Artificial Pancreas Control System in an Inpatient Setting
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|ClinicalTrials.gov Identifier: NCT01552603|
Recruitment Status : Completed
First Posted : March 13, 2012
Results First Posted : September 17, 2014
Last Update Posted : June 3, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type I Diabetes Mellitus||Device: Artificial Pancreas Control Software||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Sensor-controlled Insulin- and Glucagon Delivery in Subjects With Type 1 Diabetes: Testing of an Automated System in a Supervised Inpatient Setting|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||August 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Artificial Pancreas Control
Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.
Device: Artificial Pancreas Control Software
This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm.
- Mean Percent of Time in Target Blood Glucose Range [ Time Frame: all 28 hour studies ]Mean percent of time venous blood glucose was sampled between 70-180 mg/dl
- Mean Deviation From Target Blood Glucose [ Time Frame: all 28 hour studies ]Mean difference of venous blood glucose from glucose target. Daytime venous blood glucose values (7am-11pm) subtracted from daytime target of 115 mg/dl. Nighttime venous blood glucose values (11pm-7am) subtracted from nighttime target of 140 mg/dl. This is a metric of how successful the closed loop algorithm was at controlling glucose.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01552603
|United States, Oregon|
|Legacy Good Samaritan Hospital|
|Portland, Oregon, United States, 97210|
|Oregon Health and Science University|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||W K Ward, MD||Legacy Health Research|