Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Family/friend Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS' effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. METHODS: Persons with diabetes (PWDs) were randomized to FAMS or control with their support person (family/friend, optional). FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. RESULTS: PWDs (N = 329) were 52 % male, 39 % reported minoritized race or ethnicity, with mean HbA1c 8.6 ± 1.7 %. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64 %; 95 % CI [-1.22 %, -0.05 %]), but overall mean effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27 %; 95 % CI [-0.49 %, -0.09 %]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19 %; 95 % CI [-0.40 %, -0.01 %]). CONCLUSIONS: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friends Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. Methods: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9-months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. Results: PWDs (N=329) were 52% male and 39% from minoritized racial or ethnic groups; 50% enrolled with elevated diabetes distress. Support persons (N=294) were 26% male and 33% minoritized racial or ethnic groups. FAMS improved PWDs' diabetes distress ( d =-0.19) and global well-being ( d =0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. Conclusions: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Glycemic outcomes of a family-focused intervention for adults with type 2 diabetes: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

Aims: Family/friends Activation to Motivate Self-care (FAMS) is a self-care support intervention delivered via mobile phones. We evaluated FAMS effects on hemoglobin A1c (HbA1c) and intervention targets among adults with type 2 diabetes in a 15-month RCT. Methods: Persons with diabetes (PWDs) and their support persons (family/friend, optional) were randomized to FAMS or control. FAMS included monthly phone coaching and text messages for PWDs, and text messages for support persons over a 9-month intervention period. Results: PWDs (N=329) were 52% male, 39% from minoritized racial or ethnic groups, with mean HbA1c 8.6±1.7%. FAMS improved HbA1c among PWDs with a non-cohabitating support person (-0.64%; 95% CI [-1.22%, -0.05%]), but overall effects were not significant. FAMS improved intervention targets including self-efficacy, dietary behavior, and family/friend involvement during the intervention period; these improvements mediated post-intervention HbA1c improvements (total indirect effect -0.27%; 95% CI [-0.49%, -0.09%]) and sustained HbA1c improvements at 12 months (total indirect effect -0.19%; 95% CI [-0.40%, -0.01%]). Conclusions: Despite improvements in most intervention targets, HbA1c improved only among PWDs engaging non-cohabitating support persons suggesting future family interventions should emphasize inclusion of these relationships. Future work should also seek to identify intervention targets that mediate improvements in HbA1c.

Well-being outcomes of a family-focused intervention for persons with type 2 diabetes and support persons: Main, mediated, and subgroup effects from the FAMS 2.0 RCT.

AIMS: Type 2 diabetes self-management occurs within social contexts. We sought to test the effects of Family/friend Activation to Motivate Self-care (FAMS), a self-care support intervention delivered via mobile phones, on psychosocial outcomes for persons with diabetes (PWDs) and their support persons. METHODS: PWDs had the option to enroll with a friend/family member as a support person in a 15-month RCT to evaluate FAMS versus enhanced usual care. FAMS included 9 months of monthly phone coaching and text message support for PWDs, and text message support for enrolled support persons. RESULTS: PWDs (N = 329) were 52% male and 39% reported minoritized race or ethnicity ; 50% enrolled with elevated diabetes distress. Support persons (N = 294) were 26% male and 33% reported minoritized race or ethnicity. FAMS improved PWDs' diabetes distress (d = -0.19) and global well-being (d = 0.21) during the intervention, with patterns of larger effects among minoritized groups. Post-intervention (9-month) and sustained (15-month) improvements were driven by changes in PWDs' self-efficacy, self-care behaviors, and autonomy support. Among support persons, FAMS improved helpful involvement without increasing burden or harmful involvement. CONCLUSIONS: FAMS improved PWDs' psychosocial well-being, with post-intervention and sustained improvements driven by improved self-efficacy, self-care, and autonomy support. Support persons increased helpful involvement without adverse effects.

Primary Occurrence of Cardiovascular Events After Adding Sodium-Glucose Cotransporter-2 Inhibitors or Glucagon-like Peptide-1 Receptor Agonists Compared With Dipeptidyl Peptidase-4 Inhibitors: A Cohort Study in Veterans With Diabetes.

