Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) |
Level 2 hypoglycemia events (ADA, <54 mg/dL) as measured by CGM and defined as the number of events captured by CGM with glucose measures <54 mg/dL during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. |
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) |
|
Secondary |
Rate of Level 2 Hypoglycemia (ADA, <54 mg/dL) as Measured by SMBG |
Distinct episodes of Level 2 hypoglycemia (SMBG glucose <54 mg/dL), divided by number of days for run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. |
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) |
|
Secondary |
Rate of Level 3 Hypoglycemia |
Severe events during each treatment period characterized by altered mental and/or physical functioning that requires assistance from another person for recovery; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. This would apply regardless of whether a patient actually received external assistance. |
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) |
|
Secondary |
Percent Time in Level 2 Hypoglycemia (<54 mg/dL) as Measured by CGM (Diurnal Time) |
Percentage of time in level 2 hypoglycemia (<54mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. |
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) |
|
Secondary |
Percent Time in Level 1 Hypoglycemia (<70 mg/dL) as Measured by CGM (Diurnal Time) |
Percentage of time in level 1 hypoglycemia (<70mg/dL by CGM) during diurnal hours (8am-10pm) within the run-in period and respective treatment period; for each period data were collected for 14 days, then divided by number of days, then normalized to duration of 14 days. |
Run-in period (14 days), treatment period 1 (14 days), and treatment period 2 (14 days) |
|
Secondary |
Postprandial Glycemia During Standardized Mixed Meal Consumption |
Change from Baseline in glycemia During Standardized Mixed Meal Consumption |
3 Hours Following Standardized Liquid Meal |
|