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Staged Diabetes Management Staged Diabetes Management Roger S. Mazze Ellie S. Strock Richard M. Bergenstal Amy Criego Robert Cuddihy Oded Langer Gregg D. Simonson Margaret A. Powers 3RD EDITION A John Wiley & Sons, Ltd., Publication This edition fi rst published 2012, © 2000, 2004, 2012 by John Wiley & Sons, Ltd. Wiley-Blackwell is an imprint of John Wiley & Sons, formed by the merger of Wiley’s global Scientifi c, Technical and Medical business with Blackwell Publishing. Registered offi ce: John Wiley & Sons, Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial offi ces: 9600 Garsington Road, Oxford, OX4 2DQ, UK The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK 111 River Street, Hoboken, NJ 07030-5774, USA For details of our global editorial offi ces, for customer services and for information about how to apply for permission to reuse the copyright material in this book please see our website at www.wiley.com/ wiley-blackwell The right of the author to be identifi ed as the author of this work has been asserted in accordance with the UK Copyright, Designs and Patents Act 1988. All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by the UK Copyright, Designs and Patents Act 1988, without the prior permission of the publisher. Designations used by companies to distinguish their products are often claimed as trademarks. All brand names and product names used in this book are trade names, service marks, trademarks or registered trademarks of their respective owners. The publisher is not associated with any product or vendor mentioned in this book. This publication is designed to provide accurate and authoritative information in regard to the subject matter covered. It is sold on the understanding that the publisher is not engaged in rendering professional services. If professional advice or other expert assistance is required, the services of a competent professional should be sought. The contents of this work are intended to further general scientifi c research, understanding, and discussion only and are not intended and should not be relied upon as recommending or promoting a specifi c method, diagnosis, or treatment by physicians for any particular patient. The publisher and the author make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifi cally disclaim all warranties, including without limitation any implied warranties of fi tness for a particular purpose. In view of ongoing research, equipment modifi cations, changes in governmental regulations, and the constant fl ow of information relating to the use of medicines, equipment, and devices, the reader is urged to review and evaluate the information provided in the package insert or instructions for each medicine, equipment, or device for, among other things, any changes in the instructions or indication of usage and for added warnings and precautions. Readers should consult with a specialist where appropriate. The fact that an organization or Website is referred to in this work as a citation and/or a potential source of further information does not mean that the author or the publisher endorses the information the organization or Website may provide or recommendations it may make. Further, readers should be aware that Internet Websites listed in this work may have changed or disappeared between when this work was written and when it is read. No warranty may be created or extended by any promotional statements for this work. Neither the publisher nor the author shall be liable for any damages arising herefrom. Library of Congress Cataloging-in-Publication Data Staged diabetes management / Roger S. Mazze ... [et al.]. – 3rd ed. p. ; cm. Includes bibliographical references and index. ISBN-13: 978-0-470-65466-8 (hardcover : alk. paper) ISBN-10: 0-470-65466-X (hardcover : alk. paper) 1. Diabetes. 2. Medical protocols. 3. Evidence-based medicine. I. Mazze, R. S. II. International Diabetes Center. [DNLM: 1. Diabetes Mellitus–therapy–Practice Guideline. 2. Diabetes Mellitus–diagnosis–Practice Guideline. WK 815] RC660.S67 2011 616.4'62–dc22 2011011047 A catalogue record for this book is available from the British Library. This book is published in the following electronic formats: ePDF 9781119950394; Wiley Online Library 9781119950424; ePub 9781119950400; Mobi 9781119950417 Set in 8.75/11.5 pt Sabon by Toppan Best-set Premedia Limited 01 2012 Dedication In 2004 we dedicated the second edition of S taged Diabetes entists, educators, clinicians, and people with diabetes. He taught Management to the memory of Donnell D. Etzwiler, founder and us that it would be selfi sh to accumulate but not share knowledge; fi rst president of the International Diabetes Center. A person of that successful treatment and education strategies should be dis- ideas and