EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE

Launched by PERSEI VIVARIUM · Jan 21, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a software called Caaring® that helps people with diabetes who are using insulin manage their condition better from home. The main goal is to see if using this software can help patients keep their blood sugar levels stable (known as Time in Range) and reduce the number of visits they need to make to their doctors or nurses. The study has two groups: one group will use the Caaring® platform for remote monitoring, while the other group will have their data collected from the past 12 weeks without using the software. Researchers will compare the results from both groups to understand the effectiveness of Caaring®.

To participate in this trial, you should be an adult with diabetes who uses insulin and a glucose monitoring system. You need to be able to complete study questionnaires and give your consent to join. If you're in the remote monitoring group, you'll need to be comfortable using a smartphone. However, people with certain medical or cognitive challenges, or those who are pregnant or breastfeeding, will not be eligible. If you join, you can expect to use the Caaring® software to help you track and manage your diabetes more effectively while being monitored by the study team from home.

Gender

ALL

Eligibility 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.