'Is Insulin Right for Me?': Web-based intervention to reduce psychological barriers to insulin therapy among adults with non-insulin-treated type 2 diabetes-A randomised controlled trial.

AIMS: To test 'Is Insulin Right for Me?', a theory-informed, self-directed, web-based intervention designed to reduce psychological barriers to insulin therapy among adults with type 2 diabetes. Further, to examine resource engagement and associations between minimum engagement and outcomes. METHODS: Double-blind, two-arm randomised controlled trial (1:1), comparing the intervention with freely available online information (control). Eligible participants were Australian adults with type 2 diabetes, taking oral diabetes medications, recruited primarily via national diabetes registry. EXCLUSION CRITERIA: prior use of injectable medicines; being 'very willing' to commence insulin. Data collections were completed online at baseline, 2-week and 6-month follow-up. PRIMARY OUTCOME: negative insulin treatment appraisal scale (ITAS) scores; secondary outcomes: positive ITAS scores and hypothetical willingness to start insulin. ANALYSES: intention-to-treat (ITT); per-protocol (PP) examination of outcomes by engagement. TRIAL REGISTRATION: ACTRN12621000191897. RESULTS: No significant ITT between-arm (intervention: n = 233; control: n = 243) differences were observed in primary (2 weeks: Mdiff [95% CI]: -1.0 [-2.9 to 0.9]; 6 months: -0.01 [-1.9 to 1.9]), or secondary outcomes at either follow-up. There was evidence of lower Negative ITAS scores at 2-week, but not 6-month, follow-up among those with minimum intervention engagement (achieved by 44%) compared to no engagement (-2.7 [-5.1 to -0.3]). CONCLUSIONS: Compared to existing information, 'Is insulin right for me?' did not improve outcomes at either timepoint. Small intervention engagement effects suggest it has potential. Further research is warranted to examine whether effectiveness would be greater in a clinical setting, following timely referral among those for whom insulin is clinically indicated.

My Diabetes Coach, a Mobile App-Based Interactive Conversational Agent to Support Type 2 Diabetes Self-Management: Randomized Effectiveness-Implementation Trial.

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.

Smartphone Applications to Prevent Type 2 Diabetes: A Systematic Review and Meta-Analysis.

INTRODUCTION: Evidence supporting the use of apps for lifestyle behavior change and diabetes prevention in people at high risk of diabetes is lacking. The aim of this systematic review was to determine the acceptability and effectiveness of smartphone applications (apps) for the prevention of type 2 diabetes. METHODS: PubMed, Embase, CINAHL and PsychInfo were searched from 2008 to 2023. Included studies involved adults at high risk of developing diabetes evaluating an app intervention with the aim of preventing type 2 diabetes. Random-effects meta-analyses were conducted for weight loss, body mass index (BMI), glycated hemoglobin, and waist circumference. Narrative synthesis was conducted for all studies, including qualitative studies exploring user perspectives. RESULTS: Twenty-four studies (n=2,378) were included in this systematic review, including 9 randomized controlled trials (RCTs) with an average duration of 6 months, 10 quasi-experimental and 7 qualitative studies. Socially disadvantaged groups were poorly represented. Six RCTs were combined in meta-analyses. Apps were effective at promoting weight loss [mean difference (MD) -1.85; 95% CI -2.90 to -0.80] and decreasing BMI [MD -0.90, 95% CI -1.53 to -0.27], with no effect on glycated hemoglobin and waist circumference. No studies reported on diabetes incidence. Qualitative studies highlighted the need for app personalization. DISCUSSION: Smartphone apps have a promising effect on preventing type 2 diabetes by supporting weight loss. Future robust trials should include diverse populations in co-design and evaluation of apps and explore the role of artificial intelligence in further personalizing interventions for higher engagement and effectiveness.

Improving the Well-Being of People With Advanced Cancer and Their Family Caregivers: Protocol for an Effectiveness-Implementation Trial of a Dyadic Digital Health Intervention (FOCUSau).

