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JAMA | 2012

Out-of-Hospital Administration of Intravenous Glucose-Insulin-Potassium in Patients With Suspected Acute Coronary Syndromes: The IMMEDIATE Randomized Controlled Trial

Harry P. Selker; Joni R. Beshansky; Patricia R. Sheehan; Joseph M. Massaro; John L. Griffith; Ralph B. D’Agostino; Robin Ruthazer; James M. Atkins; Assaad Sayah; Michael Levy; Michael E. Richards; Tom P. Aufderheide; Darren Braude; Ronald G. Pirrallo; Delanor D. Doyle; Ralph J. Frascone; Donald J. Kosiak; James M. Leaming; Carin M. Van Gelder; Gert-Paul Walter; Marvin A. Wayne; Robert Woolard; Lionel H. Opie; Charles E. Rackley; Carl S. Apstein; James E. Udelson

CONTEXT Laboratory studies suggest that in the setting of cardiac ischemia, immediate intravenous glucose-insulin-potassium (GIK) reduces ischemia-related arrhythmias and myocardial injury. Clinical trials have not consistently shown these benefits, possibly due to delayed administration. OBJECTIVE To test out-of hospital emergency medical service (EMS) administration of GIK in the first hours of suspected acute coronary syndromes (ACS). DESIGN, SETTING, AND PARTICIPANTS Randomized, placebo-controlled, double-blind effectiveness trial in 13 US cities (36 EMS agencies), from December 2006 through July 31, 2011, in which paramedics, aided by electrocardiograph (ECG)-based decision support, randomized 911 (871 enrolled) patients (mean age, 63.6 years; 71.0% men) with high probability of ACS. INTERVENTION Intravenous GIK solution (n = 411) or identical-appearing 5% glucose placebo (n = 460) administered by paramedics in the out-of-hospital setting and continued for 12 hours. MAIN OUTCOME MEASURES The prespecified primary end point was progression of ACS to myocardial infarction (MI) within 24 hours, as assessed by biomarkers and ECG evidence. Prespecified secondary end points included survival at 30 days and a composite of prehospital or in-hospital cardiac arrest or in-hospital mortality, analyzed by intent-to-treat and by presentation with ST-segment elevation. RESULTS There was no significant difference in the rate of progression to MI among patients who received GIK (n = 200; 48.7%) vs those who received placebo (n = 242; 52.6%) (odds ratio [OR], 0.88; 95% CI, 0.66-1.13; P = .28). Thirty-day mortality was 4.4% with GIK vs 6.1% with placebo (hazard ratio [HR], 0.72; 95% CI, 0.40-1.29; P = .27). The composite of cardiac arrest or in-hospital mortality occurred in 4.4% with GIK vs 8.7% with placebo (OR, 0.48; 95% CI, 0.27-0.85; P = .01). Among patients with ST-segment elevation (163 with GIK and 194 with placebo), progression to MI was 85.3% with GIK vs 88.7% with placebo (OR, 0.74; 95% CI, 0.40-1.38; P = .34); 30-day mortality was 4.9% with GIK vs 7.7% with placebo (HR, 0.63; 95% CI, 0.27-1.49; P = .29). The composite outcome of cardiac arrest or in-hospital mortality was 6.1% with GIK vs 14.4% with placebo (OR, 0.39; 95% CI, 0.18-0.82; P = .01). Serious adverse events occurred in 6.8% (n = 28) with GIK vs 8.9% (n = 41) with placebo (P = .26). CONCLUSIONS Among patients with suspected ACS, out-of-hospital administration of intravenous GIK, compared with glucose placebo, did not reduce progression to MI. Compared with placebo, GIK administration was not associated with improvement in 30-day survival but was associated with lower rates of the composite outcome of cardiac arrest or in-hospital mortality. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00091507.


