Type 1 Diabetes Clinical Trial
Official title:
Conventional Insulin Therapy Vs Intensive Insulin Management In Children With Type 1 Diabetes Mellitus
Verified date | July 2016 |
Source | Baylor College of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
In this study, we plan to examine the difference in effect on blood glucose control in patients who will be on either conventional insulin therapy (i.e. using NPH and Humalog twice daily, injected separately) or on intensive insulin management (IIM-several shots of short acting and Glargine insulin). Those on IIM will be mixing the insulin Glargine with the short-acting insulin analog prior to injecting. The Hemoglobin A1c (HbA1c) results will be used to monitor blood glucose control over a 6 month period. Twice during the course of the study, a continuous glucose monitoring system (CGMS-a device the size of a pager that records blood sugar readings every 5 minutes) will be used to record all the changes in the blood glucose levels occurring over a 72-hour period.
Status | Completed |
Enrollment | 60 |
Est. completion date | October 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Years to 25 Years |
Eligibility |
Inclusion Criteria: - Age greater than 6 years of age but less than 25 years of age (Insulin glargine has been approved for use in children 6 years and older). - Patients newly diagnosed with T1DM within the past 3 months. - Have an HgbA1c of less than 9.0%, after the initial run-in period of 3 months. - Have a BMI of less than the 90th percentile for age. - Randomization of subjects willing to participate in the study. Exclusion Criteria: - Any chronic disease (leukemia, asthma, inflammatory bowel disease, cystic fibrosis, juvenile rheumatoid arthritis, etc) that directly, or as a result of treatment, directly or indirectly affect glucose homeostasis. - Lack of supportive family. - Evidence or history of chemical abuse. - Age less than 6 years or greater than 25 years. - HbA1c level of greater than 9.0%, after the initial run-in period of 3 months. - Have a BMI greater than the 90th percentile for age. - Patients who are not newly diagnosed with T1DM. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
Baylor College of Medicine |
United States,
Kaplan W, Rodriguez LM, Smith OE, Haymond MW, Heptulla RA. Effects of mixing glargine and short-acting insulin analogs on glucose control. Diabetes Care. 2004 Nov;27(11):2739-40. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HbA1C | |||
Secondary | Glucose excursions |
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