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Saint Helena, CA, United States

Mathiesen E.R.,Copenhagen University | Hod M.,Tel Aviv University | Ivanisevic M.,University of Zagreb | Garcia S.D.,Hospital Universitario Of Valme | And 4 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - This randomized, controlled noninferiority trial aimed to compare the efficacy and safety of insulin detemir (IDet) versus neutral protamine Hagedorn (NPH) (both with prandial insulin aspart) in pregnant women with type 1 diabetes. RESEARCH DESIGN AND METHODS - Patients were randomized and exposed to IDet or NPH up to 12 months before pregnancy or at 8-12 weeks gestation. The primary analysis aimed to demonstrate noninferiority of IDet to NPH with respect to A1C at 36 gestational weeks (GWs) (margin of 0.4%). The data were analyzed using linear regression, taking several baseline factors and covariates into account. RESULTS - A total of 310 type 1 diabetic women were randomized and exposed to IDet (n = 152) or NPH (n = 158) up to 12 months before pregnancy (48%) or during pregnancy at 8-12 weeks (52%). The estimated A1C at 36 GWs was 6.27% for IDet and 6.33% for NPH in the full analysis set (FAS). IDet was declared noninferior to NPH (FAS, -0.06% [95% CI -0.21 to 0.08]; per protocol, -0.15%[-0.34 to 0.04]). Fasting plasma glucose (FPG) was significantly lower with IDet versus NPH at both 24 GWs (96.8 vs. 113.8 mg/dL, P = 0.012) and 36 GWs (85.7 vs. 97.4 mg/dL, P = 0.017). Major and minor hypoglycemia rates during pregnancy were similar between groups. CONCLUSIONS - Treatment with IDet resulted in lower FPG and noninferior A1C in late pregnancy compared with NPH insulin. Rates of hypoglycemia were comparable. © 2012 by the American Diabetes Association.

Blumer I.,Charles st Diabetes Center | Hadar E.,Helen Schneider Hospital for Women | Hadden D.R.,Royal Victoria Hospital | Jovanovic L.,Sansum Diabetes Research Institute | And 3 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013

Objective: Our objective was to formulate a clinical practice guideline for the management of the pregnant woman with diabetes. Participants: The Task Force was composed of a chair, selected by the Clinical Guidelines Subcommittee of The Endocrine Society, 5 additional experts, a methodologist, and a medical writer. Evidence: This evidence-based guideline was developed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system to describe both the strength of recommendations and the quality of evidence. Consensus Process: One group meeting, several conference calls, and innumerable e-mail communications enabled consensus for all recommendations save one with a majority decision being employed for this single exception. Conclusions: Using an evidence-based approach, this Diabetes and Pregnancy Clinical Practice Guideline addresses important clinical issues in the contemporary management of women with type 1 or type 2 diabetes preconceptionally, during pregnancy, and in the postpartum setting and in the diagnosis and management of women with gestational diabetes during and after pregnancy. Copyright © 2013 by The Endocrine Society.

Zisser H.,Sansum Diabetes Research Institute
International journal of clinical practice. Supplement | Year: 2011

Diet and exercise form the foundation of a healthy lifestyle. These are especially important for people living with diabetes mellitus, as they are the most practical non-pharmacological means by which patients may significantly improve their blood glucose levels. Exercise increases insulin sensitivity (both short and long term), lowers blood sugar levels, reduces body fat and improves cardiovascular (CV) function. Because of this, exercise offers enormous benefit to patients with diabetes. Blood glucose levels can significantly drop during and after physical activities, due to the increased utilisation of glucose as a fuel during exercise and the up-regulation of glucose transport into working muscles. Therefore, patients (especially those with type 1 diabetes) must account for the effects of exercise and adjust their medications and nutrition accordingly. Improvements in real-time continuous glucose monitoring and optimisation of basal insulin dosing may offer significant benefit to preventing hypoglycaemia in patients with type 1 diabetes who regularly exercise. Diverse exercise programmes and devices can also assist patients in monitoring their activities as well as motivating them to achieve their exercise goals. For patients with type 1 diabetes, questions such as how much, how long, how strenuous and what kind of exercise must be addressed in order for healthcare professionals to offer maximum benefit to their patients. Additionally, since patients with type 2 diabetes often have other significant co-morbidities such as obesity and CV disease, care providers must evaluate each patient's risk factors before designing an exercise programme. Several publications in the last year have addressed these issues and may serve as a valuable resource to provide safe and effective recommendations to patients and their healthcare providers. To be included in the Exercise and Diabetes chapter for the 2010 YEARBOOK, we reviewed leading peer-reviewed manuscripts that were published in the period July 2009 to June 2010. PubMed was used in the initial screening of articles. © 2011 Blackwell Publishing Ltd.

The Regents Of The University Of California and Sansum Diabetes Research Institute | Date: 2011-02-11

A method, computer implemented method and associated apparatus for the management of diabetes is provided.

Leary J.,University of California at Davis | Pettitt D.J.,Sansum Diabetes Research Institute | Jovanovic L.,Sansum Diabetes Research Institute
Best Practice and Research: Clinical Endocrinology and Metabolism | Year: 2010

The impact of gestational diabetes on maternal and fetal health has been increasingly recognized. However, universal consensus on the diagnostic methods and thresholds has long been lacking. Published guidelines from major societies differ considerably from one another, ranging in recommendations from aggressive screening to no routine screening at all. As a result, real-world practice is equally varied. The recently published Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study, and two randomized controlled trials evaluating treatment of mild maternal hyperglycemia, have served to confirm the findings of smaller, nonrandomized studies solidifying the link between maternal hyperglycemia and adverse perinatal outcomes. In response to these studies, the International Association of Diabetes and Pregnancy Study Groups (IADPSG) has formulated new guidelines for screening and diagnosis of diabetes in pregnancy. Key components of the IADPSG guidelines include the recommendation to screen high-risk women at the first encounter for pre-gestational diabetes, to screen universally at 24-28 weeks' gestation, and to screen with use of the 75-g oral glucose tolerance test interpreting abnormal fasting, 1-h, and 2-h plasma glucose concentrations as individually sufficient for the diagnosis of gestational diabetes. Furthermore, to translate the continuous association between maternal glucose and adverse outcomes demonstrated in the HAPO cohort, they recommend thresholds for positive screening tests at which the odds of elevated birth weight, cord C-peptide, and fetal percent body fat are 1.75 relative to odds of those outcomes at mean glucose values. © 2010 Published by Elsevier Ltd.

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