This is an open-label, non-randomized, pilot study to determine the safety and feasibility of the insulin-only bionic pancreas.
A total of 16 subjects, ages 18-45, will be enrolled in this crossover study. The study will consist of three 7-day study arms in the following order, one usual care arm, one bionic pancreas insulin only arm with a static glucose target, and one bionic pancreas insulin only arm with at dynamic glucose target.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Enrollment
16
Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.
Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.
Stanford University School of Medicine
Stanford, California, United States
Mean glucose
Dexcom G4P AP mean glucose
Time frame: change over 5 days
% time <50 mg/dl
Fraction of Dexcom G4P AP readings \<60 mg/dl
Time frame: change over 5 days
% time <70 mg/dl
Fraction of Dexcom G4P AP readings \<70 mg/dl
Time frame: change over 5 days
% time 70-120 mg/dl
Fraction of Dexcom G4P AP readings 70-120 mg/dl
Time frame: change over 5 days
% time 70-180 mg/dl
Fraction of Dexcom G4P AP readings 70-180 mg/dl
Time frame: change over 5 days
% time >180 mg/dl
Fraction of Dexcom G4P AP readings \>180 mg/dl
Time frame: change over 5 days
% time >250 mg/dl
Fraction of Dexcom G4P AP readings \>250 mg/dl
Time frame: change over 5 days
% time < 60 mg/dl
Fraction of Dexcom G4AP readings \< 60 mg/dl
Time frame: Change over 5 days
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