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Who Is Enrolling? The Path to Monitoring in Type 1 Diabetes TrialNet's Pathway to Prevention.

  • Sims, Emily K1
  • Geyer, Susan2
  • Johnson, Suzanne Bennett3
  • Libman, Ingrid4
  • Jacobsen, Laura M5
  • Boulware, David2
  • Rafkin, Lisa E6
  • Matheson, Della6
  • Atkinson, Mark A5
  • Rodriguez, Henry6
  • Spall, Maria7
  • Elding Larsson, Helena8
  • Wherrett, Diane K9
  • Greenbaum, Carla J10
  • Krischer, Jeffrey2
  • DiMeglio, Linda A7
  • 1 Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN [email protected] , (India)
  • 2 Health Informatics Institute, University of South Florida, Tampa, FL.
  • 3 Florida State University College of Medicine, Tallahassee, FL.
  • 4 Division of Endocrinology, Diabetes and Metabolism, University of Pittsburgh and UPMC Children's Hospital of Pittsburgh, Pittsburgh, PA.
  • 5 Department of Pediatrics, University of Florida College of Medicine, Gainesville, FL.
  • 6 University of Miami Miller School of Medicine Diabetes Research Institute, Miami, FL.
  • 7 Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN. , (India)
  • 8 Department of Clinical Sciences, Lund University Clinical Research Center, Skåne University Hospital, Malmö, Sweden. , (Sweden)
  • 9 Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, Canada. , (Canada)
  • 10 Diabetes Research Program, Benaroya Research Institute, Seattle, WA.
Published Article
Diabetes care
Publication Date
Dec 01, 2019
DOI: 10.2337/dc19-0593
PMID: 31558546


To better understand potential facilitators of individual engagement in type 1 diabetes natural history and prevention studies through analysis of enrollment data in the TrialNet Pathway to Prevention (PTP) study. We used multivariable logistic regression models to examine continued engagement of eligible participants at two time points: 1) the return visit after screening to confirm an initial autoantibody-positive (Ab+) test result and 2) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. Of 5,387 subjects who screened positive for a single autoantibody (Ab), 4,204 (78%) returned for confirmatory Ab testing. Younger age was associated with increased odds of returning for Ab confirmation (age <12 years vs. >18 years: odds ratio [OR] 2.12, P < 0.0001). Racial and ethnic minorities were less likely to return for confirmation, particularly nonwhite non-Hispanic (OR 0.50, P < 0.0001) and Hispanic (OR 0.69, P = 0.0001) relative to non-Hispanic white subjects. Of 8,234 subjects, 5,442 (66%) were identified as eligible to be enrolled in PTP OGTT monitoring. Here, younger age and identification as multiple Ab+ were associated with increased odds of returning for OGTT monitoring (age <12 years vs. >18 years: OR 1.43, P < 0.0001; multiple Ab+: OR 1.36, P < 0.0001). Parents were less likely to enroll into monitoring than other relatives (OR 0.78, P = 0.004). Site-specific factors, including site volume and U.S. site versus international site, were also associated with differences in rates of return for Ab+ confirmation and enrollment into monitoring. These data confirm clear differences between successfully enrolled populations and those lost to follow-up, which can serve to identify strategies to increase ongoing participation. © 2019 by the American Diabetes Association.

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