The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology. The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor
University of Virginia
Charlottesville, Virginia, United States
Overall Percent Time Less Than 54 mg/dL
CGM overall percent time less than 54 mg/dL, with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Severe Hypoglycemia
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment), with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Diabetic Ketoacidosis
Number of Diabetic Ketoacidosis events with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time <70 mg/dL
CGM percent time \<70 mg/dL, with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-140 mg/dL
CGM percent time 70-140 mg/dL, with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-180 mg/dL
CGM percent time 70-180 mg/dL, with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >180 mg/dL
CGM percent time \>180 mg/dL, with different feature use of the pump each week.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >250 mg/dL
CGM percent time \>250 mg/dL, with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks
Median of Mean Glucose (mg/dL)
Median of individual participants CGM Mean Glucose values (mg/dL), with different feature use of the pump each week.
Time frame: Data collected over 1 week for each intervention, up to 5 weeks