Scripps Whittier Diabetes Institute

Black Point-Green Point, CA, United States

Scripps Whittier Diabetes Institute

Black Point-Green Point, CA, United States
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Philis-Tsimikas A.,Scripps Whittier Diabetes Institute | Brod M.,Julia Group, The | Niemeyer M.,Novo Nordisk AS | Ocampo Francisco A.M.,Novo Nordisk AS | Rothman J.,University Physicians Group Research Division
Advances in Therapy | Year: 2013

Introduction: Insulin degludec (IDeg) is a new basal insulin in development with a flat, ultra-long action profile that may permit dosing using a simplified titration algorithm with less frequent self-measured blood glucose (SMBG) measurements and more simplified titration steps than currently available basal insulins. Methods: This 26-week, multi-center, open-label, randomized, treat-to-target study compared the efficacy and safety of IDeg administered once-daily in combination with metformin in insulin-naïve subjects with type 2 diabetes using two different patient-driven titration algorithms: a "Simple" algorithm, with dose adjustments based on one pre-breakfast SMBG measurement (n = 111) versus a "Step-wise" algorithm, with adjustments based on three consecutive pre-breakfast SMBG values (n = 111). IDeg was administered using the FlexTouch® insulin pen (Novo Nordisk A/S, Bagsværd, Denmark), with once-weekly dose titration in both groups. Results: Glycosylated hemoglobin (HbA1c) decreased from baseline to week 26 in both groups (-1.09%, IDegSimple; -0.93%, IDeg Step-wise). IDegSimple was non-inferior to IDeg Step-wise in lowering HbA1c [estimated treatment difference (IDegSimple - IDegStep-wise): -0.16% points (-0.39; 0.07)95% CI]. Fasting plasma glucose was reduced (-3.27 mmol/L, IDegSimple; -2.68 mmol/L, IDegStep-wise) with no significant difference between groups. Rates of confirmed hypoglycemia [1.60, IDegSimple; 1.17, IDegStep-wise events/patient year of exposure (PYE)] and nocturnal confirmed hypoglycemia (0.21, IDeg Simple; 0.10, IDegStep-wise events/PYE) were low, with no significant differences between groups. Daily insulin dose after 26 weeks was 0.61 U/kg (IDegSimple) and 0.50 U/kg (IDegStep-wise). No significant difference in weight change was seen between groups by week 26 (+1.6 kg, IDegSimple; +1.1 kg, IDegStep-wise), and there were no clinically relevant differences in adverse event profiles. Conclusion: IDeg was effective and well tolerated using either the Simple or Step-wise titration algorithm. While selection of an algorithm must be based on individual patient characteristics and goals, the ability to attain good glycemic control using a simplified titration algorithm may enable patient empowerment through self-titration, improved convenience, and reduced costs. © 2013 Springer Healthcare.

Philis-Tsimikas A.,Scripps Whittier Diabetes Institute
The Journal of family practice | Year: 2016

Insulin degludec (IDeg) is a long-acting basal human insulin analog produced using recombinant DNA technology. The insulin structure is modified at the B30 position to allow a di-hexamer conformation in the presence of phenol and zinc.

