Medtronic Minimed Overnight Closed-Loop System
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.
|Type 1 Diabetes Mellitus Autoimmune Diabetes Juvenile-Onset Diabetes Diabetes, Mellitus, Type 1||Device: ePID Algorithm on an Android Platform with Remote Monitoring|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Target sensor glucose 70-150 mg/dl [ Time Frame: Approximately 12 hours ]Compared to control nights, the percent of sensor glucose readings in the target range of 70-150 mg/dl.
- Percentage of time CGM glucose readings are <70 mg/dl and > 180 mg/dl [ Time Frame: Approximately 12 hours ]
Secondary measures of glucose efficacy comparing treatment to control nights:
- Percentage of time CGM glucose readings are <70 mg/dl and > 180 mg/dl
- Distribution of CGM and meter glucose values overnight. (min, max, median, interquartile ranges, mean, standard deviation)
- Hypoglycemia area under the curve (AUC) (CGM glucose less than 60 mg/dL, 70 mg/dL,)
- Hyperglycemia AUC (CGM glucose greater than 180 mg/dL, 240 mg/dl)
- Incidence of hypoglycemia (meter glucose less than 60 mg/dL, less than 70 mg/dL)
|Study Start Date:||June 2013|
|Study Completion Date:||July 2013|
|Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
Experimental: Overnight Closed Loop Control (OCL)
Overnight Closed Loop Control with Remote Monitoring using the ePID Algorithm on an Android Platform with Remote Monitoring
Device: ePID Algorithm on an Android Platform with Remote Monitoring
Medtronic Overnight Closed-Loop System: Revel insulin pump, Enlite sensor, Minimed transmitter, ePID algorithm on an Android platform with remote monitoring.
No Intervention: Control Nights
Sensor augmented pump without OCL (overnight closed loop) or remote monitoring
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01881009
|United States, California|
|Stanford, California, United States, 94305-5208|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|