Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study

Completed · Phase 1

Conditions studied: Diabetes Mellitus, Type 1 Diabetes, Insulin Pump

In brief

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.

Key facts

Study ID

NCT02877771

Run by

Tandem Diabetes Care, Inc.

People needed

10

Starts

2016-08-01

Expected to finish

2016-08-01

Last updated by the study team

2016-09-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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