BACKGROUND: Advanced cancer significantly impacts patients' and family caregivers' quality of life. When patients and caregivers are supported concurrently as a dyad, the well-being of each person is optimized. Family, Outlook, Communication, Uncertainty, Symptom management (FOCUS) is a dyadic, psychoeducational intervention developed in the United States, shown to improve the well-being and quality of life of patients with advanced cancer and their primary caregivers. Originally, a nurse-delivered in-person intervention, FOCUS has been adapted into a self-administered web-based intervention for European delivery. OBJECTIVE: The aims of this study are to (1) adapt FOCUS to the Australian context (FOCUSau); (2) evaluate the effectiveness of FOCUSau in improving the emotional well-being and self-efficacy of patients with advanced cancer and their primary caregiver relative to usual care control group; (3) compare health care use between the intervention and control groups; and (4) assess the acceptability, feasibility, and scalability of FOCUSau in order to inform future maintainable implementation of the intervention within the Australian health care system. METHODS: FOCUS will be adapted prior to trial commencement, using an iterative stakeholder feedback process to create FOCUSau. To examine the efficacy and cost-effectiveness of FOCUSau and assess its acceptability, feasibility, and scalability, we will undertake a hybrid type 1 implementation study consisting of a phase 3 (clinical effectiveness) trial along with an observational implementation study. Participants will include patients with cancer who are older than 18 years, able to access the internet, and able to identify a primary support person or caregiver who can also be approached for participation. The sample size consists of 173 dyads in each arm (ie, 346 dyads in total). Patient-caregiver dyad data will be collected at 3 time points-baseline (T0) completed prerandomization; first follow-up (T1; N=346) at 12 weeks post baseline; and second follow-up (T2) at 24 weeks post baseline. RESULTS: The study was funded in March 2022. Recruitment commenced in July 2024. CONCLUSIONS: If shown to be effective, this intervention will improve the well-being of patients with advanced cancer and their family caregivers, regardless of their location or current level of health care support. TRIAL REGISTRATION: ClinicalTrials.gov NCT06082128; https://clinicaltrials.gov/study/NCT06082128. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55252.

The impact of structured self-monitoring of blood glucose on clinical, behavioral, and psychosocial outcomes among adults with non-insulin-treated type 2 diabetes: a systematic review and meta-analysis.

Background: Self-monitoring of blood glucose (SMBG) is considered of little clinical benefit for adults with non-insulin-treated type 2 diabetes, but no comprehensive review of a structured approach to SMBG has been published to date. Purpose: To conduct a systematic review and meta-analysis of the impact of sSMBG on HbA1c, treatment modifications, behavioral and psychosocial outcomes, and; examine the moderating effects of sSMBG protocol characteristics on HbA1c. Data sources: Four databases searched (November 2020; updated: February 2022). Study selection: Inclusion criteria: non-randomized and randomized controlled trials (RCTs) and prospective observational studies; reporting effect of sSMBG on stated outcomes; among adults (≥18 years) with non-insulin-treated type 2 diabetes. Studies excluded if involving children or people with insulin-treated or other forms of diabetes. Data extraction and analysis: Outcome data extracted, and risk of bias/quality assessed independently by two researchers. Meta-analysis was conducted for RCTs, and moderators explored (HbA1c only). Data synthesis: From 2,078 abstracts, k=23 studies were included (N=5,372). Risk of bias was evident and study quality was low. Outcomes assessed included: HbA1c (k=23), treatment modification (k=16), psychosocial/behavioral outcomes (k=12). Meta-analysis revealed a significant mean difference favoring sSMBG in HbA1c (-0·29%, 95% CI: -0·46 to -0·11, k=13) and diabetes self-efficacy (0.17%, 95% CI: 0.01 to 0.33, k=2). Meta-analysis revealed no significant moderating effects by protocol characteristics. Limitations: Findings limited by heterogeneity in study designs, intervention characteristics, and psychosocial assessments. Conclusion: A small positive effect of sSMBG on HbA1c and diabetes self-efficacy was observed. Narrative synthesis of sSMBG intervention characteristics may guide future implementation. PROSPERO registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020208857, identifier CRD42020208857.

The Social and Emotional Well-being of Indigenous Peoples Living With Diabetes: A Systematic Review Protocol.

