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National Variations in Comorbidities, Glycosylated Hemoglobin Reduction, and Insulin Dosage in Asian Patients with Type 2 Diabetes: The FINE-Asia Registry.

ABSTRACT: INTRODUCTION:The First Basal Insulin Evaluation (FINE) Asia study was a prospective, observational registry evaluating basal insulin initiation in Asian patients with type 2 diabetes mellitus inadequately controlled by oral antihyperglycemic agents. METHODS:The objective of this post hoc analysis was to observe and report the findings from individual participating countries. The primary endpoint was change in glycosylated hemoglobin (HbA1c) from baseline to month 6 after basal insulin initiation. Secondary endpoints included change in fasting blood glucose (FBG), percent of patients achieving target HbA1c and FBG levels, average insulin doses, and hypoglycemic events. RESULTS:The study included 2921 patients from 11 Asian countries at baseline, 2679 (92%) of whom had evaluable data. Following initiation of basal insulin (neutral protamine Hagedorn insulin, glargine, or detemir), there was a significant (P < 0.001) difference in HbA1c reduction and proportions of patients meeting HbA1c and FBG targets (<7% and <110 mg/dL, respectively) across all country cohorts by month 6. Glycemic control also varied greatly, with 7.4% (Taiwan) to 71.5% (China) of patients reaching target HbA1c <7% levels. Mean (±standard deviation) insulin dose increases over the 6-month period ranged from 0.5 ± 3.1 U (Pakistan) to 6.0 ± 8.6 U (Thailand). Hypoglycemia rates also varied, with 7.1% (India) to 27.3% (China) of patients experiencing one or more events. CONCLUSIONS:Data from the FINE-Asia registry study show widely varying degrees of baseline comorbidities and glycemic control in patients among the country cohorts observed. Countries with >9 years of diabetes prior to insulin initiation had the lowest reductions in HbA1c and proportions of patients achieving HbA1c and FBG targets, suggesting that earlier basal insulin initiation may afford better glycemic control in these patients. FUNDING:This study was funded by Sanofi.

SUBMITTER: Ji L

PROVIDER: S-EPMC4674463 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background: While the relationship between hemoglobin (Hb) concentrations and pregnancy outcomes has been studied often, most reports have focused on a specific Hb cutoff used to define anemia. Fewer studies have evaluated pregnancy outcomes across the entire range of Hb values. Moreover, to date, most studies of the relationship of Hb concentrations to pregnancy outcomes have been done in high-income countries. Thus, we have sought to determine the relationship between the range of maternal Hb concentrations and adverse birth outcomes among South Asian pregnant women.Methods: For this study, we used data collected from two South Asian countries (Pakistan - Sindh Province and two sites in India - Belagavi and Nagpur) in a prospective maternal and newborn health registry study. To assess the association between Hb concentrations and various maternal and fetal outcomes, we classified the Hb concentrations into seven categories. Regression analyses adjusting for multiple potential confounders were performed to assess adverse pregnancy outcomes across the range of Hb concentrations.Findings: Between January 2012 and December 2018, 130,888 pregnant women were enrolled in the South Asian sites had a Hb measurement available, delivered and were included in the analyses. Overall, the mean Hb concentration of pregnant women from the sites was 9.9?g/dL, 10.0?g/dL in the Indian sites and 9.5?g/dL in the Pakistan site. Hb concentrations <?7?g/dL were observed in 6.9% of the pregnant Pakistani women and 0.2% of the Indian women. In both the Pakistani and Indian sites, women with higher parity and women with no formal education had lower Hb concentrations. In the Pakistani site, women >?35?years of age, women with ?4 children and those who enrolled in the third trimester were more likely to have Hb concentrations of <?7?g/dL but these associations were not found for the Indian sites. When adjusting for potential confounders, for both India and Pakistan, lower Hb concentrations were associated with stillbirth, preterm birth, lower mean birthweight, and increased risk of low birthweight. In the Pakistani site, there was evidence of a U-shaped relationship between Hb concentrations and low birth weight, and neonatal mortality, and in India with hypertensive disease.Interpretation: This study documented the relationship between maternal Hb concentrations and adverse pregnancy outcomes in women from the Pakistani and Indian sites across the range of Hb values. Both low and high Hb concentrations were associated with risk of at least some adverse outcomes. Hence, both low and high values of Hb should be considered risk factors for the mother and fetus.

Project description:BackgroundAir pollution exposures have been shown to adversely impact health through a number of biological pathways associated with glucose metabolism. However, few studies have evaluated the associations between air pollution and glycosylated hemoglobin (HbA1c) levels. Further, no studies have evaluated these associations in US populations or investigated whether associations differ in diabetic as compared to non-diabetic populations. To address this knowledge gap, we investigated the associations between airborne fine particulate matter (PM2.5) and nitrogen dioxide (NO2) and HbA1c levels in both diabetic and non-diabetic older Americans. We also examined the impact of PM2.5 and NO2 on prevalent diabetes mellitus (DM) in this cohort.MethodsWe used multilevel logistic and linear regression models to evaluate the association between long-term average air pollutant levels and prevalence of DM and HbA1c levels, respectively, among 4121 older (57+ years) Americans enrolled in the National Social Life, Health, and Aging Project between 2005 and 2011. All models adjusted for age, sex, body mass index, smoking status, race, household income, education level, neighborhood socioeconomic status, geographic region, urbanicity and diabetic medication use. We estimated participant-specific exposures to PM2.5 on a six-kilometer grid covering the conterminous U.S. using spatio-temporal models, and to NO2 using nearest measurements from the Environmental Protection Agency's Air Quality System. HbA1c levels were measured for participants in each of two data collection waves from dried blood spots and log-transformed prior to analysis. Participants were considered diabetic if they had HbA1c values≥6.5% or reported taking diabetic medication.ResultsThe prevalence of diabetes at study entry was 22.2% (n=916) and the mean HbA1c was 6.0±1.1%. Mean one-year moving average PM2.5 and NO2 exposures were 10.4±3.0μg/m3 and 13.1±7.0 ppb, respectively. An inter-quartile range (IQR, 3.9μg/m3) increase in one-year moving average PM2.5 was positively associated with increased diabetes prevalence (prevalence odds ratio, POR 1.35, 95% CI: 1.19, 1.53). Similarly, an IQR (8.6 ppb) increase in NO2 was also significantly associated with diabetes prevalence (POR 1.27, 95% CI: 1.10, 1.48). PM2.5 (1.8%±0.6%, p<0.01) and NO2 (2.0%±0.7%, p<0.01) exposures were associated with higher HbA1c levels in diabetic participants, while only NO2 was significantly associated with HbA1c in non-diabetic participants (0.8%±0.2%, p<0.01). Significant dose response relationships were identified for both pollutants in diabetic participants and for NO2 in non-diabetic participants.Conclusions/interpretationsIn a cohort of older men and women in the United States, PM2.5 and NO2 exposures were significantly associated with prevalence of DM and increased HbA1c levels among both non-diabetic and diabetic participants. These associations suggest that air pollution could be a key risk factor for abnormal glucose metabolism and diabetes in the elderly.

Dataset Information

National Variations in Comorbidities, Glycosylated Hemoglobin Reduction, and Insulin Dosage in Asian Patients with Type 2 Diabetes: The FINE-Asia Registry.

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