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Original Research
Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study
Maria S. Ruiz de Adana, Maria Rosa Alhambra-Expósito, Araceli Muñoz-Garach, Inmaculada Gonzalez-Molero, Natalia Colomo, Isabel Torres-Barea, Manuel Aguilar-Diosdado, Florentino Carral, Manuel Serrano, Maria A. Martínez-Brocca, Ana Duran, Rafael Palomares on behalf of the Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition)
Diabetes Care 2020 Jan; dc190739. https://doi.org/10.2337/dc19-0739
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Abstract

OBJECTIVE To assess the impact of a telemedicine visit using the platform Diabetic compared with a face-to-face visit on clinical outcomes, patients’ health-related quality of life (HRQoL), and physicians’ satisfaction in patients with type 1 diabetes.

RESEARCH DESIGN AND METHODS PLATEDIAN (Telemedicine on Metabolic Control in Type 1 Diabetes Mellitus Andalusian Patients) (NCT03332472) was a multicenter, randomized, 6-month follow-up, open-label, parallel-group controlled study performed in patients with type 1 diabetes with suboptimal metabolic control (HbA1c <8% [<64 mmol/mol]), treated with multiple daily injections. A total of 388 patients were assessed for eligibility; 379 of them were randomized 1:1 to three face-to-face visits (control cohort [CC]) (n = 167) or the replacement of an intermediate face-to-face visit by a telemedicine visit using Diabetic (intervention cohort [IC]) (n = 163). The primary efficacy end point was the mean change of HbA1c levels from baseline to month 6. Other efficacy and safety end points were mean blood glucose, glucose variability, episodes of hypoglycemia and hyperglycemia, patient-reported outcomes, and physicians’ satisfaction.

RESULTS At month 6, the mean change in HbA1c levels was −0.04 ± 0.5% (−0.5 ± 5.8 mmol/mol) in the CC and 0.01 ± 0.6% (0.1 ± 6.0 mmol/mol) in the IC (P = 0.4941). The number of patients who achieved HbA1c <7% (<53 mmol/mol) was 73 and 78 in the CC and IC, respectively. Significant differences were not found regarding safety end points at 6 months. Changes in HRQoL between the first visit and final visit did not differ between cohorts, and, regarding fear of hypoglycemia (FH-15 score ≥28), statistically significant differences observed at baseline remained unchanged at 6 months (P < 0.05).

CONCLUSIONS The use of telemedicine in patients with type 1 diabetes with HbA1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits.

Footnotes

  • ↵* A complete list of the Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition) can be found in the Supplementary Data.

  • This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc19-0739/-/DC1.

  • Received April 12, 2019.
  • Accepted November 16, 2019.
  • © 2019 by the American Diabetes Association.
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Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. More information is available at http://www.diabetesjournals.org/content/license.

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Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study
Maria S. Ruiz de Adana, Maria Rosa Alhambra-Expósito, Araceli Muñoz-Garach, Inmaculada Gonzalez-Molero, Natalia Colomo, Isabel Torres-Barea, Manuel Aguilar-Diosdado, Florentino Carral, Manuel Serrano, Maria A. Martínez-Brocca, Ana Duran, Rafael Palomares
Diabetes Care Jan 2020, dc190739; DOI: 10.2337/dc19-0739

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Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA1c in Andalusia (Spain): PLATEDIAN Study
Maria S. Ruiz de Adana, Maria Rosa Alhambra-Expósito, Araceli Muñoz-Garach, Inmaculada Gonzalez-Molero, Natalia Colomo, Isabel Torres-Barea, Manuel Aguilar-Diosdado, Florentino Carral, Manuel Serrano, Maria A. Martínez-Brocca, Ana Duran, Rafael Palomares
Diabetes Care Jan 2020, dc190739; DOI: 10.2337/dc19-0739
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