One Drop App With an Activity Tracker for Adults With Type 1 Diabetes: Randomized Controlled Trial

Background In 2017, mobile app support for managing diabetes was available to 64% of the global population of adults with diabetes. One Drop’s digital therapeutics solution includes an evidence-based mobile app with global reach, a Bluetooth-connected glucometer, and in-app coaching from Certified Diabetes Educators. Among people with type 1 diabetes and an estimated hemoglobin A1c level≥7.5%, using One Drop for 3 months has been associated with an improved estimated hemoglobin A1c level of 22.2 mg/dL (–0.80%). However, the added value of integrated activity trackers is unknown. Objective We conducted a pragmatic, remotely administered randomized controlled trial to evaluate One Drop with a new-to-market activity tracker against One Drop only on the 3-month hemoglobin A1c level of adults with type 1 diabetes. Methods Social media advertisements and online newsletters were used to recruit adults (≥18 years old) diagnosed (≥1 year) with T1D, naïve to One Drop’s full solution and the activity tracker, with a laboratory hemoglobin A1c level≥7%. Participants (N=99) were randomized to receive One Drop and the activity tracker or One Drop only at the start of the study. The One Drop only group received the activity tracker at the end of the study. Multiple imputation, performed separately by group, was used to correct for missing data. Analysis of covariance models, controlling for baseline hemoglobin A1c, were used to evaluate 3-month hemoglobin A1c differences in intent-to-treat (ITT) and per protocol (PP) analyses. Results The enrolled sample (N=95) had a mean age of 41 (SD 11) years, was 73% female, 88% White, diagnosed for a mean of 20 (SD 11) years, and had a mean hemoglobin A1c level of 8.4% (SD 1.2%); 11% of the participants did not complete follow up. Analysis of covariance assumptions were met for the ITT and PP models. In ITT analysis, participants in the One Drop and activity tracker condition had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.60%, 95% CI 7.8-8.2) than that of the participants in the One Drop only condition (mean 8.4%, SD 0.62%, 95% CI 8.2-8.5). In PP analysis, participants in the One Drop and activity tracker condition also had a significantly lower 3-month hemoglobin A1c level (mean 7.9%, SD 0.59%, 95% CI 7.7-8.1) than that of participants in the One Drop only condition (mean 8.2%, SD 0.58%, 95% CI 8.0-8.4). Conclusions Participants exposed to One Drop and the activity tracker for the 3-month study period had a significantly lower 3-month hemoglobin A1c level compared to that of participants exposed to One Drop only during the same timeframe. One Drop and a tracker may work better together than alone in helping people with type 1 diabetes. Trial Registration ClinicalTrials.gov NCT03459573; https://clinicaltrials.gov/ct2/show/NCT03459573.

