Promoting Problem-Solving Among Low-Income Adults With Type 2 Diabetes: Cluster-Randomized Controlled Trial of a Mobile Health Intervention With SMS Text Messaging (Mobile Diabetes Detective).
Problem-solving is essential for the self-management of type 2 diabetes but remains challenging for underserved individuals. Although mobile health (mHealth) interventions can improve diabetes self-management, few focus on problem-solving.
This study evaluates the efficacy of Mobile Diabetes Detective (MoDD), a fully automated web-based intervention with SMS text messaging that provides problem-solving support tailored to self-monitoring data, for improving glycemic control among medically underserved adults with type 2 diabetes.
This open-label, 1:1 cluster-randomized controlled trial was conducted in 2013-2018. Participants were adults with type 2 diabetes (glycated hemoglobin [HbA1c] >7.5%) receiving care at 8 Federally Qualified Health Centers serving medically underserved communities in the New York metropolitan area. The centers served as clusters and were randomized using computer-generated allocation. Recruitment and study sessions were conducted either in person or in a hybrid format. The intervention arm used MoDD for 12 months, whereas the control arm received standard diabetes education and routine care. The primary outcome was the change in HbA1c from baseline to 12 months, recorded from medical chart data. We hypothesized greater improvement in the intervention arm than in the control arm. Secondary outcomes included psychosocial measures. Outcomes were compared between groups using intention-to-treat analyses. This report presents the final analysis of the outcomes.
This trial randomized 248 participants (intervention arm: n=126; control arm: n=122); 219 were included in the final analysis (intervention arm: n=111; control arm: n=108). Participants were predominantly female (147/219, 67.1%) and ethnically and racially diverse (112/219, 51.1%, Hispanic and 92/219, 42%, African American), with a mean baseline HbA1c of 9.9%. Overall, of the 111 participants, 44 (39.6%) engaged with MoDD at least once weekly in the first 30 days, and 22 (19.8%) engaged at least once weekly in the first 90 days. HbA1c did not differ significantly between groups at baseline (intervention: 9.81%, 95% CI 9.42%-10.20%; control: 9.95%, 95% CI 9.55%-10.34%; difference=0.14%, P=.63) or at 12 months (intervention: 9.36%, 95% CI 8.95%-9.78%; control: 9.58%, 95% CI 9.15%-10.01%; difference=-0.22%, P=.47). Both groups demonstrated reductions in HbA1c from baseline to 3 months. Sustained within-group improvement at 12 months was observed in the intervention group but not in the control group. No intervention-related adverse events were reported.
This study evaluated the impact of a mobile intervention for problem-solving in diabetes. MoDD is innovative because it operates autonomously and tailors support to individuals' self-monitoring data. Although there was no significant between-group difference in HbA1c, the intervention group showed sustained within-group improvement at 12 months. These findings highlight the potential long-term benefits of autonomous mHealth interventions for problem-solving. The study observed an increase in diabetes distress, possibly reflecting heightened awareness of uncontrolled blood glucose levels. If implemented in clinical practice, MoDD could complement diabetes education and help improve glycemic control.
ClinicalTrials.gov NCT02021591; https://clinicaltrials.gov/ct2/show/NCT02021591.
This study evaluates the efficacy of Mobile Diabetes Detective (MoDD), a fully automated web-based intervention with SMS text messaging that provides problem-solving support tailored to self-monitoring data, for improving glycemic control among medically underserved adults with type 2 diabetes.
This open-label, 1:1 cluster-randomized controlled trial was conducted in 2013-2018. Participants were adults with type 2 diabetes (glycated hemoglobin [HbA1c] >7.5%) receiving care at 8 Federally Qualified Health Centers serving medically underserved communities in the New York metropolitan area. The centers served as clusters and were randomized using computer-generated allocation. Recruitment and study sessions were conducted either in person or in a hybrid format. The intervention arm used MoDD for 12 months, whereas the control arm received standard diabetes education and routine care. The primary outcome was the change in HbA1c from baseline to 12 months, recorded from medical chart data. We hypothesized greater improvement in the intervention arm than in the control arm. Secondary outcomes included psychosocial measures. Outcomes were compared between groups using intention-to-treat analyses. This report presents the final analysis of the outcomes.
This trial randomized 248 participants (intervention arm: n=126; control arm: n=122); 219 were included in the final analysis (intervention arm: n=111; control arm: n=108). Participants were predominantly female (147/219, 67.1%) and ethnically and racially diverse (112/219, 51.1%, Hispanic and 92/219, 42%, African American), with a mean baseline HbA1c of 9.9%. Overall, of the 111 participants, 44 (39.6%) engaged with MoDD at least once weekly in the first 30 days, and 22 (19.8%) engaged at least once weekly in the first 90 days. HbA1c did not differ significantly between groups at baseline (intervention: 9.81%, 95% CI 9.42%-10.20%; control: 9.95%, 95% CI 9.55%-10.34%; difference=0.14%, P=.63) or at 12 months (intervention: 9.36%, 95% CI 8.95%-9.78%; control: 9.58%, 95% CI 9.15%-10.01%; difference=-0.22%, P=.47). Both groups demonstrated reductions in HbA1c from baseline to 3 months. Sustained within-group improvement at 12 months was observed in the intervention group but not in the control group. No intervention-related adverse events were reported.
This study evaluated the impact of a mobile intervention for problem-solving in diabetes. MoDD is innovative because it operates autonomously and tailors support to individuals' self-monitoring data. Although there was no significant between-group difference in HbA1c, the intervention group showed sustained within-group improvement at 12 months. These findings highlight the potential long-term benefits of autonomous mHealth interventions for problem-solving. The study observed an increase in diabetes distress, possibly reflecting heightened awareness of uncontrolled blood glucose levels. If implemented in clinical practice, MoDD could complement diabetes education and help improve glycemic control.
ClinicalTrials.gov NCT02021591; https://clinicaltrials.gov/ct2/show/NCT02021591.
Authors
Mamykina Mamykina, Smaldone Smaldone, Bakken Bakken, Cole-Lewis Cole-Lewis, Heitkemper Heitkemper, Jia Jia, Kukafka Kukafka, Tobin Tobin, Cassells Cassells, Davidson Davidson, Mynatt Mynatt, Hripcsak Hripcsak
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