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.

Rates and Correlates of Uptake of Continuous Glucose Monitors Among Adults with Type 2 Diabetes in Primary Care and Endocrinology Settings.

BACKGROUND: Clinical trials indicate continuous glucose monitor (CGM) use may benefit adults with type 2 diabetes, but CGM rates and correlates in real-world care settings are unknown. OBJECTIVE: We sought to ascertain prevalence and correlates of CGM use and to examine rates of new CGM prescriptions across clinic types and medication regimens. DESIGN: Retrospective cohort using electronic health records in a large academic medical center in the Southeastern US. PARTICIPANTS: Adults with type 2 diabetes and a primary care or endocrinology visit during 2021. MAIN MEASURES: Age, gender, race, ethnicity, insurance, clinic type, insulin regimen, hemoglobin A1c values, CGM prescriptions, and prescribing clinic type. KEY RESULTS: Among 30,585 adults with type 2 diabetes, 13% had used a CGM. CGM users were younger and more had private health insurance (p < .05) as compared to non-users; 72% of CGM users had an intensive insulin regimen, but 12% were not taking insulin. CGM users had higher hemoglobin A1c values (both most recent and most proximal to the first CGM prescription) than non-users. CGM users were more likely to receive endocrinology care than non-users, but 23% had only primary care visits in 2021. For each month in 2021, a mean of 90.5 (SD 12.5) people started using CGM. From 2020 to 2021, monthly rates of CGM prescriptions to new users grew 36% overall, but 125% in primary care. Most starting CGM in endocrinology had an intensive insulin regimen (82% vs. 49% starting in primary care), whereas 28% starting CGM in primary care were not using insulin (vs. 5% in endocrinology). CONCLUSION: CGM uptake for type 2 diabetes is increasing rapidly, with most growth in primary care. These trends present opportunities for healthcare system adaptations to support CGM use and related workflows in primary care to support growth in uptake.

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.

Association of Treatment With Metformin vs Sulfonylurea With Major Adverse Cardiovascular Events Among Patients With Diabetes and Reduced Kidney Function.

IMPORTANCE: Before 2016, safety concerns limited metformin use in patients with kidney disease; however, the effectiveness of metformin on clinical outcomes in patients with reduced kidney function remains unknown. OBJECTIVE: To compare major adverse cardiovascular events (MACE) among patients with diabetes and reduced kidney function who continued treatment with metformin or a sulfonylurea. DESIGN, SETTING, AND PARTICIPANTS: Retrospective cohort study of US veterans receiving care within the national Veterans Health Administration, with data supplemented by linkage to Medicare, Medicaid, and National Death Index data from 2001 through 2016. There were 174 882 persistent new users of metformin and sulfonylureas who reached a reduced kidney function threshold (estimated glomerular filtration rate <60 mL/min/1.73 m2 or creatinine ≥1.4 mg/dL for women or ≥1.5 mg/dL for men). Patients were followed up from reduced kidney function threshold until MACE, treatment change, loss to follow-up, death, or study end (December 2016). EXPOSURES: New users of metformin or sulfonylurea monotherapy who continued treatment with their glucose-lowering medication after reaching reduced kidney function. MAIN OUTCOMES AND MEASURES: MACE included hospitalization for acute myocardial infarction, stroke, transient ischemic attack, or cardiovascular death. The analyses used propensity score weighting to compare the cause-specific hazard of MACE between treatments and estimate cumulative risk accounting for the competing risks of changing therapy or noncardiovascular death. RESULTS: There were 67 749 metformin and 28 976 sulfonylurea persistent monotherapy users; the weighted cohort included 24 679 metformin and 24 799 sulfonylurea users (median age, 70 years [interquartile range {IQR}, 62.8-77.8]; 48 497 men [98%]; and 40 476 white individuals [82%], with median estimated glomerular filtration rate of 55.8 mL/min/1.73 m2 [IQR, 51.6-58.2] and hemoglobin A1c level of 6.6% [IQR, 6.1%-7.2%] at cohort entry). During follow-up (median, 1.0 year for metformin vs 1.2 years for sulfonylurea), there were 1048 MACE outcomes (23.0 per 1000 person-years) among metformin users and 1394 events (29.2 per 1000 person-years) among sulfonylurea users. The cause-specific adjusted hazard ratio of MACE for metformin was 0.80 (95% CI, 0.75-0.86) compared with sulfonylureas, yielding an adjusted rate difference of 5.8 (95% CI, 4.1-7.3) fewer events per 1000 person-years of metformin use compared with sulfonylurea use. CONCLUSIONS AND RELEVANCE: Among patients with diabetes and reduced kidney function persisting with monotherapy, treatment with metformin, compared with a sulfonylurea, was associated with a lower risk of MACE.