access is open to everyone, but requires payment/subscription/in-app purchases app/intervention no longer accessible Other: (e.g. "English, French") Arabic, Chinese, English, French, German URL of your Intervention Website or App e.g. a direct link to the mobile app on app in appstore (itunes, Google Play), or URL of the website. If the intervention is a DVD or hardware, you can also link to an Amazon page.
abetes-management/id972238816 and URL of an image/screenshot (optional) Your answer Accessibility * Can an enduser access the intervention presently? Primary Medical Indication/Disease/Condition * e.g. "Stress", "Diabetes", or define the target group in brackets after the condition, e.g. "Autism 1a-i) Identify the mode of delivery in the title Identify the mode of delivery. Preferably use "web-based" and/or "mobile" and/or "electronic game" in the title. Avoid ambiguous terms like "online", "virtual", "interactive". Use "Internet-based" only if Intervention includes non-web-based Internet components (e.g. email), use "computer-based" or "electronic" only if offline products are used. Use "virtual" only in the context of "virtual reality" (3-D worlds). Use "online" only in the context of "online support groups". Complement or substitute product names with broader terms for the class of products (such as "mobile" or "smart phone" instead of "iphone"), especially if the application runs on different platforms.
Does your paper address subitem 1a-i? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The mode of delivery is implied in the title. "Randomized Control Trial: One Drop with an Activity Tracker Lowers the A1c of Adults with Type 1 Diabetes" 1a-ii) Non-web-based components or important co-interventions in title Mention non-web-based components or important co-interventions in title, if any (e.g., "with telephone support"). Does your paper address subitem 1a-ii?
Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a 1a-iii) Primary condition or target group in the title Mention primary condition or target group in the title, if any (e.g., "for children with Type I Diabetes") Example: A Web-based and Mobile Intervention with Telephone Support for Children with Type I Diabetes: Randomized Controlled Trial Does your paper address subitem 1a-iii? * Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Randomized Control Trial: Does your paper address subitem 1b-i? * Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants (N = 99) were randomized to get OD plus activity tracker at study start or OD at start and an activity tracker after 3 mos." OD = One Drop 1b-ii) Level of human involvement in the METHODS section of the ABSTRACT Clarify the level of human involvement in the abstract, e.g., use phrases like "fully automated" vs. "therapist/nurse/care provider/physician-assisted" (mention number and expertise of providers involved, if any). (Note: Only report in the abstract what the main paper is reporting. If this information is missing from the main body of text, consider adding it) Does your paper address subitem 1b-ii?
Copy and paste relevant sections from the manuscript abstract (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted a pragmatic, remotely-administered, randomized control trial to evaluate One Drop with an activity tracker on the A1c of adults with T1D." 1b-iii) Open vs. closed, web-based (self-assessment) vs. face-toface assessments in the METHODS section of the ABSTRACT Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic or a closed online user group (closed usergroup trial), and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment). Clearly say if outcomes were self-assessed through questionnaires (as common in web-based trials Does your paper address subitem 2a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Studies consistently associate using One Drop with improved A1c, but none to date have been randomized control trials or included people with T1D using an activity tracker or smartwatch." Does your paper address CONSORT subitem 2b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "We conducted a three-month prospective, randomized control trial to evaluate the effect of One Drop and an activity tracker on the A1c of people with T1D." 3b) Important changes to methods after trial commencement (such as eligibility criteria), with reasons subitem not at all important 1 2 3 4 5 essential 4a) Eligibility criteria for participants Does your paper address CONSORT subitem 3a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The study design was a pragmatic, parallel group, randomized control trial." Does your paper address CONSORT subitem 3b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "There were no methodological changes during the trial period." 3b-i) Bug fixes, Downtimes, Content Changes Bug fixes, Downtimes, Content Changes: ehealth systems are often dynamic systems. A description of changes to methods therefore also includes important changes made on the intervention or comparator during the trial (e.g., major bug fixes or changes in the functionality or content) (5-iii) and other "unexpected events" that may have influenced study design such as staff changes, system failures/downtimes, etc. [2].
Does your paper address subitem 3b-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "As is the case with all apps, occasional minor bug fixes are typical. None resulted in major system failures or downtimes during the trial period." subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 4a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Initially eligible persons met criteria on the online, screening survey. They selfreported age 18-75 years, a valid U.S. mailing address, a diagnosis of T1D for more than one year, not currently participating in a diabetes education or coaching program, not pregnant or planning to become pregnant, using an Android or iOS smartphone, and never having used the activity tracker and One Drop (no app activity, 7-day trial, testing supply subscription, or coaching)." For people who screened initially eligible, " DTI laboratories shipped an AccuBase A1c test kit to each respondent's mailing address. People with an A1c greater than or equal to 7% were considered eligible for the study, randomized to condition, and notified of their A1c test result and condition assignment."

