Glycemic control and diabetes complications across health status categories in older adults treated with insulin or insulin secretagogues: The Diabetes & Aging Study.

BACKGROUND: For older adults with type 2 diabetes (T2D) treated with insulin or sulfonylureas, Endocrine Society guideline recommends HbA1c between 7% to <7.5% for those in good health, 7.5% to <8% for those in intermediate health, and 8% to <8.5% for those in poor health. Our aim was to examine associations between attained HbA1c below, within (reference), or above recommended target range and risk of complication or mortality. METHODS: Retrospective cohort study of adults ≥65 years old with T2D treated with insulin or sulfonylureas from an integrated healthcare delivery system. Cox proportional hazards models of complications during 2019 were adjusted for sociodemographic and clinical variables. Primary outcome was a combined outcome of any microvascular or macrovascular event, severe hypoglycemia, or mortality during 12-month follow-up. RESULTS: Among 63,429 patients (mean age: 74.2 years, 46.8% women), 8773 (13.8%) experienced a complication. Complication risk was significantly elevated for patients in good health (n = 16,895) whose HbA1c was above (HR 1.97, 95% CI 1.62-2.41) or below (HR 1.29, 95% CI 1.02-1.63) compared to within recommended range. Among those in intermediate health (n = 30,129), complication risk was increased for those whose HbA1c was above (HR 1.45, 95% CI 1.30-1.60) but not those below the recommended range (HR 0.99, 95% CI 0.89-1.09). Among those in poor health (n = 16,405), complication risk was not significantly different for those whose HbA1c was below (HR 0.98, 95% CI 0.89-1.09) or above (HR 0.96, 95% CI 0.88-1.06) recommended range. CONCLUSIONS: For older adults with T2D in good health, HbA1c below or above the recommended range was associated with significantly elevated complication risk. However, for those in poor health, achieving specific HbA1c levels may not be helpful in reducing the risk of complications.

Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes.

Importance: Continuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking. Objective: To estimate clinical outcomes of real-time CGM initiation. Design, Setting, and Participants: Exploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included. Exposures: Initiation vs noninitiation of real-time CGM (reference group). Main Outcomes and Measures: Ten end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits. Results: The real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason. Conclusions and Relevance: In this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.

Clinical Response to Real-Time Patient-Reported Diabetic Peripheral Neuropathy Symptoms.

INTRODUCTION: To assess clinician response to real-time patient-reported data about diabetic peripheral neuropathy (DPN) symptoms, we analyzed DPN diagnosis and treatment patterns after administration of a 4-question symptom questionnaire in a large vertically integrated health care system. METHODS: Retrospective cohort study to analyze data from 160,852 patients screened for DPN symptoms from April 2012 to March 2014. Electronic medical record data were used to study changes in DPN diagnosis, treatment initiation, and treatment intensification. We used logistic regression to study the association of patient characteristics with the odds of clinical response. RESULTS: Of patients queried, 50,684 (31.5%) reported symptoms. Patients reporting DPN symptoms experienced a greater increase in new DPN diagnoses (16 percentage points; p < 0.0001) and medication use (4 percentage points; p < 0.0001) compared with those denying symptoms. Among patients reporting symptoms, women and nonwhite patients were less likely to receive a DPN diagnosis, whereas older patients were more likely to receive a DPN diagnosis. Overall, patients who were older, were Asian (hazard ratio = 0.67, 95% confidence interval = 0.63-0.77), and had lower socioeconomic status (hazard ratio = 0.89, 95% confidence interval = 0.80-0.99) were less likely to be treated. However, these racial and socioeconomic differences were not statistically significant for patients with preexisting DPN diagnoses. CONCLUSION: Patients' real-time reports of DPN symptoms were associated with increased clinical activity. Patient- and clinician-level factors associated with the likelihood of receiving a DPN diagnosis need further study because a formal diagnosis may be associated with more equitable treatment.

Adherence to Newly Prescribed Diabetes Medications Among Insured Latino and White Patients With Diabetes.

