Matthew Reichert

Background: Group-based diabetes care, both technology-enabled and in-person, can improve diabetes outcomes in low-income minority women, but the mechanism remains unclear. Objective: We tested whether diabetes group medical visits (GMVs) reduced hemoglobin A_1c (HbA_1c) by mitigating diabetes distress (DD), an emotional response affecting nearly half of adults with type 2 diabetes in community settings. Methods: We conducted a mediation and moderation analysis of data from the Women in Control 2.0 comparative effectiveness study, which showed that both technology-enabled and in-person diabetes GMVs improve HbA_1c. We tested whether DD mediated the relationship between diabetes GMV engagement and reductions in HbA_1c. We also tested whether this relationship was moderated by depressive symptoms and social support. Participants were 309 low-income and minority women. Diabetes GMV engagement was measured using the Group Climate Questionnaire. The mediator, DD, was measured using the Diabetes Distress Screening Scale. The outcome was the 6-month change in HbA_1c. Social support was measured using the Medical Outcomes Study Social Support Survey. Results: DD mediated the relationship between engagement and 6-month HbA_1c. Specifically, group engagement affected HbA_1c by reducing distress associated with the regimen of diabetes self-management (P=.04), and possibly the emotional burden of diabetes (P=.09). The relationship between engagement and 6-month HbA_1c was moderated by depressive symptoms (P=.02), and possibly social support (P=.08). Conclusions: Engagement in diabetes GMVs improved HbA_1c because it helped reduce diabetes-related distress, especially related to the regimen of diabetes management and possibly related to its emotional burden, and especially for women without depressive symptoms and possibly for women who lacked social support.

BACKGROUND Group-based diabetes care, both technology-enabled and in-person, can improve diabetes outcomes in low-income minority women, but the mechanism remains unclear. OBJECTIVE We tested whether diabetes medical group visits (DMGVs) reduced hemoglobin A1c (A1c) by mitigating diabetes distress, an emotional response affecting nearly half of adults with type 2 diabetes in community settings. METHODS We conducted a mediation and moderation analysis of data from the Women in Control 2.0 (WIC2) comparative effectiveness study, which showed that both technology-enabled and in-person DMGVs improve A1c. We tested whether diabetes distress mediated the relationship between DMGV engagement and reductions in A1c. We also tested whether this relationship was moderated by depressive symptoms and social support. Participants were 309 low-income and minority women. DMGV engagement was measured using the Group Climate questionnaire (GCQ-S). The mediator, diabetes distress, was measured using the Diabetes Distress Scale (DDS-17). The outcome was the 6-month change in A1c (A1c). Social support was measured using the Medical Outcomes Study Social Support Survey. RESULTS Diabetes distress mediated the relationship between engagement and 6-month A1c. Specifically, group engagement affected A1c by reducing distress associated with the emotional burden of diabetes (P = 0.09) and the regimen of diabetes self-management (P = 0.04). The relationship between engagement and 6-month A1c was moderated by depressive symptoms (P = 0.02), and social support (P = 0.08). CONCLUSIONS Engagement in DMGVs improved A1c because it helped reduce diabetes-related distress, especially related to the regimen of diabetes management and its emotional burden, and especially for women without depressive symptoms and who lacked social support. CLINICALTRIAL ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425

Background: 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. Objective: 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 A1c (HbA1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. Methods: 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 HbA1c ≥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 HbA1c 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. Results: 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 HbA1c 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author). Background: 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. Objective: 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_1c (HbA_1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months. Methods: 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_1c ≥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_1c 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. Results: 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_1c 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. Conclusions: 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. Trial Registration: ClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425