Introduction: Globally, Indigenous people have a greater incidence and earlier onset of diabetes than the general population and have higher documented rates of emotional distress and mental illness. This systematic review will provide a synthesis and critical appraisal of the evidence focused on the social and emotional well-being of Indigenous peoples living with diabetes, including prevalence, impact, moderators, and the efficacy of interventions. Methods: We will search MEDLINE Complete, EMBASE, APA PsycINFO, and CINAHL Complete from inception until late April 2021. Search strategies will include keywords related to Indigenous peoples, diabetes, and social and emotional well-being. All abstracts will be rated independently by two researchers against specified inclusion criteria. Eligible studies will report social and emotional well-being data for Indigenous people with diabetes, and/or report on the efficacy of interventions designed to address social and emotional well-being in this population. For each eligible study, quality will be rated using standard checklists to appraise each study's internal validity, to be determined based on study type. Any discrepancies will be resolved through discussions and consultation with other investigators as needed. We expect to present a narrative synthesis of the evidence. Discussion: The findings of the systematic review will enable greater understanding of the impact of relationships between diabetes and emotional well-being among Indigenous peoples to inform research, policy and practice. The findings will be accessible to Indigenous people affected by diabetes through a summary published in plain language on our research centre's website. Systematic Review Registration: PROSPERO registration number: CRD42021246560.

User Experiences With a Type 2 Diabetes Coaching App: Qualitative Study.

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.

Acceptability of an Embodied Conversational Agent for Type 2 Diabetes Self-Management Education and Support via a Smartphone App: Mixed Methods Study.

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.

Prevalence of non-communicable diseases and their risk factors in Papua New Guinea: A systematic review.

INTRODUCTION: The mortality associated with non-communicable diseases has increased significantly in most countries in the World Health Organization Western Pacific Region over the last 20 years, as have the underlying risk factors. This study aimed to collate evidence on the prevalence of four major non-communicable diseases and their risk factors in Papua New Guinea in order to inform appropriate policy for their prevention and management. METHODS: We performed a systematic review of Papua New Guinea-based population prevalence studies of cardiovascular diseases, type 2 diabetes mellitus, chronic respiratory diseases, and cancers, as well as non-communicable disease risk factors published before 2016. Five online databases were searched and screened against eligibility criteria according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. RESULTS: A total of 57 articles were included in this review, most of which (n = 48) were published prior to 2000. Eleven articles reported on diabetes, six reported on chronic lung disease/asthma, two reported on cardiovascular diseases, and two reported cancer as the primary outcome, while the remaining 36 papers reported non-communicable disease risk factors. CONCLUSION: This review demonstrated variations in the prevalence of non-communicable diseases (0%-19%) and their risk factors (0%-80.6%) attributed to the lifestyle and genetic diversity of the Papua New Guinea population. There is a strong suggestion that the prevalence of non-communicable diseases (particularly type 2 diabetes mellitus) and key non-communicable disease risk factors (hypertension, overweight, and obesity) has increased, but there is a lack of recent data. As such, there is an urgent need for new and up-to-date data in all areas of Papua New Guinea.

What Do Adults with Type 2 Diabetes Want from the "Perfect" App? Results from the Second Diabetes MILES: Australia (MILES-2) Study.

Background: We investigated what Australian adults with type 2 diabetes (T2D) want from the "perfect" diabetes self-management application. Methods: Adults with T2D completed a national online survey including an open-ended question: "If you were describing the perfect app to help you manage your diabetes, what would it do?" Qualitative responses were subjected to thematic analysis. Results: Of the 339 participants who provided usable responses, 153 (45%) were women, the mean age was 58 ± 10 years, and 139 participants (41%) managed their diabetes with insulin. Two primary themes emerged. First, participants expressed a desire for assistance with practical aspects of diabetes self-management to improve, and reduce the cognitive burden of, self-management; this included tracking and visualizing multiple sources of data, using data to inform automated, personalized coaching, reminders, and alarms, and automating upload and linking of data through connected devices. Second, they desired assistance with psychological and emotional aspects of diabetes self-management; this included ongoing encouragement and motivation, help with stress management or negative emotions, and complementing existing health care by facilitating interconnectivity with health professionals. Conclusions: Our findings suggest that the clear desire of people with type 2 diabetes is for the "perfect app" to reduce not only the practical, but also the cognitive and emotional burden of diabetes self-management. They provide further evidence that understanding the desires of people living with diabetes needs to be the first step in app development to ensure that apps provide features, support, and benefits that people with diabetes value.

The Use of Mobile Applications Among Adults with Type 1 and Type 2 Diabetes: Results from the Second MILES-Australia (MILES-2) Study.

