The current study is designed to test the feasibility of the a wearable bionic pancreas system that automatically delivers insulin and glucagon can provide superior regulation of glycemia versus usual care for adults and children with cystic fibrosis related diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
Massachusetts General Hospital
Boston, Massachusetts, United States
Percentage of Time in Glucose Target Range (70-180 mg/dl) as Determined by Continuous Glucose Monitor (CGM) on Days 3-14
Percentage of time spent with CGM glucose values between 70 and 180 mg/dl
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose: < 54 mg/dl
Percentage of time spent with CGM glucose in this range
Time frame: Days 3-14
Mean CGM Glucose
Average CGM glucose
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose < 70 mg/dl
Percent of time the participant spent with CGM glucose in this range
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose >180 mg/dL
The percent of time the participant spent with CGM glucose in this range
Time frame: Days 3-14
Percentage of Time Spent With CGM Glucose > 250mg/dL
The percent of time the participant spent with CGM glucose in this range
Time frame: Days 3-14
Standard Deviation
Standard deviation of participants' mean CGM glucose
Time frame: Days 3-14
Coefficient of Variation
Coefficient of variation of CGM glucose values
Time frame: Days 3-14
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Number of Episodes of Self-reported Symptomatic Hypoglycemia
Number of episodes subjects reported experiencing symptoms of low blood sugar (hypoglycemia)
Time frame: Days 3-14
Number of Subjects With Mean CGMG <154 mg/dl
Number of subjects who achieve a mean CGM glucose \< 154 mg/dl, which is the estimated average glucose for a hemoglobin A1c of 7% (ADA goal for therapy)
Time frame: Days 3-14
Number of Subjects With Percentage of Time < 54 mg/dl < 1%
Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl
Time frame: Days 3-14
Number of Subjects With Percentage of Time < 54 mg/dl < 1% and Mean CGM Glucose < or Equal to 154 mg/dl
Number of subjects who have less than 1% percent of CGM glucose values \< 54 mg/dl and also have a mean CGM glucose that is less than or equal to 154 mg/dl
Time frame: Days 3-14
Number of Subjects With Time in Range (70-180 mg/dl) of 70% or Greater
Number of subjects who have 70% percent or more of their CGM glucose values between 70 and 180 mg/dl
Time frame: Days 3-14