Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Feasibility Study Assessing The Ability Of An Insulin Pump-Controlling Algorithm To Minimize Hypoglycemia And Hyperglycemia In Patients With Type 1 Diabetes In A Clinical Research Setting|
- To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting. [ Time Frame: End of Study - in approximately 5 months from first subject enrolled ] [ Designated as safety issue: Yes ]Measuring the response of the investigational device, including insulin delivery dosing changes in response to glucose changes. Also, the ability of the system to mitigate Hypoglycemia.
- Safety Evaluation [ Time Frame: End of Study - in approximately 5 months from first subject enrolled ] [ Designated as safety issue: Yes ]
Measuring the following:
- the number and type of adverse events, including Adverse device effects, Serious Adverse Events, Unanticipated Adverse Device Effects, device malfunctions
- Resulting glucose data from 24 hour clinical research center visit
|Study Start Date:||July 2011|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Device: Hypoglycemia-Hyperglycemia Minimizer System
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 24 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
Total subject participation approximately 1 week for screening to completion. This includes approximately 24 hours usage of the investigation device in the clinical research center under close medical supervision.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01401751
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|Principal Investigator:||Howard Zisser, MD||William Sansum Diabetes Center|