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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Animas Corporation
ClinicalTrials.gov Identifier:
NCT01401751
First received: July 21, 2011
Last updated: July 28, 2017
Last verified: July 2017
  Purpose
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.

Condition Intervention
Type 1 Diabetes Mellitus Device: Hypoglycemia-Hyperglycemia Minimizer System

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Animas Corporation:

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. [ 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.


Secondary Outcome Measures:
  • 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


Enrollment: 13
Actual Study Start Date: July 1, 2011
Study Completion Date: December 1, 2011
Primary Completion Date: November 1, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01401751

Locations
United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Animas Corporation
Investigators
Principal Investigator: Howard Zisser, MD William Sansum Diabetes Center
  More Information

Responsible Party: Animas Corporation
ClinicalTrials.gov Identifier: NCT01401751     History of Changes
Other Study ID Numbers: 3076823
Study First Received: July 21, 2011
Last Updated: July 28, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

Keywords provided by Animas Corporation:
Type 1 Diabetes Mellitus
Artificial Pancreas

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017