will be undertaken.
Method:
The core terms of 'Diabetes', 'HbA1c' and 'Capillary sampling' will be used to search MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Web of Science Core Collection, Google Scholar, OpenGrey, and other grey literature, from database inception until 2021. Risk of bias will be assessed using the 'COSMIN Risk of Bias tool to assess the quality of studies on reliability and measurement error'.
Conclusion:
A narrative synthesis will be produced to explore whether there are viable postal alternatives to venous sampling, as well as exploring acceptability and safety of patient self-collection.
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