Dec. 8, 2016 -- (BRONX, NY) --The National Institutes of Health has awarded researchers at Albert Einstein College of Medicine and Montefiore Health System a five-year, $2.9-million grant to launch a new center, one of only 8 in the country, for diabetes translation research. The center -- the New York Regional Center for Diabetes Translation Research (NY Regional CDTR)--also includes faculty from the Icahn School of Medicine at Mt. Sinai and the New York Academy of Medicine and will serve as a collaborative hub for investigators conducting studies on pre-diabetes, diabetes and its complications. The two principal investigators on the grant are Elizabeth A. Walker, Ph.D., R.N., professor of medicine and of epidemiology & population health at Einstein, and Judith Wylie-Rosett, Ed.D., R.D. professor and division head of health promotion and nutrition research in the department of epidemiology & population health, and Atran Foundation Chair in Social Medicine at Einstein. "Our overall goal is to improve the health of people who have diabetes or are at risk for developing it, with a focus on low-income communities and various racial and ethnic groups that are disproportionately affected by the disease and poor access to care," says Dr. Wylie-Rosett. "Einstein and Montefiore have a long-standing commitment to social justice, and this center provides a way for us to share our research expertise with others trying to reduce health disparities and promote health equity." Members of certain ethnic and racial groups -- including Latinos/Hispanics, African-Americans and Asian-Americans -- face a higher risk for developing diabetes than do non-Latino white adults. They are also at increased risk for diabetes-related complications, such as lower limb amputations, vision loss and kidney failure. In addition, diabetes is 70 percent more common in high-poverty neighborhoods than in more affluent ones. This regional research center will concentrate on improving diabetes prevention, care and diabetes self-management education among these groups through research activities. "Our center will support and promote collaborative, innovative programs of research to tailor diabetes interventions for different ethnicities and age groups and to reduce obesity, a major risk factor for diabetes, and make the best use of electronic medical records and telecommunication -- efforts aimed at prevention of diabetes and its complications," says Dr. Walker. "We are particularly excited that the center will include the newly-created Latino Network for Diabetes Translation Research, a joint effort with investigators from the NIH-funded Hispanic Community Health Study (HCHS)/Study of Latinos (SOL)," adds Dr. Walker. Consultative resources within the NY Regional CDTR will support diabetes prevention and control research: across the lifespan; in population health and health systems; and for intervention research methods including biological, behavioral, psychological and social factors. Other key Einstein-Montefiore faculty leaders include: associate center directors Carmen Isasi, M.D., Ph.D. and Jeffrey S. Gonzalez, Ph.D. and co-investigators Carol Derby, Ph.D., M. Diane McKee, M.D., M.S. and Urvashi Patel, Ph.D., M.P.H.. The new center's multidisciplinary members include 77 investigators doing research in diabetes prevention and control from 16 institutions including: Columbia University; Weill Cornell Medical College; Drexel University; University of Massachusetts Medical School at Worcester; New York University; Penn State University; San Diego State University; Scripps Whittier Diabetes Institute; Stanford University; Tufts University; University of California at Irvine; and University of Illinois at Chicago. The grant is titled "The New York Regional Center for Diabetes Translation Research" (P30DK111022). Albert Einstein College of Medicine is one of the nation's premier centers for research, medical education and clinical investigation. During the 2016-2017 academic year, Einstein is home to 717 M.D. students, 166 Ph.D. students, 103 students in the combined M.D./Ph.D. program, and 278 postdoctoral research fellows. The College of Medicine has more than 1,900 full-time faculty members located on the main campus and at its clinical affiliates. In 2016, Einstein received more than $160 million in awards from the National Institutes of Health (NIH). This includes the funding of major research centers)at Einstein in aging, intellectual development disorders, diabetes, cancer, clinical and translational research, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Einstein runs one of the largest residency and fellowship training programs in the medical and dental professions in the United States through Montefiore and an affiliation network involving hospitals and medical centers in the Bronx, Brooklyn and on Long Island. For more information, please visit http://www. , read our blog, follow us on Twitter, like us on Facebook and view us on YouTube. Montefiore Health System is one of New York's premier academic health systems and is a recognized leader in providing exceptional quality and personalized, accountable care to approximately three million people in communities across the Bronx, Westchester and the Hudson Valley. It is comprised of 10 hospitals, including the Children's Hospital at Montefiore, Burke Rehabilitation Hospital and close to 200 outpatient care sites. The advanced clinical and translational research at its' medical school, Albert Einstein College of Medicine, directly informs patient care and improves outcomes. From the Montefiore-Einstein Centers of Excellence in cancer, cardiology and vascular care, pediatrics, and transplantation, to its' preeminent school-based health program, Montefiore is a fully integrated healthcare delivery system providing coordinated, comprehensive care to patients and their families. For more information please visit http://www. . Follow us on Twitter and view us on Facebook and YouTube.

Fortmann A.L.,San Diego State University | Gallo L.C.,San Diego State University | Philis-Tsimikas A.,Scripps Whittier Diabetes Institute
Health Psychology | Year: 2011

