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)
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)
1 other identifier
interventional
48
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2022
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2022
CompletedFirst Submitted
Initial submission to the registry
January 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2023
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedMarch 26, 2024
March 1, 2024
5 months
January 12, 2023
March 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Time in Range
To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
12 months
Secondary Outcomes (4)
A1c levels
12 months
Time below range
12 months
Time above range
12 months
Health-Related Quality of Life in Patients with Type 1 Diabetes
12 months
Study Arms (2)
Closed loop system
ACTIVE COMPARATORMinimed 780G (Medtronic)
SmartPen
EXPERIMENTALInPen (Medtronic)
Interventions
Patients with DM1 ≥ 18 years of age who initiate Inpen system.
Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.
Eligibility Criteria
You may qualify if:
- Diagnostic criteria for DM1 according to ADA
- Candidates for both systems (closed loop or smart insulin pen) for their usual healthcare team.
- Acceptance of participation in the study and signing of the informed consent
You may not qualify if:
- Gestation
- Institutionalization, serious or terminal illness or renal replacement therapy.
- Inability to undertake the training and / or acquire the degree of knowledge to use both systems
- Refusal to participate in the study or to sign the informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lía 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)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 12, 2023
First Posted
February 1, 2023
Study Start
August 19, 2022
Primary Completion
January 27, 2023
Study Completion
January 27, 2023
Last Updated
March 26, 2024
Record last verified: 2024-03