BACKGROUND: The effectiveness of glucagon-like peptide-1 receptor agonists (GLP1RA) and sodium-glucose cotransporter-2 inhibitors (SGLT2i) in preventing major adverse cardiac events (MACE) is uncertain for those without preexisting cardiovascular disease. OBJECTIVE: To test the hypothesis that MACE incidence was lower with the addition of GLP1RA or SGLT2i compared with dipeptidyl peptidase-4 inhibitors (DPP4i) for primary cardiovascular prevention. DESIGN: Retrospective cohort study of U.S. veterans from 2001 to 2019. SETTING: Veterans aged 18 years or older receiving care from the Veterans Health Administration, with data linkage to Medicare, Medicaid, and the National Death Index. PATIENTS: Veterans adding GLP1RA, SGLT2i, or DPP4i onto metformin, sulfonylurea, or insulin treatment alone or in combination. Episodes were stratified by history of cardiovascular disease. MEASUREMENTS: Study outcomes were MACE (acute myocardial infarction, stroke, or cardiovascular death) and heart failure (HF) hospitalization. Cox models compared the outcome between medication groups using pairwise comparisons in a weighted cohort adjusted for covariates. RESULTS: The cohort included 28 759 GLP1RA versus 28 628 DPP4i weighted pairs and 21 200 SGLT2i versus 21 170 DPP4i weighted pairs. Median age was 67 years, and diabetes duration was 8.5 years. Glucagon-like peptide-1 receptor agonists were associated with lower MACE and HF versus DPP4i (adjusted hazard ratio [aHR], 0.82 [95% CI, 0.72 to 0.94]), yielding an adjusted risk difference (aRD) of 3.2 events (CI, 1.1 to 5.0) per 1000 person-years. Sodium-glucose cotransporter-2 inhibitors were not associated with MACE and HF (aHR, 0.91 [CI, 0.78 to 1.08]; aRD, 1.28 [-1.12 to 3.32]) compared with DPP4i. LIMITATION: Residual confounding; use of DPP4i, GLP1RA, and SGLT2i as first-line therapies were not examined. CONCLUSION: The addition of GLP1RA was associated with primary reductions of MACE and HF hospitalization compared with DPP4i use; SGLT2i addition was not associated with primary MACE prevention. PRIMARY FUNDING SOURCE: VA Clinical Science Research and Development and supported in part by the Centers for Diabetes Translation Research.

Interventions Incorporating Therapeutic Alliance to Improve Medication Adherence in Black Patients with Diabetes, Hypertension and Kidney Disease: A Systematic Review.

Background: Black Americans have a disproportionately increased risk of diabetes, hypertension, and kidney disease, and higher associated morbidity, mortality, and hospitalization rates than their White peers. Structural racism amplifies these disparities, and negatively impacts self-care including medication adherence, critical to chronic disease management. Systematic evidence of successful interventions to improve medication adherence in Black patients with diabetes, hypertension, and kidney disease is lacking. Knowledge of the impact of therapeutic alliance, ie, the unique relationship between patients and providers, which optimizes outcomes especially for minority populations, is unclear. The role and application of behavioral theories in successful development of medication adherence interventions specific to this context also remains unclear. Objective: To evaluate the existing evidence on the salience of a therapeutic alliance in effective interventions to improve medication adherence in Black patients with diabetes, hypertension, or kidney disease. Data Sources: Medline (via PubMed), EMBASE (OvidSP), Cumulative Index of Nursing and Allied Health Literature (CINAHL) (EBSCOhost), and PsycINFO (ProQuest) databases. Review Methods: Only randomized clinical trials and pre/post intervention studies published in English between 2009 and 2022 with a proportion of Black patients greater than 25% were included. Narrative synthesis was done. Results: Eleven intervention studies met the study criteria and eight of those studies had all-Black samples. Medication adherence outcome measures were heterogenous. Five out of six studies which effectively improved medication adherence, incorporated therapeutic alliance. Seven studies informed by behavioral theories led to significant improvement in medication adherence. Discussion/Conclusion: Study findings suggest that therapeutic alliance-based interventions are effective in improving medication adherence in Black patients with diabetes and hypertension. Further research to test the efficacy of therapeutic alliance-based interventions to improve medication adherence in Black patients should ideally incorporate cultural adaptation, theoretical framework, face-to-face delivery mode, and convenient locations.

