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Trial record 2 of 4 for:    DIABETES | TANDEM

Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02877771
First Posted: August 24, 2016
Last Update Posted: September 1, 2016
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.
Collaborator:
Jaeb Center for Health Research
Information provided by (Responsible Party):
Tandem Diabetes Care, Inc.
  Purpose
The goal of this study is to assess the functionality of an integrated predictive low glucose suspend system designed to minimize the incidence and duration of hypoglycemia by suspending insulin delivery if hypoglycemia is projected.

Condition Intervention Phase
Diabetes Mellitus Type 1 Diabetes Insulin Pump Device: t:slim insulin pump with predictive low glucose suspend Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)

Resource links provided by NLM:


Further study details as provided by Tandem Diabetes Care, Inc.:

Primary Outcome Measures:
  • Suspension of Insulin Delivery [ Time Frame: 8 hours between 9pm and 5am ]
    To test functionality of the system

  • Restoration of insulin delivery [ Time Frame: 8 hours between 9pm and 5am ]
    To test functionality of the system

  • Agreement between algorithm-recommended pump action [ Time Frame: 8 hours between 9pm and 5am ]
    To test functionality of the system


Other Outcome Measures:
  • Duration of insulin suspension [ Time Frame: 8 hours between 9pm and 5am ]
    To test functionality of the system

  • Continuous Glucose Monitoring (CGM) glucose nadir [ Time Frame: 8 hours between 9pm and 5am ]
    To test functionality of the system

  • Reference blood glucose [ Time Frame: 8 hours between 9pm and 5am ]
    To test functionality of the system


Enrollment: 10
Study Start Date: August 2016
Study Completion Date: August 2016
Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: t:slim insulin pump with predictive low glucose suspend
To assess the functionality of a predictive low glucose suspend (PLGS) system that uses CGM values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.
Device: t:slim insulin pump with predictive low glucose suspend
To assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.

Detailed Description:
This protocol is designed to test the functionality of a predictive low glucose suspend system under supervised conditions where basal insulin rates are manually increased until a system generated suspension occurs. The study will collect data that will be used for planning a pivotal study, and the study data are intended to be used to support a Premarket Approval (PMA) application.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of type 1 diabetes requiring insulin therapy for at least 12 months
  • Insulin pump therapy for at least 6 months
  • Age ≥18.0 years
  • Subject demonstrates stable insulin regimen including basal rates, insulin sensitivity factor and insulin:carbohydrate ratio for at least 3 months

Exclusion Criteria:

  • Pregnant (female subjects must have negative urine or serum pregnancy screening test)
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrollment
  • Diabetic ketoacidosis in the month prior to enrollment
  • A current condition that would prevent the use of a CGM sensor or insulin pump, or in the judgment of the investigator is a contraindication to study participation
  • Use of acetaminophen during study participation
  • Current use of any medication intended to lower glucose other than insulin including naturaceuticals, oral or non-insulin injectable medications
  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): NCT02877771


Locations
United States, California
Stanford University
Palo Alto, California, United States, 94304
United States, Colorado
Barbara Davis Center for Childhood Diabetes
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
Tandem Diabetes Care, Inc.
Jaeb Center for Health Research
  More Information

Responsible Party: Tandem Diabetes Care, Inc.
ClinicalTrials.gov Identifier: NCT02877771     History of Changes
Other Study ID Numbers: 010300
First Submitted: August 9, 2016
First Posted: August 24, 2016
Last Update Posted: September 1, 2016
Last Verified: August 2016

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