Digital health outreach to promote postpartum screening after gestational diabetes: A randomized factorial pilot study.

Objective: We examined the acceptability and feasibility of a multi-component digital health outreach intervention to promote uptake of guideline-recommended postpartum screening for type 2 diabetes among patients with gestational diabetes (GDM). Methods: We conducted a 24 randomized factorial experiment as part of the Multiphase Optimization Strategy (MOST) preparation phase for developing behavioral interventions. Participants with current or recent GDM in an integrated healthcare system were randomized to receive an outreach message with up to four intervention components, designed to be self-administered in about 10 min and efficiently delivered online via REDCap: a streamlined values affirmation, personalized information on diabetes risk, an interactive motivational interviewing-based component, and an interactive action planning component. Patient-reported acceptability and feasibility outcomes were assessed via survey. Results: Among 162 participants, 72% self-identified with a racial/ethnic minority group. Across components, acceptability scores averaged 3.9/5; ≥91% of participants read most or all of the outreach message; ≥89% perceived the amount of information as "about right"; and ≥ 87% completed ≥1 interactive prompt. Conclusion: Each intervention component was acceptable to diverse patients and feasible to deliver in a brief, self-directed, online format. Innovation: These novel components target unaddressed barriers to patient engagement in guideline-recommended postpartum diabetes screening and adapt theory-based behavior change techniques for large-scale use.

Prenatal Health Care Outcomes Before and During the COVID-19 Pandemic Among Pregnant Individuals and Their Newborns in an Integrated US Health System.

Importance: The COVID-19 pandemic accelerated the use of telemedicine. However, data on the integration of telemedicine in prenatal health care and health outcomes are sparse. Objective: To evaluate a multimodal model of in-office and telemedicine prenatal health care implemented during the COVID-19 pandemic and its association with maternal and newborn health outcomes. Design, Setting, and Participants: This cohort study of pregnant individuals using longitudinal electronic health record data was conducted at Kaiser Permanente Northern California, an integrated health care system serving a population of 4.5 million people. Individuals who delivered a live birth or stillbirth between July 1, 2018, and October 21, 2021, were included in the study. Data were analyzed from January 2022 to May 2023. Exposure: Exposure levels to the multimodal prenatal health care model were separated into 3 intervals: unexposed (T1, birth delivery between July 1, 2018, and February 29, 2020), partially exposed (T2, birth delivery between March 1, 2020, and December 5, 2020), and fully exposed (T3, birth delivery between December 6, 2020, and October 31, 2021). Main Outcomes and Measures: Primary outcomes included rates of preeclampsia and eclampsia, severe maternal morbidity, cesarean delivery, preterm birth, and neonatal intensive care unit (NICU) admission. The distributions of demographic and clinical characteristics, care processes, and health outcomes for birth deliveries within each of the 3 intervals of interest were assessed with standardized mean differences calculated for between-interval contrasts. Interrupted time series analyses were used to examine changes in rates of perinatal outcomes and its association with the multimodal prenatal health care model. Secondary outcomes included gestational hypertension, gestational diabetes, depression, venous thromboembolism, newborn Apgar score, transient tachypnea, and birth weight. Results: The cohort included 151 464 individuals (mean [SD] age, 31.3 [5.3] years) who delivered a live birth or stillbirth. The mean (SD) number of total prenatal visits was similar in T1 (9.41 [4.75] visits), T2 (9.17 [4.50] visits), and T3 (9.15 [4.66] visits), whereas the proportion of telemedicine visits increased from 11.1% (79 214 visits) in T1 to 20.9% (66 726 visits) in T2 and 21.3% (79 518 visits) in T3. NICU admission rates were 9.2% (7014 admissions) in T1, 8.3% (2905 admissions) in T2, and 8.6% (3615 admissions) in T3. Interrupted time series analysis showed no change in NICU admission risk during T1 (change per 4-week interval, -0.22%; 95% CI, -0.53% to 0.09%), a decrease in risk during T2 (change per 4-week interval, -0.91%; 95% CI, -1.77% to -0.03%), and an increase in risk during T3 (change per 4-week interval, 1.75%; 95% CI, 0.49% to 3.02%). There were no clinically relevant changes between T1, T2, and T3 in the rates of risk of preeclampsia and eclampsia (change per 4-week interval, 0.76% [95% CI, 0.39% to 1.14%] for T1; -0.19% [95% CI, -1.19% to 0.81%] for T2; and -0.80% [95% CI, -2.13% to 0.55%] for T3), severe maternal morbidity (change per 4-week interval , 0.12% [95% CI, 0.40% to 0.63%] for T1; -0.39% [95% CI, -1.00% to 1.80%] for T2; and 0.99% [95% CI, -0.88% to 2.90%] for T3), cesarean delivery (change per 4-week interval, 0.06% [95% CI, -0.11% to 0.23%] for T1; -0.03% [95% CI, -0.49% to 0.44%] for T2; and -0.05% [95% CI, -0.68% to 0.59%] for T3), preterm birth (change per 4-week interval, 0.23% [95% CI, -0.11% to 0.57%] for T1; -0.37% [95% CI, -1.29% to 0.55%] for T2; and -0.15% [95% CI, -1.41% to 1.13%] for T3), or secondary outcomes. Conclusions and Relevance: These findings suggest that a multimodal prenatal health care model combining in-office and telemedicine visits performed adequately compared with in-office only prenatal health care, supporting its continued use after the pandemic.

Uptake of guideline-recommended postpartum diabetes screening among diverse women with gestational diabetes: associations with patient factors in an integrated health system in USA.

INTRODUCTION: Clinical guidelines urge timely postpartum screening for diabetes among women with gestational diabetes mellitus (GDM), yet patient factors associated with screening uptake remain unclear. We aimed to identify patient factors associated with completed postpartum diabetes screening (2-hour oral glucose tolerance test within 4-12 weeks postpartum), as recommended by the American Diabetes Association (ADA). RESEARCH DESIGN AND METHODS: Within the context of Gestational Diabetes' Effects on Moms (GEM), a pragmatic cluster randomized trial (2011-2012), we examined survey and electronic health record data to assess clinical and sociodemographic factors associated with uptake of ADA-recommended postpartum screening. Participants included 1642 women (76% racial/ethnic minorities) identified with GDM according to the Carpenter and Coustan criteria in a health system that deploys population-level strategies to promote screening. To contextualize these analyses, screening rates derived from the GEM trial were compared with those in the health system overall using registry data from a concurrent 10-year period (2007-2016, n=21 974). RESULTS: Overall 52% (n=857) completed recommended postpartum screening in the analytic sample, comparable to 45.7% (n=10 040) in the registry. Screening in the analytic sample was less likely among women at elevated risk for type 2 diabetes, assessed using items from an ADA risk test (vs non-elevated; adjusted rate ratio (aRR)=0.86 (95% CI 0.75 to 0.98)); perinatal depression (0.88 (0.79 to 0.98)); preterm delivery (0.84 (0.72 to 0.98)); parity ≥2 children (vs 0; 0.80 (0.69 to 0.93)); or less than college education (0.79 (0.72 to 0.86)). Screening was more likely among Chinese Americans (vs White; 1.31 (1.15 to 1.49)); women who attended a routine postpartum visit (5.28 (2.99 to 9.32)); or women who recalled receiving healthcare provider advice about screening (1.31 (1.03 to 1.67)). CONCLUSIONS: Guideline-recommended postpartum diabetes screening varied by patient clinical and sociodemographic factors. Findings have implications for developing future strategies to improve postpartum care.

Racial/Ethnic Disparities in the Prevalence of Diabetes and Prediabetes by BMI: Patient Outcomes Research To Advance Learning (PORTAL) Multisite Cohort of Adults in the U.S.

