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

Overview

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

Interventions

• 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.

Primary outcome measures

• Determinate the efficacy of the remote monitoring in insulin-treated diabetic patients with a software called Caaring®. [Time frame: 12 weeks]

Secondary outcome measures (11)

• PROs. Changes in Health-related quality of life (HRQOL): EsDQOL [Time frame: Day 0 and week 12]
• PROs. in Health-related quality of life (HRQOL): KINDL [Time frame: Day 0 and week 12]
• PROs. Patient satisfaction with the software Caaring [Time frame: Week 12]
• PROs. Variation in clinical parameters of glycemic control: HbA1c [Time frame: Day 0 and Week 12]
• PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIR [Time frame: Day 0 and Biweekly up to 12 weeks]
• PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TBR [Time frame: Day 0 and Biweekly up to 12 weeks]
• PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: TIT [Time frame: Day 0 and Biweekly up to 12 weeks]
• PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: CV [Time frame: Day 0 and Biweekly up to 12 weeks]
• PROs. Variation in clinical parameters of glycemic control, HbA1c and CGM data: GRI [Time frame: Day 0 and Biweekly up to 12 weeks]
• PROs. Number of Medical Visits [Time frame: Day 0 and Monthly up to 12 weeks]
• PROs. Adherence of treatment [Time frame: Day 0 and Weekly up to 12 weeks]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Spain · 2 centers

• Hospital Clínico Universitario de Valladolid — Valladolid
• Hospital Infantil Universitario Niño Jesús — Madrid

Identifiers

NCT: NCT06794658 · GluCaaring

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