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Considerations for more actionable consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes. Reply to Mallone R [letter] [Letter]
Phillip, Moshe; Achenbach, Peter; Addala, Ananta; Albanese-O'Neill, Anastasia; Battelino, Tadej; Bell, Kirstine J; Besser, Rachel E J; Bonifacio, Ezio; Colhoun, Helen M; Couper, Jennifer J; Craig, Maria E; Danne, Thomas; de Beaufort, Carine; Dovc, Klemen; Dutta, Sanjoy; Ebekozien, Osagie; Elding Larsson, Helena; Frohnert, Brigitte I; Gallagher, Mary P; Greenbaum, Carla J; Griffin, Kurt J; Hagopian, William; Haller, Michael J; Hendriks, Emile; Holt, Richard I G; Ismail, Heba M; Jacobsen, Laura M; Kolb, Leslie E; Kordonouri, Olga; Lange, Karin; Lash, Robert W; Lernmark, Åke; Libman, Ingrid; Lundgren, Markus; Maahs, David M; Marcovecchio, M Loredana; Mathieu, Chantal; Oron, Tal; Patil, Shivajirao P; Rewers, Marian J; Rich, Stephen S; Schatz, Desmond A; Schulman-Rosenbaum, Rifka; Simmons, Kimber M; Sims, Emily K; Skyler, Jay S; Speake, Cate; Steck, Andrea K; Tonyushkina, Ksenia N; Veijola, Riitta; Wentworth, John M; Wherrett, Diane K; Wood, Jamie R; Ziegler, Anette-Gabriele; DiMeglio, Linda A
PMID: 39934371
ISSN: 1432-0428
CID: 5793442
Consensus guidance for monitoring individuals with islet autoantibody-positive pre-stage 3 type 1 diabetes
Phillip, Moshe; Achenbach, Peter; Addala, Ananta; Albanese-O'Neill, Anastasia; Battelino, Tadej; Bell, Kirstine J; Besser, Rachel E J; Bonifacio, Ezio; Colhoun, Helen M; Couper, Jennifer J; Craig, Maria E; Danne, Thomas; de Beaufort, Carine; Dovc, Klemen; Driscoll, Kimberly A; Dutta, Sanjoy; Ebekozien, Osagie; Larsson, Helena Elding; Feiten, Daniel J; Frohnert, Brigitte I; Gabbay, Robert A; Gallagher, Mary P; Greenbaum, Carla J; Griffin, Kurt J; Hagopian, William; Haller, Michael J; Hendrieckx, Christel; Hendriks, Emile; Holt, Richard I G; Hughes, Lucille; Ismail, Heba M; Jacobsen, Laura M; Johnson, Suzanne B; Kolb, Leslie E; Kordonouri, Olga; Lange, Karin; Lash, Robert W; Lernmark, Ã…ke; Libman, Ingrid; Lundgren, Markus; Maahs, David M; Marcovecchio, M Loredana; Mathieu, Chantal; Miller, Kellee M; O'Donnell, Holly K; Oron, Tal; Patil, Shivajirao P; Pop-Busui, Rodica; Rewers, Marian J; Rich, Stephen S; Schatz, Desmond A; Schulman-Rosenbaum, Rifka; Simmons, Kimber M; Sims, Emily K; Skyler, Jay S; Smith, Laura B; Speake, Cate; Steck, Andrea K; Thomas, Nicholas P B; Tonyushkina, Ksenia N; Veijola, Riitta; Wentworth, John M; Wherrett, Diane K; Wood, Jamie R; Ziegler, Anette-Gabriele; DiMeglio, Linda A
Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programmes are being increasingly emphasised. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk of (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in non-specialised settings. To inform this monitoring, JDRF in conjunction with international experts and societies developed consensus guidance. Broad advice from this guidance includes the following: (1) partnerships should be fostered between endocrinologists and primary-care providers to care for people who are IAb+; (2) when people who are IAb+ are initially identified there is a need for confirmation using a second sample; (3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; (4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; (5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and (6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasises significant unmet needs for further research on early-stage type 1 diabetes to increase the rigour of future recommendations and inform clinical care.