Diabetes Care | 2014

Rationale and Design of the Vitamin D and Type 2 Diabetes (D2d) Study: A Diabetes Prevention Trial

Anastassios G. Pittas; Bess Dawson-Hughes; Patricia R. Sheehan; Clifford J. Rosen; James H. Ware; William C. Knowler; Myrlene A. Staten

OBJECTIVE Observational studies suggest that vitamin D may lower the risk of type 2 diabetes. However, data from long-term trials are lacking. The Vitamin D and Type 2 Diabetes (D2d) study is a randomized clinical trial designed to examine whether a causal relationship exists between vitamin D supplementation and the development of diabetes in people at high risk for type 2 diabetes. RESEARCH DESIGN AND METHODS D2d was designed with support from a U34 planning grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The final protocol was approved by the D2d Research Group, the data and safety monitoring board, and NIDDK. Key eligibility criteria are age ≥30 years, BMI of 24 (22.5 for Asian Americans) to 42 kg/m2, increased risk for diabetes (defined as meeting two of three glycemic criteria for prediabetes established by the American Diabetes Association [fasting glucose 100–125 mg/dL (5.5–6.9 mmol/L), 2-h postload glucose after 75-g glucose load 140–199 mg/dL (7.7–11.0 mmol/L), hemoglobin A1c 5.7–6.4% (39–46 mmol/mol)]), and no hyperparathyroidism, nephrolithiasis, or hypercalcemia. D2d participants are randomized to once-daily vitamin D3 (cholecalciferol 4,000 IU) or placebo and followed for an average of 3 years. The primary end point is time to incident diabetes as assessed by laboratory criteria during the study or by adjudication if diagnosed outside of D2d. Recruitment was initiated at the end of 2013. CONCLUSIONS D2d will test whether vitamin D supplementation is safe and effective at lowering the risk of progression to diabetes in people at high risk for type 2 diabetes.


American Journal of Cardiology | 2014

One-year outcomes of out-of-hospital administration of intravenous glucose, insulin, and potassium (GIK) in patients with suspected acute coronary syndromes (from the IMMEDIATE [Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care] Trial).

Harry P. Selker; James E. Udelson; Joseph M. Massaro; Robin Ruthazer; Ralph B. D'Agostino; John L. Griffith; Patricia R. Sheehan; Patrice Desvigne-Nickens; Yves Rosenberg; Xin Tian; Ellen M. Vickery; James M. Atkins; Tom P. Aufderheide; Assaad Sayah; Ronald G. Pirrallo; Michael Levy; Michael E. Richards; Darren Braude; Delanor D. Doyle; Ralph J. Frascone; Donald J. Kosiak; James M. Leaming; Carin M. Van Gelder; Gert Paul Walter; Marvin A. Wayne; Robert Woolard; Joni R. Beshansky

The Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care Trial of very early intravenous glucose-insulin-potassium (GIK) for acute coronary syndromes (ACS) in out-of-hospital emergency medical service (EMS) settings showed 80% reduction in infarct size at 30 days, suggesting potential longer-term benefits. Here we report 1-year outcomes. Prespecified 1-year end points of this randomized, placebo-controlled, double-blind, effectiveness trial included all-cause mortality and composites including cardiac arrest, mortality, or hospitalization for heart failure (HF). Of 871 participants randomized to GIK versus placebo, death occurred within 1 year in 11.6% versus 13.5%, respectively (unadjusted hazard ratio [HR] 0.83, 95% confidence interval [CI] 0.57 to 1.23, p = 0.36). The composite of cardiac arrest or 1-year mortality was 12.8% versus 17.0% (HR 0.71, 95% CI 0.50 to 1.02, p = 0.06). The composite of hospitalization for HF or mortality within 1 year was 17.2% versus 17.2% (HR 0.98, 95% CI 0.70 to 1.37, p = 0.92). The composite of mortality, cardiac arrest, or HF hospitalization within 1 year was 18.1% versus 20.4% (HR 0.85, 95% CI 0.62 to 1.16, p = 0.30). In patients presenting with suspected ST elevation myocardial infarction, HRs for 1-year mortality and the 3 composites were, respectively, 0.65 (95% CI 0.33 to 1.27, p = 0.21), 0.52 (95% CI 0.30 to 0.92, p = 0.03), 0.63 (95% CI 0.35 to 1.16, p = 0.14), and 0.51 (95% CI 0.30 to 0.87, p = 0.01). In patients with suspected acute coronary syndromes, serious end points generally were lower with GIK than placebo, but the differences were not statistically significant. However, in those with ST elevation myocardial infarction, the composites of cardiac arrest or 1-year mortality, and of cardiac arrest, mortality, or HF hospitalization within 1 year, were significantly reduced.


American Heart Journal | 2012

Study design for the Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care (IMMEDIATE) Trial: A double-blind randomized controlled trial of intravenous glucose, insulin, and potassium for acute coronary syndromes in emergency medical services.

