We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 9 of 2792 for:    Type 1 Diabetes

Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01919385
Recruitment Status : Completed
First Posted : August 9, 2013
Last Update Posted : September 19, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will be conducted in a Clinical Research Center (CRC) setting and recruiting type 1 diabetes that are currently using an insulin pump.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Predictive Low Glucose Minimizer Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Feasibility Study Assessing the Ability of an Insulin Pump-controlling Algorithm to Minimize Hypoglycemia in Patients With Type 1 Diabetes in a Clinical Research Setting
Study Start Date : July 2013
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: type 1 diabetes
Predictive Low Glucose Minimizer (PLGM) System
Device: Predictive Low Glucose Minimizer
This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators 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.
Other Name: type 1 diabetes


Outcome Measures

Primary Outcome Measures :
  1. Evaluate the performance of the System while the subject is under close medical supervision in the Clinical Research Center (CRC) setting [ Time Frame: 1 week after subject is enrolled in the study ]

    Evaluating the ability of the system to predict a fall or rise in glucose values below or above a low glucose threshold, and take the corresponding appropriate action of reducing or suspending insulin delivery in order to keep the subject's glucose above this threshold, or resuming insulin delivery at the current basal rate upon the increase of glucose above this threshold.

    Ability of the system to issue timely and accurate warnings.



Secondary Outcome Measures :
  1. Capturing the number of Adverse Events as a measure of assessing subject safety [ Time Frame: 1 week after subject is enrolled in the study ]
    Understand the System's ability to safely keep the subject glucose levels within designated threshold. The subject and the device will be continuously monitored by the Principle Investigator and Algorithm Engineer to ensure proper function of the device and subject safety. All Adverse Events will be captured on the CRF.


Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • History of severe hypoglycemia (Seizure, unconsciousness) in the past 6 months
Contacts and Locations

Information from the National Library of Medicine

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): NCT01919385


Locations
United States, California
Samsum Diabetes Reserach Inst.
Santa Barbara, California, United States, 93105
Sponsors and Collaborators
Animas Corporation
Investigators
Principal Investigator: Howard Zisser, MD Samsum Diabetes Reserach Inst.
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Animas Corporation
ClinicalTrials.gov Identifier: NCT01919385     History of Changes
Other Study ID Numbers: 3108873,
First Posted: August 9, 2013    Key Record Dates
Last Update Posted: September 19, 2013
Last Verified: September 2013

Keywords provided by Animas Corporation:
Type 1 diabetes
Insulin Pump

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