Microsoft word - prediabetes-scoping-rev-reportv6.doc

Evidence Summary: Pre-Diabetes
To the Champlain Diabetes Strategy Advisory Committee Prepared by the CIHR-funded Knowledge to Action research group: Sara Khangura, Jeremy Grimshaw, David Moher
Is it clinically beneficial to screen patients for
• “The term ‘prediabetes’ is a practical and convenient term for impaired fasting glucose (IFG) Systematic Review Evidence
and impaired glucose tolerance (IGT).” An AHRQ-funded systematic review failed to locate direct evidence that systematic primary • A meta-analysis of studies predicting risk for care screening for T2D, IFG, or IGT among progression from pre-diabetes to type 2 diabetes (T2D) concluded that, compared to individuals with normoglycemia, annualized relative risks are: Is it clinically beneficial to treat patients for
o 12.13 for those with both IFG and IGT. [Gerstein 2007] levels for diagnosis of IFG,
Precise data on the incidence and prevalence of demonstrated that T2D can be delayed and/or pre-diabetes in Canada are not available. Estimates prevented in those with pre-diabetes: the Diabetes for 2004 were that 5 million Canadians had Prevention Program (DPP) [DPPRG 2009]; the Da pre-diabetes. This number is projected to reach Qing trial [Li 2008] and the Finnish Diabetes Prevention Study (DPS). [Tuomilehto 2001] This report seeks to summarize existing evidence • Several large drug trials also demonstrate on pre-diabetes to assist health service providers of improvements in patients with IFG and/or IGT [e.g. challenges in caring for the pre-diabetic population, Systematic Review Evidence
o how best to leverage primary care in the screening and treatment of pre-diabetes; RCTs concludes that treatment of IFG/IGT delays progression to T2D. [Norris 2008] populations with pre-diabetes screening/treatment interventions; Which interventions are effective in screening for
socioeconomic challenges e.g. rural versus pre-diabetes?
• There has been debate over which diagnostic test is best: fasting plasma glucose (FPG) lacks sensitivity highlighted in shaded boxes – these emphasize and specificity; oral glucose tolerance testing evidence from systematic reviews or expert (OGTT) is burdensome to patients and health systems and has poor reproducibility. There has been debate among experts as to the value of the Some of the highlighted evidence comes from the type 2 diabetes literature and is labeled as • The CDA’s 2008 Clinical Practice Guidelines state “… the lack of standardization of the A1C test precludes its use in the diagnosis of diabetes.” [CDA 2008] Recent International Expert Committee
• Two Cochrane systematic reviews of non- Consensus Statement on HbA1c
and/or exercise, behavioural) to prevent T2D concluded that these interventions produce a consensus statement on the use of HbA1c in significant improvement in weight loss and the diagnosis of T2D. They conclude that: 1. The HbA1c is the diagnostic tool of
interventions. [Norris 2005, Orozco 2008] choice in diagnosing T2D.
2. The usefulness of HbA1c in diagnosing • There has been debate over whether medical pre-diabetes is questionable because “…the interventions actually prevent T2D or merely mask classification of subdiabetic hyperglycemia as the symptoms – the DPP study addressed this issue with a washout period after which the benefits 3. “The categorical clinical states pre-diabetes, IFG, and IGT fail to capture the continuum of risk and will be phased out of use as A1C Systematic Review Evidence
measurements.” [Int’l Expert Cmte 2009] A Cochrane systematic review and meta-analysis examined RCTs of acarbose A recent consensus statement from the American authors conclude that “There is evidence College of Endocrinology (ACE) and the American that acarbose reduces the incidence of type 2 Association of Clinical Endocrinologists (AACE) diabetes in patients with IGT. However, it is recommends primary care diabetic screening for all patients based on identified risk factors; those prevention, delay or masking of diabetes.” determined to be high-risk should then receive a diagnostic test to establish their status. A systematic review and meta-analysis of The FINDRISC Score is a widely used and RCTs of metformin in individuals at risk for validated risk assessment tool. [Lindstrom 2003] T2D concludes that “Metformin treatment in persons at risk for diabetes improves weight, Which interventions are effective in the treatment
lipid profiles, and insulin resistance, and of pre-diabetes?
As yet, there is no expert consensus on the management of pre-diabetes. [Sharma 2009] • The CDA recommends metformin or acarbose for patients with IGT. For patients with IGT and/or IFG Systematic Review Evidence
• A systematic review and meta-analysis of • As yet in the US, there are no medications approved trials of lifestyle interventions for those at by the FDA for the treatment of pre-diabetes. high-risk of developing T2D concluded that Both lifestyle and medical interventions • A Cochrane systematic review of diet-only Systematic Review Evidence
• A systematic review and meta-analysis comparing the effectiveness of lifestyle examined diet-only interventions (n=2) they diabetes concluded that they are equally as effective in reducing the risk of developing • A systematic review of studies examining o Among other things, study authors recommend 1) CME programs on pre-diabetes 2) fee codes interventions for delaying and/or preventing specific to pre-diabetes 3) increased awareness T2D concluded that while intervention is of the inadequacy of FPG in the diagnosis of shown to be effective in clinical research, implementing such interventions in clinical • While generally effective for reducing IFG and IGT, lifestyle interventions are resource intensive, have limited adherence and modest success over the Is it cost-effective to screen and treat patients for
Relevant Systematic Review Evidence from
In general, there is consensus that delaying and/or the T2D literature
