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  • 1
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    Online Resource
    281-OR: Neonatal Outcomes in Early and Incident Gestational Diabetes Mellitus—Are They Normalized with Treatment from 24–28 Weeks’ Gestation?
    American Diabetes Association ; 2023
    In:  Diabetes Vol. 72, No. Supplement_1 ( 2023-06-20)
    Details
    In: Diabetes, American Diabetes Association, Vol. 72, No. Supplement_1 ( 2023-06-20)
    Abstract: Aim: To compare neonatal outcomes between women with early GDM (eGDM: diagnosed & lt;20 weeks’ gestation), incident GDM (iGDM: diagnosed ≥ 24 weeks’ gestation) and normoglycemia Methods: Pregnant women with GDM risk factors were enrolled & lt;20 weeks’ gestation into an eGDM treatment trial across 17 sites in Australia, India, Europe. Women undertook a 2-h 75g oral glucose tolerance test on entry & at 24-28 weeks’ gestation. GDM was defined by WHO 2013 criteria. Logistic regression compared outcomes between women with eGDM, iGDM and normoglycemia adjusted for age, body mass index (BMI), site, smoking status, parity and tertiary qualifications. Women randomized to receive eGDM treatment were excluded from this analysis. Results: Baseline characteristics differed by age, BMI, parity and glycemia across the 3211 women (Table 1). Similar proportions of eGDM and iGDM women received pharmacotherapy. eGDM group gestational weight gain was lower; eGDM and iGDM neonatal outcomes were similar; neonatal intensive care unit admission and respiratory distress were higher in offspring of eGDM than normoglycemic women. Conclusions: Adverse neonatal outcomes are increased in pregnancies complicated by eGDM with delayed treatment. Disclosure D.Simmons: Consultant; Sanofi, Speaker's Bureau; Abbott Diabetes. M.Mclean: None. A.Sweeting: None. V.Mohan: None. J.Harreiter: None. Tobogm core investigator group: n/a. J.Immanuel: None. N.Cheung: None. W.Hague: None. H.Teede: None. C.J.Nolan: None. H.E.Backman: None. E.Hibbert: None. M.J.Peek: None. Funding National Health and Medical Research Council (1104231, 2009326); Region Örebro Research Committee (OLL-970566, OLL-942177); Medical Scientific Fund of the Mayor of Vienna (15205); South Western Sydney Local Health District Academic Unit (2016); Western Sydney University Ainsworth Trust (2019)
    Type of Medium: Online Resource
    ISSN: 0012-1797
    URL: Article
    DOI: 10.2337/db23-281-OR
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2023
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  • 2
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    Evaluation of an Algorithm to Guide Patients With Type 1 Diabetes Treated With Continuous Subcutaneous Insulin Infusion on How to Respond to Real-Time Continuous Glucose Levels
    American Diabetes Association ; 2010
    In:  Diabetes Care Vol. 33, No. 6 ( 2010-06-01), p. 1242-1248
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 33, No. 6 ( 2010-06-01), p. 1242-1248
    Abstract: To evaluate an algorithm guiding responses of continuous subcutaneous insulin infusion (CSII)–treated type 1 diabetic patients using real-time continuous glucose monitoring (RT-CGM). RESEARCH DESIGN AND METHODS Sixty CSII-treated type 1 diabetic participants (aged 13–70 years, including adult and adolescent subgroups, with A1C ≤9.5%) were randomized in age-, sex-, and A1C-matched pairs. Phase 1 was an open 16-week multicenter randomized controlled trial. Group A was treated with CSII/RT-CGM with the algorithm, and group B was treated with CSII/RT-CGM without the algorithm. The primary outcome was the difference in time in target (4–10 mmol/l) glucose range on 6-day masked CGM. Secondary outcomes were differences in A1C, low (≤3.9 mmol/l) glucose CGM time, and glycemic variability. Phase 2 was the week 16–32 follow-up. Group A was returned to usual care, and group B was provided with the algorithm. Glycemia parameters were as above. Comparisons were made between baseline and 16 weeks and 32 