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
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hypoglycemia-Hyperglycemia Minimizer System
Sponsored by
About this trial
This is an interventional device feasibility trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Artificial Pancreas
Eligibility Criteria
Summary of Key inclusion/exclusion criteria:
Inclusion Criteria:
- Age 21-65 years
- Type 1 diabetes mellitus for at least one year
- Using an insulin infusion pump for at least the past 6 months
Exclusion Criteria:
- Pregnancy
- History of diabetic ketoacidosis (DKA) in the past six months
- History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months
Other Inclusion/Exclusion criteria apply.
Please contact clinical study site for complete details.
Sites / Locations
- Sansum Diabetes Research Institute
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
non-randomized, uncontrolled, feasibility study
Outcomes
Primary Outcome Measures
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
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.
Secondary Outcome Measures
Safety Evaluation
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01401751
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
July 1, 2011 (Actual)
Primary Completion Date
November 1, 2011 (Actual)
Study Completion Date
December 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Animas Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the performance of an insulin pump controlling algorithm while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes Mellitus, Artificial Pancreas
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
non-randomized, uncontrolled, feasibility study
Intervention Type
Device
Intervention Name(s)
Hypoglycemia-Hyperglycemia Minimizer System
Intervention Description
Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm
Primary Outcome Measure Information:
Title
To evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Description
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.
Time Frame
End of Study - in approximately 5 months from first subject enrolled
Secondary Outcome Measure Information:
Title
Safety Evaluation
Description
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
Time Frame
End of Study - in approximately 5 months from first subject enrolled
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Summary of Key inclusion/exclusion criteria:
Inclusion Criteria:
Age 21-65 years
Type 1 diabetes mellitus for at least one year
Using an insulin infusion pump for at least the past 6 months
Exclusion Criteria:
Pregnancy
History of diabetic ketoacidosis (DKA) in the past six months
History of severe hypoglycemia (seizure, unconsciousness) in the past 6 months
Other Inclusion/Exclusion criteria apply.
Please contact clinical study site for complete details.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Howard Zisser, MD
Organizational Affiliation
Sansum Diabetes Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sansum Diabetes Research Institute
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
12. IPD Sharing Statement
Learn more about this trial
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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