preventing T2D is cost-beneficial for health interventions designed to improve adherence to treatment for T2D concluded that: “Current Various analyses on the DPP dataset using different efforts to improve or facilitate adherence of models have resulted in different conclusions. This people with type 2 diabetes to treatment has spawned debate among experts as to precisely how cost-effective lifestyle interventions for effects nor harms. The question whether any pre-diabetes truly are. [Eddy 2005, Herman 2005, intervention enhances adherence to treatment effectively, thus still remains unanswered.” What are some of the challenges in screening for
and treating pre-diabetes?
• A study of mediating factors behind poor adherence Systems are not in place to implement the lifestyle to lifestyle interventions for chronic disease in a interventions that are known to be effective; meds general population found that diagnosis and may be easier for primary care physicians to knowledge of IGT improves acceptance of and adherence to a diet and exercise program. Interventions do not often produce the same impact when transferred from the ideal conditions of clinical research into the real-world conditions of • A qualitative UK study of patients recently Physician ambivalence: Canadian primary care diagnosed with pre-diabetes found the recurring theme from interviews was that of uncertainty about their diagnosis and a need for information and A 2007 series of focus groups with Canadian general/family physicians found that there is debate over the existence of pre-diabetes as a clinical Which frameworks and/or models for the
entity. There is also limited and inconsistent use of screening and treatment of pre-diabetes at a
population level have been described and/or
o Physicians expressed that screening for and trialed?
treating pre-diabetes is not generally a priority National T2D prevention programs around the world o While physicians were aware of some risk factors for pre-diabetes i.e. obesity, age, family • Finland: The FIN-D2D program is part of a large, history, they were largely unaware of other risk national initiative to prevent T2D. It is an 3- pronged, national, integrated strategy that aims o Physicians expressed skepticism over their prevention at a population level; prevention for patients’ ability or willingness to take part in high-risk individuals; and early diagnosis and lifestyle interventions for pre-diabetes. • EU: An international effort known as the IMAGE with comparable success in preventing T2D. project (Development and Implementation of a
[Greaves 2008, Penn 2009, Whittemore 2009] European Guideline and Training Standards for
Diabetes prevention). The initiative aims to meet Systematic Review Evidence
four primary objectives and implement them into A systematic review and meta-analysis of o establishment of joint European guidelines; interventions concludes: “Motivational interviewing in a scientific setting outperforms o European standards for quality control of traditional advice giving in the treatment of a UK: The NHS has developed a national initiative Which strategies could the Champlain LHIN use
entitled ‘NHS Health Check’. The programme aims to engage with and leverage primary care in the
to identify individuals with, or at risk of developing screening and treatment of pre-diabetes?
heart disease, stroke, diabetes and kidney disease. Delivered through primary care, the programme • Little work has been done on how best to translate aims to invite all adults ages 40-74 who have not the findings of effective clinical research been diagnosed with any one of the four conditions interventions for pre-diabetes into the real-world of to undergo a preventive assessment. [DOH 2009] public health and primary care. [Crandall 2008] Germany: The TUMAINI model is a framework designed to effectively translate evidence on the prevention of T2D into primary health care using • A Danish trial trained GPs in optimal management o identify those at high risk to develop T2D; of individuals with IFG/IGT; authors conclude that, o short-term intensive intervention based on self- compared with controls, the trained GPs did not o long-term intervention to maintain motivation. • The GOAL trial is a “real-world” implementation study – 3yr follow up has just been published and The International Diabetes Foundation
improvements in body mass, blood glucose and (IDF) consensus statement on the
other critical outcomes have been maintained. treatment of T2D
Three steps are proposed as a framework for • Nurse Practitioner (NP) primary care practices were randomized to deliver either a more intensive or less intensive lifestyle intervention to patients at risk for diabetes – results showed that both interventions were effective in helping patients • A large trial is underway in the Netherlands using NPs in primary care offices; patients screened as high-risk will be randomized to a cognitive behaviour program or control. Follow up will be • Motivational interviewing is a suggested technique for managing the challenge of patient ambivalence • Pilot of a primary care educational toolkit to around adherence to preventive lifestyle measures. address the information needs of pre-diabetic Studies with chronic disease populations suggest it patients and health professionals found the is effective in producing the desired behaviour and intervention to be acceptable and useful to results, and can be cost- and resource-efficient. participants. The study identified 3 key messages for health professionals and pre-diabetic patients: • The motivational interviewing model has been studied in several populations at risk for diabetes. 2. the preventability of progression to diabetes; Results indicate that it is less resource-intensive 3. the need for lifestyle change. [Evans 2007] than other lifestyle interventions for pre-diabetes Relevant Systematic Review Evidence and
Commentary from the T2D literature