The My Diabetes Care Patient Portal Intervention: Usability and Pre-Post Assessment.

BACKGROUND: My Diabetes Care (MDC) is a novel, multifaceted patient portal intervention designed to help patients better understand their diabetes health data and support self-management. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, and provides literacy level-appropriate educational resources. OBJECTIVES: We aimed to assess the usability, acceptability, perceptions, and potential impact of MDC. METHODS: We recruited 69 participants from four clinics affiliated with Vanderbilt University Medical Center. Participants were given 1 month of access to MDC and completed pre- and post-questionnaires including validated measures of usability and patient activation, and questions about user experience. RESULTS: Sixty participants completed the study. Participants' mean age was 58, 55% were females, 68% were Caucasians, and 48% had limited health literacy (HL). Most participants (80%) visited MDC three or more times and 50% spent a total of ≥15 minutes on MDC. Participants' median System Usability Scale (SUS) score was 78.8 [Q1, Q3: 72.5, 87.5] and significantly greater than the threshold value of 68 indicative of "above average" usability (p < 0.001). The median SUS score of patients with limited HL was similar to those with adequate HL (77.5 [72.5, 85.0] vs. 82.5 [72.5, 92.5]; p = 0.41). Participants most commonly reported the literacy level-appropriate educational links and health data infographics as features that helped them better understand their diabetes health data (65%). All participants (100%) intended to continue to use MDC. Median Patient Activation Measure® scores increased postintervention (64.3 [55.6, 72.5] vs. 67.8 [60.6, 75.0]; p = 0.01). CONCLUSION: Participants, including those with limited HL, rated the usability of MDC above average, anticipated continued use, and identified key features that improved their understanding of diabetes health data. Patient activation improved over the study period. Our findings suggest MDC may be a beneficial addition to existing patient portals.

Evaluation of the My Diabetes Care Patient Portal Intervention: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: My Diabetes Care (MDC) is a multi-faceted intervention embedded within an established patient portal, My Health at Vanderbilt. MDC is designed to help patients better understand their diabetes health data and support self-care. MDC uses infographics to visualize and summarize patients' diabetes health data, incorporates motivational strategies, provides literacy-level appropriate educational resources, and links to a diabetes online patient support community and diabetes news feeds. OBJECTIVE: This study aims to evaluate the effects of MDC on patient activation in adult patients with type 2 diabetes mellitus. Moreover, we plan to assess secondary outcomes, including system use and usability, and the effects of MDC on cognitive and behavioral outcomes (eg, self-care and self-efficacy). METHODS: We are conducting a 6-month, 2-arm, parallel-design, pragmatic pilot randomized controlled trial of the effect of MDC on patient activation. Adult patients with type 2 diabetes mellitus are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible for the study if they are currently being treated with at least one diabetes medication, are able to speak and read in English, are 21 years or older, and have an existing My Health at Vanderbilt account and reliable access to a desktop or laptop computer with internet access. We exclude patients living in long-term care facilities, patients with known cognitive deficits or severe visual impairment, and patients currently participating in any other diabetes-related research study. Participants are randomly assigned to MDC or usual care. We collect self-reported survey data, including the Patient Activation Measure (R) at baseline, 3 months, and 6 months. We will use mixed-effects regression models to estimate potentially time-varying intervention effects while adjusting for the baseline measure of the outcome. The mixed-effects model will use fixed effects for patient-level characteristics and random effects for health care provider variables (eg, primary care physicians). RESULTS: This study is ongoing. Recruitment was closed in May 2020; 270 patients were randomized. Of those randomized, most (214/267, 80.1%) were non-Hispanic White, and 13.1% (35/267) were non-Hispanic Black, 43.7% (118/270) reported being 65 years or older, and 33.6% (90/268) reported limited health literacy. We obtained at least 95.6% (258/270) completion among participants through the 3-month follow-up assessment. CONCLUSIONS: This randomized controlled trial will be one of the first to evaluate a patient-facing diabetes digital health intervention delivered via a patient portal. By embedding MDC into Epic's MyChart platform with more than 127 million patient records, our intervention is directly integrated into routine care, highly scalable, and sustainable. Our findings and evolving patient portal functionality will inform the continued development of MDC to best meet users' needs and a larger trial focused on the impact of MDC on clinical end points. TRIAL REGISTRATION: ClinicalTrials.gov NCT03947333; https://clinicaltrials.gov/ct2/show/NCT03947333. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25955.

Hospitalization for Heart Failure Among Patients With Diabetes Mellitus and Reduced Kidney Function Treated With Metformin Versus Sulfonylureas: A Retrospective Cohort Study.

Background Metformin and sulfonylurea are commonly prescribed oral medications for type 2 diabetes mellitus. The association of metformin and sulfonylureas on heart failure outcomes in patients with reduced estimated glomerular filtration rate remains poorly understood. Methods and Results This retrospective cohort combined data from National Veterans Health Administration, Medicare, Medicaid, and the National Death Index. New users of metformin or sulfonylurea who reached an estimated glomerular filtration rate of 60 mL/min per 1.73 m2 or serum creatinine of 1.5 mg/dL and continued metformin or sulfonylurea were included. The primary outcome was hospitalization for heart failure. Echocardiogram reports were obtained to determine each patient's ejection fraction (EF) (reduced EF <40%; midrange EF 40%-49%; ≥50%). The primary analysis estimated the cause-specific hazard ratios for metformin versus sulfonylurea and estimated the cumulative incidence functions for heart failure hospitalization and competing events. The weighted cohort included 24 685 metformin users and 24 805 sulfonylurea users with reduced kidney function (median age 70 years, estimated glomerular filtration rate 55.8 mL/min per 1.73 m2). The prevalence of underlying heart failure (12.1%) and cardiovascular disease (31.7%) was similar between groups. There were 16.9 (95% CI, 15.8-18.1) versus 20.7 (95% CI, 19.5-22.0) heart failure hospitalizations per 1000 person-years for metformin and sulfonylurea users, respectively, yielding a cause-specific hazard of 0.85 (95% CI, 0.78-0.93). Among heart failure hospitalizations, 44.5% did not have echocardiogram information available; 29.3% were categorized as reduced EF, 8.9% as midrange EF, and 17.2% as preserved EF. Heart failure hospitalization with reduced EF (hazard ratio, 0.79; 95% CI, 0.67-0.93) and unknown EF (hazard ratio, 0.84; 95% CI 0.74-96) were significantly lower in metformin versus sulfonylurea users. Conclusions Among patients with type 2 diabetes mellitus who developed worsening kidney function, persistent metformin compared with sulfonylurea use was associated with reduced heart failure hospitalization.

Mixed-Methods Randomized Evaluation of FAMS: A Mobile Phone-Delivered Intervention to Improve Family/Friend Involvement in Adults' Type 2 Diabetes Self-Care.

BACKGROUND: Family and friends have both helpful and harmful effects on adults' diabetes self-management. Family-focused Add-on to Motivate Self-care (FAMS) is a mobile phone-delivered intervention designed to improve family/friend involvement, self-efficacy, and self-care via monthly phone coaching, texts tailored to goals, and the option to invite a support person to receive texts. PURPOSE: We sought to evaluate how FAMS was received by a diverse group of adults with Type 2 diabetes and if FAMS improved diabetes-specific family/friend involvement (increased helpful and reduced harmful), diabetes self-efficacy, and self-care (diet and physical activity). We also assessed if improvements in family/friend involvement mediated improvements in self-efficacy and self-care. METHODS: Participants were prospectively assigned to enhanced treatment as usual (control), an individualized text messaging intervention alone, or the individualized text messaging intervention plus FAMS for 6 months. Participants completed surveys at baseline, 3 and 6 months, and postintervention interviews. Between-group and multiple mediator analyses followed intention-to-treat principles. RESULTS: Retention, engagement, and fidelity were high. FAMS was well received and helped participants realize the value of involving family/friends in their care. Relative to control, FAMS participants had improved family/friend involvement, self-efficacy, and diet (but not physical activity) at 3 and 6 months (all ps < .05). Improvements in family/friend involvement mediated effects on self-efficacy and diet for FAMS participants but not for the individualized intervention group. CONCLUSIONS: The promise of effectively engaging patients' family and friends lies in sustained long-term behavior change. This work represents a first step toward this goal by demonstrating how content targeting helpful and harmful family/friend involvement can drive short-term effects. TRIAL REGISTRATION NUMBER: NCT02481596.

