The aim of this pilot observation trial is to determine feasibility, acceptability, and impact of the combination of mySugr and structured SMBG for Spanish-literate Hispanic/Latino adults with poorly controlled T2D. The study will be single site (Sansum Diabetes Research Institute – SDRI), prospective data collection, with pre- and post-intervention comparison. A total of 30 people with T2D will be randomly allocated (2:1 randomization) to the interventional group (n = 20) that will use the digital self-management application during the 12-week study period or the control group (n = 10) without the app. Pre- and post-intervention assessments will measure diabetes distress as well as self-efficacy to manage diabetes, HbA1c, weight, and blood glucose. MySugr app perceived usefulness, ease of use, content, efficacy, and usability will be measured post-intervention. To maximize retention, both participant groups will receive a disturbance allowance as they progress through the study.
Spanish-literate Hispanic/Latino adults with T2D and HbA1c 7.5% – 10% and who reside in the Central Coast of California and currently use a compatible smartphone will be enrolled.
Study interaction and procedures will be conducted in Spanish by an existing, trusted bilingual Hispanic/Latino Certified Diabetes Educator (CDE) and SDRI Community Scientists. Following informed consent, participants will be randomly assigned to the interventional group that will use the digital self-management application during the 12-week study period or the control group that will not use the app. The interventional group will be trained in the use of the mySugr app and receive education focusing on SMBG based on paired (before and 2 hours after a meal) BG testing, which participants will conduct twice daily for 6 days once monthly for 3 months. Participants will continue structured SMBG with mySugr PRO for 12 weeks and will have access to mySugr proactive coaching consisting of 3 virtual engagements focused on reviewing and reacting to participant-derived structured SMBG data.
At Visit 1, vital signs health measurements (height, weight, waist circumference and resting blood pressure) will be conducted by trained clinical staff, and fingerstick HbA1c will be measured using the Abbott Afinion 2 Point of Care (POC) Analyzer or FDA-approved equivalent. Several questionnaires will be completed. Subjects will measure their blood glucose at home using the Accu Check Guide Me blood glucose meter and their weight at home using a smartphone connected weight scale.
If subjects are randomized to the Active or intervention group, they will download and be trained in the use of the mySugr app. Active group participants will be asked to use the mobile application throughout the duration of the study. The app will be used to collect data from glucometers in their mobile phones and to have access to mySugr proactive coaching. The coach visits will be conducted in Spanish with a duration of 30-minutes each month and focusing on reviewing and reacting to participant derived structured SMBG data. In the control group, people with diabetes will neither have access to the mySugr Pro app nor coaching during the 12-week Intervention Period; they will continue with their usual, discretionary mode of therapy, data documentation, and glucose monitoring.
After 12 weeks, subjects will complete a second and final visit with vital signs, HbA1c, and questionnaires repeated. A disturbance allowance will be given to each subject for their time and participation.
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