vision, he was steadfast in his mission to improve the seminated; and that the true importance of scientifi c discoveries lives of people with diabetes throughout the world. Don wel- was how successfully they were translated into practice. Most comed the challenges of scientifi c enquiry and the inevitability of important, he taught us that the true hero in this endeavor is the criticism. He was tireless in his willingness to share his ideas individual with diabetes. through training programs that reached tens of thousands of We dedicate our third edition to Don’ s fellow travelers, the men health professionals; yet, he always had time for the child with and women who work to improve the lives of those with diabetes diabetes. As we enter our 45th year as simply the IDC, his wisdom through research, education and care; and especially to those seems even more germane to the tasks at hand. His travels rein- individuals with diabetes who as advocates for others emulate forced a tradition that opened a worldwide dialogue among sci- Don ’ s generosity of spirit. Contents About the authors, ix Acknowledgments, xi Introduction, 1 Part 1: Diabetes care from the perspective of Staged Diabetes Management 1 Introduction to Staged Diabetes Management, 7 2 Implementation of Staged Diabetes Management, 17 3 Characterization of glucose metabolism, 29 Part 2: The treatment of diabetes 4 Detection and treatment of type 1 diabetes, 43 5 Type 2 diabetes in adults, 77 6 Diabetes in pregnancy, 139 7 Type 2 diabetes and metabolic syndrome in children and adolescents, 165 Part 3: Diabetes complications and comorbidities and glucose management in the hospital setting 8 Complications associated with diabetes, 203 9 Diabetes-associated comorbidities, 251 10 Glucose management in the hospital setting, 261 Index, 273 vii About the a uthors Roger S. Mazze PhD is the Head of the World Health Organization Bergenstal was named the American Diabetes Association ’ s Collaborating Center at the International Diabetes Center (IDC) Outstanding Physician Clinician of the Year. His clinical research and Mayo Clinic and Professor as well as Vice President of the has focused on glucose control and diabetes complications as a Park Nicollet Institute and Chief Academic Offi cer of the IDC. Principal Investigator of two National Institutes of Health trials: For the past 24 years he has held the rank of Clinical Professor the Diabetes Control and Complications Trial in type 1 diabetes of Family Medicine and Community Health at the University of and the Action to Control Cardiovascular Risks in Diabetes study Minnesota Medical School, and, previously, Professor of in type 2 diabetes. Dr. Bergenstal ’ s clinical efforts have been Biostatistics, Epidemiology, and Community Health and Executive directed toward improving systems of care for patients with dia- Director and Coprincipal Investigator of the Diabetes Research betes by translating new research fi ndings into practice. He and Training Center at Albert Einstein College of Medicine. He teaches nationally and internationally on the importance of was also Distinguished Visiting Scientist of the United States patient - centered team care, and has been listed in Best Doctors in Centers for Disease Control. Dr. Mazze is a past Cochairperson America on numerous occasions. Dr. Bergenstal ’ s contributions for the American Diabetes Association Council on Health Care focused on assuring continuity between sections and a future Delivery. Author of more than 100 articles, chapters, comments, perspective. and arguments, he served as visiting professor to medical schools throughout Europe, Asia, and Latin America. As principal author Amy Criego MD MS attended undergraduate and medical school of S taged Diabetes Management ’ s three editions, beyond his own at the University of North Dakota. She underwent residency train- contributions, his responsibility was to provide a single “ voice ” ing in pediatrics at DeVos Children ’ s Hospital in Grand Rapids, to the text. MI, and completed her fellowship training in pediatric endo- crinology at the University of Minnesota. She joined the Pediatric Ellie S. Strock APRN - BC FAANP CDE is Director of Technology Endocrinology group at Park Nicollet Clinic/International Development and Translational Research at the International Diabetes Center in 2005 and became the Department Chair for Diabetes Center and Chief Education Director for the World Pediatric Endocrinology in 2009. She continues to care clinically Health Organization Collaborating Center at the International for children with diabetes and other endocrine disorders while Diabetes Center and Mayo Clinic. She is a board - certifi ed Adult actively participating in research and medical education. Dr. Nurse Practitioner for Park Nicollet Health Services. Mrs. Strock