Congenital Hyperinsulinism Clinical Trial
Official title:
Treatment With Lanreotide Autogel (Somatostatin Analogue) in Patients With Congenital Hyperinsulinism of Infancy Already Treated With Somatostatin Analog by Pump
Verified date | April 2024 |
Source | Sheba Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump. Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to recurrent hypoglycemic episodes are at increased risk of developmental disorders, so identification and prompt management of patients are essential. Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for patients and families as it demands intensive daily care. In an effort to simplify the daily care of our patients and improve their quality of life we will study the efficacy and safety of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by injection once a month
Status | Completed |
Enrollment | 3 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 8 Years |
Eligibility | Inclusion Criteria: - Age 2-8 years, - Diagnosed with congenital hyperinsulinism, - Treated by Octreotide continuous infusion (pump). Exclusion Criteria: - Family not interested in participating. |
Country | Name | City | State |
---|---|---|---|
Israel | Pediatric Endocrinology Unit, Sheba Medical Center | Ramat-Gan |
Lead Sponsor | Collaborator |
---|---|
Sheba Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Euglycemia as recorded by Continuous Glucose Monitoring System (CGMS) | 1 year |
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