Effects of a Tailored Text Messaging Intervention Among Diverse Adults With Type 2 Diabetes: Evidence From the 15-Month REACH Randomized Controlled Trial.

OBJECTIVE: Text messaging interventions have high potential for scalability and for reductions in health disparities. However, more rigorous, long-term trials are needed. We examined the long-term efficacy and mechanisms of a tailored text messaging intervention. RESEARCH DESIGN AND METHODS: Adults with type 2 diabetes participated in a parallel-groups, 15-month randomized controlled trial and were assigned to receive Rapid Education/Encouragement and Communications for Health (REACH) for 12 months or control. REACH included interactive texts and tailored texts addressing medication adherence and nontailored texts supporting other self-care behaviors. Outcomes included hemoglobin A1c (HbA1c), diabetes medication adherence, self-care, and self-efficacy. RESULTS: Participants (N = 506) were approximately half racial/ethnic minorities, and half were underinsured, had annual household incomes <$35,000, and had a high school education or less; 11% were homeless. Average baseline HbA1c was 8.6% ± 1.8%; 70.0 ± 19.7 mmol/mol) with n = 219 having HbA1c ≥8.5% (69 mmol/mol). Half were prescribed insulin. Retention was over 90%. Median response rate to interactive texts was 91% (interquartile range 75%, 97%). The treatment effect on HbA1c at 6 months (-0.31%; 95% CI -0.61%, -0.02%) was greater among those with baseline HbA1c ≥8.5% (-0.74%; 95% CI -1.26%, -0.23%), and there was no evidence of effect modification by race/ethnicity or socioeconomic disadvantage. REACH improved medication adherence and diet through 12 months and self-efficacy through 6 months. Treatment effects were not significant for any outcome at 15 months. REACH reduced barriers to adherence, but barrier reduction did not mediate outcome improvements. CONCLUSIONS: REACH engaged at-risk patients in diabetes self-management and improved short-term HbA1c. More than texts alone may be needed to sustain the effects.

Gestational Diabetes and Maternal Weight Management During and After Pregnancy.

Background: Women diagnosed with gestational diabetes mellitus (GDM) substantially modify their diets during pregnancy to control hyperglycemia. These changes could also affect maternal weight management. Materials and Methods: From July 2014 to December 2015 we enrolled women with and without GDM in a prospective cohort study to compare their mean rates of (1) weight gain before GDM screening, (2) weight gain after GDM screening, and (3) postpartum weight loss. All GDM-affected women were referred to Medical Nutrition Therapy and asked to self-monitor blood glucose until delivery. Rate comparisons were conducted separately for each interval using weighted t-tests and inverse probability of treatment weighting (IPTW) to account for age and prepregnancy body mass index (BMI). Linear regression models were developed to characterize the association of GDM status and rate of weight change. Results: The study included 40 women with GDM and 49 women without GDM. The IPTW analysis found that (1) women with and without GDM had similar mean rates of gestational weight gain before GDM screening (0.41 ± 0.26 kg/week vs. 0.45 ± 0.35 kg/week, respectively, p = 0.86), (2) women with GDM gained weight at a significantly lower mean rate than women without GDM following GDM screening (0.30 ± 0.28 kg/week vs. 0.53 ± 0.28 kg/week, respectively, p = 0.001), and (3) women with and without GDM had similar mean rates of postpartum weight loss (-1.37 ± 0.58 kg/week vs. -1.28 ± 0.46 kg/week, respectively, p = 0.73). The linear regression model (adjusted for age and prepregnancy BMI) demonstrated that women with GDM gained 0.19 kg/week less than women without GDM (p = 0.004) during pregnancy after GDM screening. Conclusions: In the postpartum period, women with GDM lose weight at similar rates to women without GDM despite gaining weight at significantly lower rates following GDM screening. Diagnosis and treatment of GDM may improve maternal weight management, but this benefit is limited to late pregnancy.

A Patient-Facing Diabetes Dashboard Embedded in a Patient Web Portal: Design Sprint and Usability Testing.