Criego has been involved with the collaboration between the served as co - investigator on numerous clinical trials focusing on diabetes and eating disorder teams at the International Diabetes advanced technologies and clinical decision - making. She organ- Center and Melrose Institute since joining Park Nicollet in 2005. ized and directed Staged Diabetes Management (SDM) training Her contributions to the text focused on children with type 1 and programs throughout the USA, Europe, Asia, and Latin America type 2 diabetes. and has been recognized as a leader in international patient and professional education. In 2009, she was inducted as a Fellow of Robert Cuddihy MD is Vice- President— Medical Diabetes Head, the American Academy of Nurse Practitioners (FAANP) and in US Medical Affairs, Sanofi US. Before joining Sanofi - Aventis, Dr. 2011 was named Visiting Professor at Nanjing Medical University, Cuddihy was Medical Director at the International Diabetes Nanjing, China. Mrs. Strock has authored more than 40 articles Center and Associate Professor at the Univ ersity of Minnesota in national and international journals. As coauthor of Staged Medical School. Before joining the Intern ational Diabetes Center, Diabetes Manage ment , she contributed to the original ideas that Dr. Cuddihy was at the Massachusetts General Hospital Diabetes led to the development of SDM, served as the major content Center in Boston and served as Chairman of the Division of organizer and reviewer throughout all chapters, and lent her Endocrinology at Newton- W ellesley Hospital and as Assistant practical expertise to assuring a focus on patient education and Clinical Professor of Medicine at Harvard Medical School. He nutrition. taught extensively in diabetes- r elated courses at Harvard Medical School and in Harvard Medical School/Massachusetts General Richard M. Bergenstal MD is an endocrinologist and Executive Hospital- s ponsored national/international continuing medical Director of the International Diabetes Center at Park Nicollet. He education courses. Before practicing in Boston, Dr. Cuddihy was is Clinical Professor in the Department of Medicine at the a staff physician and Assistant Professor at Mayo Clinic/Mayo University of Minnesota and served as President, Science & Medical School. He also served as the Associate Program Director Medicine of the American Diabetes Association. In 2007, Dr. of Mayo’ s Internal Medicine residency program. Dr. Cuddihy ix ABOUT THE AUTHORS reviewed each chapter, adding both common sense and scientifi c academic appointment as Adjunct Assistant Professor in the rigor. Department of Family Practice and Community Health at the University of Minnesota Medical School. Dr. Simonson earned Oded Langer MD is the Babcock Professor and Chairman of the his doctorate in molecular cell biology and biochemistry at the Department of Obstetrics and Gynecology at St. Luke ’ s - Roosevelt University of Minnesota. He held a postdoctoral research position Hospital Center, a University Hospital of Columbia University. at the University of Wisconsin Children ’ s Diabetes Center and He graduated from Sackler Medical School in Israel, and obtained was awarded a Juvenile Diabetes Foundation Postdoctoral his PhD from Poznan University of Medical Science. In the course Fellowship for his research on diabetes gene therapy. Dr. Simonson of his career and his longtime interest in high - risk pregnancy, is a member of the American Diabetes Association and Chair particularly diabetes in pregnancy, Dr. Langer has served as prin- of the Minnesota Department of Health Diabetes Steering cipal or coinvestigator on several National Institutes of Health Committee. His contributions focused on type 2 diabetes and and pharmaceutical grants. He was principal investigator of the complications. Maternal Fetal Medicine Unit Network (NICHD) in San Antonio, TX. In addition, on multiple occasions his work was recognized with the Award of Research Excellence from the Society of Margaret A. Powers PhD RD CDE is a registered dietitian and Maternal – Fetal Medicine. Dr. Langer has over 200 peer- reviewed certifi ed diabetes educator. She is a Research Scientist at the articles in obstetrics and maternal – fetal medicine; over 49 chap- International Diabetes Center, where her research focuses on ters and review articles; and more than 310 accepted abstracts performance improvement with organizations and individuals to presented in both national and international forums. He has improve diabetes outcomes. She recently completed research with served on a variety of journal editorial boards and has been a 12 health organizations around the county that focused on guest editor and ad hoc reviewer for many peer- reviewed journals. improving blood pressure measures in people with diabetes. In addition, he