Clinical Trial Search

Primary: Diurnal Level 2 Hypoglycemia Events (ADA, <54 mg/dL) as Measured by CGM in Patients With Severe Hyperinsulinemic Hypoglycemia (HH) — 5.2; 5.2; 2.7; 2.1 events per 14…

Primary: Accuracy of 18F-DOPA PET/CT Scans to Detect Focal Lesions in Children With Congenital Hyperinsulinism — 34; 10; 4; 52 cases

Primary: Number of Subjects With Clinically Meaningful Reduction in Glucose Infusion Rate (Double-Blind) — 2; 0 Participants

Primary: The Accuracy of FDOPA PET to Identify Focal Forms of Hyperinsulinism — 40; 6; 3; 46 Participants

Primary: Mean Blood Glucose Area Under the Curve (AUC 0-6h) — 2,096; 1,678 mmol*min/L

Primary: Mean Plasma Glucose Area Under the Curve (AUC 0-3h) — 22,192.5; 25,207.1; 21,715.9 mg*min/dl

Primary: Median of Average Daily Percent Time Within a Glucose Target Range of 70-180 mg/dL (3.9-10 mmol/L) by CGM at Baseline (BL) and End of Treatment (EOT) — 81.7; 72.9; 83.4…

Primary: Area Over the Curve and <60 mg/dl (CGM) Measured in mg/dl *Min — 1066.30; 2004.80 mg/dl *minute

Primary: Percentage With Growth Hormone (GH) Suppression to < 0.4 ng/ml — 0; 7; 8 Participants

Primary: Mean Intravenous Glucose Infusion Rate — 4.33; 9.51 mg/kg/minute — p=0.0037

Primary: Peak Epinephrine Levels — 609 pg/mL

Primary: Insulin Secretion — 56766 pmol/l * 90 minutes

Primary: Change From Baseline in Insulin Secretion Rate (ISR) Normalized to Ambient Plasma Glucose — 2.14; 1.49; 0.53; 2.95 (ng/min) / (mg/dL) — p=<0.001

Primary: Postprandial Glucose Nadir — 57.1; 59.2; 47.1 mg/dL

Primary: Glucagon Response to Acute Hypoglycaemia — 1.33; 1.0; 1.33 pmol/L — p=1.0

Primary: Percent Enrichment of Bicarbonate as Measured by Magnetic Resonance Spectroscopy (MRS) — 61.9 % enrichment — p=0.0053

Primary: Number of Participants With Meal-provoked Hypoglycemia, Defined as Sensor Glucose <65 mg/dL — 1; 5 participants — p=0.103

Primary: Mean Plasma Glucose Level. — 149.666118; 162.574753 mg/dL

Primary: Insulin Sensitivity — 3.06; 3.33 units on a scale

Primary: Hypoglycemia Incidence — 53; 10 participants — p=<0.001

Primary: Area Under the Curve (AUC) Plasma Glucose — 26994.7; 32122.2 mg*min/dL

Primary: Plasma Glucose Levels in Response to Mixed Meal Testing - Area Under the Curve for Plasma Glucose — 2828; 2893 mg*min/dL — p=0.90

Primary: Insulin Sensitivity — 3.37*10^-4 1/min per uU/mL

Primary: Nadir Glucose — 41; 43; 39; 42 mg/dL

Primary: Hypoglycemia Episode Rate — 5.29; 5.85; -3.05; -3.15 episodes per week — p=0.5028

Primary: Assessment of Immediate Verbal Memory — 50; 48 RAVLT scores on a scale (range 0 to 69) — p=0.90

Primary: Detection/Notification of Hypoglycemia — 9 successful events

Primary: ISR in Response to a Glucose Clamp and Oral Glucose Ingestion Before and After 2 Months of Insulin Treatment to Improve Average Glycemia. — 0.67; 0.75; 1.11; 0.76 pmol/min

Primary: Percent Changes in Endothelial Function as Measured by Flow Mediated Dilation by 2D Doppler Ultrasound on Day 2 — 2; 7 percentage of change

Primary: Homeostasis Model Assessment Insulin Resistance (HOMA-IR) Index — 1.91; 0.84 units on a scale — p=0.001