Comparative Effectiveness of Insulin versus Combination Sulfonylurea and Insulin: a Cohort Study of Veterans with Type 2 Diabetes.

BACKGROUND: Type 2 diabetes patients often initiate treatment with a sulfonylurea and subsequently intensify their therapy with insulin. However, information on optimal treatment regimens for these patients is limited. OBJECTIVE: To compare risk of cardiovascular disease (CVD) and hypoglycemia between sulfonylurea initiators who switch to or add insulin. DESIGN: This was a retrospective cohort assembled using national Veterans Health Administration (VHA), Medicare, and National Death Index databases. PARTICIPANTS: Veterans who initiated diabetes treatment with a sulfonylurea between 2001 and 2008 and intensified their regimen with insulin were followed through 2011. MAIN MEASURES: The association between insulin versus sulfonylurea + insulin and time to CVD or hypoglycemia were evaluated using Cox proportional hazard models in a 1:1 propensity score-matched cohort. CVD included hospitalization for acute myocardial infarction or stroke, or cardiovascular mortality. Hypoglycemia included hospitalizations or emergency visits for hypoglycemia, or outpatient blood glucose measurements <60 mg/dL. Subgroups included age < 65 and ≥ 65 years and estimated glomerular filtration rate ≥ 60 and < 60 ml/min. KEY FINDINGS: There were 1646 and 3728 sulfonylurea monotherapy initiators who switched to insulin monotherapy or added insulin, respectively. The 1596 propensity score-matched patients in each group had similar baseline characteristics at insulin initiation. The rate of CVD per 1000 person-years among insulin versus sulfonylurea + insulin users were 49.3 and 56.0, respectively [hazard ratio (HR) 0.85, 95 % confidence interval (CI) 0.64, 1.12]. Rates of first and recurrent hypoglycemia events per 1000 person-years were 74.0 and 100.0 among insulin users compared to 78.9 and 116.8 among sulfonylurea plus insulin users, yielding HR (95 % CI) of 0.94 (0.76, 1.16) and 0.87 (0.69, 1.10), respectively. Subgroup analysis results were consistent with the main findings. CONCLUSIONS: Compared to sulfonylurea users who added insulin, those who switched to insulin alone had numerically lower CVD and hypoglycemia events, but these differences in risk were not statistically significant.

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.

Risk of hypoglycemia following intensification of metformin treatment with insulin versus sulfonylurea.