Objective: Although active diabetes self-management is required to achieve glycemic control, adherence is poor among ethnic minorities, especially Latinos. Research shows that individuals who report greater social-environmental support resources for disease management manage their diabetes more effectively than those with fewer support resources. Methods: Path analysis was conducted to investigate the value of a multiple-mediator model in explaining how support resources for disease management influence hemoglobin A1c (HbA1c) levels in a sample of 208 Latinos with Type 2 diabetes recruited from low-income serving community clinics in San Diego County. We hypothesized that the relationship between support resources for disease-management and HbA1c would be mediated by diabetes self-management and/or depression. Results: Participants who perceived greater support resources for disease-management reported better diabetes self-management (β = .40, p < .001) and less depression (β = -19, p < .01). In turn, better diabetes self-management and less depression were associated with tighter glycemic control (HbA1c; β = -17, p < .05 and β = .15, p < .05, respectively). Once the indirect effects via diabetes self-management (95% CI [-25; -03]) and depression (95% CI [-14; -01]) were statistically controlled, the direct pathway from support resources to HbA1c was markedly reduced (p = .57). Conclusions: These findings demonstrate the important connection that support resources for disease management can have with diabetes self-management, emotional well-being, and glycemic control among Latinos. Thus, programs targeting diabetes self-management and glycemic control in this population should consider culturally relevant, multilevel influences on health outcomes. © 2011 American Psychological Association.

Philis-Tsimikas A.,Scripps Whittier Diabetes Institute | Fortmann A.,San Diego State University | Lleva-Ocana L.,Scripps Whittier Diabetes Institute | Walker C.,Scripps Whittier Diabetes Institute | Gallo L.C.,San Diego State University
Diabetes Care | Year: 2011

OBJECTIVE - To evaluate the effect of a culturally sensitive diabetes self-management education programthat uses a low-cost, peer-educator format (Project Dulce) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS - A total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA 1c>8% were randomly assigned to the Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome of interest was HbA 1c. RESULTS - The majority of subjects were born in Mexico, were female, were middle-aged, had less than an eighth-grade education, and had high baseline HbA 1c levels. Significant time-by-group interaction effects for HbA 1c (P = 0.02) and diastolic blood pressure (P = 0.04) indicated that the Project Dulce group exhibited greater improvement (i.e., decreases) across time. Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA 1c (-1.7%, P = 0.001) and HDL cholesterol (+1.4 mg/dL, P = 0.01) and from baseline to month 10 in absolute levels of HbA 1c (-1.5%, P = 0.01), total cholesterol (-7.2 mg/dL, P = 0.04), HDL cholesterol (+1.6 mg/dL, P = 0.01), and LDL cholesterol (-8.1 mg/dL, P = 0.02). No significant changes were noted in the control group. CONCLUSIONS - This randomized trial, using the Project Dulce model of culturally sensitive, peer-led education, demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic populations is effective. © 2011 by the American Diabetes Association.

Zinman B.,Samuel Lunenfeld Research Institute | Philis-Tsimikas A.,Scripps Whittier Diabetes Institute | Cariou B.,Nantes University Hospital Center | Handelsman Y.,Metabolic Institute of America | And 4 more authors.
Diabetes Care | Year: 2012

OBJECTIVE - To compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patientswith type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS - In this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7-10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9-4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis. RESULTS - In all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI -0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar. CONCLUSIONS - Insulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec. © 2012 by the American Diabetes Association.

Mathieu C.,Catholic University of Leuven | Rodbard H.W.,Endocrine and Metabolic Consultants | Cariou B.,Nantes University Hospital Center | Handelsman Y.,Metabolic Institute of America | And 4 more authors.
Diabetes, Obesity and Metabolism | Year: 2014

Aim: Two treatment strategies were compared in patients with type 2 diabetes (T2DM) on basal insulin requiring intensification: addition of once-daily (OD) liraglutide (Lira) or OD insulin aspart (IAsp) with largest meal. Methods: Subjects completing 104weeks (52-week main trial BEGIN ONCE-LONG + 52-week extension) on insulin degludec (IDeg) OD + metformin with HbA1c≥7.0% (≥53mmol/mol) were randomized to IDeg+Lira [n=88, mean HbA1c: 7.7% (61mmol/mol)] or IDeg+IAsp (n=89, mean HbA1c: 7.7%) for 26weeks, continuing metformin. Subjects completing 104weeks with HbA1c <7.0% continued IDeg+metformin in a third, non-randomized arm (n=236). Results: IDeg+Lira reduced HbA1c (-0.74%-points) significantly more than IDeg+IAsp (-0.39%-points); estimated treatment difference (ETD) (IDeg+Lira-IDeg+IAsp) -0.32%-points (95% CI -0.53; -0.12); p=0.0024. More IDeg+Lira (49.4%) than IDeg+IAsp (7.2%) subjects achieved HbA1c <7.0% without confirmed hypoglycaemia [plasma glucose <3.1mmol/l (<56mg/dl) or severe hypoglycaemia) and without weight gain; estimated odds ratio (IDeg+Lira/IDeg+IAsp) 13.79 (95% CI 5.24; 36.28); p<0.0001. IDeg+Lira subjects had significantly less confirmed and nocturnal confirmed hypoglycaemia, and significantly greater weight loss (-2.8kg) versus IDeg+IAsp (+0.9kg); ETD (IDeg+Lira-IDeg+IAsp) -3.75kg (95% CI -4.70; -2.79); p<0.0001. Other than more gastrointestinal side effects with IDeg+Lira, no safety differences occurred. Durability of IDeg was established in the non-randomized arm, as mean HbA1c remained <7.0% [mean 6.5% (48mmol/mol) at end-of-trial]. Conclusions: IDeg+Lira improved long-term glycaemic control, with weight loss and less hypoglycaemia versus adding a single daily dose of IAsp in patients with T2DM inadequately controlled with IDeg+metformin. © 2014 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.

