Effect of Early Multifactorial Therapy Compared With Routine Care on Microvascular Outcomes at 5 Years in People With Screen-Detected Diabetes: A Randomized Controlled Trial
| Autor: | Annelli Sandbæk, Stephen J. Sharp, Rebecca K. Simmons, Torsten Lauritzen, Nicholas J. Wareham, Kamlesh Khunti, Knut Borch-Johnsen, Melanie J. Davies, Maureen van den Donk, Guy E.H.M. Rutten, Simon J. Griffin |
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| Rok vydání: | 2014 |
| Předmět: |
Advanced and Specialized Nursing
medicine.medical_specialty Intention-to-treat analysis Randomization business.industry Endocrinology Diabetes and Metabolism Odds ratio Type 2 diabetes medicine.disease law.invention Randomized controlled trial law Internal medicine Diabetes mellitus Internal Medicine medicine Physical therapy Albuminuria medicine.symptom business Retinopathy |
| Zdroj: | Diabetes Care. 37:2015-2023 |
| ISSN: | 1935-5548 0149-5992 |
| DOI: | 10.2337/dc13-1544 |
| Popis: | OBJECTIVE To determine the benefit of multifactorial treatment on microvascular complications among people with type 2 diabetes detected by screening. RESEARCH DESIGN AND METHODS This study was a multicenter cluster randomized controlled trial in primary care with randomization at the practice level. In four centers in Denmark; Cambridge, U.K.; the Netherlands; and Leicester, U.K., 343 general practices participated in the trial. Eligible for follow-up were 2,861 of the 3,057 people with diabetes detected by screening included in the original trial. Biomedical data on nephropathy were collected in 2,710 (94.7%) participants, retinal photos in 2,190 (76.6%), and questionnaire data on peripheral neuropathy in 2,312 (80.9%). The prespecified microvascular end points were analyzed by intention to treat. Results from the four centers were pooled using fixed-effects meta-analysis. RESULTS Five years after diagnosis, any kind of albuminuria was present in 22.7% of participants in the intensive treatment (IT) group and in 24.4% in the routine care (RC) group (odds ratio 0.87 [95% CI 0.72–1.07]). Retinopathy was present in 10.2% of the IT group and 12.1% of the RC group (0.84 [0.64–1.10]), and severe retinopathy was present in one patient in the IT group and seven in the RC group. Neuropathy was present in 4.9% and 5.9% (0.95 [0.68–1.34]), respectively. Estimated glomerular filtration rate increased between baseline and follow-up in both groups (4.31 and 6.44 mL/min, respectively). CONCLUSIONS Compared with RC, an intervention to promote target-driven, intensive management of patients with type 2 diabetes detected by screening was not associated with significant reductions in the frequency of microvascular events at 5 years. |
| Databáze: | OpenAIRE |
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