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
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|ClinicalTrials.gov Identifier: NCT01401751|
Recruitment Status : Completed
First Posted : July 25, 2011
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: Hypoglycemia-Hyperglycemia Minimizer System||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Device Feasibility|
|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|
|Actual Study Start Date :||July 1, 2011|
|Actual Primary Completion Date :||November 1, 2011|
|Actual Study Completion Date :||December 1, 2011|
non-randomized, uncontrolled, feasibility study
Device: Hypoglycemia-Hyperglycemia Minimizer System
Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm
- 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 ]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 ]
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
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): NCT01401751
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|Principal Investigator:||Howard Zisser, MD||Sansum Diabetes Research Institute|