Clinical trial NCT06794658: EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring SOFTWARE
Official title: DETERMINATION OF THE EFFICACY OF REMOTE MONITORING OF PATIENTS WITH DIABETES UNDER INSULIN TREATMENT, BY USING Caaring(r) SOFTWARE
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Persei Vivarium
Sponsor class: OTHER
Collaborators: name: Effice Servicios Para la Investigacion S.L.
First posted: 2025-01-27
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®.
timeFrame: 12 weeks
Secondary outcomes:
measure: PROs. Changes in Health-related quality of life (HRQOL): EsDQOL
timeFrame: Day 0 and week 12
measure: PROs. in Health-related quality of life (HRQOL): KINDL
timeFrame: Day 0 and week 12
measure: PROs. Patient satisfaction with the software Caaring
timeFrame: Week 12
measure: PROs. Variation in clinical parameters of glycemic control: HbA1c
timeFrame: Day 0 and Week 12
measure: PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI
timeFrame: Day 0 and Biweekly up to 12 weeks
measure: PROs. Number of Medical Visits
timeFrame: Day 0 and Monthly up to 12 weeks
measure: PROs. Adherence of treatment
timeFrame: Day 0 and Weekly up to 12 weeks
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clínico Universitario de Valladolid
state: Castilla y León
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Niño Jesús
Study officials:
References: