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

Sponsor:	University of Calgary
Collaborators:	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)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Effectiveness of Glucose, Sucrose and Fructose in Treating Hypoglycemia in Children With Type 1 Diabetes

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Type 1 Hypoglycemia

Drug Information available for: Fructose Sucrose Dextrose

U.S. FDA Resources

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
Active Comparator: Glucose 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.
Active Comparator: Fructose 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.
Active Comparator: Sucrose 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:

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:	Allison Husband, RN, MN, CDE, Alberta Children's Hospital
ClinicalTrials.gov Identifier:	NCT00706693 History of Changes
Other Study ID Numbers:	17089-AH
Study First Received:	June 25, 2008
Last Updated:	July 7, 2008
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University of Calgary:

hypoglycemia
treatment
glucose
sucrose
fructose

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders

Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on February 09, 2012