The use of telemedicine care has a similar effect on glycemic control, acute complications, and quality of life as routine face-to-face visits for patients with type 1 diabetes (T1D), according to study results published in Diabetes Care.
Telemedicine, defined as the delivery of healthcare services using information and communication technologies, has been proven to be an important tool in the management of chronic conditions and may be helpful in optimizing management of patients with T1D living in rural areas or in places far from specialty care centers.
As there were no known previous randomized clinical trials to assess the benefits of telemedicine in patients with T1D, the goal of the current study was to explore the effect of this platform for 6 months on patients with T1D treated with multiple daily injections.
PLATEDIAN (ClinicalTrials.gov Identifier: NCT03332472) was a randomized 6-month follow-up open-label multicenter parallel-group controlled study that enrolled patients aged 18 to 65 years with T1D treated at 10 hospitals in Andalusia, Spain. All patients had hemoglobin A1c (HbA1c) levels <8%, used a basal-bolus regimen for multiple daily injections, and had T1D for >2 years. Of 388 adults with T1D who participated, 330 completed the study and were included in the analysis. The patients were randomly assigned to the telemedicine group (intervention group: 163 patients), with the second of 3 clinical visits performed using telemedicine, or routine care (control group: 167 patients), with all visits occurring in person.
The primary outcome was the mean change in HbA1c levels from baseline to 6 months. Secondary efficacy end points included changes in mean blood glucose and glucose variability. Furthermore, patient-reported outcomes and health-related quality of life measures were assessed.
At 6 months, mean HbA1c remained similar in the control group (7.0%±0.7%) and the intervention group (7.0%±0.8%). Thus, mean change in HbA1c levels was similar between the groups: -0.04%±0.5% vs 0.01%±0.6% (P =.4941), respectively. HbA1c <7% was achieved by 73 patients (43.71%) in the control group and 78 patients (47.75%) in the intervention group.
No significant differences were found in the number of hypoglycemia episodes between the cohorts at 6 months and there were no significant differences in the other safety end points, including hyperglycemia episodes, ketoacidosis, or hospital admissions for glycemic decompensation.
As for patient-reported outcomes, although there were significant differences in quality of life impact and satisfaction of treatment subscales between cohorts at baseline, there was no difference in the change in health-related quality of life during the study. Fear of hypoglycemia was more common in the control group compared with the intervention group at baseline (54.6% vs 40.8%, respectively; P <.05) and at the end of the study (58.7% vs 40.2%, respectively; P <.05). Physicians’ satisfaction with the use of the telemedicine platform was moderate to high.
The researchers acknowledged several study limitations, including lack of data on diabetes duration, use of capillary blood glucose and not continuous glucose monitoring to assess glucose variability, and lack of internal reliability of the questionnaire used to asses physicians’ satisfaction.
“[T]he study allows us to prove the advantages of this innovative care option in the usual follow-up of this specific profile of people with type 1 diabetes and shows that telemedicine may improve patient access to health care and diabetes management in some geographic areas,” concluded the researchers.
Disclosure: This clinical trial was supported by Sanofi. Please see the original reference for a full list of authors’ disclosures.
Ruiz de Adana MS, Alhambra-Expósito MR, Muñoz-Garach A, et al. 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 [published online December 12, 2019]. Diabetes Care. doi:10.2337/dc19-0739