Harry P. Selker; Joni R. Beshansky; John L. Griffith; Ralph B. D'Agostino; Joseph M. Massaro; James E. Udelson; Eric J. Rashba; Robin Ruthazer; Patricia R. Sheehan; Patrice Desvigne-Nickens; Yves Rosenberg; James M. Atkins; Assaad Sayah; Tom P. Aufderheide; Charles E. Rackley; Lionel H. Opie; Costas T. Lambrew; Leonard A. Cobb; Bruce A. MacLeod; Joanne S. Ingwall; Robert J. Zalenski; Carl S. Apstein

BACKGROUND Experimental studies suggest that metabolic myocardial support by intravenous (IV) glucose, insulin, and potassium (GIK) reduces ischemia-induced arrhythmias, cardiac arrest, mortality, progression from unstable angina pectoris to acute myocardial infarction (AMI), and myocardial infarction size. However, trials of hospital administration of IV GIK to patients with ST-elevation myocardial infarction (STEMI) have generally not shown favorable effects possibly because of the GIK intervention taking place many hours after ischemic symptom onset. A trial of GIK used in the very first hours of ischemia has been needed, consistent with the timing of benefit seen in experimental studies. OBJECTIVE The IMMEDIATE Trial tested whether, if given very early, GIK could have the impact seen in experimental studies. Accordingly, distinct from prior trials, IMMEDIATE tested the impact of GIK (1) in patients with acute coronary syndromes (ACS), rather than only AMI or STEMI, and (2) administered in prehospital emergency medical service settings, rather than later, in hospitals, after emergency department evaluation. DESIGN The IMMEDIATE Trial was an emergency medical service-based randomized placebo-controlled clinical effectiveness trial conducted in 13 cities across the United States that enrolled 911 participants. Eligible were patients 30 years or older for whom a paramedic performed a 12-lead electrocardiogram to evaluate chest pain or other symptoms suggestive of ACS for whom electrocardiograph-based acute cardiac ischemia time-insensitive predictive instrument indicated a ≥75% probability of ACS, and/or the thrombolytic predictive instrument indicated the presence of a STEMI, or if local criteria for STEMI notification of receiving hospitals were met. Prehospital IV GIK or placebo was started immediately. Prespecified were the primary end point of progression of ACS to infarction and, as major secondary end points, the composite of cardiac arrest or in-hospital mortality, 30-day mortality, and the composite of cardiac arrest, 30-day mortality, or hospitalization for heart failure. Analyses were planned on an intent-to-treat basis, on a modified intent-to-treat group who were confirmed in emergency departments to have ACS, and for participants presenting with STEMI. CONCLUSION The IMMEDIATE Trial tested whether GIK, when administered as early as possible in the course of ACS by paramedics using acute cardiac ischemia time-insensitive predictive instrument and thrombolytic predictive instrument decision support, would reduce progression to AMI, mortality, cardiac arrest, and heart failure. It also tested whether it would provide clinical and pathophysiologic information on GIKs biological mechanisms.


Prehospital Emergency Care | 2011

Emergency medical service predictive instrument-aided diagnosis and treatment of acute coronary syndromes and ST-segment elevation myocardial infarction in the IMMEDIATE trial.

Harry P. Selker; Joni R. Beshansky; Robin Ruthazer; Patricia R. Sheehan; Assaad Sayah; James M. Atkins; Tom P. Aufderheide; Ronald G. Pirrallo; Ralph B. D'Agostino; Joseph M. Massaro; John L. Griffith

