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Role of structured individual patient education in the prevention of vascular complications in newly diagnosed type 2 diabetes: the INdividual Therapeutic Education in Newly Diagnosed type 2 diabetes (INTEND) randomized controlled trial

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Abstract

Objective

Recent studies showed that a structured patient therapeutic education (PTE) may decrease both mortality and the development of diabetes complications. Nevertheless, no data are available in the literature on the impact of individual PTE on the complications in newly diagnosed type 2 diabetic patients. Aim of the present randomized controlled trial is to evaluate the impact of individual PTE on the occurrence of macrovascular complications in newly diagnosed type 2 diabetic patients when compared to usual care (UC) and group PTE.

Design and methods

Six hundred newly diagnosed type 2 diabetic patients will be enrolled. The patients will be randomly assigned to one of these three groups: individual PTE, group PTE and UC. A comprehensive and complete PTE will be delivered to all the patients: PTE will include eleven themes. Primary composite endpoint of the study is occurrence of vascular complications, including cardiovascular death, non fatal coronary disease, non fatal stroke, peripheral artery disease. Secondary endpoints are: foot ulcers, amputations, sexual dysfunction, quality of life, microvascular complications, bone health, intensification of diabetes and hypertension therapy.

Results and Conclusions

The present trial can give precious information on the features for the most effective PTE.

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Authors and Affiliations

  1. Diabetes and endocrine and metabolic diseases Unit and the Centre for Applied Clinical Research (Ce.R.C.A.) Clinical Institute “Beato Matteo” (Hospital Group San Donato), Vigevano, Italy

    Adriana Coppola & Carmine Gazzaruso

  2. Department of Biomedical Sciences for Health, Università degli Studi di Milano, Milan, Italy

    Livio Luzi

  3. Metabolism Research Center, IRCCS Policlinico San Donato, San Donato Milanese, Italy

    Livio Luzi

  4. Department of Clinical and Experimental Medicine, Nutrition Unit, University Magna Grecia, Catanzaro, Italy

    Tiziana Montalcini

  5. Chair of Endocrinology San Raffaele Vita-Salute University, Milan, Italy

    Andrea Giustina

Authors
  1. Adriana Coppola
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  2. Livio Luzi
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  3. Tiziana Montalcini
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  4. Andrea Giustina
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  5. Carmine Gazzaruso
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Corresponding author

Correspondence to Carmine Gazzaruso.

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Conflict of interest

The authors declare that they have no competing interests.

Ethical approval

The present trial complies with ethical requirements.

Informed consent

Informed consent will be required to any patient will be recruited.

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Coppola, A., Luzi, L., Montalcini, T. et al. Role of structured individual patient education in the prevention of vascular complications in newly diagnosed type 2 diabetes: the INdividual Therapeutic Education in Newly Diagnosed type 2 diabetes (INTEND) randomized controlled trial. Endocrine 60, 46–49 (2018). https://doi.org/10.1007/s12020-017-1427-x

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  • DOI: https://doi.org/10.1007/s12020-017-1427-x

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