has authored a textbook on diabetes in pregnancy Additionally, she is pioneering work with continuous glucose and coauthored four additional textbooks on diabetes in preg- monitoring to study the glycemic response to food. Dr. Powers nancy. Dr. Langer contributed tirelessly to the pregnancy sections has been instrumental in designing programs that help health of the book, making certain that scientifi c evidence, not opinion, organizations improve diabetes care and education and in devel- be the basis of treatment of diabetes in pregnancy. oping additional programs and products designed to improve healthcare outcomes. Throughout the text she assured that nutri- Gregg D. Simonson PhD is Director, Professional Training and tion was addressed, balancing the scientifi c evidence with a Consulting at the International Diabetes Center and holds an behavioral approach. x Acknowledgments It is generally a daunting task to identify and thank those indi- have been impossible. Helping Jeanne and me fi nd all of the viduals whose extraordinary efforts made this work possible. In fi gures, produce new drawings and organize them to fi t the text this case it is quite simple. Jeanne Mettner worked almost 1 year was Bryan Akkerman. His work was somewhat monumental as to guide the authors through the creation of this third edition of more than 100 fi gures had to be produced and properly placed Staged Diabetes Management . She acted as research, content, in the text. We are very grateful that the production stages of copy, and production editor. Without her, seven authors could this book were so ably undertaken by Lindsey Williams, on not possibly have completed their work. As principal author I behalf of Wiley - Blackwell. Lindsey ’ s patience and support have relied on Jeanne to help capture the unique contributions of been integral in making sure this book turned out so well. The each of the authors and then to organize them into a coherent authors are also grateful to the International Diabetes Center single work. Each chapter was ultimately my responsibility to staff, most especially my program coordinator, Dina Melnik, and form into a single voice. Without Jeanne ’ s assistance it would our editors at Wiley - Blackwell for their devotion to this project. xi Introduction Staged Diabetes Management (SDM) is a systematic approach to edly improving diabetes care outcomes. Because of this stagna- preventing, detecting, and treating diabetes, metabolic syndrome, tion, researchers have initiated studies to determine precisely and associated disorders. It uses practice guidelines and clinical which factors have stalled the trend towards improved care. pathways, or algorithms, which refl ect the responsibilities of the diabetes care clinician, especially the primary care provider and The c ase for an i ntegrated m odel of o rganizational the primary care team. c hange in h ealthcare d elivery The purpose of SDM is as follows: The most accepted method of encouraging change continues to • to provide an organized, evidence- based approach for clinical be a combination of (1) improving the competency of clinicians decision- making through ongoing professional education and (2) the development • to provide a consistent set of scientifi cally based practice guide- of mechanisms for rapid translation of research fi ndings and care lines that can be adapted by a community according to its innovations into practice. In part because of the failure of this resources approach, there has recently been a reemphasis on government - • to identify appropriate criteria for initiating and altering thera- issued care guidelines, direct patient involvement in treatment pies during three treatment phases: start, adjust, and maintain decisions, and public awareness campaigns. 5 The purpose of this • to provide a common, customized Master DecisionPath for the redirection is to ensure better compliance with treatment recom- metabolic syndrome and each type of diabetes that both mendations and to enhance the ability for disease self - management. patients and providers can use to understand treatment options, Such strategies have in common multiple goals: improve care, to enhance communication, and to optimize therapies lower cost, reduce error, and satisfy both the patient and payer. • to facilitate the detection and treatment of diabetes, insulin Not surprisingly, single strategies are likely to fail, and successful resistance, and their complications by primary care providers, strategies are characterized by a multifaceted approach. 6 in consultation with specialists • to foster a patient- centered team approach to the management Theoretical p rinciples for an i ntegrated a pproach to of diabetes and associated complications. d iabetes c are SDM does not occur in a vacuum. It requires careful prepara- Consistent with this new strategic direction in chronic disease man- tion in order to assure successful implementation. This prepara- agement, the International Diabetes Center’ s approach to innova- tion requires addressing four key areas that affect change: tions in diabetes care is multifaceted and based on an integrated organization, innovation, measurement, and incentives. The fol- model (Figure 0 .1 ). Within this model, the initial stimulant of lowing section explains the theoretical framework at the founda- change can come from any component of the healthcare delivery tion of SDM as it is translated into practice. system. However, in order for the change to be successful, several key early ingredients are required, including alignment, specifi city, application of evidence- based data, and customization. From t heory to p ractice: an i ntegrated a pproach to d iabetes c are Alignment of p olicy, v alues, and r esources Alignment of policy, organizational values, and resource alloca- Research worldwide has indicated that the quality of diabetes care tion, however, are recognized as early requirements if change is in both developed and developing countries, whether at major to be successful. For this alignment to occur, the following must medical centers or in small clinics, is suboptimal. 1 – 4 Despite be in place: numerous attempts to raise the level of care, studies show that • organizational buy - in to the theoretical principles, which may the sentinel events that characterize diabetes care — the level of require organizational alignment and/or o rganizational change hemoglobin A (HbA ), retinal and neurological examinations, • identifi cation/recognition of the change champion— a clinical 1c 1c screening for renal disease, blood pressure management, smoking or administrative leader who directs all efforts that support the cessation, and patient education — have had little effect on mark- required changes Staged Diabetes Management, Third Edition. Roger S. Mazze, Ellie S. Strock, Richard M. Bergenstal, Amy Criego, Robert Cuddihy, Oded Langer, Gregg D. Simonson, Margaret A. Powers. © 2011 John Wiley & Sons, Ltd. Published 2011 by John Wiley & Sons, Ltd. 1 INTRODUCTION Organization Incentives Policy Reimbursement (cid:129) Private healthcare (cid:129) Assure organizational fit (cid:129) Health insurance (cid:129) Match organizational climate (cid:129) Public healthcare Champion Values Pay for performance (cid:129) Clinical leader (cid:129) Organizational and individual (cid:129) Administrative leader payments (cid:129) Improvement Resource allocation (cid:129) Meeting standards (cid:129) Based on cost/benefit analysis (cid:129) Requires organizational commitment to change Quality assurance (cid:129) Align with legal/contractual and peer review obligations (cid:129) Assign authority Leadership Standards Information technology Learning (cid:129) Evidence-based medicine Customized (cid:129) Reflects the current medical Implementation culture and system Clinical Educational Administrative Patient (cid:129) Standards (cid:129) Knowledge (cid:129) Financial (cid:129) Clinical (cid:129) Processes (cid:129) Skills (cid:129) Utilization (cid:129) Educational Skills development (cid:129) Outcomes development review (cid:129) Scheduling (cid:129) Adherence (cid:129) Quality (cid:129) Satisfaction (cid:129) Operationalization of care assurance (cid:129) Patient- guidelines through (cid:129) Reimbursement centered care observation of practice Implementation planning Measurement (cid:129) Recognition of obstacles to implementation (cid:129) Plan for each obstacle Innovation Figure 0.1 Model for organizational change in healthcare. • identifi cation of the clinical issues that have made change and adjusting each therapeutic intervention. Specifi city also necessary— recognition of a problem that can be quantifi ed permits the development of an implementation plan. The imple- establishes the criteria by which the intervention will be mentation plan is based on a healthcare system ’ s unique needs measured. and will facilitate the effi cient use of the clinical pathways. (Chronic conditions, such as diabetes, are especially suited to this Process s pecifi city and c are s pecifi city approach.) By quantifying the clinical problem, healthcare administrators and clinicians can specify precisely how the clinical problem will Use of e vidence- b ased d ata be addressed— t hen use outcomes data to gauge how well these Establishing standards of care in the absence of an evidence- interventions are working. Specifi city requires suffi cient details, based, targeted approach to changing care has often been cited such as clinical pathways that provide the criteria for initiating as the key factor explaining poor care practices. 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