BACKGROUND: Health apps and Web-based interventions designed for patients with diabetes offer novel and scalable approaches to engage patients and improve outcomes. However, careful attention to the design and usability of these apps and Web-based interventions is essential to reduce the barriers to engagement and maximize use. OBJECTIVE: The aim of this study was to apply design sprint methodology paired with mixed-methods, task-based usability testing to design and evaluate an innovative, patient-facing diabetes dashboard embedded in an existing patient portal and integrated into an electronic health record. METHODS: We applied a 5-day design sprint methodology developed by Google Ventures (Alphabet Inc, Mountain View, CA) to create our initial dashboard prototype. We identified recommended strategies from the literature for using patient-facing technologies to enhance patient activation and designed a dashboard functionality to match each strategy. We then conducted a mixed-methods, task-based usability assessment of dashboard prototypes with individual patients. Measures included validated metrics of task performance on 5 common and standardized tasks, semistructured interviews, and a validated usability satisfaction questionnaire. After each round of usability testing, we revised the dashboard prototype in response to usability findings before the next round of testing until the majority of participants successfully completed tasks, expressed high satisfaction, and identified no new usability concerns (ie, stop criterion was met). RESULTS: The sample (N=14) comprised 5 patients in round 1, 3 patients in round 2, and 6 patients in round 3, at which point we reached our stop criterion. The participants' mean age was 63 years (range 45-78 years), 57% (8/14) were female, and 50% (7/14) were white. Our design sprint yielded an initial patient-facing diabetes dashboard prototype that displayed and summarized 5 measures of patients' diabetes health status (eg, hemoglobin A1c). The dashboard used graphics to visualize and summarize health data and reinforce understanding, incorporated motivational strategies (eg, social comparisons and gamification), and provided educational resources and secure-messaging capability. More than 80% of participants were able to successfully complete all 5 tasks using the final prototype. Interviews revealed usability concerns with design, the efficiency of use, and content and terminology, which led to improvements. Overall satisfaction (0=worst and 7=best) improved from the initial to the final prototype (mean 5.8, SD 0.4 vs mean 6.7, SD 0.5). CONCLUSIONS: Our results demonstrate the utility of the design sprint methodology paired with mixed-methods, task-based usability testing to efficiently and effectively design a patient-facing, Web-based diabetes dashboard that is satisfying for patients to use.

Patients' perspectives on social and goal-based comparisons regarding their diabetes health status.

OBJECTIVE: Social comparisons (ie, self-evaluation in comparison with others) influence patients' perspectives of their disease and may impact motivation and health behavior; however, little is known about patients' perspectives toward receiving such information in a clinical context (eg, from their doctor's office or health system). This study aims to understand patients' perspectives and anticipated responses to receiving social comparison information regarding measures of their diabetes-related health status (eg, A1C) and how receiving such information would compare with goal-based comparisons (ie, self-evaluation in comparison with goal). RESEARCH DESIGN AND METHODS: We conducted semistructured interviews with 25 patients with type 2 diabetes mellitus (T2DM) regarding social and goal-based comparisons involving their diabetes health status and qualitatively analyzed interviews for themes. RESULTS: We identified seven major themes: self-relevance, motivation, self-concept, emotions, information seeking, medical care, and self-care. Participants commonly anticipated increased motivation and improved health behaviors in response to both social and goal-based comparisons. Subthemes unique to social comparisons included belief that this information would be motivating by engaging some patients' competitiveness, perception that this information was more 'personalized' than comparisons with a standard goal (eg, A1C<7), and desire to learn from individuals similar to oneself who were doing better. CONCLUSIONS: Our findings provide significant insights into the anticipated response of patients with T2DM to receiving social and goal-based comparison information regarding their diabetes health status. Providing patients with diabetes with social and goal-based comparison information may affect motivation, mood, and self-concept in ways that may improve or sustain diabetes self-care behaviors for some patients.

Mobile Phone Support for Diabetes Self-Care Among Diverse Adults: Protocol for a Three-Arm Randomized Controlled Trial.