BACKGROUND: Hypoglycemia remains a common life-threatening event associated with diabetes treatment. We compared the risk of first or recurrent hypoglycemia event among metformin initiators who intensified treatment with insulin versus sulfonylurea. METHODS: We assembled a retrospective cohort using databases of the Veterans Health Administration, Medicare and the National Death Index. Metformin initiators who intensified treatment with insulin or sulfonylurea were followed to either their first or recurrent hypoglycemia event using Cox proportional hazard models. Hypoglycemia was defined as hospital admission or an emergency department visit for hypoglycemia, or an outpatient blood glucose value of less than 3.3 mmol/L. We conducted additional analyses for risk of first hypoglycemia event, with death as the competing risk. RESULTS: Among 178,341 metformin initiators, 2948 added insulin and 39,990 added sulfonylurea. Propensity score matching yielded 2436 patients taking metformin plus insulin and 12,180 taking metformin plus sulfonylurea. Patients took metformin for a median of 14 (interquartile range [IQR] 5-30) months, and the median glycated hemoglobin level was 8.1% (IQR 7.2%-9.9%) at intensification. In the group who added insulin, 121 first hypoglycemia events occurred, and 466 first events occurred in the group who added sulfonylurea (30.9 v. 24.6 events per 1000 person-years; adjusted hazard ratio [HR] 1.30, 95% confidence interval [CI] 1.06-1.59). For recurrent hypoglycemia, there were 159 events in the insulin group and 585 events in the sulfonylurea group (39.1 v. 30.0 per 1000 person-years; adjusted HR 1.39, 95% CI 1.12-1.72). In separate competing risk analyses, the adjusted HR for hypoglycemia was 1.28 (95% CI 1.04-1.56). INTERPRETATION: Among patients using metformin who could use either insulin or sulfonylurea, the addition of insulin was associated with a higher risk of hypoglycemia than the addition of sulfonylurea. This finding should be considered by patients and clinicians when discussing the risks and benefits of adding insulin versus a sulfonylurea.

Utilization and determinants of palliative care in the trauma intensive care unit: results of a national survey.

BACKGROUND: There is a paucity of data evaluating utilization of palliative care in trauma intensive care units. AIM: We sought to determine current indications and determinants of palliative care consultation in the trauma intensive care units. DESIGN: Using a cross-sectional assessment, we surveyed trauma surgeons to understand indications, benefits, and barriers trauma surgeons perceive when consulting palliative care. SETTING/PARTICIPANTS: A total of 1232 surveys were emailed to all members of the Eastern Association for the Surgery of Trauma. RESULTS: A total of 362 providers responded (29% response rate). Majority of respondents were male (n = 287, 80.2%) and practiced in Level 1 (n = 278, 77.7%) trauma centers. Most common indicators for referral to palliative care were expected survival 1 week to 1 month, multisystem organ dysfunction >3 weeks, minimal neurologic responsiveness >1 week, and referral to hospice. In post hoc analysis, there was a significant difference in frequency of utilization of palliative care when respondents had access to board-certified palliative care physicians (χ(2) = 56.4, p < 0.001). Although half of the respondents (n = 199, 55.6%) reported palliative care consults beneficial all or most of the time, nearly still half (n = 174, 48.6%) felt palliative care was underutilized. Most frequent barriers to consultation included resistance from families (n = 144, 40.2%), concerns that physicians were "giving up" (n = 109, 30.4%), and miscommunication of prognosis (n = 98, 27.4%) or diagnosis (n = 58, 16.2%) by the palliative care physician. CONCLUSION: Although a plurality of trauma surgeons reported palliative care beneficial, those surveyed indicate that palliative care is underutilized. Barriers identified provide important opportunities to further appropriate utilization of palliative care services.

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.

Effects of a Patient Portal Intervention to Address Diabetes Care Gaps: Protocol for a Pragmatic Randomized Controlled Trial.

BACKGROUND: Despite the potential to significantly reduce complications, many patients do not consistently receive diabetes preventive care. Our research team recently applied user-centered design sprint methodology to develop a patient portal intervention empowering patients to address selected diabetes care gaps (eg, no diabetes eye examination in last 12 months). OBJECTIVE: This study aims to evaluate the effect of our novel diabetes care gap intervention on completion of selected evidence-based diabetes preventive care services and secondary outcomes. METHODS: We are conducting a pragmatic randomized controlled trial of the effect of the intervention on diabetes care gaps. Adult patients with diabetes mellitus (DM) are recruited from primary care clinics affiliated with Vanderbilt University Medical Center. Participants are eligible if they have type 1 or 2 DM, can read in English, are aged 18-75 years, have a current patient portal account, and have reliable access to a mobile device with internet access. We exclude patients with medical conditions that prevent them from using a mobile device, severe difficulty seeing, pregnant women or women who plan to become pregnant during the study period, and patients on dialysis. Participants will be randomly assigned to the intervention or usual care. The primary outcome measure will be the number of diabetes care gaps among 4 DM preventive care services (diabetes eye examination, pneumococcal vaccination, hemoglobin A1c, and urine microalbumin) at 12 months after randomization. Secondary outcomes will include diabetes self-efficacy, confidence managing diabetes in general, understanding of diabetes preventive care, diabetes distress, patient portal satisfaction, and patient-initiated orders at baseline, 3 months, 6 months, and 12 months after randomization. An ordinal logistic regression model will be used to quantify the effect of the intervention on the number of diabetes care gaps at the 12-month follow-up. For dichotomous secondary outcomes, a logistic regression model will be used with random effects for the clinic and provider variables as needed. For continuous secondary outcomes, a regression model will be used. RESULTS: This study is ongoing. Recruitment was closed in February 2022; a total of 433 patients were randomized. Of those randomized, most (n=288, 66.5%) were non-Hispanic White, 33.5% (n=145) were racial or ethnic minorities, 33.9% (n=147) were aged 65 years or older, and 30.7% (n=133) indicated limited health literacy. CONCLUSIONS: The study directly tests the hypothesis that a patient portal intervention-alerting patients about selected diabetes care gaps, fostering understanding of their significance, and allowing patients to initiate care-will reduce diabetes care gaps compared with usual care. The insights gained from this study may have broad implications for developing future interventions to address various care gaps, such as gaps in cancer screening, and contribute to the development of effective, scalable, and sustainable approaches to engage patients in chronic disease management and prevention. TRIAL REGISTRATION: ClinicalTrials.gov NCT04894903; https://classic.clinicaltrials.gov/ct2/show/NCT04894903. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/56123.

Impact of Insulin Sensitivity and ß-Cell Function Over Time on Glycemic Outcomes in the Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study (GRADE): Differential Treatment Effects of Dual Therapy.

OBJECTIVE: To compare the effects of insulin sensitivity and ß-cell function over time on HbA1c and durability of glycemic control in response to dual therapy. RESEARCH DESIGN AND METHODS: GRADE participants were randomized to glimepiride (n = 1,254), liraglutide (n = 1,262), or sitagliptin (n = 1,268) added to baseline metformin and followed for mean ± SD 5.0 ± 1.3 years, with HbA1c assessed quarterly and oral glucose tolerance tests at baseline, 1, 3, and 5 years. We related time-varying insulin sensitivity (HOMA 2 of insulin sensitivity [HOMA2-%S]) and early (0-30 min) and total (0-120 min) C-peptide (CP) responses to changes in HbA1c and glycemic failure (primary outcome HbA1c ≥7% [53 mmol/mol] and secondary outcome HbA1c >7.5% [58 mmol/mol]) and examined differential treatment responses. RESULTS: Higher HOMA2-%S was associated with greater initial HbA1c lowering (3 months) but not subsequent HbA1c rise. Greater CP responses were associated with a greater initial treatment response and slower subsequent HbA1c rise. Higher HOMA2-%S and CP responses were each associated with lower risk of primary and secondary outcomes. These associations differed by treatment. In the sitagliptin group, HOMA2-%S and CP responses had greater impact on initial HbA1c reduction (test of heterogeneity, P = 0.009 HOMA2-%S, P = 0.018 early CP, P = 0.001 total CP) and risk of primary outcome (P = 0.005 HOMA2-%S, P = 0.11 early CP, P = 0.025 total CP) but lesser impact on HbA1c rise (P = 0.175 HOMA2-%S, P = 0.006 early CP, P < 0.001 total CP) in comparisons with the glimepiride and liraglutide groups. There were no differential treatment effects on secondary outcome. CONCLUSIONS: Insulin sensitivity and ß-cell function affected treatment outcomes irrespective of drug assignment, with greater impact in the sitagliptin group on initial (short-term) HbA1c response in comparison with the glimepiride and liraglutide groups.

