Article Information.
Acknowledgements: The skilled and dedicated assistance of the following individuals for the clinical components of the study is acknowledged, none of whom were compensated for their contributions: Spartanburg Regional Hospital, Spartanburg, SC: Jill Cole; University of Melbourne, Australia: Christine Knight, Dr Jennifer Conn, Susan Hiscock, Dr Jeremy Oats, Peter Wein; University of Oklahoma, Oklahoma City, OK: Azar Dashti.
Declaration of interests: The authors have declared that no conflicts of interest exist.
Ethics approval: The study was approved by the Institutional Review Boards of all the participating institutions and by the Ethics Committee of the Medical University of South Carolina (IRB#: 81076, Date: Aug 14, 2018); it was conducted according to the principles of the Declaration of Helsinki.
Data Availability: The data that support the findings of this study are available from the corresponding author on reasonable request.
Funding/Sponsor: This work was supported by Research Grants from the Juvenile Diabetes Research Foundation (JDRF 1-2001-844), and Novo Nordisk to TJL, and by NIH (NCRR) Grants M01-RR-1070 and M01 RR-14467 to the General Clinical Research Centers at MUSC and OUHSC respectively. Support from Novo Nordisk enabled the participation of the Barbara Davis Diabetes Center for Childhood Diabetes at the University of Colorado.
Role of the Funder/Sponsor: The sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.