Sponsor study identifier
interventional
37
1 country
1
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 3, 2013
Actual (reported)Study Completion
August 3, 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 3, 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 16, 2013
Actual (reported)June 19, 2013
Actual (reported)August 3, 2013
Actual (reported)August 3, 2013
Actual (reported)November 14, 2019
Actual (reported)Target Sensor Glucose 70-150 mg/dl
Compared to control nights, the percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.
Approximately 12 hours
Target Sensor Glucose 70-150 mg/dl
Percent of time in the target range of 70-150 mg/dl according to sensor glucose readings.
Approximately 12 hours
Target Sensor Glucose 70-180 mg/dl
Approximately 12 hours
Participants in this group will have an overnight evaluation to test safety of the closed-loop system therapy device.
Participants in this group will receive either the sensor augmented pump or the close loop controller on the first night, then alternated treatment type each night for the duration of the study.
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.
Stanford University
Stanford, California, 94305-5208, United States
Ly TT, Keenan DB, Roy A, Han J, Grosman B, Cantwell M, Kurtz N, von Eyben R, Clinton P, Wilson DM, Buckingham BA. Automated Overnight Closed-Loop Control Using a Proportional-Integral-Derivative Algorithm with Insulin Feedback in Children and Adolescents with Type 1 Diabetes at Diabetes Camp. Diabetes Technol Ther. 2016 Jun;18(6):377-84. doi: 10.1089/dia.2015.0431. Epub 2016 May 16.
Bruce Buckingham, MD
Stanford University
37 participants (actual enrollment reported by the registry).
First Submitted
June 16, 2013
First Posted
June 19, 2013
Study Start
June 2013
Date type not reportedThis date has not been verified as actual or estimated.
Artificial Pancreas With Different Stress Assessments in the Outpatient Setting
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
August 3, 2013
Actual (reported)Study Completion
August 3, 2013
Actual (reported)Last Updated
November 14, 2019
Results First Posted
November 14, 2019
Record last verified: 2019-10
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Source: ClinicalTrials.gov.
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