Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

August 30, 2016 updated by: Tandem Diabetes Care, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center for Childhood Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Suspension of Insulin Delivery
Time Frame: 8 hours between 9pm and 5am
To test functionality of the system
8 hours between 9pm and 5am
Restoration of insulin delivery
Time Frame: 8 hours between 9pm and 5am
To test functionality of the system
8 hours between 9pm and 5am
Agreement between algorithm-recommended pump action
Time Frame: 8 hours between 9pm and 5am
To test functionality of the system
8 hours between 9pm and 5am

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of insulin suspension
Time Frame: 8 hours between 9pm and 5am
To test functionality of the system
8 hours between 9pm and 5am
Continuous Glucose Monitoring (CGM) glucose nadir
Time Frame: 8 hours between 9pm and 5am
To test functionality of the system
8 hours between 9pm and 5am
Reference blood glucose
Time Frame: 8 hours between 9pm and 5am
To test functionality of the system
8 hours between 9pm and 5am

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tandem Diabetes Care, Inc.

Collaborators

Jaeb Center for Health Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

August 9, 2016

First Submitted That Met QC Criteria

August 19, 2016

First Posted (Estimate)

August 24, 2016

Study Record Updates

Last Update Posted (Estimate)

September 1, 2016

Last Update Submitted That Met QC Criteria

August 30, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010300

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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