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Skittles(TM) Effective for Treating Hypoglycemia in Children With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborators:
Canadian Diabetes Association
LifeScan Canada
Becton, Dickinson and Company
Information provided by:
University of Calgary
ClinicalTrials.gov Identifier:
NCT00706693
First received: June 25, 2008
Last updated: July 7, 2008
Last verified: July 2008
History of Changes
  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:

  1. Sucrose and Fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.
  2. Children and teens will use a variety of treatment practices for the management of hypoglycemia.
  3. 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:

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.

  Show Detailed Description

  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 May 19, 2013