2018
DOI: 10.1111/pedi.12763
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Eligibility for clinical trials is limited for youth with type 2 diabetes: Insights from the Pediatric Diabetes Consortium T2D Clinic Registry

Abstract: Eligibility criteria for current clinical trials still exclude a large proportion of pediatric T2D patients because of HbA1c levels. Including patients with HbA1c <6.5% (<48 mmol/mol) would enhance recruitment and allow comparisons of the investigational treatment with placebo-assigned subjects in whom HbA1c levels would on average increase during the 6 to 12 months of the trial.

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Cited by 11 publications
(9 citation statements)
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“…The demographics of the participant population in this study were consistent with previous reports of youth with T2D, 4,50–54 with appropriate representation of minority racial and ethnic categories making the results generalizable. In addition, >50% of participants were <15 years of age.…”
Section: Discussionsupporting
confidence: 85%
“…The demographics of the participant population in this study were consistent with previous reports of youth with T2D, 4,50–54 with appropriate representation of minority racial and ethnic categories making the results generalizable. In addition, >50% of participants were <15 years of age.…”
Section: Discussionsupporting
confidence: 85%
“…The demographics of the participant population were consistent with previous reports of youth with T2D, 4,42–46 with appropriate representation of minority racial and ethnic categories, and participants <15 years of age making the results generalizable.…”
Section: Discussionsupporting
confidence: 80%
“…In terms of registry scope, 15 of the 24 included studies reported using national registries for trial pre-screening (Supplementary material 4 , papers 12/18/20/16/10/9/13/21/24/14/4/8/5/6/23) (respectively [ 42 , 43 , 45 , 46 , 48 51 , 54 , 57 – 59 , 62 , 63 , 65 ]), and 9 of 24 studies reported using local registries (Supplementary material 4 , papers 22/17/24/1/19/7/2/5/3) (respectively [ 44 , 53 56 , 60 62 , 64 ]). Local registries were either at a state level (Supplementary material 4 , papers 17 and 19) [ 53 , 56 ], or a specific site level (Supplementary material 4 , papers 22/1/7/2/3) (respectively [ 44 , 55 , 60 , 61 , 64 ]).…”
Section: Resultsmentioning
confidence: 99%