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7. 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

Author

Ruiz de Adana, Maria S, Alhambra-Expósito, Maria Rosa, Muñoz-Garach, Araceli, Gonzalez-Molero, Inmaculada, Colomo, Natalia, Torres-Barea, Isabel, Aguilar-Diosdado, Manuel, Carral, Florentino, Serrano, Manuel, Martínez-Brocca, Maria A, Duran, Ana, Palomares, Rafael, Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition), Sociedad Andaluza de Endocrinología, Diabetes y Nutrición, and Ministerio de Economía y Competitividad (España)

Subjects
Adult, Blood Glucose, Male, Research design, medicine.medical_specialty, Office Visits, Endocrinology, Diabetes and Metabolism, medicine.medical_treatment, 030209 endocrinology & metabolism, Injections, law.invention, Young Adult, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, Quality of life, law, Internal medicine, Diabetes mellitus, Internal Medicine, medicine, Humans, Hypoglycemic Agents, Insulin, 030212 general & internal medicine, Young adult, Glycated Hemoglobin, Advanced and Specialized Nursing, Type 1 diabetes, Dose-Response Relationship, Drug, Primary Health Care, business.industry, Middle Aged, medicine.disease, Hypoglycemia, Telemedicine, Diabetes Mellitus, Type 1, Treatment Outcome, Spain, Metabolic control analysis, Quality of Life, Female, business, Follow-Up Studies
Abstract

Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition)., [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, [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, [Conclusions] The use of telemedicine in patients with type 1 diabetes with HbA1c, This study was sponsored by the Andalusian Society of Endocrinology, Diabetes, and Nutrition (SAEDYN). A.M.-G. was the recipient of a postdoctoral grant (Juan Rodes JR 17/00023) from the Spanish Ministry of Economy and Competitiveness.

Published
2020

8. 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

Author

Sociedad Andaluza de Endocrinología, Diabetes y Nutrición, Ministerio de Economía y Competitividad (España), Ruiz de Adana, María S., Alhambra-Expósito, María R., Muñoz-Garach, Araceli, González-Molero, Inmaculada, Colomo, Natalia, Torres-Barea, Isabel, Aguilar-Diosdado, Manuel, Carral, Florentino, Serrano, Manuel, Martínez-Brocca, María Asunción, Durán, Ana, Palomares, Rafael, Sociedad Andaluza de Endocrinología, Diabetes y Nutrición, Ministerio de Economía y Competitividad (España), Ruiz de Adana, María S., Alhambra-Expósito, María R., Muñoz-Garach, Araceli, González-Molero, Inmaculada, Colomo, Natalia, Torres-Barea, Isabel, Aguilar-Diosdado, Manuel, Carral, Florentino, Serrano, Manuel, Martínez-Brocca, María Asunción, Durán, Ana, and Palomares, Rafael

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.

Published
2020

11. 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

Author

Ruiz de Adana, Maria S., primary, Alhambra-Expósito, Maria Rosa, additional, Muñoz-Garach, Araceli, additional, Gonzalez-Molero, Inmaculada, additional, Colomo, Natalia, additional, Torres-Barea, Isabel, additional, Aguilar-Diosdado, Manuel, additional, Carral, Florentino, additional, Serrano, Manuel, additional, Martínez-Brocca, Maria A., additional, Duran, Ana, additional, and Palomares, Rafael, additional

Published
2019
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12. 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.

Author

Ruiz de Adana, Maria S., Alhambra-Expósito, Maria Rosa, Muñoz-Garach, Araceli, Gonzalez-Molero, Inmaculada, Colomo, Natalia, Torres-Barea, Isabel, Aguilar-Diosdado, Manuel, Carral, Florentino, Serrano, Manuel, Martínez-Brocca, Maria A., Duran, Ana, Palomares, Rafael, and Diabetes Group of SAEDYN (Andalusian Society of Endocrinology, Diabetes, and Nutrition)

Subjects
TYPE 1 diabetes, TELEMEDICINE, INSULIN pumps, BLOOD sugar, INSULIN, METABOLIC regulation, RESEARCH, INJECTIONS, RESEARCH methodology, HYPOGLYCEMIC agents, EVALUATION research, MEDICAL cooperation, PRIMARY health care, TREATMENT effectiveness, COMPARATIVE studies, RANDOMIZED controlled trials, HYPOGLYCEMIA, DOSE-effect relationship in pharmacology, QUALITY of life, MEDICAL appointments, STATISTICAL sampling, LONGITUDINAL method
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. [ABSTRACT FROM AUTHOR]

Published
2020
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26. Primary adrenal lymphoma: case report

Author

Marquez-Pardo, Rosa, primary, Baena-Nieto, Maria-Gloria, additional, Cayon-Blanco, Manuel, additional, Garcia-Garcia-Doncel, Lourdes, additional, Lopez-Velasco, Rosario, additional, and Torres-Barea, Isabel, additional

Published
2015
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28. Randomized Study to Evaluate the Impact of Telemedicine Care in Patients With Type 1 Diabetes With Multiple Doses of Insulin and Suboptimal HbA 1c in Andalusia (Spain): PLATEDIAN Study.

Author

Ruiz de Adana MS, Alhambra-Expósito MR, Muñoz-Garach A, Gonzalez-Molero I, Colomo N, Torres-Barea I, Aguilar-Diosdado M, Carral F, Serrano M, Martínez-Brocca MA, Duran A, and Palomares R

Subjects
Adult, Blood Glucose drug effects, Blood Glucose metabolism, Diabetes Mellitus, Type 1 drug therapy, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Humans, Hypoglycemia chemically induced, Hypoglycemia epidemiology, Hypoglycemic Agents administration & dosage, Injections, Male, Middle Aged, Office Visits, Primary Health Care organization & administration, Quality of Life, Spain, Treatment Outcome, Young Adult, Diabetes Mellitus, Type 1 metabolism, Diabetes Mellitus, Type 1 therapy, Glycated Hemoglobin metabolism, Insulin administration & dosage, Primary Health Care methods, Telemedicine methods
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 (HbA 1c <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 HbA 1c 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 HbA 1c 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 HbA 1c <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 HbA 1c <8% (<64 mmol/mol) provides similar efficacy and safety outcomes as face-to-face visits., (© 2019 by the American Diabetes Association.)

Published
2020
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