PMID: 38910151
ISSN: 1432-0428
CID: 5719142
Correction to: Consensus guidance for monitoring individuals with islet autoantibody‑positive pre‑stage 3 type 1 diabetes
Phillip, Moshe; Achenbach, Peter; Addala, Ananta; Albanese-O'Neill, Anastasia; Battelino, Tadej; Bell, Kirstine J; Besser, Rachel E J; Bonifacio, Ezio; Colhoun, Helen M; Couper, Jennifer J; Craig, Maria E; Danne, Thomas; de Beaufort, Carine; Dovc, Klemen; Driscoll, Kimberly A; Dutta, Sanjoy; Ebekozien, Osagie; Larsson, Helena Elding; Feiten, Daniel J; Frohnert, Brigitte I; Gabbay, Robert A; Gallagher, Mary P; Greenbaum, Carla J; Griffin, Kurt J; Hagopian, William; Haller, Michael J; Hendrieckx, Christel; Hendriks, Emile; Holt, Richard I G; Hughes, Lucille; Ismail, Heba M; Jacobsen, Laura M; Johnson, Suzanne B; Kolb, Leslie E; Kordonouri, Olga; Lange, Karin; Lash, Robert W; Lernmark, Ã…ke; Libman, Ingrid; Lundgren, Markus; Maahs, David M; Marcovecchio, M Loredana; Mathieu, Chantal; Miller, Kellee M; O'Donnell, Holly K; Oron, Tal; Patil, Shivajirao P; Pop-Busui, Rodica; Rewers, Marian J; Rich, Stephen S; Schatz, Desmond A; Schulman-Rosenbaum, Rifka; Simmons, Kimber M; Sims, Emily K; Skyler, Jay S; Smith, Laura B; Speake, Cate; Steck, Andrea K; Thomas, Nicholas P B; Tonyushkina, Ksenia N; Veijola, Riitta; Wentworth, John M; Wherrett, Diane K; Wood, Jamie R; Ziegler, Anette-Gabriele; DiMeglio, Linda A
PMID: 39230637
ISSN: 1432-0428
CID: 5687982
Consensus Guidance for Monitoring Individuals With Islet Autoantibody-Positive Pre-Stage 3 Type 1 Diabetes
Phillip, Moshe; Achenbach, Peter; Addala, Ananta; Albanese-O'Neill, Anastasia; Battelino, Tadej; Bell, Kirstine J; Besser, Rachel E J; Bonifacio, Ezio; Colhoun, Helen M; Couper, Jennifer J; Craig, Maria E; Danne, Thomas; de Beaufort, Carine; Dovc, Klemen; Driscoll, Kimberly A; Dutta, Sanjoy; Ebekozien, Osagie; Elding Larsson, Helena; Feiten, Daniel J; Frohnert, Brigitte I; Gabbay, Robert A; Gallagher, Mary P; Greenbaum, Carla J; Griffin, Kurt J; Hagopian, William; Haller, Michael J; Hendrieckx, Christel; Hendriks, Emile; Holt, Richard I G; Hughes, Lucille; Ismail, Heba M; Jacobsen, Laura M; Johnson, Suzanne B; Kolb, Leslie E; Kordonouri, Olga; Lange, Karin; Lash, Robert W; Lernmark, Ã…ke; Libman, Ingrid; Lundgren, Markus; Maahs, David M; Marcovecchio, M Loredana; Mathieu, Chantal; Miller, Kellee M; O'Donnell, Holly K; Oron, Tal; Patil, Shivajirao P; Pop-Busui, Rodica; Rewers, Marian J; Rich, Stephen S; Schatz, Desmond A; Schulman-Rosenbaum, Rifka; Simmons, Kimber M; Sims, Emily K; Skyler, Jay S; Smith, Laura B; Speake, Cate; Steck, Andrea K; Thomas, Nicholas P B; Tonyushkina, Ksenia N; Veijola, Riitta; Wentworth, John M; Wherrett, Diane K; Wood, Jamie R; Ziegler, Anette-Gabriele; DiMeglio, Linda A
Given the proven benefits of screening to reduce diabetic ketoacidosis (DKA) likelihood at the time of stage 3 type 1 diabetes diagnosis, and emerging availability of therapy to delay disease progression, type 1 diabetes screening programs are being increasingly emphasized. Once broadly implemented, screening initiatives will identify significant numbers of islet autoantibody-positive (IAb+) children and adults who are at risk for (confirmed single IAb+) or living with (multiple IAb+) early-stage (stage 1 and stage 2) type 1 diabetes. These individuals will need monitoring for disease progression; much of this care will happen in nonspecialized settings. To inform this monitoring, JDRF, in conjunction with international experts and societies, developed consensus guidance. Broad advice from this guidance includes the following: 1) partnerships should be fostered between endocrinologists and primary care providers to care for people who are IAb+; 2) when people who are IAb+ are initially identified, there is a need for confirmation using a second sample; 3) single IAb+ individuals are at lower risk of progression than multiple IAb+ individuals; 4) individuals with early-stage type 1 diabetes should have periodic medical monitoring, including regular assessments of glucose levels, regular education about symptoms of diabetes and DKA, and psychosocial support; 5) interested people with stage 2 type 1 diabetes should be offered trial participation or approved therapies; and 6) all health professionals involved in monitoring and care of individuals with type 1 diabetes have a responsibility to provide education. The guidance also emphasizes significant unmet needs for further research on early-stage type 1 diabetes to increase the rigor of future recommendations and inform clinical care.
PMID: 38912694
ISSN: 1935-5548
CID: 5701752
Type 1 and Covid-19: Diagnosis, Clinical Care, and Health Outcomes during the Pandemic
Breidbart, Emily; Gallagher, Mary Pat
The coronavirus disease 2019 (COVID-19) pandemic disrupted health care, creating challenges for people with diabetes and health care systems. Diabetes was recognized as a risk factor for severe disease early in the pandemic. Subsequently, risk factors specific for people with type 1 diabetes were identified, including age, hemoglobin A1c level, and lack of continuous glucose monitoring . Telemedicine, especially when accompanied by diabetes data, allowed effective remote care delivery. However, pre-existing racial disparities in access to diabetes technology persisted and were associated with worse outcomes. Events of the COVID-19 pandemic underscore the importance of continuing to develop flexible and more equitable health care delivery systems.
PMID: 38272592
ISSN: 1558-4410
CID: 5625282
Increasing Social Determinants of Health Screening Rates Among Six Endocrinology Centers Across the United States: Results From the T1D Exchange Quality Improvement Collaborative
Odugbesan, Ori; Wright, Trevon; Jones, Nana-Hawa Yayah; Dei-Tutu, Selorm; Gallagher, Mary Pat; DeWit, Emily; Izquierdo, Roberto E; Desimone, Marisa; Rioles, Nicole; Ebekozien, Osagie; ,
Social determinants of health (SDOH) are strongly associated with outcomes for people with type 1 diabetes. Six centers in the T1D Exchange Quality Improvement Collaborative applied quality improvement principles to design iterative Plan-Do-Study-Act cycles to develop and expand interventions to improve SDOH screening rates. The interventions tested include staff training, a social risk index, an electronic health record patient-facing portal, partnerships with community organizations, and referrals to community resources. All centers were successful in improving SDOH screening rates, with individual site improvements ranging from 41 to 70% and overall screening across the six centers increasing from a baseline of 1% to 70% in 27 months.
