We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00706693
Recruitment Status : Completed
First Posted : June 27, 2008
Last Update Posted : July 9, 2008
Sponsor:
Collaborators:
Canadian Diabetes Association
LifeScan Canada
Becton, Dickinson and Company
Information provided by:
University of Calgary

Brief Summary:

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 or disease Intervention/treatment
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)

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effectiveness of Glucose, Sucrose and Fructose in Treating Hypoglycemia in Children With Type 1 Diabetes
Study Start Date : August 2003
Primary Completion Date : September 2006
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. To determine present hypoglycemia treatment practices of children and teens with type 1 diabetes (prior to entry into the study).
  2. To determine preferred mode of treatment for hypoglycemia after completing the study.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Allison Husband, RN, MN, CDE, Alberta Children's Hospital
ClinicalTrials.gov Identifier: NCT00706693     History of Changes
Other Study ID Numbers: 17089-AH
First Posted: June 27, 2008    Key Record Dates
Last Update Posted: July 9, 2008
Last Verified: July 2008

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