Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

Phase 1

Completed

• Conditions: Insulin Pump; Type 1 Diabetes; Diabetes Mellitus

• Registration Number: NCT02877771
• Lead Sponsor: Tandem Diabetes Care, Inc.

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.

Study Timeline

• Status Verified: 2016-08
• Study Start: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Study First Submitted: 2016-08-09
• Study First Submitted QC: 2016-08-19
• Study First Posted: 2016-08-24
• Last Update Submitted: 2016-08-30
• Last Update Posted: 2016-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Agreement between algorithm-recommended pump action	8 hours between 9pm and 5am	To test functionality of the system
Restoration of insulin delivery	8 hours between 9pm and 5am	To test functionality of the system
Suspension of Insulin Delivery	8 hours between 9pm and 5am	To test functionality of the system

Trial Locations

Locations (2)

Barbara Davis Center for Childhood Diabetes; 🇺🇸 Aurora, Colorado, United States

Stanford University; 🇺🇸 Palo Alto, California, United States