Pilot study of a physician-delivered education tool to increase patient knowledge about CKD.

BACKGROUND: Limited research exists on physician-delivered education interventions. We examined the feasibility and impact of an educational tool on facilitating physician-patient kidney disease communication. STUDY DESIGN: Pilot feasibility clinical trial with a historical control to examine effect size on patient knowledge and structured questions to elicit physician and patient feedback. SETTING & PARTICIPANTS: Adults with chronic kidney disease (CKD) stages 1-5, seen in nephrology clinic. INTERVENTION: 1-page educational worksheet, reviewed by physicians with patients. OUTCOMES: Kidney knowledge between patient groups and provider/patient feedback. MEASUREMENTS: Patient kidney knowledge was measured using a previously validated questionnaire compared between patients receiving the intervention (April to October 2010) and a historical cohort (April to October 2009). Provider input was obtained using structured interviews. Patient input was obtained through survey questions. Patient characteristics were abstracted from the medical record. RESULTS: 556 patients were included, with 401 patients in the historical cohort and 155 receiving the intervention. Mean age was 57 ± 16 (SD) years, with 53% men, 81% whites, and 78% with CKD stages 3-5. Compared with the historical cohort, patients receiving the intervention had higher adjusted odds of knowing they had CKD (adjusted OR, 2.20; 95% CI, 1.16-4.17; P = 0.02), knowing their kidney function (adjusted OR, 2.25; 95% CI, 1.27-3.97; P = 0.005), and knowing their stage of CKD (adjusted OR, 3.22; 95% CI, 1.49-6.92; P = 0.003). Physicians found the intervention tool easy and feasible to integrate into practice and 98% of patients who received the intervention recommended it for future use. LIMITATIONS: Study design did not randomly assign patients for comparison and enrollment was performed in clinics at one center. CONCLUSIONS: In this pilot study, a physician-delivered education intervention was feasible to use in practice and was associated with higher patient kidney disease knowledge. Further examination of physician-delivered education interventions for increasing patient disease understanding should be tested through randomized trials.

Comparative effectiveness of sulfonylurea and metformin monotherapy on cardiovascular events in type 2 diabetes mellitus: a cohort study.

BACKGROUND: The effects of sulfonylureas and metformin on outcomes of cardiovascular disease (CVD) in type 2 diabetes are not well-characterized. OBJECTIVE: To compare the effects of sulfonylureas and metformin on CVD outcomes (acute myocardial infarction and stroke) or death. DESIGN: Retrospective cohort study. SETTING: National Veterans Health Administration databases linked to Medicare files. PATIENTS: Veterans who initiated metformin or sulfonylurea therapy for diabetes. Patients with chronic kidney disease or serious medical illness were excluded. MEASUREMENTS: Composite outcome of hospitalization for acute myocardial infarction or stroke, or death, adjusted for baseline demographic characteristics; medications; cholesterol, hemoglobin A1c, and serum creatinine levels; blood pressure; body mass index; health care utilization; and comorbid conditions. RESULTS: Among 253 690 patients initiating treatment (98 665 with sulfonylurea therapy and 155 025 with metformin therapy), crude rates of the composite outcome were 18.2 per 1000 person-years in sulfonylurea users and 10.4 per 1000 person-years in metformin users (adjusted incidence rate difference, 2.2 [95% CI, 1.4 to 3.0] more CVD events with sulfonylureas per 1000 person-years; adjusted hazard ratio [aHR], 1.21 [CI, 1.13 to 1.30]). Results were consistent for both glyburide (aHR, 1.26 [CI, 1.16 to 1.37]) and glipizide (aHR, 1.15 [CI, 1.06 to 1.26]) in subgroups by CVD history, age, body mass index, and albuminuria; in a propensity score-matched cohort analysis; and in sensitivity analyses. LIMITATION: Most of the veterans in the study population were white men; data on women and minority groups were limited but reflective of the Veterans Health Administration population. CONCLUSION: Use of sulfonylureas compared with metformin for initial treatment of diabetes was associated with an increased hazard of CVD events or death. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality and the U.S. Department of Health and Human Services.

