Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

Study Overview
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Brief Summary
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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
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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
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Diabetes Mellitus, Type 1 Diabetes, Insulin Pump

Intervention / Treatment
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* Device: t:slim insulin pump with predictive low glucose suspend


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Intervention 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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

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