• “There is little good evidence for the • A cluster-randomized trial comparing a group- effectiveness of primary care interventions based Diabetes Prevention Program intervention versus brief individual counseling – results at 12- laboratory indicators, such as glycosylated 14mos showed statistically significant reduction in weight, BMI and total cholesterol for YMCA DPP participants [Finch 2009, Ackermann 2008] brief advice from physicians with links to community resources including dietitians, nurses, exercise programs, and specialized diabetes education centres.” [Harris 2003] Systematic Review Evidence from the T2D
interventions aimed at health professionals to improve process of care and/or health significant improvement in HbA1c levels. that “Multifaceted professional interventions “… due to the clinical significance of reported improvements in A1C, further trials facilitate structured and regular review of patients were effective in improving the warranted. Prospective assessments of the process of care. The addition of patient education to these interventions and the diabetes care led to improvements in patient How could the Champlain LHIN engage with and
• A small trial of a workplace diabetes screening and leverage the community in the screening and
prevention program delivered by the occupational treatment of pre-diabetes?
health nurse showed a significant reduction in waist circumference and improvement in IGT at 24mos • A retrospective examination of occupational health Systematic Review Evidence from the T2D
records in Germany revealed that, as part of a literature
routine exam, 5% of previously-undiagnosed employees were identified as having pre-diabetes; interventions examining the effectiveness of authors conclude that integrating T2D screening into an existing occupational health program can care of people with T2D found that “There detect a significant number of individuals suffering improvements in participant knowledge and • Toronto Public Health plans to integrate diabetes prevention measures into their existing “Health Options at Work” program. [TPH Diabetes Strategy • A meta-analysis of studies examining self- found an inverse relationship between GHb levels of participants and the amount of time • A small US trial demonstrated modest improvement in the body mass of pre-diabetic patients randomized to an interactive voice response (IVR) intervention delivered via telephone. [Estabrooks 2008] How best can the Champlain LHIN ensure that
Relevant Systematic Review Evidence from
various high risk groups e.g. rural, Francophone,
the T2D literature
ethnic minority populations are reached with
screening interventions for pre-diabetes?
socially disadvantaged people with diabetes • Canadian primary care physicians need to be made found: “…evidence for the effectiveness of acutely aware of their role in and the importance of screening high-risk populations, as well as which among socially disadvantaged populations groups are at greater risk. [Ipsos-Reid 2007] and identifies key intervention features that • The QDScore is a newly validated T2D risk score that takes into account ethnicity and socioeconomic status (UK). It is shown to be accurate, does not require lab tests and can be self-administered in training, community and family outreach, • The ‘Screening for Impaired Glucose Tolerance Study’ has assessed screening performance of • Another systematic review examined studies random plasma glucose (RPG) tests for a large of interventions designed to address health cohort of individuals without known diabetes. They conclude that: “Use of age, BMI, and race/ethnicity minorities with T2D. The study concludes: in guidelines for screening to detect diabetes and “There is evidence supporting the use of pre-diabetes may be less important than evaluation interventions that target patients (primarily of RPG. RPG should be investigated further as a convenient, inexpensive screen with good providers (especially through one-on-one feedback and education), and health systems (particularly with nurse case managers and How best can the Champlain LHIN ensure that
various high risk groups e.g. rural, Francophone,
ethnic minority populations are reached with
interventions for treating pre-diabetes?
• Pre-diabetes is a significant problem in Canada and • Cultural beliefs must be considered and addressed • International experts have suggested that the term e.g. perceptions of overweight [Alberti 2007] “pre-diabetes” may outlive its usefulness as • Determination of risk-level must not rely solely on understanding of the disease evolves into a risk measures that have been shown effective in Caucasian populations; e.g. risk measurements such • Several European nations are launching ambitious as waist circumference and BMI must take into population-level initiatives specifically aimed at the account the individuals’ ethnic group [Alberti 2007] • An Israeli analysis of health records and national • While there is an ever-growing body of evidence on socioeconomic data revealed that: “Individuals the effectiveness of screening and treatment living in lower socioeconomic areas were less likely strategies for pre-diabetes in clinical research, there to have blood tests. Among tested patients, the is limited evidence on how best to transfer effective prevalence of pre-diabetes was higher in areas of interventions into the ‘real-world’ of primary care lower SES and their dietitian visits were less • There is a rich body of literature around the • Dr. Baiju Shah of the Sunnybrook Health Sciences implementation of effective interventions into Centre in Toronto has received funding for an primary care for T2D and chronic disease. exploratory study to examine diabetics of Chinese • Lessons learned in implementation research around T2D and other chronic diseases may help inform the gaps in our understanding of implementing o how well they self-manage their diabetes; effective interventions for pre-diabetes into primary o whether the ethnicity of their doctor influences their care. [CDA Research Report 2008-9] References
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Other references consulted and of relevance to pre-diabetes

