Tu Salud (Your Health) Randomized Control Study in Patients With Diabetes Using a Mobile App.

This is a parallel arm, open-label, randomized controlled, partial cross-over study. Subjects will be randomized into intervention group or control group in a 2:1 ratio. Intervention group will use the Flex blood glucose meter and OneTouch Reveal Mobile App and receive text messages every 2 weeks from the Health Care Professional for 12 weeks. The intervention group will continue under the same conditions until 24 weeks to explore durability of effects. The control group will use their own blood glucose meter without connectivity to a diabetes app for the first 12 weeks of the study. At that point, control group subjects will cross-over to the same treatment as the intervention group for an additional 12 weeks. A target of 100 subjects will be enrolled in the Intervention arm and a target of 50 subjects will be enrolled in the Control arm. Randomization will be stratified based on type of diabetes (Type 1 or Type 2) and A1c (above or below 9.0%). Each subject will attend visits at Screening/Baseline, 12 weeks and 24 weeks after Baseline. In most cases, Screening and Baseline will occur on the same day. Study Periods The study will be conducted in the following periods: Visit 1 (Screening/Baseline): All screening procedures will be performed including informed consent, demographics, medical history, a capillary blood draw for POC A1c determination and evaluation of entrance criteria. If subject A1c meets inclusion criteria and subject meets all other inclusion criteria and none of the exclusion criteria, subject will be randomized into one of two arms via randomization scheme. The time of randomization becomes Day 1. Visit 2 (Week 12 ± 7 days): A capillary blood draw will be performed for measurement of POC A1c. The HCP will discuss diabetes management progress with all subjects: for the control group based on their own meter data; for the intervention group, the HCP will download SMBG data from Flex meters and discuss diabetes management based on OTRM APP and Flex meter information. The HCP will review and consider if the glucose range limits on the Flex meter and/or OTRM need to be updated. Intervention subjects will continue in the same group for an additional 12 weeks. Control subjects will be switched to Flex and OTRM for 12 weeks. Visit 3 (Week 24 ± 7 days): A capillary blood draw will be performed for measurement of POC A1c. The HCP will download SMBG data from all Flex meters. Subjects will return study materials.