Understanding patient portal use: implications for medication management.

BACKGROUND: The Internet can be leveraged to provide disease management support, including medication adherence promotion that, when tailored, can effectively improve adherence to medications. The growing adoption of patient portals represents an opportunity to support medication management and adherence more broadly, but virtually no data exist about the real and potential impact of existing portals on these outcomes. OBJECTIVE: We sought to (1) understand who uses an existing patient portal and reasons for use and nonuse, (2) understand how portal users are using a portal to manage their medications, and (3) explore participants' ideas for improving portal functionality for medication management and adherence support. METHODS: A total of 75 adults with type 2 diabetes participated in a mixed-methods study involving focus groups, a survey, and a medical chart review. We used quantitative data to identify differences between portal users and nonusers, and to test the relationship between the frequency of portal use and glycemic control among users. We used qualitative methods to understand how and why participants use a portal and their ideas for improving its medication management functionality. RESULTS: Of the enrolled participants, 81% (61/75) attended a focus group and/or completed a survey; portal users were more likely than nonusers to participate in that capacity (Fisher exact test; P=.01). Users were also more likely than nonusers to be Caucasian/white (Fisher exact test; P<.001), have higher incomes (Fisher exact test; P=.005), and be privately insured (Fisher exact test; P<.001). Users also tended to have more education than nonusers (Mann-Whitney U; P=.05), although this relationship was not significant at P<.05. Among users, more frequent use of a portal was associated with better A1C (Spearman rho =-0.30; P=.02). Reasons for nonuse included not knowing about the portal (n=3), not having access to a computer (n=3), or having a family member serve as an online delegate (n=1). Users reported using the portal to request prescription refills/reauthorizations and to view their medication list, and they were enthusiastic about the idea of added refill reminder functionality. They were also interested in added functionality that could streamline the refill/reauthorization process, alert providers to fill/refill nonadherence, and provide information about medication side effects and interactions. CONCLUSIONS: Although there are disparities in patient portal use, patients use portals to manage their medications, are enthusiastic about further leveraging portals to support medication management and adherence, and those who use a portal more frequently have better glycemic control. However, more features and functionality within a portal platform is needed to maximize medication management and adherence promotion.

Empowering patients to address diabetes care gaps: formative usability testing of a novel patient portal intervention.

Objective: The aim of this study was to design and assess the formative usability of a novel patient portal intervention designed to empower patients with diabetes to initiate orders for diabetes-related monitoring and preventive services. Materials and Methods: We used a user-centered Design Sprint methodology to create our intervention prototype and assess its usability with 3 rounds of iterative testing. Participants (5/round) were presented with the prototype and asked to perform common, standardized tasks using think-aloud procedures. A facilitator rated task performance using a scale: (1) completed with ease, (2) completed with difficulty, and (3) failed. Participants completed the System Usability Scale (SUS) scored 0-worst to 100-best. All testing occurred remotely via Zoom. Results: We identified 3 main categories of usability issues: distrust about the automated system, content concerns, and layout difficulties. Changes included improving clarity about the ordering process and simplifying language; however, design constraints inherent to the electronic health record system limited our ability to respond to all usability issues (eg, could not modify fixed elements in layout). Percent of tasks completed with ease across each round were 67%, 60%, and 80%, respectively. Average SUS scores were 87, 74, and 93, respectively. Across rounds, participants found the intervention valuable and appreciated the concept of patient-initiated ordering. Conclusions: Through iterative user-centered design and testing, we improved the usability of the patient portal intervention. A tool that empowers patients to initiate orders for disease-specific services as part of their existing patient portal account has potential to enhance the completion of recommended health services and improve clinical outcomes.

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/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.

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.

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.