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)

Not Applicable

Completed

• Conditions: Type1diabetes
• Interventions: Device: Minimed 780G system; Device: InPen Medtronic

• Registration Number: NCT05708040
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-19
• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-24
• Primary Completion: 2023-01-27
• Study Completion: 2023-01-27
• Study First Posted: 2023-02-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-23
• Last Update Posted: 2024-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SmartPen	Minimed 780G system	InPen (Medtronic)
Closed loop system	InPen Medtronic	Minimed 780G (Medtronic)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
A1c levels	12 months	To assess the differences in serum A1c levels (%)
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.
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).

Trial Locations

Locations (1)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain