Diabetes Mellitus
Conditions
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
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
Interventions
DEVICEsoftware
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.
Sponsors
Effice Servicios Para la Investigacion S.L.
Persei Vivarium
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. 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. 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 |
| PROs. Adherence of treatment | Day 0 and Weekly up to 12 weeks | Adherence to therapy (insulin) |
| 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). |
Countries
Spain
Contacts
Primary ContactPatricia Dominguez
Backup ContactRoberto Bravo
Outcome results
None listed