4a-i) Computer / Internet literacy
Computer / Internet literacy is often an implicit "de facto" eligibility criterion -this should be explicitly clarified.
Does your paper address subitem 4a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study As noted above, "using an Android or iOS smartphone" was required for participation in the study.
4a-ii) Open vs. closed, web-based vs. face-to-face assessments: Open vs. closed, web-based vs. face-to-face assessments: Mention how participants were recruited (online vs. offline), e.g., from an open access website or from a clinic, and clarify if this was a purely web-based trial, or there were face-to-face components (as part of the intervention or for assessment), i.e., to what degree got the study team to know the participant. In online-only trials, clarify if participants were quasi-anonymous and whether having multiple identities was possible or whether technical or logistical measures (e.g., cookies, email confirmation, phone calls) were used to detect/prevent these. Does your paper address subitem 4a-ii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Once respondents electronically signed both forms, they landed on an online, HIPAA-compliant baseline survey. Upon completing the baseline survey, DTI laboratories shipped an AccuBase A1c test kit to each respondent's mailing address. Study personnel provided written, illustrated, and video A1c test kit instructions and offered over-the-phone help with collecting a blood sample.
People returned blood samples to the lab in a pre-addressed and pre-stamped box. The lab processed each sample and uploaded results into a HIPAAcompliant online portal. Study personal reviewed each result to determine A1c eligibility. After three months, all participants received an initial and series of reminder emails instructing them to complete an online, HIPAA-compliant follow-up survey with an embedded hyperlink in the email. Upon completing this survey, DTI laboratories mailed participants a second, final A1c test kit. Again, study personnel sent instructions in various formats along with study contact information to aid with collecting a blood sample. Participants returned blood samples in a pre-addressed and pre-stamped box. The lab processed each sample and uploaded results into the HIPAA-compliant online portal. " 4a-iii) Information giving during recruitment Information given during recruitment. Specify how participants were briefed for recruitment and in the informed consent procedures (e.g., publish the informed consent documentation as appendix, see also item X26), as this information may have an effect on user self-selection, user expectation and may also bias results.
4b) Settings and locations where the data were collected 1 2 3 4 5 Does your paper address subitem 4a-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Facebook advertisements and One Drop's email list of non-customers (i.e., people without a One Drop meter and testing supplies, or a coach) remotely recruited potential participants from March through May 2018. Online advertisements and email messages briefly described study eligibility (e.g., diagnoses of type 1), study scope (e.g., 3-month duration), and asked people interested in the study to click a link to get in-depth information about the study and complete an online, HIPAA-compliant survey to self-screen for initial eligibility. People self-screening eligible ... landed on an electronic IRB-approved consent form and HIPAA authorization form, requiring review and signature. All respondents were invited to contact study personnel to receive a verbal explanation of the forms and/or get any study-related questions answered." Does your paper address CONSORT subitem 4b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "...self-reported surveys were self-administered via online, HIPAA-compliant surveys and forms. Participants used a mail-in A1c test to self-collect and supply two blood specimens. Study personnel provided virtually-disseminated instruction and support (via phone and email) to remotely eligible participants into their respective conditions. Only participants accessing all intervention components were considered enrolled." 4b-i) Report if outcomes were (self-)assessed through online questionnaires Clearly report if outcomes were (self-)assessed through online questionnaires (as common in webbased trials) or otherwise.
subitem not at all important essential subitem not at all important 1 2 3 4 5 essential 5) The interventions for each group with sufficient details to allow replication, including how and when they were actually administered Does your paper address subitem 4b-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Once respondents electronically signed both forms, they landed on an online, HIPAA-compliant baseline survey. Upon completing the baseline survey, DTI laboratories shipped an AccuBase A1c test kit to each respondent's mailing address. Study personnel provided written, illustrated, and video A1c test kit instructions and offered over-the-phone help with collecting a blood sample.
People returned blood samples to the lab in a pre-addressed and pre-stamped box. After three months, all participants received an initial and series of reminder emails instructing them to complete an online, HIPAA-compliant follow-up survey with an embedded hyperlink in the email. Upon completing this survey, DTI laboratories mailed participants a second, final A1c test kit. Again, study personnel sent instructions in various formats along with study contact information to aid with collecting a blood sample." 4b-ii) Report how institutional affiliations are displayed Report how institutional affiliations are displayed to potential participants [on ehealth media], as affiliations with prestigious hospitals or universities may affect volunteer rates, use, and reactions with regards to an intervention.(Not a required item -describe only if this may bias results) Does your paper address subitem 4b-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study The informed consent document listed the study investigator names and affiliations.