Importance: Medication adherence is essential to diabetes care. Patient-physician language barriers may affect medication adherence among Latino individuals. Objective: To determine the association of patient race/ethnicity, preferred language, and physician language concordance with patient adherence to newly prescribed diabetes medications. Design, Setting, and Participants: This observational study was conducted from January 1, 2006, to December 31, 2012, at a large integrated health care delivery system with professional interpreter services. Insured patients with type 2 diabetes, including English-speaking white, English-speaking Latino, or limited English proficiency (LEP) Latino patients with newly prescribed diabetes medication. Exposures: Patient race/ethnicity, preferred language, and physician self-reported Spanish-language fluency. Main Outcomes and Measures: Primary nonadherence (never dispensed), early-stage nonpersistence (dispensed only once), late-stage nonpersistence (received ≥2 dispensings, but discontinued within 24 months), and inadequate overall medication adherence (>20% time without sufficient medication supply during 24 months after initial prescription). Results: Participants included 21 878 white patients, 5755 English-speaking Latino patients, and 3205 LEP Latino patients with a total of 46 131 prescriptions for new diabetes medications. Among LEP Latino patients, 50.2% (n = 1610) had a primary care physician reporting high Spanish fluency. For oral medications, early adherence varied substantially: 1032 LEP Latino patients (32.2%), 1565 English-speaking Latino patients (27.2%), and 4004 white patients (18.3%) were either primary nonadherent or early nonpersistent. Inadequate overall adherence was observed in 1929 LEP Latino patients (60.2%), 2975 English-speaking Latino patients (51.7%), and 8204 white patients (37.5%). For insulin, early-stage nonpersistence was 42.8% among LEP Latino patients (n = 1372), 34.4% among English-speaking Latino patients (n = 1980), and 28.5% among white patients (n = 6235). After adjustment for patient and physician characteristics, LEP Latino patients were more likely to be nonadherent to oral medications and insulin than English-speaking Latino patients (relative risks from 1.11 [95% CI, 1.06-1.15] to 1.17 [95% CI, 1.02-1.34]; P < .05) or white patients (relative risks from 1.36 [95% CI, 1.31-1.41] to 1.49 [95% CI, 1.32-1.69]; P < .05). English-speaking Latino patients were more likely to be nonadherent compared with white patients (relative risks from 1.23 [95% CI, 1.19-1.27] to 1.30 [95% CI, 1.23-1.39]; P < .05). Patient-physician language concordance was not associated with rates of nonadherence among LEP Latinos (relative risks from 0.92 [95% CI, 0.71-1.19] to 1.04 [95% CI, 0.97-1.1]; P > .28). Conclusions and Relevance: Nonadherence to newly prescribed diabetes medications is substantially greater among Latino than white patients, even among English-speaking Latino patients. Limited English proficiency Latino patients are more likely to be nonadherent than English-speaking Latino patients independent of the Spanish-language fluency of their physicians. Interventions beyond access to interpreters or patient-physician language concordance will be required to improve medication adherence among Latino patients with diabetes.

Association of Patient-Physician Language Concordance and Glycemic Control for Limited-English Proficiency Latinos With Type 2 Diabetes.

Importance: Providing culturally competent care to the growing number of limited-English proficiency (LEP) Latinos with diabetes in the United States is challenging. Objective: To evaluate changes in risk factor control among LEP Latinos with diabetes who switched from language-discordant (English-only) primary care physicians (PCPs) to language-concordant (Spanish-speaking) PCPs or vice versa. Design, Setting, and Participants: This pre-post, difference-in-differences study selected 1605 adult patients with diabetes who self-identified as Latino, whose preferred language was Spanish, and who switched PCPs between January 1, 2007, and December 31, 2013. Study participants were members of the Kaiser Permanente Northern California health care system (an integrated health care delivery system with access to bilingual PCPs and/or professional interpreter services). Spanish-speaking and English-only PCPs were identified by self-report or utilization data. Exposures: Change in patient-PCP language concordance after switching PCPs. Main Outcomes and Measures: Glycemic control (glycated hemoglobin [HbA1c] < 8%), poor glycemic control (HbA1c > 9%), low-density-lipoprotein (LDL) control (LDL < 100 mg/dL), and systolic blood pressure (SBP) control (SBP < 140 mm Hg). Results: Overall, 1605 LEP Latino adults with diabetes (mean [SD] age, 60.5 [13.1] years) were included in this study, and there was a significant net improvement in glycemic and LDL control among patients who switched from language-discordant PCPs to concordant PCPs relative to those who switched from one discordant PCP to another discordant PCP. After adjustment and accounting for secular trends, the prevalence of glycemic control increased by 10% (95% CI, 2% to 17%; P = .01), poor glycemic control decreased by 4% (95% CI, -10% to 2%; P = .16) and LDL control increased by 9% (95% CI, 1% to 17%; P = .03). No significant changes were observed in SBP control. Prevalence of LDL control increased 15% (95% CI, 7% to 24%; P < .001) among LEP Latinos who switched from concordant to discordant PCPs. Risk factor control did not worsen following a PCP switch in any group. Conclusions and Relevance: We observed significant improvements in glycemic control among LEP Latino patients with diabetes who switched from language-discordant to concordant PCPs. Facilitating language-concordant care may be a strategy for diabetes management among LEP Latinos.

