Prevalence of Neuropathy and Peripheral Arterial Disease and the Impact of Treatment in People With Screen-Detected Type 2 Diabetes: The ADDITION-Denmark study

Diabetes Care, Oct 2011

OBJECTIVE There 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.

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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. - 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)


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Morten Charles, Niels Ejskjaer, Daniel R. Witte, Knut Borch-Johnsen, Torsten Lauritzen, Annelli Sandbaek. Prevalence of Neuropathy and Peripheral Arterial Disease and the Impact of Treatment in People With Screen-Detected Type 2 Diabetes: The ADDITION-Denmark study, Diabetes Care, 2011, pp. 2244-2249, 34/10, DOI: 10.2337/dc11-0903