NCT00706693

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2003

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2008

Completed
Last Updated

July 9, 2008

Status Verified

July 1, 2008

Enrollment Period

3.1 years

First QC Date

June 25, 2008

Last Update Submit

July 7, 2008

Conditions

Type 1 Diabetes MellitusHypoglycemia

Keywords

hypoglycemiatreatmentglucosesucrosefructose

Outcome Measures

Primary Outcomes (1)

  • To determine if sucrose and fructose are equally effective as glucose in the treatment of spontaneous hypoglycemia in children with type 1 diabetes.

    15 minutes

Secondary Outcomes (2)

  • To determine present hypoglycemia treatment practices of children and teens with type 1 diabetes (prior to entry into the study).

  • To determine preferred mode of treatment for hypoglycemia after completing the study.

Study Arms (3)

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)

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)

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)

Interventions

Ingestion of BD glucose tablets (TM)DIETARY_SUPPLEMENT

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.

Glucose
Ingestion of Skittles (TM)DIETARY_SUPPLEMENT

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.

Sucrose
Ingestion of Fruit to Go (TM)DIETARY_SUPPLEMENT

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.

Fructose

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

Related Publications (1)

  • Husband AC, Crawford S, McCoy LA, Pacaud D. The effectiveness of glucose, sucrose, and fructose in treating hypoglycemia in children with type 1 diabetes. Pediatr Diabetes. 2010 May;11(3):154-8. doi: 10.1111/j.1399-5448.2009.00558.x. Epub 2009 Aug 3.

    PMID: 19663922RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Allison Husband, RN, MN, CDE

    Alberta Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2008

First Posted

June 27, 2008

Study Start

August 1, 2003

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

July 9, 2008

Record last verified: 2008-07

Locations

CA(1)