NCT05171751CompletedNot Applicable
Beijing Children's Hospital, Capital Medical University, National Center for Children's Health
Beijing Children's Hospital1 site in 1 country50 target enrollmentStarted: November 1, 2021Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- blood glucose
Study Overview
Brief Summary
To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.
Detailed Description
Octreotide subcutaneous injection is effective and safe in the treatment of congenital hyperinsulinemia in children with inefficacy of diazazine.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consistent with the diagnosis of congenital hyperinsulinemia with ineffective diazine; With the maximum dose of diazine at 15mg/kg/d for 5 days, fasting blood glucose/postprandial blood glucose could not be stabilized at the target value of 3.3mmol/L without intravenous glucose infusion.
- •patients treated with octreotide subcutaneous injection.
Exclusion Criteria
- •Before the diagnosis of CHI and the treatment related to CHI, the child had received total pancreatectomy without octreotide
- •Secondary hypoglycemia caused by diseases other than CHI
- •Patients who refused to take octreotide due to parents or family economic reasons, but not hospital treatment factors.
- •Patients who intervene/interfere with octreotide treatment regimen for parental reasons
Outcomes
Primary Outcomes
blood glucose
Time Frame: 1 year
Maintain target blood glucose ≥3.3mmo/L
Secondary Outcomes
No secondary outcomes reported
Investigators
Chunxiu Gong
director
Beijing Children's Hospital
Study Sites (1)
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