CONSORT-EHEALTH Checklist V1.6.2 Report

1b-i) Key features/functionalities/components of the intervention and comparator in the METHODS section of the ABSTRACT "The telehealth RM tablet computer transmitted glucose data and facilitated a CFL to educate participants, analyze actionable glucose data, and provide feedback. Data from paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis and were shared with patients via the EHR weekly. CDEs called participants monthly to discuss paired glucose testing trends and treatment changes. " 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT "paired glucose testing were analyzed asynchronously using computer-assisted pattern analysis" 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-to-face assessments in the METHODS section of the ABSTRACT "The telehealth RM tablet computer transmitted glucose data 1b-iv) RESULTS section in abstract must contain use data Not applicable we were not evaluating 1b-v) CONCLUSIONS/DISCUSSION in abstract for negative trials outcomes were not negative INTRODUCTION 2a-i) Problem and the type of system/solution "Practice guidelines promote the use of SMBG for informing healthcare providers about glycemic control and providing patient feedback to increase knowledge, self-efficacy, and behavior change" "A complete feedback loop (CFL)—data collection and interpretation combined with feedback to the patient to modify treatment plans—has been associated with improved outcomes [19]. While the CFL has been identified as an essential component of both SMBG [20] and remote monitoring (RM), there remains limited and inconsistent incorporation of SMBG feedback in diabetes management " 2a-ii) Scientific background, rationale: What is known about the (type of) system "Telehealth RM may improve clinical outcomes, care coordination, engagement and satisfaction" METHODS 3a) CONSORT: Description of trial design (such as parallel, factorial) including allocation ratio "The purpose of this study was to test the effectiveness of a telehealth RM intervention with paired glucose testing for adults with noninsulin treated type 2 diabetes. The hypothesis was that a telehealth RM intervention with paired glucose testing would result in a greater change in A1C, improved selfmanagement, self-efficacy, and diabetes knowledge compared to usual care over six months. " 3b) CONSORT: Important changes to methods after trial commencement (such as eligibility criteria), with reasons No changes 3b-i) Bug fixes, Downtimes, Content Changes N/A no issues to report 4a) CONSORT: Eligibility criteria for participants "Inclusion criteria: • Type 2 diabetes diagnosis treated with oral anithyperglycemic medications or lifestyle alone, • Participant in the diabetes management program for previous 12 months, • 30-70 years of age, • A1C between 7.5% and 10.9% in previous six months, • Internet or 3G connection with e-mail access, • Land line or cellular phone, • English speaking. • PCP in health system. Exclusion criteria identified by medical chart review including: • Insulin prescription, • Unable to independently self-manage (diagnosis of dementia, severe depression, schizophrenia, or cognitive impairment for previous 12 months), • Diagnoses of stroke, heart failure, end-stage renal disease, or legally blind. " 4a-i) Computer / Internet literacy "Internet or 3G connection with e-mail access, " 4a-ii) Open vs. closed, web-based vs. face-to-face assessments: "Eligible participants were contacted through e-mail, postal mail, and telephone. (See Figure 1). Consent forms were e-mailed and mailed to participants with informed consent conducted over the telephone and consent forms returned by mail." 4a-iii) Information giving during recruitment