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.

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) () 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.