Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia
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|ClinicalTrials.gov Identifier: NCT01919385|
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : September 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Device: Predictive Low Glucose Minimizer||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: type 1 diabetes
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.
Other Name: type 1 diabetes
- Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting [ Time Frame: 1 week after subject is enrolled in the study ]
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.
- Capturing the number of Adverse Events as a measure of assessing subject safety [ Time Frame: 1 week after subject is enrolled in the study ]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.
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): NCT01919385
|United States, California|
|Samsum Diabetes Reserach Inst.|
|Santa Barbara, California, United States, 93105|
|Principal Investigator:||Howard Zisser, MD||Samsum Diabetes Reserach Inst.|