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
Not provided
Not provided
Not provided
Not provided
The primary objective is to assess the impact on quality of life after a follow-up program using a telemedicine platform designed for patients with DM1 treated with an hybrid closed loop insulin infusion system. Open-label, randomized 1:1 controlled clinical trial during 12 months.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine Arm | Experimental | Use of a telemedicine platform combined with face-to-face visits according to protocol |
|
| Control Arm | No Intervention | conventional follow-up according to routine clinical practice. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine Arm | Device | Patients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Impact on quality of life | Health-related quality of life in patients with type 1 diabetes (the ViDa1 questionnaire). The four-dimensional structure for ViDa1 are:
| 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolic control | A1c levels | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| LÃa Nattero Chávez, MD PhD | Hospital Ramón y CajaDiabetes, Obesity and Human Reproduction Research Group, Department of Endocrinology and Nutrition, Hospital Universitario Ramón y Cajal, Universidad de Alcalá, Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| LÃa Nattero Chávez | Madrid | Please Select | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39493410 | Derived | Nattero-Chavez L, de La Calle E, Lecumberri-Pascual E, Bayona Cebada A, Ruiz Gracia T, Quintero Tobar A, Lorenzo Monino M, Sanchez Rodriguez C, Izquierdo A, Escobar-Morreale HF, Luque-Ramirez M. Comparing quality of life in traditional face-to-face visits with a hybrid approach of telemedicine with in-person follow-ups in recent users of advanced closed-loop systems: a randomized controlled clinical trial in patients with type 1 diabetes. Ther Adv Endocrinol Metab. 2024 Oct 25;15:20420188241288789. doi: 10.1177/20420188241288789. eCollection 2024. | |
| 36940793 |
Not provided
Not provided
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
Not provided
Not provided
| Derived |
| Nattero-Chavez L, Lecumberri Pascual E, De La Calle E, Bayona Cebada A, Ruiz T, Quintero Tobar A, Lorenzo M, Sanchez C, Izquierdo A, Luque-Ramirez M, Escobar-Morreale HF. Switching to an advanced hybrid closed-loop system in real-world practice improves hypoglycemia awareness and metabolic control in adults with type 1 diabetes, particularly in those with impaired perception of hypoglycemia symptoms. Diabetes Res Clin Pract. 2023 May;199:110627. doi: 10.1016/j.diabres.2023.110627. Epub 2023 Mar 20. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |