Status:
COMPLETED
Continuous Subcutaneous Infusion of Pramlintide and Insulin
Lead Sponsor:
Baylor College of Medicine
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
13-22 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to see if giving the study drug in a slow and steady dose will lower blood sugars during the meal and after-meal time.
Detailed Description
The Diabetes Control and Complications Trial (DCCT) showed that improving blood sugar control for individuals with Type 1 diabetes (T1DM) stopped or delayed the onset of long-term health problems. Ins...
Eligibility Criteria
Inclusion
- These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be
- 13-22 years of age at the time of enrollment.
- Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%).
- Be on continuous subcutaneous insulin infusion using an insulin pump.
- Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.
- Menstruating women must have a negative pregnancy test.
- Hemoglobin equal to or greater than 12 g/dL before each study.
- Weight more than 44 kg. -
Exclusion
- Age greater than 23 years or less than 13 years at the time of study
- Any chronic disease: leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc or on treatment that might directly or indirectly affect glucose homeostasis, except for diabetes and hypothyroidism stable on medications
- Anemia (hemoglobin less than 12mg/dl)
- Lack of a supportive family environment
- Positive pregnancy test in menstruating young women
- Evidence or history of chemical abuse
- Hgb A1C greater than 8.5 % in a diabetic subject
- BMI \> 90 % tile for age or \< 10 % tile for age
- Weight less than 44 kg. -
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00291772
Start Date
January 1 2006
End Date
November 1 2007
Last Update
July 14 2016
Active Locations (1)
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1
Texas Children's Hospital
Houston, Texas, United States, 77030