Skittles(TM) Effective for Treating Hypoglycemia in Children With Type 1 Diabetes - Full Text View

Sponsors and Collaborators:	University of Calgary Canadian Diabetes Association LifeScan Canada Becton, Dickinson and Company
Information provided by:	University of Calgary
ClinicalTrials.gov Identifier:	NCT00706693

Purpose

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:

Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.
Children and teens will use a variety of treatment practices for the management of hypoglycemia.
Children and teens will prefer the mode of treatment that was most effective in treating hypoglycemia.

Condition	Intervention
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)

MedlinePlus related topics: Diabetes Diabetes Type 1 Dietary Supplements Hypoglycemia

Drug Information available for: Dextrose Fructose Sucrose

U.S. FDA Resources

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

Further study details as provided by University of Calgary:

Primary Outcome Measures:

To determine if sucrose and fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes. [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine present hypoglycemia treatment practices of children and teens with type 1 diabetes (prior to entry into the study). [ Designated as safety issue: No ]
To determine preferred mode of treatment for hypoglycemia after completing the study. [ Designated as safety issue: No ]

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
Glucose: Active Comparator BD glucose tablets (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm	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.
Fructose: Active Comparator Fruit to Go (TM) is taken PO in response to a hypoglycemic event by participants randomized to this arm	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.
Sucrose: Active Comparator Skittles (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm	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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Eligibility

Ages Eligible for Study:	3 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Type 1 diabetes mellitus
Diagnosed 6 or more months ago
Patient of the Alberta Children's Hospital Diabetes Clinic

Exclusion Criteria:

Adrenal insufficiency
Uncompensated hypothyroidism
Clinical autonomic neuropathy
Celiac disease
Lack of family support
Unwilling or unable to follow the study protocol
Subjects with less than 4 hypoglycemic events per month

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00706693

Locations

Canada, Alberta
Alberta Children's Hospital
Calgary, Alberta, Canada, T3B 6A8

Sponsors and Collaborators

University of Calgary

Canadian Diabetes Association

LifeScan Canada

Becton, Dickinson and Company

Investigators

Principal Investigator:

Allison Husband, RN, MN, CDE

Alberta Children's Hospital

More Information

Publications of Results:

Husband, A, Lau L, Crawford S, Pacaud D. The effectiveness of Glucose, Sucrose and Fructose in Treating Hypoglycemia in Children with Type 1 Diabetes. Diabetes 56(Suppl 1):a475, 2007.

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

Keywords provided by University of Calgary:

hypoglycemia
treatment
glucose

sucrose
fructose
treatment

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Hypoglycemia

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009