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Sponsored by: |
Baylor College of Medicine |
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Information provided by: | Baylor College of Medicine |
ClinicalTrials.gov Identifier: | NCT00564395 |
We study blood sugars in the children with T1DM, who are given insulin detemir and a rapid acting insulin. We hypothesize that there is no difference in the patterns of blood sugars when detemir is given in the same syringe or in separate syringes with rapid acting insulin.
Condition | Intervention | Phase |
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Type 1 Diabetes Mellitus |
Drug: insulin detemir |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Estimated Enrollment: | 20 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 10 Years to 25 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Thanh M Nguyen, MD, PhD | 832 822 3790 | thanhn@bcm.tmc.edu |
Contact: Kimbery J Mason, RN, CDE | 832 822 1010 | kjmason@bcm.tmc.edu |
United States, Texas | |
Texas Children's Hospital Endocrine and Diabetes Clinic | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Rubina A Heptulla, MD |
Principal Investigator: | Rubina A Heptulla, MD | Baylor College of Medicine |
Responsible Party: | Baylor ( Rubina Heptulla, MD ) |
Study ID Numbers: | H-16541 |
Study First Received: | November 27, 2007 |
Last Updated: | January 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00564395 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Insulin, Asp(B28)- Diabetes Mellitus Endocrine System Diseases |
Diabetes Mellitus Type 1 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Insulin |
Autoimmune Diseases Metabolic Diseases Immune System Diseases Diabetes Mellitus, Type 1 |
Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders |