Journal Article

Effectiveness of an Immersive Telemedicine Platform for Delivering Diabetes Medical Group Visits for African American, Black and Hispanic, or Latina Women With Uncontrolled Diabetes: The Women in Control 2.0 Noninferiority Randomized Clinical Trial

Gardiner, Paula, Bragg, Alexa, Laird, Lance D, Reichert, Matthew J, De La Cruz, Barbara A, Winter, Michael R, Parker, Kimberly N, Martin-Howard, Jessica, Moldovan, Ioana A, Mitchell, Suzanne E

2023

Overview

Medically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap. The purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A (HbA ) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. This study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms. Of 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA by group at 6 months (IP: -0.8%, SD 1.9%; VW: -0.5%, SD 1.8%; mean difference 0.3, 97.5% CI -∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: -6.5, SD 43.6; VW: -9.6, SD 44.8 MET-hours; mean difference -3.1, 97.5% CI -6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups. In this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs. ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425.

• Publisher: Gunther Eysenbach MD MPH, Associate Professor,JMIR Publications
• Subject: Adolescent / Adult / African Americans / African cultural groups / Black or African American / Changes / Clinical research / Clinical trials / Community health services / Curricula / Data collection / Diabetes / Diabetes Mellitus, Type 2 - therapy / Diabetics / Digital health / Disease control / Enrollments / Ethnicity / Exercise / Female / Glycemic control / Health Behavior / Health facilities / Health promotion / Health services / Hemoglobin / Hispanic Americans / Hispanic or Latino / Humans / Immersive technology / Informed consent / Instructional design / Latin American cultural groups / Management development programmes / Medical technology / Mental depression / Middle Aged / Original Paper / Physical activity / Physical fitness / Pilot projects / Psychological distress / Race / Registration / Selfmanagement / Social support / Sociodemographics / Software / Symptoms / Technology / Telecommunications / Telemedicine / Telemedicine - methods / Type 2 diabetes mellitus / Underserved populations / Virtual communities / Women / Womens health