Chiasson, JL. Prevention of Type 2 diabetes: fact or fiction? Exp Op Pharmacotherapy 2007 8:18; 3147-3158. Yates T, Davies M, Khunti K. Preventing type 2 diabetes: can we make the evidence work? Postgrad Med J 2009;85:475–480.
Screening interventions

Aekplakorn W, Bunnag P, Woodward M, Sritara P, Cheepudomwit S, Yamwong S. A risk score for predicting incident diabetes in the Thai Population. Diabetes Care 2006; 29: 1872–1877. Allen P, Thompson JL, Herman CJ, Qualls C, Helitzer DL, Whyte AN, et al. Impact of periodic follow-up testing among urban American Indian women with impaired fasting glucose. Prev Chronic Dis 2008;5(3). American Diabetes Association. Diabetes Risk Test. Available from: (accessed November 2009). Canadian Diabetes Association. Are you at risk? (accessed November 2009) Christensen JO, Sandbaek A, Lauritzen T, Borch-Johnsen K. Population-based stepwise screening for unrecognised Type 2 diabetes is ineffective in general practice despite reliable algorithms. Diabetologia 2004; 47:9, 1566–1573. Griffin SJ, Little PS, Hales CN, Kinmonth AL, Wareham NJ. Diabetes risk score: towards earlier detection of type 2 diabetes in general practice. Diabetes Metab Res Rev 2000; 16: 164–171. Heikes K, Eddy D, Arondekar B, Schlessinger L. Diabetes Risk Calculator: A simple tool for detecting undiagnosed diabetes and pre-diabetes Diabetes Care 2008; 31:1040–1045. Schwarz PE, Li J, Lindstrom J, Tuomilehto J. Tools for predicting the risk of type 2 diabetes in daily practice. Horm Metab Res 2009;41:86-97. Waugh N, Scotland G, McNamee P, et al. Screening for type 2 diabetes: literature review and economic modelling. Health Technol Assess 2007; 11.
Treatment intervetions

Daniel M, Green LW, Marion SA et al. Effectiveness of community-directed diabetes prevention and control in a rural Aboriginal population in British Columbia, Canada. Soc Sci Med 1999; 48, 815–832. Gucciardi E, DeMelo M, Lee RN, Grace SL. Assessment of two culturally competent diabetes education methods: Individual versus individual plus group education in Canadian Portuguese adults with type 2 diabetes. Ethnicity & Health 2007; 12:2, 163-187. Pan XR, Li GW, Hu YH, Wang JX, Yang WY, An ZX, Hu ZX, Lin J, Xiao JZ, Cao HB, Liu PA, Jiang XG, Jiang YY, Wang JP, Zheng H, Zhang H, Bennett PH, Howard BV. Effects of diet and exercise in preventing NIDDM in people with impaired glucose tolerance. The Da Qing IGT and Diabetes Study. Diabetes Care 1997 20:537–54. Simmons D, Rush E, Crook N on behalf of the Te Wai o Rona: Diabetes Prevention Strategy Team. Development and piloting of a community health worker-based intervention for the prevention of diabetes among New Zealand Maori in Te Wai o Rona: Diabetes Prevention Strategy. Public Health Nutrition: 11(12), 1318–1325 doi:10.1017/S1368980008002711.
Cost-effectiveness studies

Josse RG, McGuire AJ, Saal GB. A review of the economic evidence for acarbose in the prevention of diabetes and cardiovascular events in individuals with impaired glucose tolerance Int J Clin Pract 2006; 60:7, 847–855.
Consensus statements/guidelines

Nathan DM, Davidson MB, Defronzo RA, Heine RJ, Henry RR, Pratley R, Zinman B. ADA Consensus Statement: Impaired Fasting Glucose and Impaired Glucose Tolerance: Implications for care. Diabetes Care 2007; 30:3, 753-759.


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