5-i) Mention names, credential, affiliations of the developers, sponsors, and owners
Mention names, credential, affiliations of the developers, sponsors, and owners [6] (if authors/evaluators are owners or developer of the software, this needs to be declared in a "Conflict of interest" section or mentioned elsewhere in the manuscript).
Does your paper address subitem 5-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -this information is publicly available 5-ii) Describe the history/development process Describe the history/development process of the application and previous formative evaluations (e.g., focus groups, usability testing), as these will have an impact on adoption/use rates and help with interpreting results.
Does your paper address subitem 5-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -this, too, is publicly available

5-iii) Revisions and updating
Revisions and updating. Clearly mention the date and/or version number of the application/intervention (and comparator, if applicable) evaluated, or describe whether the intervention underwent major changes during the evaluation process, or whether the development and/or content was "frozen" during the trial. Describe dynamic components such as news feeds or changing content which may have an impact on the replicability of the intervention (for unexpected events see item 3b).

5-iv) Quality assurance methods
Provide information on quality assurance methods to ensure accuracy and quality of information provided [1], if applicable.
Does your paper address subitem 5-iv?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Quality assurance efforts identified two participants ineligible for the study (i.e., they had used One Drop before) that we excluded from all analyses (n = 1 in OD + activity tracker and n = 1 in OD only), resulting in 95 participants in ITT and 77 participants in PP." 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-v) Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used Ensure replicability by publishing the source code, and/or providing screenshots/screen-capture video, and/or providing flowcharts of the algorithms used. Replicability (i.e., other researchers should in principle be able to replicate the study) is a hallmark of scientific reporting.
Does your paper address subitem 5-v?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -this information is proprietary

5-vi) Digital preservation
Digital preservation: Provide the URL of the application, but as the intervention is likely to change or disappear over the course of the years; also make sure the intervention is archived (Internet Archive, webcitation.org, and/or publishing the source code or screenshots/videos alongside the article). As pages behind login screens cannot be archived, consider creating demo pages which are accessible without login.
Does your paper address subitem 5-vi?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -the intervention is a suite of consumer health technologies available in the public domain subitem not at all important 1 2 3 4 5 essential

5-vii) Access
Access: Describe how participants accessed the application, in what setting/context, if they had to pay (or were paid) or not, whether they had to be a member of specific group. If known, describe how participants obtained "access to the platform and Internet" [1]. To ensure access for editors/reviewers/readers, consider to provide a "backdoor" login account or demo mode for reviewers/readers to explore the application (also important for archiving purposes, see vi).
Does your paper address subitem 5-vii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study personnel provided virtually-disseminated instruction and support (via phone and email) to remotely eligible participants into their respective conditions." "Once randomized to condition, eligible participants received an email message containing their condition assignment, a series of instructions, and unique verification code.

5-ix) Describe use parameters
Describe use parameters (e.g., intended "doses" and optimal timing for use). Clarify what instructions or recommendations were given to the user, e.g., regarding timing, frequency, heaviness of use, if any, or was the intervention used ad libitum.
Does your paper address subitem 5-ix?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -people use consumer health technologies as needed in a variety of ways; there is no recommended dose; 'as needed' dosing is mentioned in the paper

