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Evidence-based
Management of

Jiten Vora
/ John Buse
Evidence-based
Management of
DIABETES

Jiten Vora
John Buse
tfm Publishing Limited, Castle Hill Barns, Harley, Nr Shrewsbury, SY5 6LX, UK.
Tel: +44 (0)1952 510061; Fax: +44 (0)1952 510192
E-mail: [email protected]; Web site: www.tfmpublishing.com

Design & Typesetting: Nikki Bramhill BSc Hons Dip Law

First Edition: © October 2012
Reprinted: November 2012
Cover image: © 2011 3d4medical, www.3d4medical.com
Hardback ISBN: 978-1-903378-78-6

E-book editions: 2014

ePub ISBN: 978-1-908986-69-6
Mobi ISBN: 978-1-908986-70-2
Web pdf ISBN: 978-1-908986-71-9

The entire contents of Evidence-based Management of Diabetes is copyright tfm Publishing Ltd. Apart from any fair dealing for
the purposes of research or private study, or criticism or review, as permitted under the Copyright, Designs and Patents Act 1988,
this publication may not be reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic, digital,
mechanical, photocopying, recording or otherwise, without the prior written permission of the publisher.

Neither the editors, the authors nor the publisher can accept responsibility for any injury or damage to persons or property
occasioned through the implementation of any ideas or use of any product described herein. Neither can they accept any
responsibility for errors, omissions or misrepresentations, howsoever caused.

Whilst every care is taken by the editors, the authors and the publisher to ensure that all information and data in this book are as
accurate as possible at the time of going to press, it is recommended that readers seek independent verification of advice on drug
or other product usage, surgical techniques and clinical processes prior to their use.

The editors, authors and publisher gratefully acknowledge the permission granted to reproduce the copyright material where
applicable in this book. Every effort has been made to trace copyright holders and to obtain their permission for the use of
copyright material. The publisher apologizes for any errors or omissions and would be grateful if notified of any corrections that
should be incorporated in future reprints or editions of this book.
Contents
Foreword

Contributors

Acknowledgements

Using evidence-based medicine

Where does insulin resistance start; contribution to the

Chapter 1 development of diabetes?
Michael Roden, Kitt Falk Petersen

Chapter 2 Genetics studies in diabetes – how do they help?

Stephen C. Bain

Prevention of type 2 diabetes in high-risk individuals:

Chapter 3 achievable?
Vanita R. Aroda, Robert E. Ratner

Chapter 4 The glucocentric approach to diabetes care

Ramzi A. Ajjan, Peter J. Grant

Supplying the missing link in diabetes care: evidence-based

Chapter 5 structured education for people with type 2 diabetes
Marian E. Carey, Melanie J. Davies, Kamlesh Khunti

The role of blood glucose monitoring in type 2 diabetes; a plea

Chapter 6 for common sense?
Katrien Benhalima, Chantal Mathieu

The role of continuous glucose monitoring in the management

Chapter 7 of type 1 and type 2 diabetes
Stanley Schwartz, Gary Scheiner
Chapter 8 Treatment of diabetes through targeting weight loss
Sravan Kumar Thondam, John Wilding

Chapter 9 Weight loss therapies in diabetes – is there a future?

Luc F. Van Gaal

Goals of treatment in type 2 diabetes mellitus:β-cell

Chapter 10 preservation
Daniël H. van Raalte, Michaela Diamant

Chapter 11 Early insulin initiation in type 2 diabetes

Biju Jose, Abd A. Tahrani, Anthony Barnett

Chapter 12 Immune intervention in type 1 diabetes

Jay S. Skyler

Chapter 13 Pancreas and islet transplantation: an evidence-based analysis

R. Paul Robertson

Chapter 14 Hypoglycemia in type 2 diabetes: does it matter?

Nicola N. Zammitt, Brian M. Frier

Chapter 15 Mental illness and diabetes – intricate interplay

Richard I. G. Holt

Chapter 16 Diabetes treatments and cancer

Samy Suissa, Agnieszka Majdan

Chapter 17 Screening for diabetic retinopathy

Deborah M. Broadbent

Chapter 18 Medical therapies for diabetic eye disease–how good are they?
Ian A. Pearce, Simon P. Harding

Chapter 19 Diabetic neuropathic pain – assessment and treatment

Aaron Vinik
Chapter 20 The diabetic foot: where are we?
Andrew J. M. Boulton

Non-alcoholic fatty liver disease (NAFLD) in diabetes:

