A Phase 1 interventional study of Predictive Low Glucose Minimizer in Type 1 Diabetes, sponsored by Animas Corporation. Completed at 1 site in United States. Open to participants aged 21 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-09-19.
Sponsored by Animas Corporation · Phase 1, Interventional, and Basic science
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.
This study is a non-randomized, uncontrolled feasibility study that looks to enroll people with type 1 diabetes who are currently using an insulin pump. During the subject's participation, the study staff will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's planned enrollment of 12 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Animas Corporation is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Predictive Low Glucose Minimizer (PLGM) System
Device: Predictive Low Glucose Minimizer
This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Also known as: type 1 diabetes
Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting
Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold. Ability of the system to issue timely and accurate warnings.
Time frame: 1 week after subject is enrolled in the study
Capturing the number of Adverse Events as a measure of assessing subject safety
Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.
Time frame: 1 week after subject is enrolled in the study
This study is completed, as verified in Sep 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Animas Corporation