Actively Recruiting
EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE
Led by Persei Vivarium · Updated on 2025-07-31
200
Participants Needed
2
Research Sites
37 weeks
Total Duration
On this page
Sponsors
P
Persei Vivarium
Lead Sponsor
E
Effice Servicios Para la Investigacion S.L.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with diabetes mellitus treated with insulin.
- Patients treated with subcutaneous insulin in multiple daily doses or continuous subcutaneous infusion systems.
- Patients using a glucose monitoring system.
- Patients able to complete the study questionnaires.
- Informed consent is obtained from the patient.
- Control group patients must have clinical and glucose monitoring data from the 12 weeks prior to inclusion available in medical records or device platforms.
- Caaring group patients must have sufficient skills to use a smartphone.
You will not qualify if you...
- Patients with cognitive or sensory difficulties or insufficient Spanish language skills that impair understanding, unless a legal representative can participate.
- Transient patients unlikely to complete follow-up due to change of residence.
- Patients currently participating in any other clinical trial (observational studies allowed).
- Patients with poorly controlled mental disorders or other medical illnesses as main diagnosis.
- Patients with terminal illness or in palliative care per SECPAL criteria.
- Institutionalized patients.
- Patients who are pregnant or breastfeeding.
- Patients under specific follow-up in other hospital units (hemodialysis, transplants, etc.) requiring hospital attendance less often than every two months, if investigator considers inclusion inadvisable.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Hospital Clínico Universitario de Valladolid
Valladolid, Castille and León, Spain, 47003
Actively Recruiting
2
Hospital Infantil Universitario Niño Jesús
Madrid, Madrid, Spain, 28009
Actively Recruiting
Research Team
P
Patricia Dominguez
CONTACT
R
Roberto Bravo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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