Accuracy of Three Commercial Home-Use Hemoglobin A1c Tests.

Background: The COVID-19 pandemic and the rapid expansion of telemedicine have increased the need for accurate and reliable capillary hemoglobin A1c (HbA1c) testing. Nevertheless, validation studies of commercially available products suitable for home use have been in short supply. Methods: Three commercial home-use capillary blood sample HbA1c tests (Home Access, CoreMedica, and A1cNow+) were evaluated in 219 participants with type 1 or type 2 diabetes (4-80 years years of age, HbA1c 5.1%-13.4% [32-123 mmol/mol]) at four clinical sites. Comparisons were made between HbA1c measurements from the commercial tests and paired venous samples for which HbA1c was measured at two central reference laboratories. The primary outcome was percentage of commercial HbA1c values within 5% of the corresponding reference values. Results: HbA1c values were within 5% (relative difference) of paired reference values for 82% of Home Access samples, 29% of CoreMedica samples, and 46% of A1cNow+ samples. Absolute differences were within 0.3% of the reference value for 75% of Home Access samples, 28% of CoreMedica samples, and 44% of A1cNow+ samples and exceeded 0.5% for 8%, 55%, and 37%, respectively. Conclusions: None of the commercial home-use HbA1c tests produced the National Glycohemoglobin Standardization Program goal of ≥90% measurements within 5% of a DCCT venous reference. However, the Home Access product performed substantially better than the CoreMedica or A1cNow+ products. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home-based HbA1c assessment represents an urgent need for the diabetes community.

Challenges and Opportunities in Using Telehealth for Diabetes Care.

The ongoing coronavirus pandemic led to a rapid and dramatic increase in the use of telehealth for diabetes care. In the wake of this transition, we examine new opportunities and ongoing challenges for using telehealth within diabetes management, based on data and experiences from the pre-pandemic and pandemic time frames.

The Inaccuracy of Commercial Home Hemoglobin A1c Tests

The COVID-19 pandemic and rapid expansion of telemedicine has increased the need for accurate and reliable capillary A1c testing. Nevertheless, validation studies of commercially available kits have been in short supply. As such, capillary and venous A1c samples were assessed using 3 commercial home kits (Home Access, CoreMedica, A1cNow) and 2 non-commercial kits from academic centers (U of MN Advanced Research and Diagnostic Lab [ARDL] and Children's Mercy Hospital [CMH]). Samples were collected either with study staff guidance (non-commercial) or hands-on assistance (commercial) and sent by USPS for processing except for the immediate response A1cNow+ kit. Differences in A1c between commercial kits and reference values were appreciable (Table). Notably, none of the commercially tested kits reached the National Glycohemoglobin Standardization Program target of more than 90% of values within 5% of DCCT venous reference values although the Home Access kit performed much better than the other two. In contrast, evaluation of kits from ARDL and CMH showed 97.4% of values within the 5% standard. Ease of use and discomfort with sample collection varied between kits. While the accuracy of the commercial kits analyzed was limited, participants' response was positive overall. Telemedicine is likely to persist as a mainstay of diabetes care well after the COVID-19 era. As such, accurate home A1c testing represents an urgent need for the diabetes community.

Using Peer Power to Reduce Health Disparities: Implementation of a Diabetes Support Coach Program in Federally Qualified Health Centers

There are pervasive disparities in health outcomes for people living with diabetes based on socioeconomic status, race, and ethnicity. These longstanding disparities are magnified by the devastating impact of COVID-19 for underserved communities with diabetes. As part of a Project Extension for Community Healthcare Outcomes (ECHO™) Diabetes outreach program in Florida and California, over 15 participating Federally Qualified Health Centers (FQHC) were provided Diabetes Support Coaches (DSC) to facilitate patient engagement. DSCs hold invaluable expert knowledge as they live with diabetes, themselves, and reside in the geographic catchment areas they serve - combining a traditional Community Health Worker (CHW) role with peer support models. DSCs complete standardized training in health coaching and receive Diabetes Paraprofessional Level 1 certification through the American Association of Diabetes Care and Education Specialists (ADCES). DSCs offer one-on-one peer support for interested patients, create local resource guides for diabetes management, host community events, disseminate information about technologies like continuous glucose monitors (CGM), and assist with appointment reminders and other engagement activities. Patient encounters with DSCs are documented in REDCap® and pre/post-test evaluation for patients includes HbA1c, the Diabetes Distress Scale, use of diabetes technology, and social support density. Preliminary data from n=19 adults with T1D and T2D (9 Hispanic, 10 Non-Hispanic Black) participating with DSCs at two FQHCs in Miami show statistically significant improvement in HbA1c mean ± SD: -1.21 ± 1.49, 95% CI (-1.93, -0.49) p<0.01). The mechanisms of patient engagement implemented by DSC became a critical tool for patient engagement during COVID-19. The use of DSC and CHWs, during COVID-19 and beyond, is critical for reaching underserved communities with diabetes.