OBJECTIVE: To examine racial/ethnic disparities in the prevalence of diabetes and prediabetes by BMI category. RESEARCH DESIGN AND METHODS: In a consortium of three U.S. integrated health care systems, 4,906,238 individuals aged ≥20 years during 2012-2013 were included. Diabetes and prediabetes were ascertained by diagnosis and laboratory results; antihyperglycemic medications were also included for diabetes ascertainment. RESULTS: The age-standardized diabetes and prediabetes prevalence estimates were 15.9% and 33.4%, respectively. Diabetes but not prediabetes prevalence increased across BMI categories among all racial/ethnic groups (P for trend < 0.001). Racial/ethnic minorities reached a given diabetes prevalence at lower BMIs than whites; Hawaiians/Pacific Islanders and Asians had a diabetes prevalence of 24.6% (95% CI 24.1-25.2%) in overweight and 26.5% (26.3-26.8%) in obese class 1, whereas whites had a prevalence of 23.7% (23.5-23.8%) in obese class 2. The age-standardized prediabetes prevalence estimates in overweight among Hispanics (35.6% [35.4-35.7%]), Asians (38.1% [38.0-38.3%]), and Hawaiians/Pacific Islanders (37.5% [36.9-38.2%]) were similar to those in obese class 4 among whites (35.3% [34.5-36.0%]), blacks (36.8% [35.5-38.2%]), and American Indians/Alaskan Natives (34.2% [29.6-38.8%]). In adjusted models, the strength of association between BMI and diabetes was highest among whites (relative risk comparing obese class 4 with normal weight 7.64 [95% CI 7.50-7.79]) and lowest among blacks (3.16 [3.05-3.27]). The association between BMI and prediabetes was less pronounced. CONCLUSIONS: Racial/ethnic minorities had a higher burden of diabetes and prediabetes at lower BMIs than whites, suggesting the role of factors other than obesity in racial/ethnic disparities in diabetes and prediabetes risk and highlighting the need for tailored screening and prevention strategies.

Plasma phospholipid n-3 and n-6 polyunsaturated fatty acids in relation to cardiometabolic markers and gestational diabetes: A longitudinal study within the prospective NICHD Fetal Growth Studies.

BACKGROUND: Despite dietary recommendations of polyunsaturated fatty acids (PUFAs) for cardiometabolic health, n-3 and n-6 PUFAs and their interplay in relation to diabetes risk remain debated. Importantly, data among pregnant women are scarce. We investigated individual plasma phospholipid n-3 and n-6 PUFAs in early to midpregnancy in relation to subsequent risk of gestational diabetes mellitus (GDM). METHODS AND FINDINGS: Within the National Institute of Child Health and Human Development (NICHD) Fetal Growth Studies-Singleton Cohort (n = 2,802), individual plasma phospholipid n-3 and n-6 PUFAs levels were measured at gestational weeks (GWs) 10-14, 15-26, 23-31, and 33-39 among 107 GDM cases (ascertained on average at GW 27) and 214 non-GDM controls. Conditional logistic regression was used, adjusting for major risk factors for GDM. After adjusting for covariates, individual n-3 eicosapentaenoic acid (EPA), docosapentaenoic acid (DPA), and docosahexaenoic acid (DHA) were inversely correlated with insulin-resistance markers, whereas individual n-6 dihomo-gamma-linolenic acid (DGLA) was positively correlated with insulin-resistance markers. At GW 15-26, a standard deviation (SD) increase in total n-3 PUFAs and individual n-3 DPA was associated with a 36% (adjusted odds ratio 0.64; 95% CI 0.42-0.96; P = 0.042) and 33% (0.67; 95% CI 0.45-0.99; P = 0.047) lower risk of GDM, respectively; however, the significance did not persist after post hoc false-discovery rate (FDR) correction (FDR-corrected P values > 0.05). Associations between total n-6 PUFAs and GDM were null, whereas associations with individual n-6 PUFAs were differential. Per SD increase, gamma-linolenic acid (GLA) at GWs 10-14 and DGLA at GWs 10-14 and 15-26 were significantly associated with a 1.40- to 1.95-fold higher risk of GDM, whereas docosatetraenoic acid (DTA) at GW 15-26 was associated with a 45% (0.55; 95% CI 0.37-0.83) lower risk of GDM (all FDR-corrected P values < 0.05). Null associations were observed for linoleic acid (LA) in either gestational window in relation to risk of GDM. Women with high (≥median) n-3 PUFAs and low (

Gestational weight gain and optimal wellness (GLOW): rationale and methods for a randomized controlled trial of a lifestyle intervention among pregnant women with overweight or obesity.