Chapter 21 distraction or impending disaster?
Romina Lomonaco, Kenneth Cusi

Chapter 22 Management of kidney risk in diabetes

Amy K. Mottl, Katherine R. Tuttle

Chapter 23 Use of dual RAAS blockade in diabetic nephropathy

Suneel Udani, George L. Bakris

Chapter 24 Glucose control and macrovascular disease/morbidity

Sveeta Badiani, Hanney Gonna, Kausik K. Ray

Chapter 25 Hyperglycemia in acute coronary syndromes

M. Odette Gore, Mikhail Kosiborod, Darren K. McGuire

Screening for coronary artery disease in patients with type 2

Chapter 26 diabetes
Tessey Jose, Frans J. Th. Wackers, Silvio Inzucchi

Index
Foreword
This textbook provides all health care professionals involved in diabetes care with the latest
evidence base for their practice. We personally have found some difficulty in distilling the large
volume of information available, in all aspects of diabetes care including diagnosis and
treatment, and also the management of complications. Consequently, we are delighted to have
been able to gather an incredible faculty who are all renowned international experts in their
field. They have provided robust and concise summaries of the evidence in their fields of
diabetes. We have been delighted to work with this faculty.

We are grateful to all the authors for this phenomenal task in putting all the available
evidence-based information together. We hope that readers will enjoy all the chapters as much
as we did.

Jiten Vora BA MB BChir MA MD FRCP

Professor & Consultant Physician and Endocrinologist
Royal Liverpool University Hospital, Liverpool, UK

John Buse MD PhD

Professor of Medicine
Director, Diabetes Care Center
Chief, Division of Endocrinology
Executive Associate Dean for Clinical Research
University of North Carolina School of Medicine
Chapel Hill, North Carolina, USA
Contributors
Ramzi A. Ajjan MBChB PhD FRCP Senior Lecturer/Consultant in Diabetes and Endocrinology,
Division of Cardiovascular and Diabetes Research, Multidisciplinary Cardiovascular Research
Centre, Leeds Institute of Genetics Health and Therapeutics, Faculty of Medicine and Health,
University of Leeds, Leeds, UK

Vanita R. Aroda MD Physician Investigator, MedStar Health Research Institute, Hyattsville,

Maryland, USA; Assistant Professor, Georgetown University School of Medicine, District of
Columbia, USA

Sveeta Badiani MRCP Cardiology Registrar, Worthing Hospital, Worthing, UK

Stephen C. Bain MA MD FRCP Professor of Medicine (Diabetes) & Honorary Consultant

Physician, Institute of Life Sciences, Swansea University & ABM University Health Board,
Singleton Hospital, Swansea, Wales, UK

George L. Bakris MD FASN FASH Director, ASH Comprehensive Hypertension Center, The
University of Chicago Medicine, Chicago, Illinois, USA

Anthony Barnett BSc(Hons) MD FRCP Emeritus Professor of Medicine, Consultant

Physician, University of Birmingham and Diabetes Centre, Heart of England NHS Foundation
Trust, Birmingham, UK

Katrien Benhalima MD Supervisor of Endocrinology, Department of Diabetes & Endocrinology,

UZ Gasthuisberg, Catholic University of Leuven, Belgium

Andrew J. M. Boulton MD DSc FRCP Professor of Medicine, University of Manchester,

Manchester, UK; Consultant Physician, Manchester Royal Infirmary, Manchester, UK; Visiting
Professor of Medicine, University of Miami, Miami, Florida, USA; President, European
Association for the Study of Diabetes

Deborah M. Broadbent MRCOphth Director of Diabetic Eye Screening, St Paul's Eye Unit,
Royal Liverpool University Hospital, Liverpool, UK

John Buse MD PhD Professor of Medicine; Director, Diabetes Care Center and Chief, Division
of Endocrinology; Executive Associate Dean for Clinical Research; University of North Carolina
School of Medicine, Chapel Hill, North Carolina, USA

Marian E. Carey BA(Hons) PhD National Director: DESMOND Programme, Leicester

Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
Kenneth Cusi MD Chief and Professor, Division of Endocrinology, Diabetes and Metabolism,
University of Florida, Gainesville, Florida and the Malcom Randall Veterans Affairs Medical
Center (VAMC), Gainesville, Florida, USA

Melanie J. Davies MBChB MRCP (UK) MD FRCP Professor of Diabetes Medicine,

Department of Cardiovascular Sciences, University of Leicester and Honorary Consultant
Physician, University Hospitals of Leicester NHS Trust UK, Leicester, UK

Michaela Diamant MD PhD FRCPE Professor of Internal Medicine, Chair of Diabetology,

