CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 48 enrolled
Drug / intervention
artificial pancreas +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02620878
NCT02620878N/ACompleted
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Use of Artificial Pancreas in Pediatric Patients. Feasibility , Safety and Efficacy Study of an Automatic Control of Blood Glucose 24/24 at a Diabetes Camp

University of Padova·interventional·Posted Dec 3, 2015·Updated Jul 12, 2019

In Brief

A clinical study evaluating artificial pancreas and sensor augmented pump for Type 1 Diabetes. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesItaly
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 3, 2015
Enrollment StartJul 1, 2015
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 10.6 years ago

Interventions

artificial pancreasdevice

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.

sensor augmented pumpother

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