BACKGROUND: Excess gestational weight gain (GWG) is common among women with overweight or obesity, increasing their risks for pregnancy complications, delivering a large infant, and postpartum weight retention. To date, only intensive interventions have had success and few interventions have been designed for implementation in healthcare settings. METHODS: We describe the development, rationale, and methods of GLOW (GestationaL Weight Gain and Optimal Wellness), a randomized controlled trial evaluating the efficacy of a lifestyle intervention to prevent excess GWG among racially/ethnically diverse women with overweight or obesity in an integrated healthcare delivery system. Participants in Kaiser Permanente Northern California will be randomized, within 2 weeks of completing a study baseline clinic visit at 10 weeks' gestation, to either usual medical care or a multi-component pregnancy lifestyle intervention adapted from the Diabetes Prevention Program (target N = 400). Informed by focus groups with patients and designed to be feasible in a clinical setting, the intervention will include 13 weekly individual sessions (11 delivered by telephone) focused on behavior change for weight management, healthy eating, physical activity, and stress management. Outcomes will be assessed in women and their infants from randomization to 12 months postpartum. The primary outcome is GWG. Secondary outcomes include changes in diet and physical activity during pregnancy and infant birthweight. Exploratory outcomes include cardiometabolic profile assessed via pregnancy blood samples and cord blood samples; and postpartum weight retention and infant anthropometrics up to 12 months of age. The trial includes systematic approaches to enhance intervention fidelity, intervention adherence, and participant retention in trial assessments. DISCUSSION: GLOW is among few trials targeting excess GWG among diverse women with overweight or obesity in a healthcare setting, with long-term maternal and infant outcomes assessed up to 12 months after delivery. This evaluation of a multi-component intervention is designed to produce generalizable results to inform potential adoption of the intervention in clinical settings. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02130232 ): submitted April 30, 2014; posted May 5, 2014.

Leveraging EHRs for patient engagement: perspectives on tailored program outreach.

OBJECTIVES: Electronic health records (EHRs) present healthcare delivery systems with scalable, cost-effective opportunities to promote lifestyle programs among patients at high risk for type 2 diabetes, yet little consensus exists on strategies to enhance patient engagement. We explored patient perspectives on program outreach messages containing content tailored to EHR-derived diabetes risk factors-a theory-driven strategy to increase the persuasiveness of health communications. STUDY DESIGN: Convergent mixed methods. METHODS: Within an integrated healthcare delivery system, women with a history of gestational diabetes participated in 1 of 6 ethnic-specific focus groups to elicit diverse perspectives and a survey yielding quantitative data to contextualize qualitative responses. RESULTS: The sample included 35 participants (80% racial/ethnic minorities; mean age = 36 years). Themes regarding tailored messages centered on diabetes risk communication (opposing attitudes about whether to feature diabetes risk factors), privacy (how and whether patient data should be accessed), authenticity (perceiving messages as personalized vs generically computer generated), and preferences for messages sent by one's personal physician. Trust in the medical profession and perceived risk for diabetes were similar to levels reported in comparable samples. CONCLUSIONS: Patient reactions highlight the challenges of leveraging EHRs for tailored messages. Some viewed messages as caring reminders to take preventive action and others raised concerns over intrusiveness. Optimal lifestyle program outreach to improve quality of care for women at high risk for diabetes may require communication from personal physicians, careful development to mitigate concerns over privacy and authenticity, and techniques to counteract the threatening nature of personalized risk communication.

Cardiometabolic Risk Factors Among 1.3 Million Adults With Overweight or Obesity, but Not Diabetes, in 10 Geographically Diverse Regions of the United States, 2012-2013.