BACKGROUND: While the number of diabetes-specific mobile applications (apps) continues to grow, there is a lack of knowledge about their actual use. METHODS: The second MILES (Management and Impact for Long-term Empowerment and Success)-Australia study was a national cross-sectional survey of the psychological, behavioral, and social aspects of diabetes for adults with type 1 diabetes (T1D) and type 2 diabetes (T2D). Associations between diabetes-specific app usage and demographic, clinical, and psychosocial variables were examined. RESULTS: Of the 1589 respondents responding to the diabetes-specific app questions, 795 had T1D (mean ± standard deviation age 43 ± 14 years; 61% women; diabetes duration 19 ± 14 years) and 794 had T2D (age 60 ± 9 years; 40% women; diabetes duration 11 ± 7 years). Among adults with T1D, 24% (n = 188) reported using apps, with carbohydrate counting (74%; n = 139) as the most common cited purpose. App usage was significantly associated with shorter diabetes duration, more frequent glucose monitoring, and lower self-reported HbA1c. Among adults with T2D, 8% (n = 64) reported using apps, with glucose monitoring (62%; n = 39) as the most common purpose. For all respondents, the most commonly reported reason for not using apps was a belief that they could not help with diabetes self-management. CONCLUSIONS: 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.

Using digital interventions to improve the cardiometabolic health of populations: a meta-review of reporting quality.

OBJECTIVES: We conducted a meta-review to determine the reporting quality of user-centered digital interventions for the prevention and management of cardiometabolic conditions. MATERIALS AND METHODS: Using predetermined inclusion criteria, systematic reviews published between 2010 and 2015 were identified from 3 databases. To assess whether current evidence is sufficient to inform wider uptake and implementation of digital health programs, we assessed the quality of reporting of research findings using (1) endorsement of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, (2) a quality assessment framework (eg, Cochrane risk of bias assessment tool), and (3) 8 parameters of the Consolidated Standards of Reporting Trials of Electronic and Mobile HEalth Applications and onLine TeleHealth (CONSORT-eHEALTH) guidelines (developed in 2010). RESULTS: Of the 33 systematic reviews covering social media, Web-based programs, mobile health programs, and composite modalities, 6 reported using the recommended PRISMA guidelines. Seven did not report using a quality assessment framework. Applying the CONSORT-EHEALTH guidelines, reporting was of mild to moderate strength. DISCUSSION: To our knowledge, this is the first meta-review to provide a comprehensive analysis of the quality of reporting of research findings for a range of digital health interventions. Our findings suggest that the evidence base and quality of reporting in this rapidly developing field needs significant improvement in order to inform wider implementation and uptake. CONCLUSION: The inconsistent quality of reporting of digital health interventions for cardiometabolic outcomes may be a critical impediment to real-world implementation.

Inspiratory-resistive loading increases the ventilatory response to arousal but does not reduce genioglossus muscle activity on the return to sleep.

Arousals from sleep are thought to predispose to obstructive sleep apnea by causing hyperventilation and hypocapnia, which reduce airway dilator muscle activity on the return to sleep. However, prior studies of auditory arousals have not resulted in reduced genioglossus muscle activity [GG-electromyogram (EMG)], potentially because airway resistance prior to arousal was low, leading to a small ventilatory response to arousal and minimal hypocapnia. Thus we aimed to increase the ventilatory response to arousal by resistive loading prior to auditory arousal and determine whether reduced GG-EMG occurred on the return to sleep. Eighteen healthy young men and women were recruited. Subjects were instrumented with a nasal mask with a pneumotachograph, an epiglottic pressure catheter, and intramuscular GG-EMG electrodes. Mask CO(2) levels were monitored. Three- to 15-s arousals from sleep were induced with auditory tones after resting breathing (No-Load) or inspiratory-resistive loading (Load; average 8.4 cmH(2)O·l(-1)·s(-1)). Peak minute ventilation following arousal was greater after Load than No-Load (mean ± SE; 8.0 ± 0.6 vs. 7.4 ± 0.6 l/min, respectively). However, the nadir end tidal partial pressure of CO(2) did not differ between Load conditions (43.1 ± 0.6 and 42.8 ± 0.5 mmHg, respectively), and no period of reduced GG activity occurred following the return to sleep (GG-EMG baseline, minimum after Load and No-Load = 2.9 ± 1.2%, 3.1 ± 1.3%, and 3.0 ± 1.3% max, respectively). These findings indicate that the hyperventilation, which occurs following tone-induced arousal, is appropriate for the prevailing level of respiratory drive, because loading did not induce marked hypocapnia or lower GG muscle activity on the return to sleep. Whether similar findings occur following obstructive events in patients remains to be determined.