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

DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Device: software

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 Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia Dominguez; Phone Number: +34 915 004 013; Email: patricia.dominguez@perseivivarium.com
• Study Contact Backup: Name: Roberto Bravo; Phone Number: +34 915 004 013; Email: roberto.bravo@perseivivarium.com

Study Locations

• Spain
  • Madrid, Spain, 28009
    • Recruiting
    • Hospital Infantil Universitario Niño Jesús
    • Contact: Patricia Enes Romero, Dr.; Phone Number: +34 91 503 59 15; Email: patricia.enes@salud.madrid.org
  • Castilla y León
    • Valladolid, Castilla y León, Spain, 47003
      • Recruiting
      • Hospital Clinico Universitario de Valladolid
      • Contact: María del Pilar Bahíllo Curieses, PhD; Phone Number: +34-983420000; Email: pilarbahilloc@yahoo.es
      • Principal Investigator: María del Pilar Bahíllo Curieses, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Online telemonitoring group (G_CAARING); 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; 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.; Other Names: Caaring
No Intervention: Retrospective Control group; The data of these patients are collected retrospectively from the medical history, from the last 12 weeks prior to their inclusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROs. Changes in Health-related quality of life (HRQOL): EsDQOL	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).	Day 0 and week 12
PROs. in Health-related quality of life (HRQOL): KINDL	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).	Day 0 and week 12
PROs. Patient satisfaction with the software Caaring	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.	Week 12
PROs. Variation in clinical parameters of glycemic control: HbA1c	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	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR (time in range)(70-180 mg/dl)	Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR (time below range) Time < 70 mg/dL	Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT	Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT (Time in target range), (70-140 mg/dL).	Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV	Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV (Coefficient of Variation)	Day 0 and Biweekly up to 12 weeks
PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI	Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI (Glycemic Risk Index).	Day 0 and Biweekly up to 12 weeks
PROs. Number of Medical Visits	Number of medical visits, calls or interactions with specialist healthcare personnel	Day 0 and Monthly up to 12 weeks
PROs. Adherence of treatment	Adherence to therapy (insulin)	Day 0 and Weekly up to 12 weeks

Collaborators and Investigators

• Sponsor: Persei Vivarium
• Collaborators: Effice Servicios Para la Investigacion S.L.

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: January 21, 2025
• First Posted (Actual): January 27, 2025

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 30, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Digital Health; glycemic control; PROMs; Remote patient monitoring; real-world data; Diabetes Mellitus (DM); DTx; Time in Range (TIR); Caaring; Online telemonitoring; Patient-reported data
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: GluCaaring

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No