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Who is enrolling? The path to monitoring in type 1 diabetes trialnet’s pathway to prevention

Sims, Emily K. ; Geyer, Susan ; Johnson, Suzanne Bennett LU ; Libman, Ingrid ; Jacobsen, Laura M. ; Boulware, David ; Rafkin, Lisa E. ; Matheson, Della ; Atkinson, Mark A. and Rodriguez, Henry , et al. (2019) In Diabetes Care 42(12). p.2228-2236
Abstract

OBJECTIVE 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. RESEARCH DESIGN AND METHODS 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 (Ab1) test result and 2) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. RESULTS Of 5,387 subjects who screened positive for a single autoantibody (Ab), 4,204 (78%) returned for confirmatory Ab testing. Younger age was associated... (More)

OBJECTIVE 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. RESEARCH DESIGN AND METHODS 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 (Ab1) test result and 2) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. RESULTS 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 5 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 Ab1 were associated with increased odds of returning for OGTT monitoring (age <12 years vs. >18 years: OR 1.43, P < 0.0001; multiple Ab1: OR 1.36, P < 0.0001). Parents were less likely to enroll into monitoring than other relatives (OR 0.78, P 5 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 Ab1 confirmation and enrollment into monitoring. CONCLUSIONS 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.

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published
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Diabetes Care
volume
42
issue
12
pages
9 pages
publisher
American Diabetes Association
external identifiers
  • pmid:31558546
  • scopus:85075813747
ISSN
0149-5992
DOI
10.2337/dc19-0593
language
English
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yes
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77ce4ee8-3657-4452-b0ea-a79986bc67b0
date added to LUP
2019-12-16 11:07:20
date last changed
2020-01-13 02:36:34
@article{77ce4ee8-3657-4452-b0ea-a79986bc67b0,
  abstract     = {<p>OBJECTIVE 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. RESEARCH DESIGN AND METHODS 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<sup>1</sup>) test result and 2) the initial oral glucose tolerance test (OGTT) for enrollment into the monitoring protocol. RESULTS 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 &lt;12 years vs. &gt;18 years: odds ratio [OR] 2.12, P &lt; 0.0001). Racial and ethnic minorities were less likely to return for confirmation, particularly nonwhite non-Hispanic (OR 0.50, P &lt; 0.0001) and Hispanic (OR 0.69, P 5 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<sup>1</sup> were associated with increased odds of returning for OGTT monitoring (age &lt;12 years vs. &gt;18 years: OR 1.43, P &lt; 0.0001; multiple Ab<sup>1</sup>: OR 1.36, P &lt; 0.0001). Parents were less likely to enroll into monitoring than other relatives (OR 0.78, P 5 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<sup>1</sup> confirmation and enrollment into monitoring. CONCLUSIONS 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.</p>},
  author       = {Sims, Emily K. and Geyer, Susan and Johnson, Suzanne Bennett and Libman, Ingrid and Jacobsen, Laura M. and Boulware, David and Rafkin, Lisa E. and Matheson, Della and Atkinson, Mark A. and Rodriguez, Henry and Spall, Maria and Larsson, Helena Elding and Wherrett, Diane K. and Greenbaum, Carla J. and Krischer, Jeffrey and DiMeglio, Linda A.},
  issn         = {0149-5992},
  language     = {eng},
  number       = {12},
  pages        = {2228--2236},
  publisher    = {American Diabetes Association},
  series       = {Diabetes Care},
  title        = {Who is enrolling? The path to monitoring in type 1 diabetes trialnet’s pathway to prevention},
  url          = {http://dx.doi.org/10.2337/dc19-0593},
  doi          = {10.2337/dc19-0593},
  volume       = {42},
  year         = {2019},
}