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)

Type1diabetes Clinical Trial

— EBIACE-1  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05708040
• Other study ID #: 189/22
• Status: Completed
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: January 27, 2023

Study information

• Verified date: March 2024
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Device:
• InPen Medtronic
Patients with DM1 = 18 years of age who initiate Inpen system.
• Minimed 780G system
Patients with DM1 = 18 years of age who initiate Minimed 780G system.

Locations

Country	Name	City	State
Spain	Hospital Universitario Ramón y Cajal	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A1c levels	To assess the differences in serum A1c levels (%)	12 months
Secondary	Time below range	To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose).	12 months
Secondary	Time above range	To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose).	12 months
Secondary	Health-Related Quality of Life in Patients with Type 1 Diabetes	Assess health-related quality of life in patients with type 1 diabetes (by ViDa1 questionnaire).ViDa1 questionnaire has four-dimensional structure: Interference of diabetes in everyday life, Self-care, Well-being, and Worry about the disease.	12 months