INTRODUCTION: Various phenotypes of overweight and obesity pose various health risks. The objective of this study was to determine the prevalence of 4 commonly measured cardiometabolic risk factors (CRFs) among adults with overweight or obesity, but not diabetes, at the time of the study. METHODS: We analyzed data for 1,294,174 adults (aged ≥20 y) who were members of one of 4 integrated health systems. Each cohort member had a body mass index in 2012 or 2013 that indicated overweight or obesity. We determined the presence of 4 CRFs within 1 year of the first BMI measurement: elevated blood pressure (systolic ≥130 mm Hg or diastolic >85 mm Hg or ICD-9-CM [International Classification of Diseases, Ninth Revision, Clinical Modification] diagnosis code 401.0-405.9); elevated triglycerides (≥150 mg/dL or ICD-9-CM 272.1); low high-density lipoprotein cholesterol (<40 mg/dL for men or <50 mg/dL for women or ICD-9-CM 272.5); and prediabetes (fasting glucose 100-125 mg/dL or HbA1c 5.7%-6.4% or ICD-9-CM 790.2x). We tested the risk of having 1 or more CRFs after adjusting for obesity class and demographic characteristics with multivariable logistic regression. RESULTS: Among participants with overweight (52.5% of the sample), 18.6% had none of the 4 CRFs. Among the 47.5% of participants with obesity, 9.6% had none; among participants with morbid obesity, 5.8% had none. Age was strongly associated with CRFs in multivariable analysis. CONCLUSION: Almost 10% of participants with obesity had no CRFs. Overweight or obesity increases cardiometabolic risk, but the number and type of CRFs varied substantially by age, even among participants with morbid obesity.

Trends and racial and ethnic disparities in the prevalence of pregestational type 1 and type 2 diabetes in Northern California: 1996-2014.

BACKGROUND: Despite concern for adverse perinatal outcomes in women with diabetes mellitus before pregnancy, recent data on the prevalence of pregestational type 1 and type 2 diabetes mellitus in the United States are lacking. OBJECTIVE: The purpose of this study was to estimate changes in the prevalence of overall pregestational diabetes mellitus (all types) and pregestational type 1 and type 2 diabetes mellitus and to estimate whether changes varied by race-ethnicity from 1996-2014. STUDY DESIGN: We conducted a cohort study among 655,428 pregnancies at a Northern California integrated health delivery system from 1996-2014. Logistic regression analyses provided estimates of prevalence and trends. RESULTS: The age-adjusted prevalence (per 100 deliveries) of overall pregestational diabetes mellitus increased from 1996-1999 to 2012-2014 (from 0.58 [95% confidence interval, 0.54-0.63] to 1.06 [95% confidence interval, 1.00-1.12]; Ptrend <.0001). Significant increases occurred in all racial-ethnic groups; the largest relative increase was among Hispanic women (121.8% [95% confidence interval, 84.4-166.7]); the smallest relative increase was among non-Hispanic white women (49.6% [95% confidence interval, 27.5-75.4]). The age-adjusted prevalence of pregestational type 1 and type 2 diabetes mellitus increased from 0.14 (95% confidence interval, 0.12-0.16) to 0.23 (95% confidence interval, 0.21-0.27; Ptrend <.0001) and from 0.42 (95% confidence interval, 0.38-0.46) to 0.78 (95% confidence interval, 0.73-0.83; Ptrend <.0001), respectively. The greatest relative increase in the prevalence of type 1 diabetes mellitus was in non-Hispanic white women (118.4% [95% confidence interval, 70.0-180.5]), who had the lowest increases in the prevalence of type 2 diabetes mellitus (13.6% [95% confidence interval, -8.0 to 40.1]). The greatest relative increase in the prevalence of type 2 diabetes mellitus was in Hispanic women (125.2% [95% confidence interval, 84.8-174.4]), followed by African American women (102.0% [95% confidence interval, 38.3-194.3]) and Asian women (93.3% [95% confidence interval, 48.9-150.9]). CONCLUSIONS: The prevalence of overall pregestational diabetes mellitus and pregestational type 1 and type 2 diabetes mellitus increased from 1996-1999 to 2012-2014 and racial-ethnic disparities were observed, possibly because of differing prevalence of maternal obesity. Targeted prevention efforts, preconception care, and disease management strategies are needed to reduce the burden of diabetes mellitus and its sequelae.

