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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-19

Study Completion Date

2023-01-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Type1diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closed loop system

Minimed 780G (Medtronic)

Group Type ACTIVE_COMPARATOR

InPen Medtronic

Intervention Type DEVICE

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

SmartPen

InPen (Medtronic)

Group Type EXPERIMENTAL

Minimed 780G system

Intervention Type DEVICE

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

Interventions

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InPen Medtronic

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

Intervention Type DEVICE

Minimed 780G system

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lía Nattero-Chávez, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

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)