Tandem Predictive Low Glucose Suspend Inpatient Feasibility Study
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
Outcome Measures
Primary Outcome Measures
- Suspension of Insulin Delivery [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
- Agreement between algorithm-recommended pump action [8 hours between 9pm and 5am]
To test functionality of the system
Other Outcome Measures
- Duration of insulin suspension [8 hours between 9pm and 5am]
To test functionality of the system
- Continuous Glucose Monitoring (CGM) glucose nadir [8 hours between 9pm and 5am]
To test functionality of the system
- Reference blood glucose [8 hours between 9pm and 5am]
To test functionality of the system
Eligibility Criteria
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:
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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
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Diabetic ketoacidosis in the month prior to enrollment
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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
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University | Palo Alto | California | United States | 94304 |
| 2 | Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | United States | 80045 |
Sponsors and Collaborators
- Tandem Diabetes Care, Inc.
- Jaeb Center for Health Research
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 010300