Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

NCT ID: NCT02877771

Last Updated: 2016-09-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-08-31

Brief Summary

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.

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.

Conditions

Diabetes Mellitus; Type 1 Diabetes; Insulin Pump

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

t:slim insulin pump with predictive low glucose suspend

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Stanford University

Palo Alto, California, United States

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, United States

Countries

United States

Other Identifiers

010300

Identifier Type: -

Identifier Source: org_study_id