Background Delivering self-management support to people with type 2 diabetes mellitus is essential to reduce the health system burden and to empower people with the skills, knowledge, and confidence needed to take an active role in managing their own health. Objective This study aims to evaluate the adoption, use, and effectiveness of the My Diabetes Coach (MDC) program, an app-based interactive embodied conversational agent, Laura, designed to support diabetes self-management in the home setting over 12 months. Methods This randomized controlled trial evaluated both the implementation and effectiveness of the MDC program. Adults with type 2 diabetes in Australia were recruited and randomized to the intervention arm (MDC) or the control arm (usual care). Program use was tracked over 12 months. Coprimary outcomes included changes in glycated hemoglobin (HbA1c) and health-related quality of life (HRQoL). Data were assessed at baseline and at 6 and 12 months, and analyzed using linear mixed-effects regression models. Results A total of 187 adults with type 2 diabetes (mean 57 years, SD 10 years; 41.7% women) were recruited and randomly allocated to the intervention (n=93) and control (n=94) arms. MDC program users (92/93 participants) completed 1942 chats with Laura, averaging 243 min (SD 212) per person over 12 months. Compared with baseline, the mean estimated HbA1c decreased in both arms at 12 months (intervention: 0.33% and control: 0.20%), but the net differences between the two arms in change of HbA1c (−0.04%, 95% CI −0.45 to 0.36; P=.83) was not statistically significant. At 12 months, HRQoL utility scores improved in the intervention arm, compared with the control arm (between-arm difference: 0.04, 95% CI 0.00 to 0.07; P=.04). Conclusions The MDC program was successfully adopted and used by individuals with type 2 diabetes and significantly improved the users’ HRQoL. These findings suggest the potential for wider implementation of technology-enabled conversation-based programs for supporting diabetes self-management. Future studies should focus on strategies to maintain program usage and HbA1c improvement. Trial Registration Australia New Zealand Clinical Trials Registry (ACTRN) 12614001229662; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12614001229662

A minority of adults with T1D and T2D use apps to support their self-management. App use among adults with T1D is associated with a more recent T1D diagnosis, more frequent glucose monitoring, and lower self-reported HbA1c. Future efforts should focus on this association and determine the mechanisms by which app use is related to better clinical outcomes.

Background Embodied conversational agents (ECAs) are increasingly used in health care apps; however, their acceptability in type 2 diabetes (T2D) self-management apps has not yet been investigated. Objective This study aimed to evaluate the acceptability of the ECA (Laura) used to deliver diabetes self-management education and support in the My Diabetes Coach (MDC) app. Methods A sequential mixed methods design was applied. Adults with T2D allocated to the intervention arm of the MDC trial used the MDC app over a period of 12 months. At 6 months, they completed questions assessing their interaction with, and attitudes toward, the ECA. In-depth qualitative interviews were conducted with a subsample of the participants from the intervention arm to explore their experiences of using the ECA. The interview questions included the participants’ perceptions of Laura, including their initial impression of her (and how this changed over time), her personality, and human character. The quantitative and qualitative data were interpreted using integrated synthesis. Results Of the 93 intervention participants, 44 (47%) were women; the mean (SD) age of the participants was 55 (SD 10) years and the baseline glycated hemoglobin A1c level was 7.3% (SD 1.5%). Overall, 66 of the 93 participants (71%) provided survey responses. Of these, most described Laura as being helpful (57/66, 86%), friendly (57/66, 86%), competent (56/66, 85%), trustworthy (48/66, 73%), and likable (40/66, 61%). Some described Laura as not real (18/66, 27%), boring (26/66, 39%), and annoying (20/66, 30%). Participants reported that interacting with Laura made them feel more motivated (29/66, 44%), comfortable (24/66, 36%), confident (14/66, 21%), happy (11/66, 17%), and hopeful (8/66, 12%). Furthermore, 20% (13/66) of the participants were frustrated by their interaction with Laura, and 17% (11/66) of the participants reported that interacting with Laura made them feel guilty. A total of 4 themes emerged from the qualitative data (N=19): (1) perceived role: a friendly coach rather than a health professional; (2) perceived support: emotional and motivational support; (3) embodiment preference acceptability of a human-like character; and (4) room for improvement: need for greater congruence between Laura’s words and actions. Conclusions These findings suggest that an ECA is an acceptable means to deliver T2D self-management education and support. A human-like character providing ongoing, friendly, nonjudgmental, emotional, and motivational support is well received. Nevertheless, the ECA can be improved by increasing congruence between its verbal and nonverbal communication and accommodating user preferences. Trial Registration Australian New Zealand Clinical Trials Registry CTRN12614001229662; https://tinyurl.com/yxshn6pd

Background Diabetes self-management apps have the potential to improve self-management in people with type 2 diabetes (T2D). Although efficacy trials provide evidence of health benefits, premature disengagement from apps is common. Therefore, it is important to understand the factors that influence engagement in real-world settings. Objective This study aims to explore users’ real-world experiences with the My Diabetes Coach (MDC) self-management app. Methods We conducted telephone-based interviews with participants who had accessed the MDC self-management app via their smartphone for up to 12 months. Interviews focused on user characteristics; the context within which the app was used; barriers and facilitators of app use; and the design, content, and delivery of support within the app. Results A total of 19 adults with T2D (8/19, 42% women; mean age 60, SD 14 years) were interviewed. Of the 19 interviewees, 8 (42%) had T2D for <5 years, 42% (n=8) had T2D for 5-10 years, and 16% (n=3) had T2D for >10 years. In total, 2 themes were constructed from interview data: (1) the moderating effect of diabetes self-management styles on needs, preferences, and expectations and (2) factors influencing users’ engagement with the app: one size does not fit all. Conclusions User characteristics, the context of use, and features of the app interact and influence engagement. Promoting engagement is vital if diabetes self-management apps are to become a useful complement to clinical care in supporting optimal self-management. Trial Registration Australia New Zealand Clinical Trials Registry CTRN126140012296; URL https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366925&isReview=true

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