Condition: Diabetes Mellitus · Sponsor: Persei Vivarium
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®. The main question it aims to answer is if the development of a self-management platform (Caaring®) that enhances the role of the patient with diabetes in the course of their disease will increase the TIR and/or reduce the number of in-person and telephone visits assisted by specialized medical and nursing personnel. This is two arms, randomized study. Online telemonitoring group: The follow-up of these patients will be carried out prospectively remotely through the Caaring® platform. And Retrospective Control group: The data of these patients are collected retrospectively from the last 12 weeks prior to their inclusion. Researchers will compare the assessments between the two groups to see if the software Caaring® improve the TIR and/or reduce the number of visits to the specialist personnel. Participants with diabetes will: Use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) systems. In addition, Control group patients must have clinical and glucometry data from the 12 weeks prior to their inclusion date available in the Medical Record, and/or through the monitoring platforms of the continuous glucose monitoring devices Caaring group patients must have sufficient technological skills to use a smartphone.
This description comes directly from the study's public registry record.
Patricia Dominguez · +34 915 004 013 · patricia.dominguez@perseivivarium.com
Roberto Bravo · +34 915 004 013 · roberto.bravo@perseivivarium.com
Always discuss trial participation with your own doctor first.
| Hospital Clínico Universitario de Valladolid | Valladolid, Castille and León, Spain | Recruiting |
| Hospital Infantil Universitario Niño Jesús | Madrid, Madrid, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06794658