Diabetes Mellitus, Insulin Pump, Type 1 Diabetes
Conditions
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.
Interventions
DEVICEt: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.
Sponsors
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed