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Validation and feasibility of a postal system for remote monitoring of HbA1c
Jen Cross1, Sanjeev Sharma1, W Garry John2
1Deptartment of Diabetes and Endocrinology, Ipswich Hospital NHS Trust, Ipswich, UK.
Insights
A new postal system allows for remote hemoglobin A1c (HbA1c) monitoring for people with diabetes. This validated method ensures accurate results, supporting virtual diabetes care.
Area of Science:
- Clinical Chemistry
- Diabetes Management
- Public Health
Background:
- The COVID-19 pandemic disrupted access to essential hemoglobin A1c (HbA1c) testing.
- Virtual diabetes clinics require reliable remote monitoring solutions.
Purpose of the Study:
- To develop and validate a user-friendly postal system for remote HbA1c monitoring.
- To assess the feasibility of integrating postal HbA1c testing into virtual diabetes care.
Main Methods:
- 123 capillary blood samples were tested using a point-of-care analyzer.
- Stored postal samples (up to 12 days at room temperature) were retested.
- 286 postal HbA1c kits were sent to people with diabetes (PWD) for remote monitoring.
Main Results:
- Strong correlation (R²=0.978) between initial and stored samples.
- Clinically insignificant bias (-1.53 mmol/mol) with 93% of results within 2 SD.
- High satisfaction (94%) among PWD using the postal system; low sample failure rate (1/286).
Conclusions:
- A robust, user-friendly postal HbA1c system was successfully developed and implemented.
- The system provides accurate results, proving invaluable for remote HbA1c monitoring in diabetes care.
- This method supports continuous diabetes management during and after the pandemic.
Introduction:
The COVID-19 pandemic has reduced the accessibility to hemoglobin A1c (HbA1c) tests required for virtual diabetes clinics. The aim was to develop and validate a user-friendly postal system for remote HbA1c monitoring.
Research Design And Methods:
Validation: A total of 123 capillary blood samples from people with diabetes (PWD) needing face-to-face consultations along with healthy volunteers were measured on a point-of-care (POC) Siemens DCA Vantage Analyzer. Another sample of 5-10 drops was simultaneously collected in a K2EDTA tube (BD Microtainer) and stored for up to 12 days at room temperature for subsequent retesting. Feasibility: During October to December 2020, a total of 286 postal HbA1c kits were sent to PWD prior to their virtual consultation. These contained sample collection guidance, the necessary equipment and a feedback form. As per Packing Instruction 650 regulations, these were posted back to the diabetes center for HbA1c testing on the POC analyzer.
Results:
There was a strong correlation between the first and the stored sample (R2=0.978). There was a small clinically insignificant negative bias -1.53 mmol/mol (2 SD = 3.10 mmol/mol). Bland-Altman plots showed 93% of results within 2 SD. Of the 87% of returned kits, only one sample failed to be analyzed. 94% of PWD who provided feedback were happy to use the postal HbA1c system again.
Conclusions:
A robust user-friendly postal HbA1c system has been created and successfully integrated into clinical practice using the existing POC equipment at the diabetes center. It provides accurate HbA1c results and is an invaluable tool for remote monitoring of HbA1c in PWD-both during and after the pandemic.
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