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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05708040

Acronym

EBIACE-1

Enrollment

Registered

2023-02-01

Start date

2022-08-19

Completion date

2023-01-27

Last updated

2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type1diabetes

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.

Interventions

DEVICEInPen Medtronic

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

DEVICEMinimed 780G system

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Time in Range	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

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026