Maria S Ruiz de Adana1,2,3, Maria Rosa Alhambra-Expósito4,5, Araceli Muñoz-Garach2,6, Inmaculada Gonzalez-Molero1,2,3, Natalia Colomo7,2,3, Isabel Torres-Barea8, Manuel Aguilar-Diosdado9,10, Florentino Carral11, Manuel Serrano12, Maria A Martínez-Brocca13,14, Ana Duran15, Rafael Palomares. 1. Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain. 2. Instituto de Investigación Biomédica de Málaga (IBIMA), Málaga, Spain. 3. Ciber de Diabetes y Enfermedades Metabólicas (CIBERDEM), Madrid, Spain. 4. Endocrinology and Nutrition Department, Hospital Universitario Reina Sofía, Córdoba, Spain. 5. Maimonides Institute of Biomedical Research of Cordoba (IMIBIC), Córdoba, Spain. 6. Endocrinology and Nutrition Department, Hospital Universitario Virgen de la Victoria, Málaga, Spain. 7. Endocrinology and Nutrition Department, Hospital Regional Universitario de Málaga, Málaga, Spain nataliacolomo@gmail.com. 8. Endocrinology and Nutrition Department, Hospital Universitario de Jerez, Jerez, Cádiz, Spain. 9. Endocrinology and Nutrition Department, Hospital Universitario Puerta del Mar, Cádiz, Spain. 10. Biomedical Institute of Research of Cadiz (INIBICA), Cadiz, Spain. 11. Endocrinology and Nutrition Department, Hospital Universitario Puerto Real, Puerto Real, Cádiz, Spain. 12. Endocrinology and Nutrition Department, Complejo Hospitalario de Jaén, Jaén, Spain. 13. Endocrinology and Nutrition Department, Hospital Universitario Virgen Macarena, Sevilla, Spain. 14. Instituto de Biomedicina de Sevilla (IBiS), Hospital Universitario Virgen del Rocío/Consejo Superior de Investigaciones Científicas/Universidad de Sevilla, Sevilla, Spain. 15. Medical Department, Sanofi Spain, Barcelona, Spain.
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.
RCT Entities:
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 AndalusianPatients) (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.
Authors: Anders Nikolai Ørsted Schultz; Robin Christensen; Georg Bollig; Kristian Kidholm; F Brandt Journal: BMJ Open Date: 2022-04-27 Impact factor: 3.006