Back to resultsStudy Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Hypo-Hyper Minimizer (HHM) System
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes Mellitus, Artificial Pancreas
Eligibility Criteria
Inclusion Criteria:
- Age 21-65 years
- type 1 diabetes mellitus for at least one year
- Currently 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
- Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months
Sites / Locations
- Samsum Diabetes Reserach Inst.
- UVA Diabetes Technology Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypo-Hyper Minimizer (HHM) System
Arm Description
Outcomes
Primary Outcome Measures
Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Secondary Outcome Measures
Number of Safety Events and any additional information that can be used for product development
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01638299
Brief Title
Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC 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
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Animas Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
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
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypo-Hyper Minimizer (HHM) System
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Hypo-Hyper Minimizer (HHM) System
Other Intervention Name(s)
Insulin delivery
Intervention Description
Adjustment of Insulin dosing during meal time
Primary Outcome Measure Information:
Title
Evaluation of the performance of the HHM system response to meal insulin while the subject is under close medical supervision in the Clinical Research Center (CRC) setting.
Time Frame
After subject is discharged from CRC, 1 week after enrolment
Secondary Outcome Measure Information:
Title
Number of Safety Events and any additional information that can be used for product development
Time Frame
After subject is discharged from CRC, 1 week after enrolment
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
Inclusion Criteria:
Age 21-65 years
type 1 diabetes mellitus for at least one year
Currently 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
Histoey of severe hypoglycemia (Seizure, unconsciousnesss) in the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Anhalt, DO
Organizational Affiliation
Animas Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Samsum Diabetes Reserach Inst.
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
UVA Diabetes Technology Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Assessing an Insulin Pump-controlling Algorithm to Minimize Hypo and Hyper in Type 1 During CRC Setting
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