5-x) Clarify the level of human involvement
Clarify the level of human involvement (care providers or health professionals, also technical assistance) in the e-intervention or as co-intervention (detail number and expertise of professionals involved, if any, as well as "type of assistance offered, the timing and frequency of the support, how it is initiated, and the medium by which the assistance is delivered". It may be necessary to distinguish between the level of human involvement required for the trial, and the level of human involvement required for a routine application outside of a RCT setting (discuss under item 21generalizability).
Does your paper address subitem 5-x?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study personnel provided virtually-disseminated instruction and support (via phone and email)." subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 5-xi) Report any prompts/reminders used Report any prompts/reminders used: Clarify if there were prompts (letters, emails, phone calls, SMS) to use the application, what triggered them, frequency etc. It may be necessary to distinguish between the level of prompts/reminders required for the trial, and the level of prompts/reminders for a routine application outside of a RCT setting (discuss under item 21 -generalizability).
Does your paper address subitem 5-xi? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "After three months, all participants received an initial and series of reminder emails instructing them to complete an online, HIPAA-compliant follow-up survey with an embedded hyperlink in the email. Upon completing this survey, DTI laboratories mailed participants a second, final A1c test kit. Again, study personnel sent instructions in various formats along with study contact information to aid with collecting a blood sample."

5-xii) Describe any co-interventions (incl. training/support)
Describe any co-interventions (incl. training/support): Clearly state any interventions that are provided in addition to the targeted eHealth intervention, as ehealth intervention may not be designed as stand-alone intervention. This includes training sessions and support [1]. It may be necessary to distinguish between the level of training required for the trial, and the level of training for a routine application outside of a RCT setting (discuss under item 21 -generalizability. Does your paper address subitem 5-xii? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a 6a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential Does your paper address CONSORT subitem 6a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Glycated hemoglobin A1c (A1c). Self-administered AccuBase A1c Mail-In Test Kits (DTI Laboratories, Thomasville, GA) assessed baseline and follow-up A1c levels. The test is FDA-approved, NGSP-certified and CLIA-waived and a highly accurate assessment of A1c used in randomized and non-randomized trials [21,22]. It is a non-fasting, finger stick, whole blood mail-in test. Upon supplying a blood sample, specimens are processed at a central lab." 6a-i) Online questionnaires: describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed If outcomes were obtained through online questionnaires, describe if they were validated for online use and apply CHERRIES items to describe how the questionnaires were designed/deployed [9].
Does your paper address subitem 6a-i?
Copy and paste relevant sections from manuscript text n/a -only self--reported demographic and health status data (e.g., number of years since being diagnosed with type 1 diabetes and body mass index) are included, not data from valid and reliable questionnaires 6a-ii) Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored Describe whether and how "use" (including intensity of use/dosage) was defined/measured/monitored (logins, logfile analysis, etc. Does your paper address subitem 7a-i? Copy and paste relevant sections from manuscript title (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -the sample size used in prior diabetes studies with the activity tracker informed the target sample of ~100 eligible participants randomized to two conditions Does your paper address CONSORT subitem 7b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a Does your paper address CONSORT subitem 8a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study 8b) Type of randomisation; details of any restriction (such as blocking and block size) 9) Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions 11a) If done, who was blinded after assignment to We used an online randomizer to block randomize... Does your paper address CONSORT subitem 8b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study personnel used a block randomization scheme of 100 groups of two randomization blocks to randomize participants to one of two conditions." Does your paper address CONSORT subitem 9? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -the study was unblinded Does your paper address CONSORT subitem 10? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study personnel used a block randomization scheme of 100 groups of two randomization blocks to randomize participants to one of two conditions." interventions (for example, participants, care providers, those assessing outcomes) and how 11a-i) Specify who was blinded, and who wasn't Specify who was blinded, and who wasn't. Usually, in web-based trials it is not possible to blind the participants [1, 3] (this should be clearly acknowledged), but it may be possible to blind outcome assessors, those doing data analysis or those administering co-interventions (if any).
Does your paper address subitem 11a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Participants and study personnel were unblinded to condition assignment." 11a-ii) Discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator" Informed consent procedures (4a-ii) can create biases and certain expectations -discuss e.g., whether participants knew which intervention was the "intervention of interest" and which one was the "comparator".
Does your paper address subitem 11a-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study personnel did not tell participants which condition was the intervention of interest and which one was the comparator, but participants may have inferred this on their own." sham intervention to a active medication/intervention) 12a) Statistical methods used to compare groups for primary and secondary outcomes NPT: When applicable, details of whether and how the clustering by care providers or centers was addressed Does your paper address CONSORT subitem 11b? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study There were "two conditions: (1) One Drop's digital therapeutics solution (i.e., the mobile app, in-app coaching, Bluetooth-connected meter with a 3-month supply of test strips) and an activity tracker at the start of the intervention period or (2) One Drop at the start of the intervention period and an activity tracker after completing follow-up measures." Does your paper address CONSORT subitem 12a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Analysis of covariance (ANCOVA) models [26] tested the group effect on followup A1c controlling for baseline A1c. For non-crossover, parallel group RCTs, CONSORT guidelines recommend reporting results from ITT and PP analyses [27,28]. ITT preserves baseline group assignment and avoids over-estimating group effects [29]. In contrast, PP may exaggerate group effects by including only participants receiving the allocated intervention and completing the study as intended [30,31]. In pragmatic trials, the appropriate reporting of both results can aid with scientific and clinical interpretation [32]. We examined ANCOVA assumptions before conducting ANCOVA models testing follow-up A1c, group differences." 12a-i) Imputation techniques to deal with attrition / missing values Imputation techniques to deal with attrition / missing values: Not all participants will use the intervention/comparator as intended and attrition is typically high in ehealth trials. Specify how participants who did not use the application or dropped out from the trial were treated in the statistical analysis (a complete case analysis is strongly discouraged, and simple imputation Does your paper address subitem 12a-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Multiple imputation corrected for missing data [25] on income (n = 4) and follow-up A1c (n = 10). In both conditions, variables used to impute included non-missing age, gender race/ethnicity, education, insurance status, diabetes duration, baseline BMI and A1c, and available data on income. Data were imputed separately by study condition. Imputed data were constrained by condition-specific minimum and maximum values. There were 20 imputations per condition. Data were merged prior to conducting intent-to-treat (ITT) and per protocol (PP) analyses." Does your paper address CONSORT subitem 12b? * 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential RESULTS to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Solutions IRB approved all study procedures prior to recruiting participants."