Telephone-Based Coaching.

PURPOSE: Many Americans continue to smoke, increasing their risk of disease and premature death. Both telephone-based counseling and in-person tobacco cessation classes may improve access for smokers seeking convenient support to quit. Little research has assessed whether such programs are effective in real-world clinical populations. DESIGN: Retrospective cohort study comparing wellness coaching participants with two groups of controls. SETTING: Kaiser Permanente Northern California, a large integrated health care delivery system. SUBJECTS: Two hundred forty-one patients who participated in telephonic tobacco cessation coaching from January 1, 2011, to March 31, 2012, and two control groups: propensity-score-matched controls, and controls who participated in a tobacco cessation class during the same period. Wellness coaching participants received an average of two motivational interviewing-based coaching sessions that engaged the patient, evoked their reason to consider quitting, and helped them establish a quit plan. MEASURES: Self-reported quitting of tobacco and fills of tobacco cessation medications within 12 months of follow-up. ANALYSIS: Logistic regressions adjusting for age, gender, race/ethnicity, and primary language. RESULTS: After adjusting for confounders, tobacco quit rates were higher among coaching participants vs. matched controls (31% vs. 23%, p < .001) and comparable to those of class attendees (31% vs. 29%, p = .28). Coaching participants and class attendees filled tobacco-cessation prescriptions at a higher rate (47% for both) than matched controls (6%, p < .001). CONCLUSION: Telephonic wellness coaching was as effective as in-person classes and was associated with higher rates of quitting compared to no treatment. The telephonic modality may increase convenience and scalability for health care systems looking to reduce tobacco use and improve health.

Associations Between Maternal Pregravid Obesity and Gestational Diabetes and the Timing of Pubarche in Daughters.

We investigated whether in utero exposure to maternal pregravid obesity and/or gestational diabetes mellitus (GDM) was associated with early puberty in girls. We used data from a longitudinal study of 421 mother-daughter pairs enrolled in an integrated health services organization, Kaiser Permanente Northern California (2005-2012). Girls aged 6-8 years were followed annually through ages 12-14 years. Onset of puberty was assessed using study clinic-based Tanner staging. We examined associations of self-reported pregravid obesity and maternal GDM with timing of the daughter's transition to pubertal maturation stage 2 or above for development of breasts and pubic hair, using accelerated failure time regression models with interval censoring to estimate time ratios and hazard ratios and corresponding 95% confidence intervals. Maternal obesity (pregravid body mass index (BMI; weight (kg)/height (m)(2)) ≥30) was associated with a daughter's earlier transition to breast and pubic hair stage 2+ in comparison with girls whose mothers had pregravid BMI <25. These associations were attenuated and not statistically significant after adjustment for covariates. Girls whose mothers had both pregravid BMI ≥25 and GDM were at higher risk of an earlier transition to pubic hair stage 2+ than those whose mothers had neither condition (adjusted time ratio = 0.89, 95% confidence interval: 0.83, 0.96; hazard ratio = 2.97, 95% confidence interval: 1.52, 5.83). These findings suggest that exposure to maternal obesity and hyperglycemia places girls at higher risk of earlier pubarche.

Patient satisfaction and perceived success with a telephonic health coaching program: the Natural Experiments for Translation in Diabetes (NEXT-D) Study, Northern California, 2011.