weeks. RESULTS In phase 1, after withdrawals 29 of 30 subjects were left in group A and 28 of 30 subjects were left in group B. The change in target glucose time did not differ between groups. A1C fell (mean 7.9% [95% CI 7.7–8.2to 7.6% [7.2–8.0]; P & lt; 0.03) in group A but not in group B (7.8% [7.5–8.1] to 7.7 [7.3–8.0] ; NS) with no difference between groups. More subjects in group A achieved A1C ≤7% than those in group B (2 of 29 to 14 of 29 vs. 4 of 28 to 7 of 28; P = 0.015). In phase 2, one participant was lost from each group. In group A, A1C returned to baseline with RT-CGM discontinuation but did not change in group B, who continued RT-CGM with addition of the algorithm. CONCLUSIONS Early but not late algorithm provision to type 1 diabetic patients using CSII/RT-CGM did not increase the target glucose time but increased achievement of A1C ≤7%. Upon RT-CGM cessation, A1C returned to baseline.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc09-1481
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2010
    detail.hit.zdb_id: 1490520-6
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  • 3
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    Effects of Medical Therapy on Insulin Resistance and the Cardiovascular System in Polycystic Ovary Syndrome
    American Diabetes Association ; 2007
    In:  Diabetes Care Vol. 30, No. 3 ( 2007-03-01), p. 471-478
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 30, No. 3 ( 2007-03-01), p. 471-478
    Abstract: OBJECTIVE—We aimed to determine the impact of medical therapy for symptom management on insulin resistance, metabolic profiles, and surrogate markers of cardiovascular disease in polycystic ovary syndrome (PCOS), an insulin-resistant pre-diabetes condition. RESEARCH DESIGN AND METHODS—One hundred overweight women (BMI & gt;27 kg/m2), average age 31 years, who were nonsmokers, were not pregnant, did not have diabetes, and were off relevant medications for 3 months completed this 6-month open-label controlled trial. Randomization was to a control group (higher-dose oral contraceptive [OCP] 35 μg ethinyl estradiol [EE] /2 mg cyproterone acetate, metformin [1 g b.d.] or low-dose OCP [20 μg EE/100 μg levonorgestrel + aldactone 50 mg b.d.] ). Primary outcome measures were insulin resistance (area under curve on oral glucose tolerance test) and surrogate markers of cardiovascular disease including arterial stiffness (pulse wave velocity [PWV]) and endothelial function. RESULTS—All treatments similarly and significantly improved symptoms including hirsutism and menstrual cycle length. Insulin resistance was improved by metformin and worsened by the high-dose OCP. Arterial stiffness worsened in the higher-dose OCP group (PWV 7.46 vs. 8.03 m/s, P & lt; 0.05), related primarily to the increased insulin resistance. CONCLUSIONS—In overweight women with PCOS, metformin and low- and high-dose OCP preparations have similar efficacy but differential effects on insulin resistance and arterial function. These findings suggest that a low-dose OCP preparation may be preferable if contraception is needed and that metformin should be considered for symptomatic management, particularly in women with additional metabolic and cardiovascular risk factors.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc06-0618
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2007
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  • 4
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    The Impact of Obesity on the Incidence of Type 2 Diabetes Among Women With Polycystic Ovary Syndrome
    American Diabetes Association ; 2019
    In:  Diabetes Care Vol. 42, No. 4 ( 2019-04-01), p. 560-567
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 42, No. 4 ( 2019-04-01), p. 560-567
