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Article History

Received: 17 January 2023

Accepted: 17 July 2023

First Online: 2 August 2023

Declarations

:

: The study was conducted according to the guidelines in the Declaration of Helsinki. All patients were given verbal and written explanations about the study, provided written informed consent, and received a monetary stipend. The study was approved by the Pennington Biomedical Institutional Review Board (2015–052-PBRC) and registered at ClinicalTrials.gov (NCT02561221).

: N/A.

: JWA, RLN, Jr., CAM, CLA, TCD, WDJ, DZ, CH, KDD, EFM, BFS, and PTK report no conflicts of interest. CKM has interests in the energy balance models and weight graph approach that was used during the trial to promote dietary adherence. Specifically, CKM is part of a US and European patent application related to this technology and he receives royalties paid to his university from the licensing of this technology. VAF has grants to Tulane from Fratyl and Jaguar Gene Therapy. He receives honoraria for consulting and lectures from Asahi, Novo Nordisk, Sanofi, Bayer, Abbott, and Boehringer Ingelheim. He has stock options in Mellitus Health and BRAVO4Health and stock in Amgen and Abbott. VAF also has patents pending for BRAVO risk engine for predicting diabetes complications andPAX4 gene therapy for type 1 diabetes. CJL is a speaker and consultant for Amgen, Sanofi, Esperion, AstraZeneca, DSM, and GOED. He is also a consultant for Novartis.