Abstract Background. A challenge for emergency medical service (EMS) is accurate identification of acute coronary syndromes (ACS) and ST-segment elevation myocardial infarction (STEMI) for immediate treatment and transport. The electrocardiograph-based acute cardiac ischemia time-insensitive predictive instrument (ACI-TIPI) and the thrombolytic predictive instrument (TPI) have been shown to improve diagnosis and treatment in emergency departments (EDs), but their use by paramedics in the community has been less studied. Objective. To identify candidates for participation in the Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care (IMMEDIATE) Trial, we implemented EMS use of the ACI-TIPI and the TPI in out-of-hospital electrocardiographs and evaluated its impact on paramedic on-site identification of ACS and STEMI as a community-based approach to improving emergency cardiac care. Methods. Ambulances in the study municipalities were outfitted with electrocardiographs with ACI-TIPI and TPI software. Using a before–after quasi-experimental design, in Phase 1, for seven months, paramedics were provided with the ACI-TIPI/TPI continuous 0–100% predictions automatically printed on electrocardiogram (ECG) text headers to supplement their identification of ACS; in Phase 2, for 11 months, paramedics were told to identify ACS based on an ACI-TIPI cutoff probability of ACS ≥ 75% and/or TPI detection of STEMI. In Phase 3, this cutoff approach was used in seven additional municipalities. Confirmed diagnoses of ACS, acute myocardial infarction (AMI), and STEMI were made by blinded physician review for 100% of patients. Results. In Phase 1, paramedics identified 107 patients as having ACS; in Phase 2, 104. In Phase 1, 45.8% (49) of patients so identified had ACS confirmed, which increased to 76.0% (79) in Phase 2 (p < 0.001). Of those with ACS, 59.2% (29) had AMI in Phase 1 versus 84.8% (67) with AMI in Phase 2 (p < 0.01), and STEMI was confirmed in 40.8% (20) versus 68.4% (54), respectively (p < 0.01). In Phase 3, of 226 patients identified by paramedics as having ACS, 74.3% (168) had ACS confirmed, of whom 81.0% (136) had AMI and 65.5% (110) had STEMI. Among patients with ACS, the proportion who received percutaneous coronary intervention (PCI) was 30.6% (15) in Phase 1, increasing to 57.0% (45) in Phase 2 (p < 0.004) and 50.6% (85) in Phase 3, and the proportions of patients with STEMI receiving PCI rose from 75.0% (15) to 83.3% (45) (p < 0.4) and 82.7% (91). Conclusions. In a wide range of EMS systems, use of electrocardiographs with ACI-TIPI and TPI decision support using a 75% ACI-TIPI cutoff improves paramedic diagnostic performance for ACS, AMI, and STEMI and increases the proportions of patients who receive PCI. Key words: acute coronary syndromes; acute myocardial infarction; electrocardiology; emergency medical service; clinical decision support.


Clinical Trials | 2014

A Community Consultation Survey to Evaluate Support for and Success of the IMMEDIATE Trial

Joni R. Beshansky; Patricia R. Sheehan; Kenneth J Klima; Nira Hadar; Ellen M. Vickery; Harry P. Selker

Background The IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency care) Trial, a randomized controlled double-blind clinical effectiveness trial of glucose–insulin–potassium (GIK) administered in ambulances in the out-of-hospital setting, used the Exception from Informed Consent Requirements (EFIC) for Emergency Research under Title 21 of the Code of Federal Regulations. EFIC requirements include community consultation that typically involves using a variety of communication methods and venues to inform the public of the research and to receive their feedback. Although not the primary purpose of the community consultation process, a common concern to research sponsors, staff, and institutional review boards (IRBs) is whether there will be a sufficient number of participants to justify mounting a study in their community. Information from community consultation regarding the community acceptance might inform this question. Purpose We evaluated the utility of telephone survey data done as part of the EFIC process as a way to project the ultimate rate of trial participant enrollment. Methods A telephone survey community consultation process was undertaken in nine communities planning to be IMMEDIATE Trial sites using a representative sampling of the target population in the areas covered by participating emergency medical service (EMS) agencies. Survey respondents were read a description of the planned study and its informed consent approach that included the option for patients to decline participation in the trial while being transported for acute care in an ambulance. Survey respondents were then asked whether they would object to participating in the study. At the conclusion of actual trial enrollment, the Coordinating Center compared the survey results with the actual rates of enrollment at each site. Results Approximately 200 (range = 200–271) respondents completed the survey in each of the study communities. Of 2079 survey respondents, 68% (range = 61%–75%) said that they would not object to participating in the trial if experiencing a heart attack, and 85% (range = 79%–89%) said that they would allow the study to be done in their community. During actual trial enrollment in the communities, 79% (range = 63%–91%) of the 828 potential participants agreed in the ambulance to have the study drug started and provided informed consent at the hospital, an average of 13 percentage-points higher than projected by the survey (95% confidence interval (CI): 9%–17%), 19% higher on a relative scale (CI: 14%–25%). Conclusions The survey-based approach to community consultation proved to be an efficient way to obtain representative input from potential clinical trial participants. The survey data generated a relatively good and conservative estimate of the ultimate rate of trial enrollment. This information could be useful to investigators and IRBs in projecting enrollment for clinical trials using EFIC.


