Remote monitoring for insulin-treated diabetes patients using Caaring software

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the efficacy of a remote monitoring platform called Caaring® for patients with diabetes who are treated with insulin. It is a randomized, two-arm study comparing a group receiving online telemonitoring through Caaring® with a retrospective control group whose data is collected from the previous 12 weeks. The aim is to determine if the use of this software can improve patients' Time in Range (TIR) and reduce the number of in-person and telephone visits to healthcare professionals. The study is multicenter and follows a non-inferiority design.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients with diabetes mellitus treated with insulin.
* Patients treated with subcutaneous insulin in multiple daily doses or patients treated with subcutaneous insulin in continuous subcutaneous infusion systems
* Patients using a glucose monitoring system
* Patients who are able to complete the study questionnaires
* Informed consent is obtained from the patient.
* For 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 - For Caaring group: Patients must have sufficient technological skills to use a smartphone.

Exclusion Criteria:

* Patients with cognitive or sensory difficulties or with insufficient command of Spanish who, in the opinion of the investigator, makes it difficult to understand the questions or the scales, as long as they do not have a legally authorized representative capable of participating in the study.
* Transient patients in whom it may be anticipated that follow-up will not be completed due to a change of residence.
* Patients Who are participating at the time of recruitment in any other clinical trial. Participation in observational studies will not be an exclusion criteria.
* Patients whose main diagnosis is a poorly controlled mental disorders or other medical illness.
* Patients with terminal illness and/or in palliative care according to the criteria of the SECPAL (Spanish Society of Palliative Care).
* Institutionalized patients
* Patients who are pregnant or breastfeeding.
* Patients whose inclusion is not considered advisable by the investigator's assessment due to they are under specific follow-up in other hospital units (hemodialysis, transplants, etc.) that require mandatory hospital attendance less frequently than once every two months.

Where it's running

• Hospital Clínico Universitario de Valladolid
  Valladolid, Castille and León, Spain Recruiting
• Hospital Infantil Universitario Niño Jesús
  Madrid, Madrid, Spain Recruiting

Study contacts

• Study coordinator: Patricia Dominguez
• Email: patricia.dominguez@perseivivarium.com
• Phone: +34 915 004 013

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.