INTRODUCTION: Health coaching can improve lifestyle behaviors known to prevent or manage chronic conditions such as diabetes. However, little is known about the patient experience with telephonic coaching programs in real-world care settings. We examined patient satisfaction, patient's perceived success in achieving program goals, and the patient-level correlates of these outcomes in a voluntary telephonic coaching program at a large integrated health care delivery system in northern California. METHODS: Kaiser Permanente Northern California patients who participated in a telephonic coaching program in 2011 were sent a cross-sectional survey about their satisfaction with health coaching and perceived success with program goals. We examined associations with patient characteristics. RESULTS: The survey response rate was 34%; analyses were based on the 32% who completed the survey. Of those who had completed 2 or more sessions (n = 232 [52%]), most reported being satisfied (70%) or neutral (20%) with the program, and 71% would recommend health coaching. Healthy weight, healthful eating, and physical activity were the most common topics discussed (88%). Adjusting for demographic characteristics, 73% of those who had 2 or more sessions reported that health coaching helped achieve their weight-related goal. Outcomes were positively correlated with patient activation but not consistently correlated with patient demographic characteristics. CONCLUSION: Levels of satisfaction and perceived success with telephonic health coaching provided by a health plan were high and positively correlated with the number of sessions completed and patient activation. Voluntary telephonic health coaching programs should promote retention and assess patients' activation levels.

Surgical outcomes of total knee replacement according to diabetes status and glycemic control, 2001 to 2009.

BACKGROUND: Poor glycemic control in patients with diabetes may be associated with adverse surgical outcomes. We sought to determine the association of diabetes status and preoperative glycemic control with several surgical outcomes, including revision arthroplasty and deep infection. METHODS: We conducted a retrospective cohort study in five regions of a large integrated health-care organization. Eligible subjects, identified from the Kaiser Permanente Total Joint Replacement Registry, underwent an elective first primary total knee arthroplasty during 2001 through 2009. Data on demographics, diabetes status, preoperative hemoglobin A1c (HbA1c) level, and comorbid conditions were obtained from electronic medical records. Subjects were classified as nondiabetic, diabetic with HbA1c < 7% (controlled diabetes), or diabetic with HbA1c ≥ 7% (uncontrolled diabetes). Outcomes were deep venous thrombosis or pulmonary embolism within ninety days after surgery and revision surgery, deep infection, incident myocardial infarction, and all-cause rehospitalization within one year after surgery. Patients without diabetes were the reference group in all analyses. All models were adjusted for age, sex, body mass index, and Charlson Comorbidity Index. RESULTS: Of 40,491 patients who underwent total knee arthroplasty, 7567 (18.7%) had diabetes, 464 (1.1%) underwent revision arthroplasty, and 287 (0.7%) developed a deep infection. Compared with the patients without diabetes, no association between controlled diabetes (HbA1c < 7%) and the risk of revision (odds ratio [OR], 1.32; 95% confidence interval [CI], 0.99 to 1.76), risk of deep infection (OR, 1.31; 95% CI, 0.92 to 1.86), or risk of deep venous thrombosis or pulmonary embolism (OR, 0.84; 95% CI, 0.60 to 1.17) was observed. Similarly, compared with patients without diabetes, no association between uncontrolled diabetes (HbA1c ≥ 7%) and the risk of revision (OR, 1.03; 95% CI, 0.68 to 1.54), risk of deep infection (OR, 0.55; 95% CI 0.29 to 1.06), or risk of deep venous thrombosis or pulmonary embolism (OR, 0.70; 95% CI, 0.43 to 1.13) was observed. CONCLUSIONS: No significantly increased risk of revision arthroplasty, deep infection, or deep venous thrombosis was found in patients with diabetes (as defined on the basis of preoperative HbA1c levels and other criteria) compared with patients without diabetes in the study population of patients who underwent elective total knee arthroplasty.

Study of Women, Infant Feeding, and Type 2 diabetes mellitus after GDM pregnancy (SWIFT), a prospective cohort study: methodology and design.

BACKGROUND: Women with history of gestational diabetes mellitus (GDM) are at higher risk of developing type 2 diabetes within 5 years after delivery. Evidence that lactation duration influences incident type 2 diabetes after GDM pregnancy is based on one retrospective study reporting a null association. The Study of Women, Infant Feeding and Type 2 Diabetes after GDM pregnancy (SWIFT) is a prospective cohort study of postpartum women with recent GDM within the Kaiser Permanente Northern California (KPNC) integrated health care system. The primary goal of SWIFT is to assess whether prolonged, intensive lactation as compared to formula feeding reduces the 2-year incidence of type 2 diabetes mellitus among women with GDM. The study also examines whether lactation intensity and duration have persistent favorable effects on blood glucose, insulin resistance, and adiposity during the 2-year postpartum period. This report describes the design and methods implemented for this study to obtain the clinical, biochemical, anthropometric, and behavioral measurements during the recruitment and follow-up phases. METHODS: SWIFT is a prospective, observational cohort study enrolling and following over 1, 000 postpartum women diagnosed with GDM during pregnancy within KPNC. The study enrolled women at 6-9 weeks postpartum (baseline) who had been diagnosed by standard GDM criteria, aged 20-45 years, delivered a singleton, term (greater than or equal to 35 weeks gestation) live birth, were not using medications affecting glucose tolerance, and not planning another pregnancy or moving out of the area within the next 2 years. Participants who are free of type 2 diabetes and other serious medical conditions at baseline are screened for type 2 diabetes annually within the first 2 years after delivery. Recruitment began in September 2008 and ends in December 2011. Data are being collected through pregnancy and early postpartum telephone interviews, self-administered monthly mailed questionnaires (3-11 months postpartum), a telephone interview at 6 months, and annual in-person examinations at which a 75 g 2-hour OGTT is conducted, anthropometric measurements are obtained, and self- and interviewer-administered questionnaires are completed. DISCUSSION: This is the first, large prospective, community-based study involving a racially and ethnically diverse cohort of women with recent GDM that rigorously assesses lactation intensity and duration and examines their relationship to incident type 2 diabetes while accounting for numerous potential confounders not assessed previously.

Comparison of glyburide and insulin for the management of gestational diabetes in a large managed care organization.

OBJECTIVE: This study was undertaken to compare the use of glyburide with insulin for the treatment of gestational diabetes mellitus (GDM) unresponsive to diet therapy. STUDY DESIGN: A retrospective study was performed among women with singleton pregnancies who had GDM diagnosed, with fasting plasma glucose 140 mg/dL or less on glucose tolerance testing, between 12 and 34 weeks who failed diet therapy from 1999 to 2002. We identified 584 women and compared those treated with insulin between 1999 and 2000 with women treated with glyburide between 2001 and 2002. Maternal and neonatal outcomes and complications were assessed. Statistical methods included univariate analyses and multivariable logistic regression. RESULTS: In 1999 through 2000, 268 women had GDM diagnosed and were treated with insulin; in 2001 through 2002, 316 women had GDM diagnosed of which 236 (75%) received glyburide. The 2 groups were similar with regard to age, nulliparity, and historical GDM risk factors; however, women in the insulin group had a higher mean body mass index (31.9 vs 30.6 kg/m 2 , P=.04), a greater proportion identified themselves as white (43%, 28%, P<.001) and fewer as Asian (24%, 37%, P=.001), and they had a significantly higher mean fasting on glucose tolerance test (105.4 vs 102.4 mg/dL , P=.005) compared with the glyburide group. There were no significant differences in birth weight (3599+/-650 g vs 3661+/-629 g, P=.3), macrosomia (24%, 25%, P=.7), or cesarean delivery (35%, 39 %, P=.4). Women in the glyburide group had a higher incidence of preeclampsia (12%, 6%, P=.02), and neonates in the glyburide group were more likely to receive phototherapy (9%, 5%, P<.05), and less likely to be admitted to the neonatal intensive care unit (NICU) (15%, 24%, P=.008) though they had a longer NICU length of stay (4.3+/-9.6 vs 8.0+/-10.1, P=.002). Posttreatment glycemic control data were available for 122 women treated with insulin and 137 women treated with glyburide. More women in the glyburide group achieved mean fasting and postprandial goals (86%, 63%, P<.001). These findings remained significant in logistic regression analysis. CONCLUSION: In a large managed care organization, glyburide was at least as effective as insulin in achieving glycemic control and similar birth weights in women with GDM who failed diet therapy. The increased risk of preeclampsia and phototherapy in the glyburide group warrant further study.