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Prevalence of Neuropathy and Peripheral Arterial Disease and the Impact of Treatment in People With Screen-Detected Type 2 Diabetes: The ADDITION-Denmark study
MORTEN CHARLES
NIELS EJSKJAER
DANIEL R. WITTE
PHD
KNUT BORCH-JOHNSEN
DRMEDSCI
TORSTEN LAURITZEN
DRMEDSCI
ANNELLI SANDBAEK
E p i d e m i o l o g y / H e a l t h OBJECTIVEdThere is limited evidence on how intensive multifactorial treatment (IT) improves outcomes of diabetes when initiated in the lead time between detection by screening and diagnosis in routine clinical practice. We examined the effects of early detection and IT of type 2 diabetes in primary care on the prevalence of diabetic peripheral neuropathy (DPN) and peripheral arterial disease (PAD) 6 years later in a pragmatic, cluster-randomized parallel group trial. RESEARCH DESIGN AND METHODSdA stepwise screening program in 190 general practices in Denmark was used to identify 1,533 people with type 2 diabetes. General practices were randomized to deliver either IT or routine care (RC) as recommended through national guidelines. Participants were followed for 6 years and measures of DPN and PAD were applied. RESULTSdWe found no statistically significant effect of IT on the prevalence of DPN and PAD compared with RC. The prevalence of an ankle brachial index #0.9 was 9.1% (95% CI 6.0-12.2) in the RC arm and 7.3% (5.0-9.6) in the IT arm. In participants tested for vibration detection threshold and light touch sensation, the prevalence of a least one abnormal test was 34.8% (26.743.0) in the RC arm and 30.1% (24.1-36.1) in the IT arm. CONCLUSIONSdIn a population with screen-detected type 2 diabetes, we did not find that screening followed by IT led to a statistically significant difference in the prevalence of DPN and PAD 6 years after diagnosis. However, treatment levels were high in both groups.
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D suitable for screening (1). However,
iabetes is increasingly considered
even though modeling studies
suggest that screening may be cost effective,
there are several critical uncertainties (2).
In particular, there is limited evidence
that benefit estimates obtained from
studies of clinically detected type 2 diabetes
also apply to screen-detected populations.
The multicenter Anglo-Danish-Dutch
Study of Intensive Treatment in People
With Screen-Detected Diabetes in
Primary Care (ADDITION) was set to obtain
this evidence base. The ADDITION study
showed that an intervention to promote
target-driven, intensive management of
patients with screen-detected type 2
diabetes was associated with a nonstatistically
c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c c
significant 17% relative reduction in the
incidence of a composite cardiovascular
event end point over 5 years (3). There
is limited trial evidence regarding
prevention of diabetic peripheral neuropathy
(DPN) and peripheral arterial disease
(PAD) in people with diabetes. As current
knowledge on PAD and DPN in diabetes
has been gained in patients with clinically
diagnosed and sometimes longstanding
diabetes, and as the prevalence of PAD
and DPN in patients with screen-detected
diabetes is unknown, our aim was to
describe the effect of early detection and
intensive multifactorial treatment (IT) on
the prevalence of DPN and PAD in
patients with screen-detected type 2
diabetes in the Danish arm of the ADDITION
study.
RESEARCH DESIGN AND
METHODS
Design
The design and rationale of the ADDITION
study have been reported (4). In brief,
ADDITION-Denmark consists of two
phases: 1) a screening phase and 2) a
pragmatic, cluster-randomized parallel group
trial. In five regions of Denmark, 744
general practices were invited to participate
and 190 agreed and were randomized to
screening plus routine care (RC) of
diabetes or screening followed by IT.
Randomization was stratified by region and the
number of full-time general practitioners
per practice.
A population-based stepwise
screening program among people aged 4069
years without known diabetes was
undertaken, and individuals were diagnosed
with diabetes according to World Health
Organization (WHO) criteria, as previously
described (5). Overall 1,533 (RC, 623; IT,
910) eligible participants with
screendetected diabetes agreed to take part in the
trial. After an average of 6 years of
followup, 1,278 participants were re-examined.
One hundred eight people were only seen
by their own general practitioner and nine
people were not examined with the tests
included in the present analysis and did
not answer the questionnaires. These
participants were excluded from our analysis,
yielding a study sample of 1,161
participants for the analysis presented in this
paper. Supplementary Fig. A1 displays the
practice and participant flow.
Intervention
The specific characteristics of the
interventions to promote IT have been
described previously in detail (4). The
purpose of the IT was to provide the
best possible evidence-based treatment
in primary care. We aimed to educate
and support general practitioners and
practice nurses in target-driven
management (using medication and promotion
of healthy lifestyle) of hyperglycemia,
blood p (...truncated)