Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Effice Servicios Para la Investigacion S.L. | INDUSTRY |
Not provided
Not provided
Not provided
Type 1 diabetes mellitus is a chronic pathology and represents a constant challenge for children and adolescents with diabetes and their families.
The objective of the treatment of DM1 in pediatric age is to achieve and maintain an optimal glycemic control in order to avoid or delay chronic micro- and macrovascular complications related to the disease.
However, currently, despite technological advances and the development of new insulin formulations, the majority of patients are unable to achieve glycemic goals.
In this context, the use of digital tools/platforms that allow remote monitoring of patients and that facilitate telemedicine have shown potential to improve treatment adherence and facilitate continued therapeutic education, improving clinical results with savings in time and associated costs.
Patients are enrolled to a prospective, observational Post-Market clinical Follow-up study. This is a pilot study.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Potential for improvement of type 1 diabetes through the use of a digital platform | Percentage of events related to diabetes reported through the use of a digital platform of the total events related to diabetes that occurred between medical visits. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of completion of data related to treatments between medical visits | The Degree of completion of data related to treatments between medical is defined as the ratio between the questionnaires requested and completed. | Day 0 up to Week 12 |
| Degree of completion of data related to intercurrent processes between visits |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
All patients from the Hospital Infantil Universitario Niño Jesús diagnosed with type 1 diabetes mellitus who meet the selection criteria and sign the informed consent will be included.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Infantil Universitario Niño Jesús | Madrid | Madrid | 28009 | Spain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
The Degree of completion by patients of data related to intercurrent processes between is defined as the ratio between the questionnaires requested and completed |
| Day 0 up to Week 12 |
| Degree of completion of therapeutic adherence between visits | The Degree of completion of therapeutic adherence by patients between visits is defined as the ratio between the questionnaires requested and completed. | Weekly up to 12 weeks |
| Change in the patient's quality of life scale | Change in the patient's quality of life scale the study compared to baseline. Health-Related Quality of Life in children and adolescents: Values (0-100), a higher score reflects a higher health-related quality of life (HRQoL). | Day 0 and week 12 |
| Degree of completion of the questionnaires | Degree of completion of the questionnaires depending on age and gender, type of treatment and degree of glycemic control | Week 12 |
| 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) | Day 0 and Biweekly up to 12 weeks |
| Percentage of patients who complete the study correctly | Percentage of patients who complete the study correctly by completing all questionnaires | Week 12 |
| 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) | Day 0 and Biweekly up to 12 weeks |
| 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 |
| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |