Continuous Subcutaneous Infusion of Pramlintide and Insulin

Completed · Phase 4

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID: NCT00291772
Run by: Baylor College of Medicine
People needed: 13
Starts: 2006-01-01
Expected to finish: 2007-11-01
Last updated by the study team: 2016-07-14

Who can join

Age: 13 and older, up to 22. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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. -

You may not qualify if…

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. -

Where it is running

Texas Children's Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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