At a glance
ClinicalIndex Comparison RecordN/ACompleted· 80 enrolled
Drug / intervention
Predictive Low Glucose Management Feature in 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.
In-Clinic Evaluation of the Predictive Low Glucose Management (PLGM) System in Adult and Pediatric Insulin Requiring Patients With Diabetes Using the Enlite 3 Sensor
In Brief
A clinical study evaluating Predictive Low Glucose Management Feature in Insulin pump for Type 1 Diabetes. Completed, enrolled 80 participants across 8 sites.
Detailed Summary
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 2014
Enrollment StartOct 2014
Primary CompletionAug 2015
Study CompletionSep 2015
TodayJul 2026
First PostedMay 5, 2014
Enrollment StartOct 1, 2014
Primary CompletionAug 1, 2015
Study CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 12.2 years ago
Interventions
Predictive Low Glucose Management Feature in Insulin pumpdevice
All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.