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 Background Is it clinically beneficial to screen patients for pre-diabetes?
• “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 pre-diabetes?
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 pre-diabetes? 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 literature
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 Conclusions 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]
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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
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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: http://www.diabetes.org/diabetes-basics/prevention/diabetes-risk-test/ (accessed November 2009).
Canadian Diabetes Association. Are you at risk? http://www.diabetes.ca/Files/are-you-at-risk.pdf (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.
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Treatment intervetions
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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
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