x26-ii) Outline informed consent procedures
Outline informed consent procedures e.g., if consent was obtained offline or online (how? Checkbox, etc.?), and what information was provided (see 4a-ii). See [6] for some items to be included in informed consent documents.
Does your paper address subitem X26-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "They landed on an electronic IRB-approved consent form and HIPAA authorization form, requiring review and signature. All respondents were invited to contact study personnel to receive a verbal explanation of the forms and/or get any study-related questions answered."

X26-iii) Safety and security procedures
Safety and security procedures, incl. privacy considerations, and any steps taken to reduce the likelihood or detection of harm (e.g., education and training, availability of a hotline) Does your paper address subitem X26-iii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Solutions IRB approved all study procedures prior to recruiting participants." and "Study instructions, consent and HIPAA authorization forms, and self-reported surveys were self-administered via online, HIPAA-compliant surveys and forms." 13a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcome NPT: The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider in each center 13b) For each group, losses and exclusions after randomisation, together with reasons Does your paper address CONSORT subitem 13a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "As shown in the CONSORT diagram (See Figure 1), 491 people self-screened for initial eligibility; 417 screened initially eligible, completed informed consent, HIPAA authorization, and the baseline survey, and were shipped an A1c test kit.
A total of 363 people returned the kit with a blood sample; 99 satisfied A1c ≥ 7% eligibility criteria and were randomized to the OD + tracker or OD only conditions; 97 received the intervention, defined as downloading the app and initiating coaching." and "Quality assurance efforts identified two participants ineligible for the study (i.e., they had used One Drop before) that we excluded from all analyses (n = 1 in OD + activity tracker and n = 1 in OD only), resulting in 95 participants in ITT and 85 participants in PP." Does your paper address CONSORT subitem 13b? (NOTE: Preferably, this is shown in a CONSORT flow diagram) * 14a-i) Indicate if critical "secular events" fell into the study period Indicate if critical "secular events" fell into the study period, e.g., significant changes in Internet resources available or "changes in computer hardware or Internet delivery resources" Does your paper address subitem 14a-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a Copy and paste relevant sections from the manuscript (include quotes in quotation marks like this to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a Does your paper address CONSORT subitem 15? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Descriptive statistics summarized the intent-to-treat sample at baseline (N = 95). The sample was 40.9 +/-10.7 years old (See Table 1). The majority were female (73%), Caucasian / White race (88%), had at least some college education (77%), an annual household income greater or equal than 50K (56%), and/or were overweight or obese (80%). The sample was diagnosed with T1D an average 20.3 +/-11.5 years ago and had an average baseline A1c of 8.41% +/-1.18%."

15-i) Report demographics associated with digital divide issues
In ehealth trials it is particularly important to report demographics associated with digital divide issues, such as age, education, gender, social-economic status, computer/Internet/ehealth literacy of the participants, if known.
Does your paper address subitem 15-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. See above and Table 1.
subitem not at all important 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 16-i) Report multiple "denominators" and provide definitions Report multiple "denominators" and provide definitions: Report N's (and effect sizes) "across a range of study participation [and use] thresholds" [1], e.g., N exposed, N consented, N used more than x times, N used more than y weeks, N participants "used" the intervention/comparator at specific pre-defined time points of interest (in absolute and relative numbers per group). Always clearly define "use" of the intervention.
Does your paper address subitem 16-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes. See Table 1.

16-ii) Primary analysis should be intent-to-treat
Primary analysis should be intent-to-treat, secondary analyses could include comparing only "users", with the appropriate caveats that this is no longer a randomized sample (see 18-i).
17a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval) Does your paper address subitem 16-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study " The assumption of homogeneity of regression slopes was not met (F-pooled = 117.84, p < .001) requiring examination of effects by different baseline A1c levels and conducting four Bonferroni-corrected t-tests (p < .01). T-tests were pooled with imputed data, i.e., follow-up A1c. T-tests examined A1c group differences at baseline, follow-up, and from baseline to follow-up for each group, separately.
A higher baseline A1c was associated with a better effect from OD + tracker than OD only (See Table 2 and Figure 2). A1c did not differ between groups at baseline (t = .49, p = 0.62) or follow-up (t-pooled = -1.26, p = .22). The OD + activity tracker group's A1c significantly improved from baseline to follow-up (8.47% v. 8.04%, .43% absolute change, t-pooled = 4.72, p < .001) whereas the OD only group's A1c did not change over time (8.35% v. 8.33%, .02% absolute change, t-pooled = .23, p = .82)." Also, see Table 2." Does your paper address CONSORT subitem 17a? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study Yes, see Table 2.
subitem not at all important 1 2 3 4 5 essential 17b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing prespecified from exploratory 17a-i) Presentation of process outcomes such as metrics of use and intensity of use In addition to primary/secondary (clinical) outcomes, the presentation of process outcomes such as metrics of use and intensity of use (dose, exposure) and their operational definitions is critical. This does not only refer to metrics of attrition (13-b) (often a binary variable), but also to more continuous exposure metrics such as "average session length". These must be accompanied by a technical description how a metric like a "session" is defined (e.g., timeout after idle time) [1] (report under item 6a).
Does your paper address subitem 17a-i? subitem not at all important 1 2 3 4 5 essential information not in the ms, or briefly explain why the item is not applicable/relevant for your study n/a -no subgroup analyses were performed

18-i) Subgroup analysis of comparing only users
A subgroup analysis of comparing only users is not uncommon in ehealth trials, but if done, it must be stressed that this is a self-selected sample and no longer an unbiased sample from a randomized trial (see 16-iii).
Does your paper address subitem 18-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study A requirement for participation was "never having used the activity tracker and One Drop (no app activity, 7-day trial, testing supply subscription, or coaching)." In this way, all participants included in analyses were non-users.
Does your paper address CONSORT subitem 19? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Study participation resulted in no reported harms, unintended effects, or adverse events."

19-i) Include privacy breaches, technical problems
Include privacy breaches, technical problems. This does not only include physical "harm" to participants, but also incidents such as perceived or real privacy breaches [1], technical problems, and other unexpected/unintended incidents. "Unintended effects" also includes unintended positive effects [2]. Does your paper address subitem 19-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study From the study team, "...data collection and analyses were completed in 6.4 months, saving time, money, and providing just-in-time results to decision makers. It takes 17 years to turn 14% of research findings into benefits for patients [39]. This trial strongly challenges how long it takes to conduct a randomized control trial and translate results into the real-world." 1 2 3 4 5 essential subitem not at all important 1 2 3 4 5 essential 22-i) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use) Restate study questions and summarize the answers suggested by the data, starting with primary outcomes and process outcomes (use).
Does your paper address subitem 22-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This is the first randomized control trial evaluating One Drop with an activity tracker on the A1c of adults with T1D. For participants with an 8-11% A1c at baseline, using One Drop with an activity tracker led to a significantly lower threemonth A1c compared to using One Drop only. Both intent-to-treat and per protocol analyses (i.e., among participants using all aspects of One Drop who also provided a follow-up) yielded this significant A1c benefit."

22-ii) Highlight unanswered new questions, suggest future research
Highlight unanswered new questions, suggest future research.
Does your paper address subitem 22-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "Results from this trial suggest One Drop and an activity tracker may work better together than alone in helping people with T1D. Additional research with a tracker only arm is needed to substantiate this finding."

20-i) Typical limitations in ehealth trials
Typical limitations in ehealth trials: Participants in ehealth trials are rarely blinded. Ehealth trials often look at a multiplicity of outcomes, increasing risk for a Type I error. Discuss biases due to non-use of the intervention/usability issues, biases through informed consent procedures, unexpected events.
Does your paper address subitem 20-i? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "The trial's predominantly female (73%) and overweight/obese (80%) sample may have been uniquely engaged and activated by using a tracker with One Drop. Results may not generalize to adults with T1D that are male and/or have a 'normal' BMI." "...this trial was 'pragmatic' [38]. Study procedures were conducted remotely in the context of participant's everyday life, maximizing the applicability and generalizability of the findings. A more controlled environment may have produced more internally valid results, but at the cost of less generalizability."

21-i) Generalizability to other populations
Generalizability to other populations: In particular, discuss generalizability to a general Internet population, outside of a RCT setting, and general patient population, including applicability of the study results for other organizations important subitem not at all important 1 2 3 4 5 essential OTHER INFORMATION 23) Registration number and name of trial registry Does your paper address subitem 21-i?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "This trial was far-reaching and representative, with people of different race/ethnicities, social classes, and education levels participating from 43/50 states." 21-ii) Discuss if there were elements in the RCT that would be different in a routine application setting Discuss if there were elements in the RCT that would be different in a routine application setting (e.g., prompts/reminders, more human involvement, training sessions or other co-interventions) and what impact the omission of these elements could have on use, adoption, or outcomes if the intervention is applied outside of a RCT setting.
Does your paper address subitem 21-ii?
Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional information not in the ms, or briefly explain why the item is not applicable/relevant for your study "While the pragmatic and remote study design allowed for recruitment, data collection, and participation to occur in the context of everyday life, making it more convenient than trials requiring study visits at clinical trial sites, remoteness also meant relying on self-reported screening data, and medication and medical history." Does your paper address CONSORT subitem 23? * Copy and paste relevant sections from the manuscript (include quotes in quotation marks "like this" to indicate direct quotes from your manuscript), or elaborate on this item by providing additional