Diabetes Care | 2017

Management of Hemoglobin Variants Detected Incidentally in HbA1c Testing: A Common Problem Currently Lacking a Standard Approach

Michael R. Lewis; Robert Macauley; Patricia R. Sheehan; Myrlene A. Staten; Lawrence S. Phillips; Neda Rasouli; Anastassios G. Pittas

Although HbA1c is widely used for diagnosis and management of diabetes in clinical practice and research studies, management of the incidental detection of hemoglobin variants (e.g., hemoglobin S [HbS], HbC) by common HbA1c methods, such as ion exchange high-performance liquid chromatography (HPLC), is not well established. Many clinical laboratories do not report the presence of hemoglobin variants, whereas others report them only if they interfere with HbA1c measurement (1). As routine HbA1c testing may incidentally yield information regarding hemoglobin variants that can affect clinical care, planning for appropriate management is warranted. The Vitamin D and Type 2 Diabetes (D2d) Study is a multicenter, randomized, placebo-controlled trial testing whether vitamin D supplementation reduces diabetes incidence in people at high risk (2). Adults meeting at least two of the three criteria for prediabetes established in 2010 by the American Diabetes Association are eligible for enrollment, and a racially and ethnically diverse study population is sought to ensure generalizability of results. HbA1c testing is performed using an HPLC method (Tosoh G8, Tosoh Bioscience, South San Francisco, CA) at the University of Vermont’s Laboratory for Clinical Biochemistry Research. Review of chromatograms can reveal unexpected peaks reflecting the presence of hemoglobin variants. Although HbS and HbC do not interfere with the assay, the presence of other variants, such as HbE, precludes reporting of HbA1c results. When an abnormal peak is seen, hemoglobin electrophoresis is performed to identify the hemoglobin variant. Because reporting of incidentally detected hemoglobin variants is not standardized, D2d investigators sought consultative opinions from …


Diabetes Care | 2018

Baseline Characteristics of the Vitamin D and Type 2 Diabetes (D2d) Study: A Contemporary Prediabetes Cohort That Will Inform Diabetes Prevention Efforts

Erin LeBlanc; Richard E. Pratley; Bess Dawson-Hughes; Myrlene A. Staten; Patricia R. Sheehan; M. Lewis; Anne L. Peters; Sun H. Kim; Ranee Chatterjee; Vanita R. Aroda; Chhavi Chadha; Lisa M. Neff; Irwin G. Brodsky; Clifford J. Rosen; Cyrus V. Desouza; John P. Foreyt; Daniel S. Hsia; Karen C. Johnson; Philip Raskin; Sangeeta R. Kashyap; Patrick M. O’Neil; Lawrence S. Phillips; Neda Rasouli; Emilia P. Liao; David C. Robbins; Anastassios G. Pittas

OBJECTIVE To describe baseline characteristics of the Vitamin D and Type 2 Diabetes (D2d) study, the first large U.S. diabetes prevention clinical trial to apply current American Diabetes Association (ADA) criteria for prediabetes. RESEARCH DESIGN AND METHODS This is a multicenter (n = 22 sites), randomized, double-blind, placebo-controlled, primary prevention clinical trial testing effects of oral daily 4,000 IU cholecalciferol (D3) compared with placebo on incident diabetes in U.S. adults at risk for diabetes. Eligible participants were at risk for diabetes, defined as not meeting criteria for diabetes but meeting at least two 2010 ADA glycemic criteria for prediabetes: fasting plasma glucose (FPG) 100–125 mg/dL, 2-h postload glucose (2hPG) after a 75-g oral glucose load 140–199 mg/dL, and/or a hemoglobin A1c (HbA1c) 5.7–6.4% (39–46 mmol/mol). RESULTS A total of 2,423 participants (45% of whom were women and 33% nonwhite) were randomized to cholecalciferol or placebo. Mean (SD) age was 60 (9.9) years and BMI 32.1 (4.5) kg/m2. Thirty-five percent met all three prediabetes criteria, 49% met the FPG/HbA1c criteria only, 9.5% met the 2hPG/FPG criteria only, and 6.3% met the 2hPG/HbA1c criteria only. Black participants had the highest mean HbA1c and lowest FPG concentration compared with white, Asian, and other races (P < 0.01); 2hPG concentration did not differ among racial groups. When compared with previous prediabetes cohorts, the D2d cohort had lower mean 2hPG concentration but similar HbA1c and FPG concentrations. CONCLUSIONS D2d will establish whether vitamin D supplementation lowers risk of diabetes and will inform about the natural history of prediabetes per contemporary ADA criteria.


