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.

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.

The Physical Activity Assessment of Adults With Type 2 Diabetes Using Accelerometer-Based Cut Points: Scoping Review.

BACKGROUND: Incorporating physical activity into lifestyle routines is recommended for individuals with type 2 diabetes. Accelerometers offer a promising method for objectively measuring physical activity and for assessing interventions. However, the existing literature for accelerometer-measured physical activity among middle-aged and older adults with type 2 diabetes is lacking. OBJECTIVE: This study aims to identify research studies in which accelerometer-based cut points were used to classify the physical activity intensity of middle-aged to older adults with type 2 diabetes as sedentary, light, moderate, vigorous, and very vigorous, and to determine if validated accelerometer cut points specifically for this population exist. METHODS: We followed the Joanna Briggs Institute methodology for scoping reviews. Between June 23 and July 12, 2020, two reviewers independently screened records from four databases (PubMed, Web of Science, Embase, Engineering Village) and the ActiGraph Corp web site for eligible studies that included patients with type 2 diabetes with a sample mean age ≥50 years, used research-grade accelerometers, applied cut points to categorize objectively measured physical activity, and were available in English. We excluded studies reporting exclusively steps or step counts measured by accelerometers or pedometers and conference abstracts or other sources that did not have a full text available. Data extraction was completed using Microsoft Excel. Data for the following variables were tabulated based on frequency distributions: study design, accelerometer type, device placement, epoch length, total wear time, and cut points used. Study aims and participant demographic data were summarized. RESULTS: A total of 748 records were screened at the abstract level, and 88 full-text articles were assessed for eligibility. Ultimately, 46 articles were retained and analyzed. Participants' mean ages ranged from 50 to 79.9 years. The ActiGraph accelerometer and the Freedson et al and Troiano et al counts-per-minute cut points were the most frequently used across the literature. Freedson et al and Troiano et al counts-per-minute cut points for light, moderate, and vigorous activity correspond to <1952, 1952-5724, and ≥5725, and 100-2019, 2020-5998, and ≥5999, respectively. The Lopes et al cut points were developed by calibrating the ActiGraph in middle-aged and older adults with overweight/obesity and type 2 diabetes. These counts-per-minute thresholds are ≥200 (light), ≥1240 (moderate), and ≥2400 (vigorous), and were applied in 1 interventional study. CONCLUSIONS: An assortment of accelerometer cut points have been used by researchers to categorize physical activity intensity for middle-aged and older adults with diabetes. Only one set of cut points was validated and calibrated in our population of interest. Additional research is warranted to address the need for diabetes-specific cut points to inform public health recommendations. This includes confirmation that the Lopes et al cut points reflect clinically meaningful changes in physical activity for adults with diabetes who have comorbidities other than overweight/obesity and the development of relative intensity cut points that may be more suitable for those with suboptimal physical functioning.