PMCID:10788654
PMID: 38230332
ISSN: 0891-8929
CID: 5737452
The Design of the Electronic Health Record in Type 1 Diabetes Centers: Implications for Metrics and Data Availability for a Quality Collaborative
Eng, Donna; Ospelt, Emma; Miyazaki, Brian; McDonough, Ryan; Indyk, Justin A; Wolf, Risa; Lyons, Sarah; Neyman, Anna; Fogel, Naomi R; Basina, Marina; Gallagher, Mary Pat; Ebekozien, Osagie; Alonso, G Todd; Jones, Nana-Hawa Yayah; Lee, Joyce M
BACKGROUND/UNASSIGNED:Systematic and comprehensive data acquisition from the electronic health record (EHR) is critical to the quality of data used to improve patient care. We described EHR tools, workflows, and data elements that contribute to core quality metrics in the Type 1 Diabetes Exchange Quality Improvement Collaborative (T1DX-QI). METHOD/UNASSIGNED:We conducted interviews with quality improvement (QI) representatives at 13 T1DX-QI centers about their EHR tools, clinic workflows, and data elements. RESULTS/UNASSIGNED:All centers had access to structured data tools, nine had access to patient questionnaires and two had integration with a device platform. There was significant variability in EHR tools, workflows, and data elements, thus the number of available metrics per center ranged from four to 17 at each site. Thirteen centers had information about glycemic outcomes and diabetes technology use. Seven centers had measurements of additional self-management behaviors. Centers captured patient-reported outcomes including social determinants of health (n = 9), depression (n = 11), transition to adult care (n = 7), and diabetes distress (n = 3). Various stakeholders captured data including health care professionals, educators, medical assistants, and QI coordinators. Centers that had a paired staffing model in clinic encounters distributed the burden of data capture across the health care team and was associated with a higher number of available data elements. CONCLUSIONS/UNASSIGNED:The lack of standardization in EHR tools, workflows, and data elements captured resulted in variability in available metrics across centers. Further work is needed to support measurement and subsequent improvement in quality of care for individuals with type 1 diabetes.
PMID: 37994567
ISSN: 1932-2968
CID: 5608672
Diabetes status and other factors as correlates of risk for thrombotic and thromboembolic events during SARS-CoV-2 infection: A nationwide retrospective case-control study using Cerner Real-World Data™
Tallon, Erin M; Gallagher, Mary Pat; Staggs, Vincent S; Ferro, Diana; Murthy, Deepa Badrinath; Ebekozien, Osagie; Kosiborod, Mikhail N; Lind, Marcus; Manrique-Acevedo, Camila; Shyu, Chi-Ren; Clements, Mark A
OBJECTIVES:We sought to examine in individuals with SARS-CoV-2 infection whether risk for thrombotic and thromboembolic events (TTE) is modified by presence of a diabetes diagnosis. Furthermore, we analysed whether differential risk for TTEs exists in type 1 diabetes mellitus (T1DM) versus type 2 diabetes mellitus (T2DM). DESIGN:Retrospective case-control study. SETTING:COVID-19 database is a deidentified, nationwide database containing electronic medical record (EMR) data from 87 US-based health systems. PARTICIPANTS:We analysed EMR data for 322 482 patients >17 years old with suspected or confirmed SARS-CoV-2 infection who received care between December 2019 and mid-September 2020. Of these, 2750 had T1DM; 57 811 had T2DM; and 261 921 did not have diabetes. OUTCOME:TTE, defined as presence of a diagnosis code for myocardial infarction, thrombotic stroke, pulmonary embolism, deep vein thrombosis or other TTE. RESULTS:Odds of TTE were substantially higher in patients with T1DM (adjusted OR (AOR) 2.23 (1.93-2.59)) and T2DM (AOR 1.52 (1.46-1.58)) versus no diabetes. Among patients with diabetes, odds of TTE were lower in T2DM versus T1DM (AOR 0.84 (0.72-0.98)). CONCLUSIONS:Risk of TTE during COVID-19 illness is substantially higher in patients with diabetes. Further, risk for TTEs is higher in those with T1DM versus T2DM. Confirmation of increased diabetes-associated clotting risk in future studies may warrant incorporation of diabetes status into SARS-CoV-2 infection treatment algorithms.
