73
Participants
Start Date
August 23, 2018
Primary Completion Date
September 9, 2023
Study Completion Date
August 19, 2025
Metformin
Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.
Placebo
A treatment with no active ingredients or therapeutic effect.
mHealth Intervention
Our Health Insurance Portability and Accountability Act (HIPAA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
Usual Care
Our HIPAA data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.
Vanderbilt University Medical Center, Nashville
Collaborators (1)
Mayo Clinic
OTHER
The Cleveland Clinic
OTHER
Vanderbilt University Medical Center
OTHER