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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)

Primary Purpose

Type1diabetes

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
InPen Medtronic
Minimed 780G system
Sponsored by
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type1diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Ramón y CajalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Closed loop system

SmartPen

Arm Description

Minimed 780G (Medtronic)

InPen (Medtronic)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

A1c levels
To assess the differences in serum A1c levels (%)
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).
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).
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.

Full Information

First Posted
January 12, 2023
Last Updated
September 1, 2023
Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT05708040
Brief Title
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)
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2022 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Closed loop system
Arm Type
Active Comparator
Arm Description
Minimed 780G (Medtronic)
Arm Title
SmartPen
Arm Type
Experimental
Arm Description
InPen (Medtronic)
Intervention Type
Device
Intervention Name(s)
InPen Medtronic
Intervention Description
Patients with DM1 ≥ 18 years of age who initiate Inpen system.
Intervention Type
Device
Intervention Name(s)
Minimed 780G system
Intervention Description
Patients with DM1 ≥ 18 years of age who initiate Minimed 780G system.
Primary Outcome Measure Information:
Title
Time in Range
Description
To assess the difference on the glycemic control expressed as time in range (% of time between 70-180 mg/dl of interstitial glucose).
Time Frame
12 months
Secondary Outcome Measure Information:
Title
A1c levels
Description
To assess the differences in serum A1c levels (%)
Time Frame
12 months
Title
Time below range
Description
To assess the difference on the glycemic control expressed as time in below range (% of time < 70 mg/dl of interstitial glucose).
Time Frame
12 months
Title
Time above range
Description
To assess the difference on the glycemic control expressed as time in above range (% of time >180 mg/dl of interstitial glucose).
Time Frame
12 months
Title
Health-Related Quality of Life in Patients with Type 1 Diabetes
Description
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.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lía Nattero-Chávez, MD.PhD
Phone
+34913369029
Email
marialia.nattero@salud.madrid.org
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Luque Ramirez, MD.PhD
Phone
+34913369029
Email
manuel.luque@salud.madrid.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lía Nattero-Chávez, MD.PhD
Organizational Affiliation
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)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lía Nattero-Chávez
Phone
635249182
Email
marialia.nattero@salud.madrid.org
First Name & Middle Initial & Last Name & Degree
Lía Nattero-Chávez, MD.PhD

12. IPD Sharing Statement

Learn more about this trial

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)

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