Identifying Spanish Language Competent Physicians: The Diabetes Study of Northern California (DISTANCE).

OBJECTIVES: Language barriers negatively impact health care access and quality for US immigrants. Latinos are the second largest immigrant group and the largest, fastest growing minority. Health care systems need simple, low cost and accurate tools that they can use to identify physicians with Spanish language competence. We sought to address this need by validating a simple and low-cost tool already in use in a major health plan. DESIGN SETTING PARTICIPANTS: A web-based survey conducted in 2012 among physicians caring for patients in a large, integrated health care delivery system. Of the 2,198 survey respondents, 111 were used in additional analysis involving patient report of those physicians' fluency. MAIN OUTCOME MEASURES: We compared health care physicians' responses to a single item, Spanish language self-assessment tool (measuring "medical proficiency") with patient-reported physician language competence, and two validated physician self-assessment tools (measuring "fluency" and "confidence"). RESULTS: Concordance between medical proficiency was moderate with patient reports (weighted Kappa .45), substantial with fluency (weighted Kappa .76), and moderate-to-substantial with confidence (weighted Kappas .53 to .66). CONCLUSIONS: The single-question self-reported medical proficiency tool is a low-cost tool useful for quickly identifying Spanish competent physicians and is potentially suitable for use in clinical settings. A reasonable approach for health systems is to designate only those physicians who self-assess their Spanish medical proficiency as "high" as competent to provide care without an interpreter.

Financial Strain and Medication Adherence among Diabetes Patients in an Integrated Health Care Delivery System: The Diabetes Study of Northern California (DISTANCE).

OBJECTIVE: To examine self-reported financial strain in relation to pharmacy utilization adherence data. DATA SOURCES/STUDY SETTING: Survey, administrative, and electronic medical data from Kaiser Permanente Northern California. STUDY DESIGN: Retrospective cohort design (2006, n = 7,773). DATA COLLECTION/EXTRACTION METHODS: We compared survey self-reports of general and medication-specific financial strain to three adherence outcomes from pharmacy records, specifying adjusted generalized linear regression models. PRINCIPAL FINDINGS: Eight percent and 9 percent reported general and medication-specific financial strain. In adjusted models, general strain was significantly associated with primary nonadherence (RR = 1.37; 95 percent CI: 1.04-1.81) and refilling late (RR = 1.34; 95 percent CI: 1.07-1.66); and medication-specific strain was associated with primary nonadherence (RR = 1.42, 95 percent CI: 1.09-1.84). CONCLUSIONS: Simple, minimally intrusive questions could be used to identify patients at risk of poor adherence due to financial barriers.

Ethnic Differences in Geriatric Conditions and Diabetes Complications Among Older, Insured Adults With Diabetes: The Diabetes and Aging Study.

OBJECTIVE: The aim of this study was to evaluate ethnic differences in burden of prevalent geriatric conditions and diabetic complications among older, insured adults with diabetes. METHOD: An observational study was conducted among 115,538 diabetes patients, aged ≥60, in an integrated health care system with uniform access to care. RESULTS: Compared with Whites, Asians and Filipinos were more likely to be underweight but had substantively lower prevalence of falls, urinary incontinence, polypharmacy, depression, and chronic pain, and were least likely of all groups to have at least one geriatric condition. African Americans had significantly lower prevalence of incontinence and falls, but higher prevalence of dementia; Latinos had a lower prevalence of falls. Except for end-stage renal disease (ESRD), Whites tended to have the highest rates of prevalent diabetic complications. DISCUSSION: Among these insured older adults, ethnic health patterns varied substantially; differences were frequently small and rates were often better among select minority groups, suggesting progress toward the Healthy People 2020 objective to reduce health disparities.

