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

NCT06794658 | Recruiting

• 1 other identifier: GluCaaring
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus (DM); Remote patient monitoring; glycemic control; Caaring; Time in Range (TIR); Online telemonitoring; Digital Health; DTx; PROMs; Patient-reported data; real-world data

Outcome Measures

Primary Outcomes (1)

• Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.

  % 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)

  12 weeks

Secondary Outcomes (11)

• PROs. Changes in Health-related quality of life (HRQOL): EsDQOL

  Day 0 and week 12

• PROs. in Health-related quality of life (HRQOL): KINDL

  Day 0 and week 12

• PROs. Patient satisfaction with the software Caaring

  Week 12

• PROs. Variation in clinical parameters of glycemic control: HbA1c

  Day 0 and Week 12

• PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR

  Day 0 and Biweekly up to 12 weeks

Study Arms (2)

Online telemonitoring group (G_CAARING)

ACTIVE COMPARATOR

The monitoring and control of these patients will be carried out remotely through the Caaring® platform. Patients will connect to an APP on a mobile phone. They will have to complete the data and questionnaires related to the study variables.

Device: software

Retrospective Control group

NO INTERVENTION

The data of these patients are collected retrospectively from the medical history, from the last 12 weeks prior to their inclusion.

Interventions

software DEVICE

Caaring is an electronic data collection notebook that allows patients to confidentially fill out data/questionnaires on their mobile phone and report them through an application that will be installed on the patient's mobile phone. Besides, This group (G\_CAARING) will receive educational and prevention recommendations relative to diabetes.

Also known as: Caaring

Online telemonitoring group (G_CAARING)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Persei Vivarium: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (2)

Hospital Clínico Universitario de Valladolid

Valladolid, Castille and León, 47003, Spain

RECRUITING

Hospital Infantil Universitario Niño Jesús

Madrid, Madrid, 28009, Spain

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Patricia Dominguez

CONTACT

+34 915 004 013; patricia.dominguez@perseivivarium.com

Roberto Bravo

CONTACT

+34 915 004 013; roberto.bravo@perseivivarium.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: January 27, 2025
• Study Start: December 11, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)