Democratizing type 1 diabetes specialty care in the primary care setting to reduce health disparities: project extension for community healthcare outcomes (ECHO) T1D.

INTRODUCTION: Project ECHO (Extension for Community Healthcare Outcomes) is a tele-education outreach model that seeks to democratize specialty knowledge to reduce disparities and improve health outcomes. Limited utilization of endocrinologists forces many primary care providers (PCPs) to care for patients with type 1 diabetes (T1D) without specialty support. Accordingly, an ECHO T1D program was developed and piloted in Florida and California. Our goal was to demonstrate the feasibility of an ECHO program focused on T1D and improve PCPs' abilities to manage patients with T1D. RESEARCH DESIGN AND METHODS: Health centers (ie, spokes) were recruited into the ECHO T1D pilot through an innovative approach, focusing on Federally Qualified Health Centers and through identification of high-need catchment areas using the Neighborhood Deprivation Index and provider geocoding. Participating spokes received weekly tele-education provided by the University of Florida and Stanford University hub specialty team through virtual ECHO clinics, real-time support with complex T1D medical decision-making, access to a diabetes support coach, and access to an online repository of diabetes care resources. Participating PCPs completed pre/post-tests assessing diabetes knowledge and confidence and an exit survey gleaning feedback about overall ECHO T1D program experiences. RESULTS: In Florida, 12 spoke sites enrolled with 67 clinics serving >1000 patients with T1D. In California, 11 spoke sites enrolled with 37 clinics serving >900 patients with T1D. During the 6-month intervention, 27 tele-education clinics were offered and n=70 PCPs (22 from Florida, 48 from California) from participating spoke sites completed pre/post-test surveys assessing diabetes care knowledge and confidence in diabetes care. There was statistically significant improvement in diabetes knowledge (p≤0.01) as well as in diabetes confidence (p≤0.01). CONCLUSIONS: The ECHO T1D pilot demonstrated proof of concept for a T1D-specific ECHO program and represents a viable model to reach medically underserved communities which do not use specialists.

An Evaluation of Two Capillary Sample Collection Kits for Laboratory Measurement of HbA1c.

Background: The COVID-19 pandemic has impacted the conduct of clinic visits. We conducted a study to evaluate two academic laboratories' fingerstick capillary blood collection kits suitable for home use for laboratory measurement of HbA1c. Methods: Four clinical sites recruited 240 participants (aged 4-80 years, HbA1c 5.1%-13.5%). Capillary blood samples were obtained by the participant or parent using collection kits from two laboratories (University of Minnesota Advanced Research and Diagnostic Laboratory (ARDL) and Children's Mercy Hospital Laboratory (CMH)) and mailed under varying shipping conditions by United States Postal Service to the laboratories. Comparisons were made between HbA1c measurements from capillary samples and contemporaneously obtained venous samples. The primary outcome was percentage of capillary HbA1c values within 5% of the corresponding venous values. Results: HbA1c values were within 5% of venous values for 96% of ARDL kit specimens shipped with a cold pack and 98% without a cold pack and 99% and 99%, respectively, for the CMH kits. R2 values were 0.98, 0.99, 0.99, and 0.99, respectively. Results appeared similar across HbA1c levels and for pediatric and adult participants. Usability survey scores were high. Conclusions: Capillary blood collection kits, suitable for home use, from two academic laboratories, were demonstrated to be easy to use and provided results that are comparable with those obtained from venous specimens. Based on these results, there is strong evidence that HbA1c measurements from capillary specimens obtained with these specific kits can be used interchangeably with HbA1c measurements from venous specimens for clinical research and clinical care.

How Do We Move Type 1 Diabetes Immunotherapies Forward During the Current COVID-19 Pandemic?

Research-based immunotherapy trials seeking to prevent or reverse a number of autoimmune diseases, including type 1 diabetes, have seen near universal suspension due to the coronavirus disease 2019 (COVID-19) pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Diabetes and hyperglycemia are now appreciated as significant risk factors for COVID-19 morbidity and mortality; however, the vast majority of studies have reported on adults. Recent data in children and adolescents with type 1 diabetes suggest no increased risk of COVID-19. Even with immense appreciation for COVID-19 morbidity and mortality, we believe compelling arguments exist to carefully and thoughtfully resume certain type 1 diabetes phase 2-3 immunotherapy trials. In this Perspective, we consider the experience of trials that never halted or have resumed in the oncology and rheumatology fields, and advocate for staged type 1 diabetes immunotherapy trial resumption. With this, we present recommendations to achieve equipoise and mitigate risks for SARS-CoV-2 infection in the weeks surrounding infusion. Given the fact that the COVID-19 pandemic is expected to persist for some time, it is in the best interest of our patients that we find ways to safely move our field forward.