    Abstract: The nature of the independent relationship between polycystic ovary syndrome (PCOS) and type 2 diabetes remains unclear. Few studies have aimed to clarify this relationship independent of obesity in longitudinal population-based cohorts. RESEARCH DESIGN AND METHODS We used the Australian Longitudinal Study on Women’s Health (ALSWH) (2000–2015) database to estimate nationwide incidence rates and predictors of type 2 diabetes among women aged 18–42 using person-time and survival analysis. RESULTS Over a follow-up of 1,919 person-years (PYs), 186 women developed type 2 diabetes. The incidence rate was 4.19/1,000 PYs and 1.02/1,000 PYs (P & lt; 0.001) in PCOS and control subjects. On subgroup analyses across healthy-weight, overweight, and obese categories of women, the incidence rates for type 2 diabetes were 3.21, 4.67, and 8.80, whereas incidence rate ratios were 4.68, 3.52, and 2.36 (P & lt; 0.005) in PCOS versus age-matched control subjects. PCOS was one of the most influential predictors for type 2 diabetes in the entire cohort (hazard ratio 3.23, 95% CI 2.07–5.05, P & lt; 0.001) adjusting for BMI, education, area of residence, and family history of type 2 diabetes. CONCLUSIONS Women with PCOS are at an increased risk of type 2 diabetes, irrespective of age and BMI. The incidence of type 2 diabetes increases substantially with increasing obesity; yet, PCOS adds a greater relative risk in lean women. Based on the overall moderate absolute clinical risk demonstrated here, guideline recommendations suggest type 2 diabetes screening every 1–3 years in all women with PCOS, across BMI categories and age ranges, with frequency influenced by additional type 2 diabetes risk factors.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc18-1738
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2019
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  • 5
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    Retinol-Binding Protein 4 and Insulin Resistance in Polycystic Ovary Syndrome
    American Diabetes Association ; 2008
    In:  Diabetes Care Vol. 31, No. 7 ( 2008-07-01), p. 1427-1432
    Details
    In: Diabetes Care, American Diabetes Association, Vol. 31, No. 7 ( 2008-07-01), p. 1427-1432
    Abstract: OBJECTIVE—Polycystic ovary syndrome (PCOS) is an insulin-resistant state with insulin resistance being an established therapeutic target; however, measurement of insulin resistance remains challenging. We aimed to 1) determine serum retinol-binding protein 4 (RBP4) levels (purported to reflect insulin resistance) in women with PCOS and control subjects, 2) examine the relationship of RBP4 to conventional markers of insulin resistance, and 3) examine RBP4 changes with interventions modulating insulin resistance in overweight women with PCOS. RESEARCH DESIGN AND METHODS—At baseline, 38 overweight women (BMI & gt;27 kg/m2) with PCOS and 17 weight-matched control subjects were compared. Women with PCOS were then randomly assigned to 6 months of a higher-dose oral contraceptive pill (OCP) (35 μg ethinyl estradiol/2 mg cyproterone acetate) or metformin (1 g b.i.d.). Outcome measures were insulin resistance (total insulin area under the curve) on an oral glucose tolerance test, RBP4, and metabolic/inflammatory markers. RESULTS—Overweight women with PCOS were more insulin resistant than control subjects, yet RBP4 levels were not different in women with PCOS versus those in control subjects (35.4 ± 4.3 vs. 28.9 ± 3.1 μg/ml, P = 0.36). RBP4 correlated with cholesterol and triglycerides but not with insulin resistance. Metformin improved insulin resistance by 35%, whereas the OCP worsened insulin resistance by 33%. However, RBP4 increased nonsignificantly in both groups (43.7 ± 6.3 vs. 42.6 ± 5.5 μg/ml, P = 0.92). CONCLUSIONS—Overweight women with PCOS were more insulin resistant than control subjects, but this finding was not reflected by RBP4 levels. RBP4 correlated with lipid levels but not with insulin resistance markers. RBP4 levels did not change when insulin resistance was reduced by metformin or increased by the OCP. These data suggest that RBP4 is not a useful marker of insulin resistance in PCOS but may reflect other metabolic features of this condition.