Impact of a pharmacy benefit change on new use of mail order pharmacy among diabetes patients: the Diabetes Study of Northern California (DISTANCE).

OBJECTIVE: To assess the impact of a pharmacy benefit change on mail order pharmacy (MOP) uptake. DATA SOURCES/STUDY SETTING: Race-stratified, random sample of diabetes patients in an integrated health care delivery system. STUDY DESIGN: In this natural experiment, we studied the impact of a pharmacy benefit change that conditionally discounted medications if patients used MOP and prepaid two copayments. We compared MOP uptake among those exposed to the benefit change (n = 2,442) and the reference group with no benefit change (n = 8,148), and estimated differential MOP uptake across social strata using a difference-in-differences framework. DATA COLLECTION/EXTRACTION METHODS: Ascertained MOP uptake (initiation among previous nonusers). PRINCIPAL FINDINGS: Thirty percent of patients started using MOP after receiving the benefit change versus 9 percent uptake among the reference group (p < .0001). After adjustment, there was a 26 percentage point greater MOP uptake (benefit change effect). This benefit change effect was significantly smaller among patients with inadequate health literacy (15 percent less), limited English proficiency (14 percent less), and among Latinos and Asians (24 and 16 percent less compared to Caucasians). CONCLUSIONS: Conditionally discounting medications delivered by MOP effectively stimulated MOP uptake overall, but it unintentionally widened previously existing social gaps in MOP use because it stimulated less MOP uptake in vulnerable populations.

Incidence of remission in adults with type 2 diabetes: the diabetes & aging study.

OBJECTIVE: To estimate the incidence of remission in adults with type 2 diabetes not treated with bariatric surgery and to identify variables associated with remission. RESEARCH DESIGN AND METHODS: We quantified the incidence of diabetes remission and examined its correlates among 122,781 adults with type 2 diabetes in an integrated healthcare delivery system. Remission required the absence of ongoing drug therapy and was defined as follows: 1) partial: at least 1 year of subdiabetic hyperglycemia (hemoglobin A1c [HbA1c] level 5.7-6.4% [39-46 mmol/mol]); 2) complete: at least 1 year of normoglycemia (HbA1c level <5.7% [<39 mmol/mol]); and 3) prolonged: complete remission for at least 5 years. RESULTS: The incidence density (remissions per 1,000 person-years; 95% CI) of partial, complete, or prolonged remission was 2.8 (2.6-2.9), 0.24 (0.20-0.28), and 0.04 (0.01-0.06), respectively. The 7-year cumulative incidence of partial, complete, or prolonged remission was 1.47% (1.40-1.54%), 0.14% (0.12-0.16%), and 0.007% (0.003-0.020%), respectively. The 7-year cumulative incidence of achieving any remission was 1.60% in the whole cohort (1.53-1.68%) and 4.6% in the subgroup with new-onset diabetes (<2 years since diagnosis) (4.3-4.9%). After adjusting for demographic and clinical characteristics, correlates of remission included age >65 years, African American race, <2 years since diagnosis, baseline HbA1c level <5.7% (<39 mmol/mol), and no diabetes medication at baseline. CONCLUSIONS: In community settings, remission of type 2 diabetes does occur without bariatric surgery, but it is very rare.

Use of the refill function through an online patient portal is associated with improved adherence to statins in an integrated health system.

BACKGROUND: Online patient portals are being widely implemented, but their impact on health behaviors are not well-studied. OBJECTIVE: To determine whether statin adherence improved after initiating use of the portal refill function. RESEARCH DESIGN: Observational cohort study within an integrated health care delivery system. SUBJECTS: Diabetic patients on statins who had registered for online portal access by 2010. A total of 8705 subjects initiated the online refill function use within the study window, including "exclusive" and "occasional" users (ie, requesting all vs. some refills online, respectively). Using risk-set sampling, we temporally matched 9055 reference group patients who never used online refills. MEASURES: We calculated statin adherence before and after refill function initiation, assessed as percent time without medications (nonadherence defined as a gap of >20%). Secondary outcome was dyslipidemia [low-density lipoprotein (LDL)≥ 100]. Difference-in-differences regression models estimated pre-post changes in nonadherence and dyslipidemia, comparing refill function users to the reference group and adjusting for age, sex, race/ethnicity, medications, frequency of portal use, and outpatient visits. RESULTS: In unadjusted examinations, nonadherence decreased only among patients initiating occasional or exclusive use of the refill function (26%-24% and 22%-15%, respectively). In adjusted models, nonadherence declined by an absolute 6% (95% confidence interval, 4%-7%) among exclusive users, without significant changes among occasional users. Similar LDL decreases were also seen among exclusive users. CONCLUSIONS: Compared with portal users who did not refill medications online, adherence to statin medications and LDL levels improved among diabetic patients who initiated and exclusively used the patient portal for refills, suggesting that wider adoption of online refills may improve adherence.