PMCID:10335498
PMID: 37423628
ISSN: 2044-6055
CID: 5536972
CONTINUOUS GLUCOSE MONITOR (CGM) DERIVED GLYCEMIC OUTCOMES AMONG REAL-TIME CGM VS. FLASH CGM USERS IN A MULTI-CENTER EMR DATABASE FOR PEOPLE WITH T1D [Meeting Abstract]
Noor, N; Ebekozien, O; Vendrame, F; Jacobsen, L; Weinstock, R; Gallagher, M P; Corathers, S; Accacha, S; Prahalad, P; Rapaport, R
Background and Aims: Evidence from clinical trials suggest that use of CGM devices decreases hypoglycemia, but no realworld studies have demonstrated efficacy of real-time CGM vs. flash CGM device use in improving CGM derived glycemic outcomes. A flash or intermittently scanning CGM (isCGM) provides glucose levels immediately upon scanning sensor; whereas real-time CGM (rtCGM) device automatically transmits a continuous stream of glucose data to the user. We examined efficacy of isCGM vs. rtCGM device use using real-world EMR data from 19 endocrinology clinics participating in the T1DX-QI Collaborative.
Method(s): Main outcomes were a) mean time in range (TIR: 70-180 mg/dL), b) time above range (TAR: >=250mg/dL) and c) time below range (TBR: <70 mg/dL). Patients >=6 years with T1D from 2018 to 2022 were included. Discriptive differences between isCGM and rtCGM groups were assessed using chisquare and Mann-Whitney U tests. Bootstrapped point estimates and 95% CIs were reported. Linear mixed models examined association between type of CGM and TIR adjusting for covariates.
Result(s): This analysis included 6234 people in the rtCGM group and 412 people in the isCGM group. In the overall study population, mean TIR was higher for rtCGM users relative to isCGM users (Mean(95% CI): 50 (49-51) vs. 40 (38-43)) [p = 0.0001], mean TBR was lower for rtCGM users relative to isCGM users (Mean (95% CI): 1.9 (1.8-2.0) vs. 2.6 (2.2-3.0)) [p = 0.001] and mean TAR was also lower for rtCGM users (Mean(95% CI): 19 (18-20) vs. 26 (23-30)) [p < 0.001].
Conclusion(s): We found improved CGM derived glycemic outcomes for rtCGM relative to the isCGM grroup
EMBASE:640507030
ISSN: 1557-8593
CID: 5512042
DIFFERENCES IN DIABETES TECHNOLOGY USE ONLY PARTIALLY EXPLAIN DISPARITIES IN TYPE 1 DIABETES OUTCOMES AMONG MINORITY YOUTH [Meeting Abstract]
Namkoong, L; Stein, C; Ilkowitz, J; Gonzalez, J; Joseph, V; Gallagher, M P
Background and Aims: Diabetes technology (DT) use is associated with lower HbA1c in type 1 diabetes (T1D). Non- Hispanic Black and Hispanic populations are more likely to have lower DT use and higher HbA1c compared to non-Hispanic White populations. We examined the extent to which differential DT use explains outcome disparities at an outpatient pediatric diabetes center in NYC.
Method(s): Patients identifying as non-White, Hispanic, or non-English language preference were grouped (minority race/ language; MRL) and compared to non-Hispanic White, Englishpreferred patients. HbA1c >9% was categorized as high. T-test and chi-square statistics compared patient characteristics by HbA1c category. Binomial regression with generalized estimating equations estimated associations (risk ratios, RR; 95% confidence intervals, CI) between MRL and high HbA1c. First, models were adjusted for insurance type and Child Opportunity Index (COI), then additionally for CGM and pump use.
Result(s): Patients (n = 331) aged 2-25 years with T1D >= 3 months attended 709 visits (mean 2.2, SD 1.2) from 2020-2021; 32% identified as MRL. At the most recent visit, 16% had HbA1c>9% (MRL 29%, non-MRL 10%), 87% used CGMs (MRL 77%, non-MRL 92%), and 78% used pumps (MRL 72%, non-MRL 81%). MRL youth were 2.5 (95% CI 1.6-4.0) times more likely to have HbA1c>9% as compared to non-MRL youth, adjusted for insurance and COI. After adjusting for DT use, MRL youth remained twice as likely to have HbA1c>9% (RR 2.0, 95% CI 1.2-3.3).
Conclusion(s): While the disparity in HbA1c between MRL and non-MRL youth can be partially attributed to DT use, disparity persists even after accounting for DT use
EMBASE:640506971
ISSN: 1557-8593
CID: 5512052