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Sponsored by: |
Children's Hospital of Eastern Ontario |
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Information provided by: | Children's Hospital of Eastern Ontario |
ClinicalTrials.gov Identifier: | NCT00146484 |
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
Condition | Intervention | Phase |
---|---|---|
Diabetes Mellitus, Type 1 |
Drug: Twice Daily versus Three Times Daily Insulin Injections |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus |
Estimated Enrollment: | 100 |
Study Start Date: | April 1996 |
Estimated Study Completion Date: | January 2001 |
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a “honeymoon” period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Children's Hospital of Eastern Ontario | |
Ottawa, Ontario, Canada, K1H 8L1 |
Principal Investigator: | Margaret L Lawson, MD | Children's Hospital of Eastern Ontario |
Study ID Numbers: | CHEO RI cc9993 |
Study First Received: | September 6, 2005 |
Last Updated: | September 6, 2005 |
ClinicalTrials.gov Identifier: | NCT00146484 |
Health Authority: | Canada: Health Canada |
Diabetes Mellitus, Type 1 Child Adolescent |
Disease Management Newly Diagnosed Hemoglobin A, Glycosylated |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |