Study to Understand Gaining Access to Blood Glucose Records (SUGAR), A Randomized Controlled Trial of the Effect of the Livongo Health Diabetes Management Program vs. Standard Care on Glycemic Control

Participants in this study will partake in study surveys, daily blood glucose monitor measurements, and blood sampling for the duration of their participation. The study intends to recruit and randomize 300 participants.

1. Surveys and Measurements

All study participants may complete surveys via their personal iOS smartphone device on: study qualification (intake survey/eligibility screener), diabetes status (initial diabetes survey), physical activity (iPAQ), quality of life (SF-12), vitals, demographics hospitalizations and interaction with health care provider (attached), and diabetes distress. Most survey data will be collected at 1, 3, and 6 months. There will also be Weekly Engagement surveys which will be two simple questions each week. At the end of the study, a Feedback survey will ask participants about their study experiences. Surveys will each have a simple description to introduce participants to the survey they are being asked to take. These surveys will be administered through the Eureka mHealth Research Platform, the study's main tool for data collection, data storage, and study management. Specific usability assessments that are native to the Livongo or iHealth platform may also be shown through the device to the participants in order to gather user feedback information.

After qualifying and providing consent to participate in the study, participants will be referred to a convenient lab or receive a mail-in lab test kit for establishing hemoglobin A1c (A1c) levels and lipid panel levels. A1c tests will be collected at months 1 (baseline), 3, and 6 (closeout). For each A1c test performed in the lab, 1mL (milliliter) of blood will be drawn. Lipid panels (total cholesterol, LDL, HDL, and triglycerides) will be collected at months 1 (baseline) and 6 (closeout). For each lipid panel, 1mL of blood will be drawn. If participants elect to use a mail-in lab test kit, for each A1c test or lipid panel, 35 microliters of blood will be collected and mailed in for testing (total 75 microliters at months 1 and 6, and 30 microliters at month 3). 2. Randomization Once the baseline A1c value is obtained, the patient will be randomized (block randomization by diabetes type). 3. Device Usage After randomization, participants will receive either the Livongo Health system or the iHealth glucose meter by mail.

If a participant is randomized to the iHealth treatment group, participants will download the iHealth iOS application and receive an iHealth blood glucose meter in the mail. Participants will link the iHealth application with a mobile version of the Eureka mHealth Research Platform.