Director Diabetes Center VUMC, Diabetes Center/Department of Internal Medicine, VU
University Medical Center, Amsterdam, The Netherlands

Brian M. Frier MD Consultant Physician and Honorary Professor of Diabetes, Department of

Diabetes, Royal Infirmary of Edinburgh, Edinburgh, Scotland

Hanney Gonna MRCP Cardiology Registrar, St George's Hospital NHS Trust, London, UK

M. Odette Gore MD Cardiology Fellow, University of Texas Southwestern Medical Center,

Dallas, Texas, USA

Peter J. Grant MBChB MD FRCP Professor of Medicine/Consultant in Diabetes, Division of

Cardiovascular and Diabetes Research, Multidisciplinary Cardiovascular Research Centre,
Leeds Institute of Genetics Health and Therapeutics, Faculty of Medicine and Health, University
of Leeds, Leeds, UK

Simon P. Harding FRCOphth MD Professor of Clinical Ophthalmology, St. Paul's Eye Unit,
Royal Liverpool University Hospital, Liverpool, UK; Department of Eye and Vision Science,
University of Liverpool, UK

Richard I. G. Holt MA MB BChir PhD FRCP FHEA Professor and Honorary Consultant in
Diabetes and Endocrinology, Endocrinology and Metabolism Sub-Division, Developmental
Origins of Adult Health and Disease Division, University of Southampton School of Medicine,
Southampton, UK

Silvio Inzucchi MD Professor of Medicine, Section of Endocrinology, Yale University School of

Medicine; Director, Yale Diabetes Center; Clinical Chief, Endocrinology, Yale-New Haven
Hospital, Connecticut, USA

Biju Jose MD MRCP Specialist Registrar Endocrinology Diabetes, West Midlands Deanery,
UK

Tessey Jose MD Endocrinology Fellow, Section of Endocrinology, Yale University School of

Medicine, New Haven, Connecticut, USA

Kamlesh Khunti MBChB PhD MD FRCGP DCH DRCOG Professor of Primary Care Diabetes
& Vascular Medicine, Department of Health Sciences, University of Leicester, Leicester, UK

Mikhail Kosiborod MD FAHA FACC Associate Professor of Medicine, University of Missouri-

Kansas City and Mid America Heart Institute of Saint Luke's Hospital, Kansas City, Missouri,
USA

Romina Lomonaco MD Assistant Professor, Division of Endocrinology, Diabetes and

Metabolism, University of Florida, Gainesville, Florida, USA

Agnieszka Majdan MD Assistant Professor of Medicine, McGill University, Division of

Endocrinology, Jewish General Hospital, Montreal, Quebec, Canada

Chantal Mathieu MD PhD Professor of Endocrinology, Department of Diabetes &

Endocrinology, UZ Gasthuisberg, Catholic University of Leuven, Belgium

Darren K. McGuire MD MHSc FAHA FACC Associate Professor of Medicine, University of

Texas Southwestern Medical Center, Dallas, Texas, USA

Amy K. Mottl MD MPH Assistant Clinical Professor of Medicine, University of North Carolina
Kidney Center, UNC-Chapel Hill School of Medicine, Chapel Hill, North Carolina, USA

Ian A. Pearce MBChB FRCOphth Consultant Ophthalmologist, St. Paul's Eye Unit, Royal
Liverpool University Hospital, Liverpool, UK

Kitt Falk Petersen MD Associate Professor of Medicine, Yale University School of Medicine,
New Haven, Connecticut, USA

Robert E. Ratner MD Senior Scientist, MedStar Health Research Institute, Hyattsville,

Maryland, USA; Professor of Medicine, Georgetown University School of Medicine, District of
Columbia, USA

Kausik K. Ray MD MPhil FRCP Professor of Cardiovascular Disease Prevention, Cardiac and
Vascular Sciences, St George's University of London, London, UK and Department of
Cardiology, St George's Hospital NHS Trust, London, UK

R. Paul Robertson MD Clinical Professor of Medicine and Affiliate Professor of Pharmacology,

Division of Metabolism, Endocrinology, and Nutrition, University of Washington and the Pacific
Northwest Diabetes Research Institute, Seattle, Washington, USA

Michael Roden MD Professor of Medicine, German Diabetes Center, Leibniz Center of

Diabetes Research, Department of Metabolic Diseases, Heinrich-Heine University Düsseldorf,
Düsseldorf, Germany

Gary Scheiner MS CDE Owner and Clinical Director, Integrated Diabetes Services LLC,
Wynnewood, Pennsylvania, USA
Stanley Schwartz MD Clinical Associate Professor of Medicine, Emeritus, University of
Pennsylvania; Affiliate, Main Line Health System, Practice in Diabetes and Cardiometabolic
Syndrome, Ardmore, Pennsylvania, USA

