Trials / Completed
CompletedNCT05708040
Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
Open-label, Randomized, Controlled Clinical Trial to Evaluate the Efficacy of the Smart Insulin Pen Associated With a Continuous Glucose Monitoring System Compared to a Closed Loop System in Patients With Type 1 Diabetes (EBIACE-1)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Analysis of glycemic control, frequency of hypoglycemia, glycemic variability, patient satisfaction and patient-perceived quality of life in patients with type 1 diabetes mellitus and continuous real-time glucose monitoring, the use of a smart pen compared to a closed loop system.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | InPen Medtronic | Patients with DM1 ≥ 18 years of age who initiate Inpen system. |
| DEVICE | Minimed 780G system | Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system. |
Timeline
- Start date
- 2022-08-19
- Primary completion
- 2023-01-27
- Completion
- 2023-01-27
- First posted
- 2023-02-01
- Last updated
- 2024-03-26
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT05708040. Inclusion in this directory is not an endorsement.