The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.
The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are: 1. SAP=sensor-augmented pump only 2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight 3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
103
The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Time <70 mg/dl by CGM
Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
Time frame: 8 weeks
Hemoglobin A1c
Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c \< 7.5% vs ≥7.5% and time of day.
Time frame: 8 weeks
Time Between 70-180 mg/dL by CGM
Time in target range 70-180 mg/dL measured by CGM
Time frame: 8 weeks
Time >180 mg/dL by CGM
Time in hyperglycemia range \>180 mg/dL measured by CGM
Time frame: 8 weeks
Mean Glucose by CGM
Mean glucose measured by CGM overall in mmol/L
Time frame: 8 weeks
Low Blood Glucose Index (LBGI)
Index measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower).
Time frame: 8 weeks
High Blood Glucose Index (HBGI)
Index measure of high blood glucose risk.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
CGM <70mg/dL
Percentage time \<70mg/dL measured by CGM in three study phases combining Group A and B.
Time frame: 8 weeks
Hemoglobin A1c by Study Session
Hemoglobin A1c after each 8 weeks study session by Group A and Group B.
Time frame: 8 weeks