This study is to test our automated hypoglycemia prevention and treatment device (glucagon-only bionic pancreas) in subjects that have undergone post-bariatric surgery that are experiencing symptoms of hypoglycemia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
10
A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
Massachusetts General Hospital
Boston, Massachusetts, United States
Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min
The measure for area over the curve is used when an integrated assessment (e.g., a measurement of something over a specific amount of time) is more useful in understanding a phenomenon. To calculate this measure, a method of approximation is often used. One way would be to estimate the curve via curve-fitting techniques. For this outcome, using area over the curve and \<60mg/dl provides a more robust method of calculating amount of hypoglycemia (by including more severe degrees of hypoglycemia in the product of mg/dl\*min as opposed to percentage of time below 60mg/dl.
Time frame: 14 days
Mean Continuous Glucose Monitor (CGM) Glucose
Time frame: 2 weeks
Percentage of Time With CGM Glucose Less Than 60 mg/dl Overnight (11:00 PM - 7:00 AM)
Time frame: 14 days
Percentage of Time With CGM Glucose Less Than 60 mg/dl During Daytime ( 7:00 AM-11:00 PM)
Time frame: 14 days
Percentage of Time Spent Within the Glucose Range 70-120 mg/dl
Time frame: 14 days
Percentage of Time Spent Within the Glucose Range 70-180 mg/dl
Time frame: 14 days
Percentage of Time Spent Within the Glucose Range >180 mg/dl
Time frame: 14 days
Fraction of Time Spent Within the Glucose Range >250 mg/dl
Time frame: 2 weeks
Mean Absolute Relative Deviation (MARD) of CGM vs. All StatStrip Xpress BG Measurements
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
MARD is computed using the difference between the CGM readings and the values measured at the same time by the reference measurement system. The mean (or average) of all the absolute relative deviations produces the MARD. In this study, the reference measurement system was the StatStrip Xpress meter, to which the CGM values were compared.
Time frame: 14 days
Number of Carbohydrate Interventions for Hypoglycemia Per Day
Number of carbohydrate interventions for hypoglycemia per day calculated from daily email survey
Time frame: 14 days
Total Number of Grams of Carbohydrate Taken for Hypoglycemia Per Day
Calculated from daily email survey
Time frame: 14 days
Total Glucagon Dosing (mcg/kg/24 Hours)
Time frame: 2 weeks
Number of Symptomatic Hypoglycemia Events Per Day
Number of symptomatic hypoglycemia events per day calculated from daily email survey
Time frame: 14 days
Percentage of Days When Participants Correctly Guessed Intervention (Glucagon vs Placebo) Out of a Total of 14 Days.
Time frame: 2 weeks
Number of Days With Nausea
Number of days with nausea calculated from daily survey
Time frame: 14 days
Severity of Nausea on Daily E-mail Survey
The visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. We used a simple VAS is a straight horizontal line of fixed length measuring 0-100mm with subscale markings every 10mm. The ends are defined as the extreme limits of the parameter to be measured (nausea) orientated from the left (least severity or 0) to the right (most severity or 100mm). Subjects can mark their response anywhere from 0 to 100mm. The mean severity of nausea for the group in each arm was calculated by averaging all responses in either arm.
Time frame: 14 days