Skip to main content
OpenTrials
Completed

NCT Number: NCT05708040

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)

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type1diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Ramón y Cajal

Madrid, 28034, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

InPen Medtronic

Device

Patients with DM1 ≥ 18 years of age who initiate Inpen system.

MiniMed 780G System

Device

Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.

Primary outcomes

  1. 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).

Secondary outcomes

  1. A1c levels

    Time frame: 12 months

    To assess the differences in serum A1c levels (%)

  2. 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).

  3. 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).

  4. 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.

Sponsors and collaborators

Lead sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Other

Registry information

Official study 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)

Acronym: EBIACE-1

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 1, 2023
Registry last updated
Mar 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.