Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

Diabetes Mellitus Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02877771
• Other study ID #: 010300
• Status: Completed
• Phase: Phase 1
• First received: August 9, 2016
• Last updated: August 30, 2016
• Start date: August 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Insulin Pump
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado
United States	Stanford University	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.	Jaeb Center for Health Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Duration of insulin suspension	To test functionality of the system	8 hours between 9pm and 5am	No
Other	Continuous Glucose Monitoring (CGM) glucose nadir	To test functionality of the system	8 hours between 9pm and 5am	No
Other	Reference blood glucose	To test functionality of the system	8 hours between 9pm and 5am	No
Primary	Suspension of Insulin Delivery	To test functionality of the system	8 hours between 9pm and 5am	No
Primary	Restoration of insulin delivery	To test functionality of the system	8 hours between 9pm and 5am	No
Primary	Agreement between algorithm-recommended pump action	To test functionality of the system	8 hours between 9pm and 5am	No