Continuous Subcutaneous Infusion of Pramlintide and Insulin

• Status: Completed
• Trial end date: 2007-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Baylor College of Medicine
• Treatments: Islet Amyloid Polypeptide; Pramlintide

Criteria

Inclusion Criteria:

These children will be subjects of the Texas Children's Hospital Diabetes Care Center. The subjects must be

1. 13-22 years of age at the time of enrollment.

2. Have been diagnosed with diabetes for at least 1 year and in good control (HbA1C less than or equal to 8.5%).

3. Be on continuous subcutaneous insulin infusion using an insulin pump.

4. Subjects must be otherwise healthy except for their T1DM and treated hypothyroidism.

5. Menstruating women must have a negative pregnancy test.

6. Hemoglobin equal to or greater than 12 g/dL before each study.

7. Weight more than 44 kg. -

Exclusion Criteria:

1. Age greater than 23 years or less than 13 years at the time of study

2. 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

3. Anemia (hemoglobin less than 12mg/dl)

4. Lack of a supportive family environment

5. Positive pregnancy test in menstruating young women

6. Evidence or history of chemical abuse

7. Hgb A1C greater than 8.5 % in a diabetic subject

8. BMI > 90 % tile for age or < 10 % tile for age

9. Weight less than 44 kg. -