Glycemic response to newly initiated diabetes therapies.

OBJECTIVE: The glycemic response to antihyperglycemic therapies for type 2 diabetes has been thoroughly evaluated in randomized controlled trials, but inadequately studied in real-world settings. STUDY DESIGN: We studied glycemic response among 15 126 type 2 diabetic patients who initiated any single new antihyperglycemic agent (metformin, sulfonylureas, thiazolidinediones, or insulin added to medical nutrition therapy or to existing diabetes therapies) during 1999-2000 within Kaiser Permanente of Northern California, an integrated healthcare delivery system. METHODS: Pre-post (3-12 months after initiation) change in glycosylated hemoglobin (A1C) was analyzed using ANCOVA (analysis of covariance) models adjusted for baseline A1C, concurrent (ongoing) antihyperglycemic therapy, demographics, health behaviors, medication adherence, clinical factors, and processes of care. RESULTS: Mean A1C was 9.01% (95% confidence interval [CI] 8.98%-9.04%) before therapy initiation and 7.87% (95% CI 7.85%-7.90%) 3 to 12 months after initiation (mean A1C reduction 1.14 percentage points; 95% CI 1.11-1.17). Overall, 30.2% (95% CI 29.2%-31.1%) of patients achieved glycemic target (A1C < 7%). Although baseline disease severity and concurrent therapies differed greatly across therapeutic classes, after adjustment for these baseline clinical characteristics, no significant differences were noted in glucose-lowering effect across therapeutic classes. Treatment effects did not differ by age, race, diabetes duration, obesity, or level of renal function. CONCLUSIONS: Metformin, sulfonylures, thiazolidinediones, and insulin were equally effective in improving glucose control. Nonetheless, most patients failed to achieve the glycemic target. Findings suggest that, to keep up with progressive worsening of glycemic control, patients and providers must commit to earlier, more aggressive therapy intensification, triggered promptly after A1C exceeds the recommended glycemic target.

Longitudinal study of new and prevalent use of self-monitoring of blood glucose.

OBJECTIVE: We sought to assess longitudinal association between self-monitoring of blood glucose (SMBG) and glycemic control in diabetic patients from an integrated health plan (Kaiser Permanente Northern California). RESEARCH DESIGN AND METHODS: Longitudinal analyses of glycemic control among 1) 16,091 patients initiating SMBG (new-user cohort) and 2) 15,347 ongoing users of SMBG (prevalent-user cohort). SMBG frequency was based on pharmacy use (number of blood glucose test strips dispensed), and glycemic control was based on HbA(1c) (A1C). In the new-user cohort, ANCOVA models (pre- and posttest design) were used to assess the effect of initiating SMBG. In the prevalent-user cohort, repeated-measure, mixed-effects models with random-intercept and time-dependent covariates were used to assess changes in SMBG and A1C. All models were stratified by therapy (no medications, oral agents only, or insulin) and adjusted for baseline A1C, sociodemographics, insulin injection frequency, comorbidity index, medication adherence, smoking status, health care use, and provider specialty. RESULTS: Greater SMBG practice frequency among new users was associated with a graded decrease in A1C (relative to nonusers) regardless of diabetes therapy (P < 0.0001). Changes in SMBG frequency among prevalent users were associated with an inverse graded change in A1C only among pharmacologically treated patients (P < 0.0001). CONCLUSIONS: These observational findings are consistent with short-term benefits of initiating SMBG practice for all patients but continuing benefits only for pharmacologically treated patients. Differences in effectiveness between new versus prevalent users of SMBG have implications for guideline development and interpretation of observational outcomes data.