At a glance
ClinicalIndex Comparison RecordN/ACompleted· 151 enrolled
Drug / intervention
Insulin Pumpdevice
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.
Safety Evaluation of the Hybrid Closed Loop (HCL) System in Pediatric Subjects With Type 1 Diabetes
In Brief
A clinical study evaluating Insulin Pump for Type 1 Diabetes. Completed, enrolled 151 participants across 11 sites in 2 countries.
Detailed Summary
This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesIsrael, United States
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartApr 2016
Primary CompletionNov 2018
Study CompletionFeb 2021
TodayJul 2026
First PostedJan 21, 2016
Enrollment StartApr 18, 2016
Primary CompletionNov 28, 2018
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 10.4 years ago
Interventions
Insulin Pumpdevice
Closed Loop Algorithm