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| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Patricia Dominguez | Contact | +34 915 004 013 | patricia.dominguez@perseivivarium.com | |
| Roberto Bravo | Contact | +34 915 004 013 | roberto.bravo@perseivivarium.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clínico Universitario de Valladolid | Recruiting | Valladolid | Castille and León | 47003 | Spain |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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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 |
| Hospital Infantil Universitario Niño Jesús | Recruiting | Madrid | Madrid | 28009 | Spain |
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