    Type of Medium: Online Resource
    ISSN: 0149-5992 , 1935-5548
    URL: Article
    DOI: 10.2337/dc07-2265
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2008
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  • 6
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    168-LB: Prediction for Risk-Stratified Care for Women with Gestational Diabetes: The PeRSonal GDM Study
    American Diabetes Association ; 2020
    In:  Diabetes Vol. 69, No. Supplement_1 ( 2020-06-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 69, No. Supplement_1 ( 2020-06-01)
    Abstract: Objective: To develop and validate a prediction model for adverse pregnancy outcomes at the time of gestational diabetes (GDM) diagnosis to stratify care. Research Design and Methods: A prediction model development and validation study was conducted on data from a retrospective population-based study. The outcome to be predicted was a composite for adverse pregnancy outcome: hypertensive disorder of pregnancy, large-for-gestational (LGA) age neonate, neonatal hypoglycaemia requiring intravenous therapy, shoulder dystocia, perinatal death, neonatal bone fracture and nerve palsy. Results: Predictors of the composite adverse pregnancy outcome were: fasting and 1 hour glucose from the diagnostic OGTT, gestational age of GDM diagnosis, previous macrosomia, previous pre-eclampsia or eclampsia, previous LGA, ethnicity, weight at GDM diagnosis and parity. The apparent performance of the model was reasonable: c-statistic was 0.691 (95% CI, 0.662 - 0.720) and the calibration plot showed near perfect agreement between predicted and observed risks (Figure 1). Conclusions: A promising prediction model for adverse pregnancy outcomes in women with GDM was developed. Model estimation using the Least Absolute Shrinkage and Selection Operator method is currently underway to correct for over-optimism. External validation and decision curve analysis will determine suitability for clinical application. Disclosure S. Cooray: None. J. Boyle: None. G. Soldatos: None. J. Zamora: None. B.M. Fernandez-Felix: None. J. Allotey: None. S. Thangaratinam: None. H. Teede: Other Relationship; Self; Roche Diagnostics France. Funding National Health and Medical Research Council of Australia (APP1151242); Australian Academy of Science; Diabetes Australia Research Program; Medical Research Future Fund of Australia; Australian Government Department of Education and Training (7167_2019)
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db20-168-LB
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2020
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  • 7
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    The Impact of Obesity on Incidence of Type 2 Diabetes Mellitus (T2DM) among Women with Polycystic Ovary Syndrome (PCOS)
    American Diabetes Association ; 2018
    In:  Diabetes Vol. 67, No. Supplement_1 ( 2018-07-01)
    Details
    In: Diabetes, American Diabetes Association, Vol. 67, No. Supplement_1 ( 2018-07-01)
    Abstract: There is controversy surrounding the impact of obesity on the development of type 2 diabetes mellitus (T2DM) among women with polycystic ovary syndrome (PCOS). We aimed to clarify the role of PCOS per se in the development of T2DM by identifying the population-based incidence rate of T2DM among women with PCOS according to risk factors including body-mass index (BMI), ethnicity, and family history of T2DM. We undertook a historical population-based cohort study of women aged 18-23 years followed-up over 15 years (between years 2000 and 2015) using the Australian Longitudinal Study on Women’s Health (ALSWH) database. The study cohort consisted of women with self-reported PCOS and women without a diagnosis of PCOS (controls). We undertook survival analysis to identify potential predictors of T2DM using Cox Proportional Hazard Model and person-time analysis to calculate incidence rates of T2DM per 1000 person-years (PY). During a follow-up of 1,919 years of person-time, 186 women developed T2DM. The incidence rate of T2DM was 4.22 per1000 (PY) in PCOS vs. 1.02 per 1000 PY in controls (p & lt;0.001). The Kaplan-Meier survival probability estimates at 15 years were: 0.952 and 0.988 for women with and without PCOS respectively. On sub-group analyses, BMI categories across lean, overweight, and obese women with PCOS [IRR (incidence rate ratio): 4.68, 3.52 and 2.36)respectively] showed a higher risk for T2DM compared to controls. In the multivariate Cox analysis, PCOS, BMI, education, and family history of T2DM all independently increased the risk for T2DM in all women. PCOS was the strongest predictor [HR: 3.38 (95% CI: 2.21, 5.18), p & lt;0.001] adjusting for BMI, education, and family history of T2DM. PCOS is independently associated with an increased incidence of T2DM among young adult women and this increased risk varies by BMI. Screening of young women for T2DM should be considered, based on their overall diabetes risk taking into account PCOS status, BMI, and other risk factors. Disclosure N. Kakoly: None. A. Earnest: None. H. Teede: None. L. Moran: None. D. Loxton: None. A.E. Joham: None.
    Type of Medium: Online Resource
    ISSN: 0012-1797 , 1939-327X
    URL: Article
    DOI: 10.2337/db18-1612-P
    Language: English
    Publisher: American Diabetes Association
    Publication Date: 2018
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