Journal of the American Association of Nurse Practitioners | 2017

Assessment of a National Diabetes Education Program diabetes prevention toolkit: The D2d experience

Roshni Devchand; Patricia R. Sheehan; Joanne Gallivan; Diane Tuncer; Christina Nicols

Background and purpose The National Diabetes Education Program created the Small Steps. Big Rewards. GAME PLAN. toolkit to deliver basic type 2 diabetes prevention information to individuals at risk. The purpose of this study is to test the impact of GAME PLAN on diabetes prevention knowledge and behavioral readiness in the vitamin D and type 2 diabetes (D2d) study and participant satisfaction with toolkit materials. Methods Three hundred sixty adults at risk for diabetes participating in the D2d study were enrolled. Participants took a pretest, were sent home with the GAME PLAN, then took a posttest at their next visit, 3 months later. The Wilcoxon-signed rank test was used to examine changes in knowledge and behavioral readiness between scale scores pre- and posttest. Conclusions There were modest increases in composite diabetes prevention knowledge scores (p < .05) and behavioral readiness scores (p < .001) from pre- to posttest. Participants also reported at posttest that the toolkit materials were appropriate, comprehensive, and relevant. Implications for practice The GAME PLAN health education materials improve knowledge and behavioral readiness among adults at risk for diabetes. Providers can use GAME PLAN as one component of diabetes prevention education.BACKGROUND AND PURPOSE The National Diabetes Education Program created the Small Steps. Big Rewards. GAME PLAN. toolkit to deliver basic type 2 diabetes prevention information to individuals at risk. The purpose of this study is to test the impact of GAME PLAN on diabetes prevention knowledge and behavioral readiness in the vitamin D and type 2 diabetes (D2d) study and participant satisfaction with toolkit materials. METHODS Three hundred sixty adults at risk for diabetes participating in the D2d study were enrolled. Participants took a pretest, were sent home with the GAME PLAN, then took a posttest at their next visit, 3 months later. The Wilcoxon-signed rank test was used to examine changes in knowledge and behavioral readiness between scale scores pre- and posttest. CONCLUSIONS There were modest increases in composite diabetes prevention knowledge scores (p < .05) and behavioral readiness scores (p < .001) from pre- to posttest. Participants also reported at posttest that the toolkit materials were appropriate, comprehensive, and relevant. IMPLICATIONS FOR PRACTICE The GAME PLAN health education materials improve knowledge and behavioral readiness among adults at risk for diabetes. Providers can use GAME PLAN as one component of diabetes prevention education.


Diabetes Care | 2017

Response to Comment on Lewis et al. Management of Hemoglobin Variants Detected Incidentally in HbA1c Testing: A Common Problem Currently Lacking a Standard Approach. Diabetes Care 2017;40:e8–e9

Michael R. Lewis; Patricia R. Sheehan; Myrlene A. Staten; Lawrence S. Phillips; Anastassios G. Pittas

We thank Drs. Little and Rohlfing for their comments (1) regarding our article on the management of incidental detection of hemoglobin (Hb) variants in HbA1c testing (2). We agree that awareness of the potential for interference to affect HbA1c results is essential in research and clinical care. Multiple studies (including that of Lin et al. [3]) prior to the 2016 article by Rohlfing et al. (4) had yielded no evidence of clinically significant bias resulting from HbAS or HbAC variants in Tosoh G8 results. In the Vitamin D and Type 2 Diabetes (D2d) Study, we excluded potential participants with HbAE and HbAD because clinically significant bias had been demonstrated. In a recent article by Rohlfing et al. (4), HbA1c testing using a Tosoh G8 with software version 5.20 was found to show …

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Assaad Sayah

Cambridge Health Alliance

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James M. Atkins

University of Texas Southwestern Medical Center

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Tom P. Aufderheide

Medical College of Wisconsin

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Myrlene A. Staten

National Institutes of Health

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Ronald G. Pirrallo

Medical College of Wisconsin

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