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Article History

Received: 19 April 2021

Accepted: 20 May 2021

First Online: 4 June 2021

Funding

: This study was supported by research grants from Dexcom, Inc., who also funded the journal’s Rapid Service Fee.

: We thank Sarah Puhr and John Welsh for their assistance in preparing the manuscript.

: All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published. We thank Wenhao Dong, Heather Tecca, Qinyu Chen, and Xiaohe Zhang for their contributions to the statistical analysis; and we thank Polachai Ernie Sakchalathorn for his assistance in running the study.

: Qianqian Deng, Stayce Beck, and David Price are employees of Dexcom, Inc. Mark Kipnes has no disclosures.

: The protocol and Health Insurance Portability and Accountability Act (HIPAA)-compliant informed consent forms were approved by Salus IRB (Board Numbers IRB00006833, IRB00006834, and IRB00009473) who agreed with the determination of non-significant risk for the device study. Written informed consent was obtained from each participant in accordance with the Code of Federal Regulations (CFR) Title per Department of Health and Human Services (DHSS) regulations (45 CFR 46, subpart A & D). Subjects were asked to sign state-specific forms, such as Subject’s Bill of Rights, or equivalent, (if applicable) and HIPAA authorization form, if not included in the site’s consent template. Subjects were provided the opportunity to review these documents prior to coming to the clinical site. The investigator or designee explained the purpose and duration of the study, the study procedures and subject requirements, and the potential risks and benefits. The consenting process was documented for each participant and a copy of the consent was provided to the participant. All procedures followed were in accordance with the ethical standards of the institutional review board and ethics committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1964, as revised in 2013.

: The datasets generated during and/or analyzed during the current study are not publicly available because this was a pilot/feasibility study. Further studies from which the data may be available from the corresponding author upon reasonable request are being considered.