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)

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal48 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type1diabetes

Interventions

InPen MedtronicDEVICE

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

Minimed 780G systemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Hospital Universitario Ramón y Cajal

Madrid, Spain

Outcomes

Primary Outcomes

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).

Time frame: 12 months

Secondary Outcomes

A1c levels

To assess the differences in serum A1c levels (%)

Time frame: 12 months

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 frame: 12 months

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).

Time frame: 12 months

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.

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.