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)

March 23, 2024 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Closed loop system
Minimed 780G (Medtronic)
Device: InPen Medtronic
Patients with DM1 ≥ 18 years of age who initiate Inpen system.
Experimental: SmartPen
InPen (Medtronic)
Device: Minimed 780G system
Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in Range
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
A1c levels
Time Frame: 12 months
To assess the differences in serum A1c levels (%)
12 months
Time below range
Time Frame: 12 months
To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose).
12 months
Time above range
Time Frame: 12 months
To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose).
12 months
Health-Related Quality of Life in Patients with Type 1 Diabetes
Time Frame: 12 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Investigators

  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2022

Primary Completion (Actual)

January 27, 2023

Study Completion (Actual)

January 27, 2023

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 24, 2023

First Posted (Actual)

February 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 23, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 189/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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