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Sponsors and Collaborators: |
University of Calgary Canadian Diabetes Association LifeScan Canada Becton, Dickinson and Company |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00706693 |
The purpose of this study is to determine the most effective treatment option for managing naturally occurring hypoglycemia in children with type 1 diabetes.
Hypotheses:
Condition | Intervention |
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Type 1 Diabetes Mellitus Hypoglycemia |
Dietary Supplement: Ingestion of BD glucose tablets (TM) Dietary Supplement: Ingestion of Skittles (TM) Dietary Supplement: Ingestion of Fruit to Go (TM) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Crossover Assignment, Efficacy Study |
Official Title: | The Effectiveness of Glucose, Sucrose and Fructose in Treating Hypoglycemia in Children With Type 1 Diabetes |
Enrollment: | 33 |
Study Start Date: | August 2003 |
Study Completion Date: | September 2006 |
Primary Completion Date: | September 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Glucose: Active Comparator
BD glucose tablets (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm
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Dietary Supplement: Ingestion of BD glucose tablets (TM)
Hypoglycemia (blood glucose is less than 4.0 mmol/L as measured by a glucose meter) will be treated with BD glucose tablets by giving 10g of glucose in children 10 and under. Children and teens over 10 will receive 15g of glucose.
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Fructose: Active Comparator
Fruit to Go (TM) is taken PO in response to a hypoglycemic event by participants randomized to this arm
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Dietary Supplement: Ingestion of Fruit to Go (TM)
Hypoglycemia (blood glucose is less than 4.0 mmol/L as measured by a glucose meter) will be treated with Fruit to Go by giving 10g of fructose in children 10 and under. Children and teens over 10 will receive 15g of fructose.
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Sucrose: Active Comparator
Skittles (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm
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Dietary Supplement: Ingestion of Skittles (TM)
Hypoglycemia (blood glucose is less than 4.0 mmol/L as measured by a glucose meter) will be treated with Skittle by giving 10g of sucrose in children 10 and under. Children and teens over 10 will receive 15g of sucrose.
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Ages Eligible for Study: | 3 Years to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
Alberta Children's Hospital | |
Calgary, Alberta, Canada, T3B 6A8 |
Principal Investigator: | Allison Husband, RN, MN, CDE | Alberta Children's Hospital |
Responsible Party: | Alberta Children's Hospital ( Allison Husband, RN, MN, CDE ) |
Study ID Numbers: | 17089-AH |
Study First Received: | June 25, 2008 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00706693 |
Health Authority: | Canada: Ethics Review Committee |
hypoglycemia treatment glucose |
sucrose fructose treatment |
Autoimmune Diseases Metabolic Diseases Diabetes Mellitus, Type 1 Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Hypoglycemia |
Immune System Diseases |