Remote monitoring for insulin-treated diabetes patients using Caaring software
DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE
This study is testing if a remote monitoring app called Caaring® can help insulin-treated diabetes patients manage their blood sugar better and reduce the need for in-person doctor visits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Persei Vivarium Academic / other |
| Locations | 2 sites (Valladolid, Castille and León and 1 other locations) |
| Trial ID | NCT06794658 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are insulin-treated diabetes patients who use a glucose monitoring system and have the technological skills to operate a smartphone.
Not a fit: Patients with cognitive or sensory difficulties, or those who cannot understand Spanish, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance self-management of diabetes and improve glycemic control for patients.
How similar studies have performed: Other studies have shown promise in using remote monitoring for diabetes management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Valladolid, Castille and León and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.