EFFICACY of REMOTE MONITORING of PATIENTS with DIABETES UNDER INSULIN TREATMENT, by USING Caaring SOFTWARE

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT06794658
• Lead Sponsor: Persei Vivarium

Brief Summary

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.

Detailed Description

This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial.

The protocol and informed consent documents have been reviewed and approved by the hospital human subjects reviewboard and the study will be performed in accordance with the Declaration of Helsinki

Study Timeline

• Study Start: 2024-12-11
• Study First Submitted: 2024-12-17
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-21
• Study First Posted: 2025-01-27
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-06
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.	12 weeks	% acceptable Time in Range (TIR) of glucose measurements defined as the percentage of how long the patient's glucose value was within the target range (70-180 mg/dL)

Secondary Outcome Measures

Name	Time	Method
PROs. Changes in Health-related quality of life (HRQOL): EsDQOL	Day 0 and week 12	Change in the patient's quality of life scale the study compared to baseline: EsDQOL questionnaire for adults (Value 0-100). A higher score reflects a higher health-related quality of life (HRQoL).
PROs. Adherence of treatment	Day 0 and Weekly up to 12 weeks	Adherence to therapy (insulin)
PROs. in Health-related quality of life (HRQOL): KINDL	Day 0 and week 12	Change in the patient's quality of life scale the study compared to baseline: KINDL and Diabetes-related quality of life questionnaire for pediatrics for the pediatric population (Value 0-100). A higher score reflects a higher health-related quality of life (HRQoL).
PROs. Patient satisfaction with the software Caaring	Week 12	The patient satisfaction will be measured through a specific satisfaction questionnaire created for this purpose. (Value 3-15). A higher score reflects greater satisfaction with software care.
PROs. Variation in clinical parameters of glycemic control: HbA1c	Day 0 and Week 12	Variation in clinical parameters of glycemic control, HbA1c
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR (time in range)(70-180 mg/dl)
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR (time below range) Time \< 70 mg/dL
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT (Time in target range), (70-140 mg/dL).
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV (Coefficient of Variation)
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI	Day 0 and Biweekly up to 12 weeks	Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI (Glycemic Risk Index).
PROs. Number of Medical Visits	Day 0 and Monthly up to 12 weeks	Number of medical visits, calls or interactions with specialist healthcare personnel

Trial Locations

Locations (2)

Hospital Clínico Universitario de Valladolid; 🇪🇸 Valladolid, Castilla y León, Spain

Hospital Infantil Universitario Niño Jesús; 🇪🇸 Madrid, Spain