BACKGROUND: Nonadherence to self-care is common among patients with type 2 diabetes (T2D) and often leads to severe complications. Moreover, patients with T2D who have low socioeconomic status and are racial/ethnic minorities disproportionately experience barriers to adherence and poor outcomes. Basic phone technology (text messages and phone calls) provides a practical medium for delivering content to address patients' barriers to adherence; however, trials are needed to explore long-term and sustainable effects of mobile phone interventions among diverse patients. OBJECTIVE: The aim of this study is to evaluate the effects of mobile phone-based diabetes support interventions on self-care and hemoglobin A1c (HbA1c) among adults with T2D using a 3-arm, 15-month randomized controlled trial with a Type 1 hybrid effectiveness-implementation approach. The intervention arms are (1) Rapid Encouragement/Education And Communications for Health (REACH) and (2) REACH + Family-focused Add-on for Motivating Self-care (FAMS). METHODS: We recruited primary care patients with T2D (N=512) from Federally Qualified Health Centers and an academic medical center, prioritizing recruitment of publicly insured and minority patients from the latter. Eligible patients were prescribed daily diabetes medication and owned a cell phone with text messaging capability. We excluded patients whose most recent HbA1c result within 12 months was <6.8% to support detection of intervention effects on HbA1c. Participants were randomly assigned to REACH only, REACH + FAMS, or the control condition. REACH provides text messages tailored to address patient-specific barriers to medication adherence based on the Information-Motivation-Behavioral skills model, whereas FAMS provides monthly phone coaching with related text message content focused on family and friend barriers to diet and exercise adherence. We collect HbA1c and self-reported survey data at baseline and at 3, 6, and 12 months, and again at 15 months to assess sustained changes. We will use generalized estimating equation models to test the effects of REACH (either intervention arm) on HbA1c relative to the control group, the potential additive effects of FAMS, and effects of either intervention on adherence to self-care behaviors and diabetes self-efficacy. RESULTS: The trial is ongoing; recruitment closed December 2017. We plan to perform analyses on 6-month outcomes for FAMS in July 2018, and project to have 15-month data for REACH analyses in April 2019. CONCLUSIONS: Our study will be one of the first to evaluate a long-term, theory-based text messaging intervention to promote self-care adherence among racially/ethnically and socioeconomically diverse adults with T2D. Moreover, our study will assess the feasibility of a family-focused intervention delivered via mobile phones and compare the effects of text messaging alone versus text messaging plus phone coaching. Findings will advance our understanding of how interventions delivered by phone can benefit diverse patients with chronic conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT02409329; https://clinicaltrials.gov/ct2/show/NCT02409329 (Archived by WebCite at http://www.webcitation.org/6yHkg9SSl); NCT02481596; https://clinicaltrials.gov/ct2/show/NCT02481596 (Archived by WebCite at http://www.webcitation.org/6yHkj9XD4).

Prevalence of Self-Reported Diabetes by Sexual Orientation: Results from the 2014 Behavioral Risk Factor Surveillance System.

PURPOSE: This study aimed to compare the prevalence of self-reported diabetes and diabetes risk factors among adult sexual minority and heterosexual populations in the United States. METHODS: Data from the 2014 Behavioral Risk Factor Surveillance System for 3776 lesbian, gay, and bisexual (LGB) adults and 142,852 heterosexual adults aged 18 years and older were used to estimate the prevalence of diabetes. Binomial logistic regression models were used to compare the odds of diabetes by sexual orientation. RESULTS: Sexual minorities were younger and more racially diverse than heterosexuals. Gay men less often and lesbian and bisexual women more often reported a body mass index of 30 kg/m2 or higher than heterosexuals. Overall, 14.2% of bisexual men, 11.4% of gay men, and 10.8% of heterosexual men reported a lifetime diabetes diagnosis, as did 8.5% of lesbian women, 5.7% of bisexual women, and 10.2% of heterosexual women. After controlling for multiple factors, gay (odds ratio [OR] = 1.50; confidence interval [95% CI] = 1.09-2.07) and bisexual men [OR = 1.55; 95% CI = 1.00-2.07] were more likely to report a lifetime diabetes diagnosis than heterosexual men. Similar differences were not found for lesbian [OR = 1.22; 95% CI = 0.76-1.95] or bisexual women [OR = 0.88; 95% CI = 0.62-1.26]. CONCLUSION: Sexual minorities may be at increased risk for diabetes than their heterosexual peers. This may be due partly to the chronic stressors associated with being a member of a marginalized population. Future research should explore the underlying causes and consequences of LGB diabetes disparities and elucidate best practices to improve diabetes screening and care for these vulnerable patient populations.