Cuddihy R.M.,International Diabetes Center | Philis-Tsimikas A.,Scripps Whittier Diabetes Institute | Nazeri A.,Novo Nordisk AS
Diabetes Educator | Year: 2011

Purpose The purpose of this study was to investigate the opinions of primary care physicians (PCPs) and diabetes specialists on their perceived role in tackling type 2 diabetes (T2D) and the challenges they face, particularly regarding insulin intensification. Methods Six hundred physicians from Germany, Japan, Spain, Turkey, the United Kingdom, and the United States were recruited to complete an online survey. Screening criteria included T2D patients seen per week (Europe/Japan: all ≥2; United States: PCPs ≥5; specialists ≥10) and years in practice (3-30 years). Results Most physicians had seen an increase in TD2 patients in the past 5 years, and almost all agreed that the burden of diabetes is increasing. Notable proportions of PCPs never initiate/modify insulin and never/rarely intensify insulin. Main barriers to insulin intensification cited were lack of experience and lack of time to educate patients. Better collaboration between primary and secondary care was considered one of the most important factors in improving insulin treatment of T2D. Conclusions PCPs are less involved in the initiation and intensification of insulin than specialists; however, all physicians appreciate the need for increased PCP involvement. A multidisciplinary approach that includes using the skills of diabetes educators will assist physicians in improving management of T2D. © 2011 The Author(s).

Philis-Tsimikas A.,Scripps Whittier Diabetes Institute
Current diabetes reports | Year: 2014

Diabetes affects a large and growing segment of the US population. Ethnic and racial minorities are at disproportionate risk for diabetes, with Hispanics and non-Hispanic Blacks showing a near doubling of risk relative to non-Hispanic Whites. There is an urgent need to identify low cost, effective, and easily implementable primary and secondary prevention approaches, as well as tertiary strategies that delay disease progression, complications, and associated deterioration in function in patients with diabetes. The Chronic Care Model provides a well-accepted framework for improving diabetes and chronic disease care in the community and primary care medical home. A number of community-based diabetes programs have incorporated this model into their infrastructure. Diabetes programs must offer accessible information and support throughout the community and must be delivered in a format that is understood, regardless of literacy and socioeconomic status. This article will discuss several successful, culturally competent community-based programs and the key elements needed to implement the programs at a community or health system level. Health systems together with local communities can integrate the elements of community-based programs that are effective across the continuum of the care to enhance patient-centered outcomes, enable patient acceptability and ultimately lead to improved patient engagement and satisfaction.

Philis-Tsimikas A.,Scripps Whittier Diabetes Institute
American Journal of Medicine | Year: 2013

Primary care practitioners are increasingly responsible for the management of the escalating numbers of patients with type 2 diabetes. The majority of these patients will require insulin replacement therapy as their disease progresses, because glycemic control is often unsustainable using oral antidiabetic drugs. This review explains the practicalities of initiating and optimizing basal insulin in clinical practice, emphasizing the need for regular glycated hemoglobin (A1c) monitoring to allow timely initiation of insulin when the A1c target is not met. The importance of patient education in overcoming barriers to insulin is discussed, as well as the choice of available basal insulins and the necessity to optimize basal insulin dosage by self-titration. The traditional view of insulin therapy as a last resort is challenged with the modern basal insulin analogues (insulin detemir and insulin glargine), which offer simple and effective glycemic control with a reduced risk of hypoglycemia compared with older insulin formulations such as neutral protamine Hagedorn. © 2013 Published by Elsevier Inc.

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