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

• 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

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

Trial Locations

Locations (1)

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain