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Artificial Pancreas in Pediatric Patients (PEDarPAN)

NCT02620878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2019-07-12

Study results available
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Summary

The purpose of this study is to determine safety, feasibility and efficacy (with respect to sensor- augmented pump therapy) of an Artificial Pancreas (AP) prototype in day and night closed-loop control in children and adolescents with type 1 diabetes.

Conditions

Interventions

DEVICE

artificial pancreas

Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.

OTHER

sensor augmented pump

During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas

Sponsors & Collaborators

  • University of Padova

    lead OTHER

Principal Investigators

  • Daniela Bruttomesso, MD · University of Padova, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-09-30
Completion
2015-09-30

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02620878 on ClinicalTrials.gov