This research study, Development of Algorithms for a Hypoglycemic Prevention Alarm, is being conducted at Stanford University Medical Center and the University of Colorado Barbara Davis Center. It is paid for by the Juvenile Diabetes Research Foundation. The purpose of doing this research study is to understand the best way to stop an insulin infusion pump from delivering insulin to prevent a subject from having hypoglycemia. Nocturnal hypoglycemia is a common problem with type 1 diabetes. This is a pilot study to evaluate the safety of a system consisting of an insulin pump and continuous glucose monitor communicating wirelessly with a bedside computer running an algorithm that temporarily suspends insulin delivery when hypoglycemia is predicted in a home setting.
After the run-in phase, there is a 21-night trial in which each night is randomly assigned 2:1 to have either the predictive low-glucose suspend (PLGS) system active (intervention night) or inactive (control night). Three predictive algorithm versions were studied sequentially during the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The algorithm uses a Kalman filter-based model to predict whether the sensor glucose level will fall below 80 mg/dL within a given time period and suspends the insulin pump if this event is predicted.
Stanford University School of Medicine
Stanford, California, United States
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States
Percentage of Nights With CGM (Continuous Glucose Monitor) Sensor Values < 60 mg/dL
Nights with CGM sensor values \< 60 mg/dL were considered to be undesirable. A Kalman filter-based model algorithm predicted whether the sensor glucose level would fall below 80 mg/dL and would suspend insulin delivery as needed. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.
Time frame: 21 days
Percentage of Nights With CGM Values >180 mg/dL
Nights with CGM sensor values \>180 mg/dL were considered to be undesirable. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.
Time frame: 21 days
Mean Morning Blood Glucose (BG)
Desirable glucose level was 70-180 mg/mL. Average of all morning BG data is presented. Participants may have received treatment using one or more of the following algorithms: Algorithm 1 had a hypoglycaemic prediction horizon of 70 minutes; algorithm 2: 50 minutes; algorithm 3: 30 minutes.
Time frame: 21 days
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