Jay S. Skyler MD MACP Deputy Director, Diabetes Research Institute, University of Miami
Miller School of Medicine, Miami, Florida, USA

Samy Suissa PhD James McGill Professor of Epidemiology, Biostatistics and Medicine, McGill
University; Director, Centre for Clinical Epidemiology, Lady Davis Research Institute – Jewish
General Hospital, Montreal, Quebec, Canada

Abd A. Tahrani MD MRCP Clinical Lecturer Endocrinology Diabetes, University of Birmingham,

UK

Sravan Kumar Thondam MBBS MRCP (UK) Specialty Registrar and Clinical Research Fellow
in Diabetes and Endocrinology, Department of Diabetes & Endocrinology, University Hospital
Aintree, Liverpool, UK

Katherine R. Tuttle MD FASN FACP Clinical Professor of Medicine, Providence Medical

Research Center, Division of Nephrology, Department of Medicine, University of Washington
School of Medicine, Spokane and Seattle, Washington, USA

Suneel Udani MD Senior Fellow in Nephrology, Department of Medicine, Section of

Nephrology, The University of Chicago Medicine, Chicago, Illinois, USA

Luc F. Van Gaal MD PhD Professor of Medicine, Head of Department, University of Antwerp,
Faculty of Medicine; Dept. of Endocrinology, Diabetology & Metabolism & LEMP Laboratory,
Antwerp University Hospital, Antwerp, Belgium

Daniël H. van Raalte MD PhD student, Diabetes Center/Department of Internal Medicine, VU

University Medical Center, Amsterdam, The Netherlands; Resident Internal Medicine, Kennemer
Gasthuis Hospital, Haarlem, The Netherlands

Aaron Vinik MD PhD FCP MACP Professor of Medicine/Pathology/Neurobiology and Director

of Research and Neuroendocrine Unit, Eastern Virginia Medical School, Strelitz Diabetes
Center and Neuroendocrine Unit at Norfolk, Virginia, USA

Jiten Vora BA MB BChir MA MD FRCP Professor & Consultant Physician and Endocrinologist,
Royal Liverpool University Hospital, Liverpool, UK

Frans J. Th. Wackers MD PhD Professor Emeritus of Diagnostic Radiology and Medicine,
Yale University School of Medicine, New Haven, Connecticut, USA

John Wilding DM FRCP Professor of Medicine & Head of Department of Obesity &
Endocrinology, University of Liverpool, and Honorary Consultant Physician, Department of
Diabetes & Endocrinology, University Hospital Aintree, Liverpool, UK

Nicola N. Zammitt MD Consultant Physician, Department of Diabetes, Royal Infirmary of

Edinburgh, Edinburgh, Scotland
Acknowledgements
We are grateful to all of the contributors for taking on this important task and hope they will
be proud to be part of a book which attempts to set out the evidence-based management of
diabetes.

We also wish to acknowledge the assistance provided by tfm publishing Ltd, particularly
Nikki Bramhill and Jonathan Gregory, who have assisted us in the production of an excellent
volume with considerable forbearance.
Using evidence-based medicine
The process of gathering evidence is a time-consuming task. One of the main reasons for
supporting the use of evidence-based medicine, is the rate of change of new practices, and the
increasing tendency for specialization. Medical information is widely available from a variety of
sources for clinicians but keeping up-to-date with current literature remains an almost
impossible task for many with a busy clinical workload. Evidence-based Management of
Diabetes has been written to aid this process. The chapters in this book have been written by
internationally renowned experts who have applied the principles of evidence-based medicine
and taken relevant clinical questions and examined the current evidence for the answers. The
authors were asked to quote levels and grades of evidence for each major point, and to provide
a summary of key points and their respective evidence levels at the end of each chapter. The
levels of evidence and grades of evidence used in this book are shown in Tables 1 and 2 and
are widely used in evidence-based medicine.
Chapter 1
Where does insulin resistance start; contribution to the
development of diabetes?
Michael Roden MD, Professor of Medicine
German Diabetes Center, Leibniz Center of Diabetes Research, Department of
Metabolic Diseases, Heinrich-Heine University Düsseldorf, Düsseldorf, Germany

Kitt Falk Petersen MD, Associate Professor of Medicine

Yale University School of Medicine, New Haven, Connecticut, USA

Introduction
The glucose-lowering effects of insulin or the sensitivity to insulin is determined by the
individual biological effects in insulin-responsive organs, mainly skeletal muscle, liver and
adipose tissue. Impaired insulin sensitivity, also termed insulin resistance (IR), is then defined
by reduced glucose clearance in skeletal muscle, impaired suppression of glucose production
by the liver and lower rates of lipolysis by adipose tissue or by decreased combined action on
whole body glucose disposal. In this chapter, we discuss the role of insulin resistance for the
development of type 2 diabetes mellitus (T2DM). Particularly, we summarize the evidence for
the contribution of different tissues, mainly skeletal muscle, the liver and adipose tissue to
whole body IR.

Assessment of IR
More than 70 years ago, Himsworth and Kerr provided the first standardized protocol for the
in vivo determination of insulin sensitivity from the glycemic response after an intravenous
insulin injection 1. The hyperinsulinemic-euglycemic clamp test 2-4 later evolved as the gold
standard test to assess whole body insulin sensitivity in vivo and to identify insulin-resistant
individuals 5, 6. This steady-state method creates conditions of constant insulin and glucose
concentrations thereby circumventing the physiological feedback loop between blood glucose
concentrations and insulin secretion. The rate of glucose infusion required to maintain constant
glycemia reflects whole body insulin sensitivity 4. Combined with indirect calorimetry, isotopic
tracer dilution and tissue-specific (muscle, liver and brain) magnetic resonance spectroscopy
(MRS), this method allows for the determination of rates of glucose production, assessment of
both oxidative and non-oxidative glucose metabolism, insulin suppression of glucose
metabolism, systemic lipolysis and even tissue-specific metabolism in vivo. In addition,
parameters of insulin action can be obtained from modeling of dynamic changes in plasma
glucose and insulin during intravenous 7 or oral 8 glucose tolerance tests 5, 6.

All these techniques are laborious, time-consuming and require trained and experienced
personnel, so that simpler tests have been used to assess insulin sensitivity in larger
epidemiological studies. Among others, the most common indices, the homeostasis model
assessment (HOMA-R, HOMA-S) 9 and the QUICKI 10, are calculated from fasting plasma
glucose and insulin or C-peptide concentrations 11. Of note, the liver is responsible for providing
fasting plasma glucose 12, 60% of which is utilized by non-insulin-dependent tissues, primarily
the brain 13. Thus, it is not surprising that the fasting IR indices do not tightly correlate with
clamp-derived glucose disposal 14,15 (Ib/A).

Insulin resistance predicts T2DM

Regardless of the method employed, IR was shown to occur independently of abnormal
insulin secretion and to precede the onset of overt type 2 diabetes mellitus (T2DM) by
decades. Although IR seems to be a prerequisite for incident diabetes 16-19, the evidence for a
time-dependent association between insulin sensitivity and development of impaired glucose
tolerance was scarce until recently (IIb/B). Tabak et al compared population trajectories of
fasting and post-glucose challenge plasma glucose concentrations and indices of insulin
sensitivity (HOMA-S) and secretion (HOMA-B) in persons developing or remaining free of
diabetes during a follow-up of 13 years in the longitudinal Whitehall II cohort of British civil
servants 20. They found that individuals who developed diabetes had 29% lower HOMA-S, but
13% greater HOMA-B values as determined 13 years before the diagnosis. HOMA-S linearly
decreased until 5 years before diagnosis and with an even steeper slope during the last 5 years
prior to diagnosis. HOMA-B remained constant until 4 years before diagnosis, then markedly
increased until 3 years and finally sharply decreased before diagnosis. These findings support
that IR is an early or primary abnormality, which is compensated by increased β-cell function
for a long time prior to decompensation of the insulin-glucose feedback loop leading to overt
diabetes. Of note, IR not only predicts T2DM, but also correlates with cardiovascular disease
and outcomes 21, 22.

Risk factors for IR and T2DM

The most important factors predicting T2DM comprise male sex, increasing age, overweight
and obesity 23 (Ia/A). The risk of T2DM is also greater in first-degree relatives of patients with
T2DM, women with a history of gestational diabetes mellitus (GDM) or polycystic ovary
syndrome (PCOS) and persons with the so-called metabolic syndrome, all of whom are
frequently insulin-resistant 14, 15, 24-27 (Ib/A).

This raises the question whether IR starts primarily as an inherited or acquired abnormality.
Despite the fact that a family history of T2DM markedly increases the risk of T2DM in relatives,
even the combination of all presently known ‘diabeto-genes’ adds only little to the prediction of
T2DM based on gender, age and body mass index 23. Likewise, lifestyle modifications
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