Self-Care Disparities Among Adults with Type 2 Diabetes in the USA.

Suboptimal glycemic control is more common among non-Hispanic Blacks (NHBs) and Hispanics than non-Hispanic Whites (NHWs). Disparities in the performance of self-care behaviors may contribute to this. To synthesize knowledge on current self-care disparities, we reviewed studies from January 2011-March 2016 that included NHWs, NHBs, and Hispanics with type 2 diabetes in the USA. Self-care behaviors included diet, exercise, medications, self-monitoring of blood glucose (SMBG), self-foot exams, and not smoking. Of 1241 articles identified in PubMed, 25 met our inclusion criteria. These studies report consistent disparities in medication adherence. Surprisingly, we found consistent evidence of no disparities in exercise and some evidence of reverse disparities: compared to NHWs, Hispanics had healthier diets and NHBs had more regular SMBG. Consistent use of validated measures could further inform disparities in diet and exercise. Additional research is needed to test for disparities in self-foot exams, not smoking, and diabetes-specific problem solving and coping.

Variation in the relationship between gestational diabetes diagnosis and total gestational weight gain by race/ethnicity.

Prior research suggests that women diagnosed and treated for gestational diabetes mellitus (GDM) gain less total gestational weight than normoglycemic women. Our study finds that race/ethnicity modifies this association. Relative to normoglycemic women, non-Hispanic white women with GDM gain less weight but non-Hispanic black and Hispanic women gain more weight.

Association between intensification of metformin treatment with insulin vs sulfonylureas and cardiovascular events and all-cause mortality among patients with diabetes.

IMPORTANCE: Preferred second-line medication for diabetes treatment after metformin failure remains uncertain. OBJECTIVE: To compare time to acute myocardial infarction (AMI), stroke, or death in a cohort of metformin initiators who added insulin or a sulfonylurea. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort constructed with national Veterans Health Administration, Medicare, and National Death Index databases. The study population comprised veterans initially treated with metformin from 2001 through 2008 who subsequently added either insulin or sulfonylurea. Propensity score matching on characteristics was performed, matching each participant who added insulin to 5 who added a sulfonylurea. Patients were followed through September 2011 for primary analyses or September 2009 for cause-of-death analyses. MAIN OUTCOMES AND MEASURES: Risk of a composite outcome of AMI, stroke hospitalization, or all-cause death was compared between therapies with marginal structural Cox proportional hazard models adjusting for baseline and time-varying demographics, medications, cholesterol level, hemoglobin A1c level, creatinine level, blood pressure, body mass index, and comorbidities. RESULTS: Among 178,341 metformin monotherapy patients, 2948 added insulin and 39,990 added a sulfonylurea. Propensity score matching yielded 2436 metformin + insulin and 12,180 metformin + sulfonylurea patients. At intensification, patients had received metformin for a median of 14 months (IQR, 5-30), and hemoglobin A1c level was 8.1% (IQR, 7.2%-9.9%). Median follow-up after intensification was 14 months (IQR, 6-29 months). There were 172 vs 634 events for the primary outcome among patients who added insulin vs sulfonylureas, respectively (42.7 vs 32.8 events per 1000 person-years; adjusted hazard ratio [aHR], 1.30; 95% CI, 1.07-1.58; P = .009). Acute myocardial infarction and stroke rates were statistically similar, 41 vs 229 events (10.2 and 11.9 events per 1000 person-years; aHR, 0.88; 95% CI, 0.59-1.30; P = .52), whereas all-cause death rates were 137 vs 444 events, respectively (33.7 and 22.7 events per 1000 person-years; aHR, 1.44; 95% CI, 1.15-1.79; P = .001). There were 54 vs 258 secondary outcomes: AMI, stroke hospitalizations, or cardiovascular deaths (22.8 vs 22.5 events per 1000 person-years; aHR, 0.98; 95% CI, 0.71-1.34; P = .87). CONCLUSIONS AND RELEVANCE: Among patients with diabetes who were receiving metformin, the addition of insulin vs a sulfonylurea was associated with an increased risk of a composite of nonfatal cardiovascular outcomes and all-cause mortality. These findings require further investigation to understand risks associated with insulin use in these patients.