At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Nocturnal Closed-Loop Control Using An ePID (Enhanced Proportional Integral Derivative) Algorithm On An Android Platform With Remote Monitoring In A Closely Monitored Camp Setting: The OCL Camp Study
In Brief
A clinical study evaluating Hybrid Closed-loop System and Sensor-augmented pump for Type 1 Diabetes Mellitus and 3 related conditions. Completed, enrolled 37 participants across 1 site.
Detailed Summary
To test the function and safety of the Medtronic Overnight Closed Loop (OCL) System in a closely monitored 12 hour overnight inpatient study. Once the safety of the device has been validated we will move the study to an outpatient diabetes camp setting. The camp setting will allow us to obtain pilot efficacy and safety data in a "real-life" environment. We plan to compare the subject control nights to the subject nights on the OCL system to assess the percent of sensor glucose readings in the target range of 70-150 mg/dl. Based on previous research, we anticipate that the use of the OCL system will contribute to a greater percentage of sensor glucose readings in the target range.
Study Details
Timeline
Interventions
Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter, PID-IFB (proportional-integral-derivative based with insulin feedback) algorithm on an Android platform with remote monitoring.
Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter.