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

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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

Tracking Information
First Submitted Date  ICMJE June 25, 2008
First Posted Date  ICMJE June 27, 2008
Last Update Posted Date July 9, 2008
Study Start Date  ICMJE August 2003
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00706693 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2008)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Skittles(TM) Effective for Treating Hypoglycemia in Children With Type 1 Diabetes
Official Title  ICMJE The Effectiveness of Glucose, Sucrose and Fructose in Treating Hypoglycemia in Children With Type 1 Diabetes
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.
Detailed Description

An open labeled, randomized, cross-over design will be used. Each subject will treat 5 hypoglycemic events with glucose, 5 with sucrose and 5 with fructose. Subjects will be randomized into order of treatment.

Primary Objective:

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

    Secondary Objectives:

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

Inclusion Criteria:

The sample will consist of 65 individuals with a history of type 1 diabetes (based on clinical presentation) for three or more months and who are between the ages of 3 and 18 years. All eligible participants will be patients of the Alberta Children's Hospital Diabetes Clinic.

Exclusion Criteria:

Individuals with the following conditions/circumstances will be excluded from the study:

  • 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

Instruments:

Blood glucose will be measured with a blood glucose meter. All meters will have a lab to meter comparison performed. In accordance with the 1998 Clinical Practice Guidelines for Diabetes Management in Canada, an acceptable meter value will be +15% of the lab value (7). Participants will be provided with a complimentary meter and strips.

All participants will be provided with a digital timer to enable accurate 15 minute timing of post treatment blood glucose.

A Demographic and Pre-Study Data tool has been developed to collect pre-study information (see Appendix B) as well as a Low Blood Glucose Treatment Log to record pre- and post-treatment blood glucose results (see Appendix C).

Study Procedure:

A letter inviting participation in the study will be mailed to all eligible participants (see Appendix D). Further recruitment will be done during clinic appointments. Six months will be allocated for recruitment of subjects. Subjects will meet with the study research assistant and informed and signed consent will be obtained. Participants will be assigned a study number based on their order of recruitment. The research assistant and participant will not determine treatment order. Each participant will be assigned a treatment order based on a randomization table (See Table 1).

The research assistant will also obtain demographic data and information on present hypoglycemia treatment practices, explain the study protocol, and provide Study Protocol instructions (see Appendix E). The lab/meter comparison will be obtained prior to data collection.

The study protocol is as follows:

  • Hypoglycemia will be confirmed with a blood glucose test.
  • If blood glucose is less than 4.0 mmol/L it will be treated with pre-packaged treatments and in the order determined by randomization.
  • The blood glucose will be re-tested 15 minutes after treatment.
  • If the blood glucose is still less than 4.0 mmol/L, it will be treated again as per study protocol and then re-tested 15 minutes later.
  • If the next meal or snack is more than 1 hour away, a snack containing 15 g of carbohydrate and a protein will be eaten.
  • Participants will record blood glucose results and treatment method on the Low Blood Glucose Treatment Log.

If participants can not follow the above outlined protocol, they will be instructed to treat as per usual practice and not record data. This will mean that most hypoglycemic events treated as per protocol will likely occur when children are with their parents or in the comfort of their own homes.

Assuming that children and teens will experience 1 to 3 hypoglycemic events per week, it is anticipated that data collection will occur over a 5 to 15 week period. The research assistant will call participants every two weeks to monitor study progress. Once the subject has treated 15 hypoglycemic episodes as per study protocol and completed the Low Blood Glucose Treatment Log, they will return it in a pre-addressed and stamped envelope. There will be a question at the end of the Low Blood Glucose Treatment Log asking preferred method of hypoglycemia treatment following completion of the study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes Mellitus
  • Hypoglycemia
Intervention  ICMJE
  • 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.
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Glucose
    BD glucose tablets (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm
    Intervention: Dietary Supplement: Ingestion of BD glucose tablets (TM)
  • Active Comparator: Fructose
    Fruit to Go (TM) is taken PO in response to a hypoglycemic event by participants randomized to this arm
    Intervention: Dietary Supplement: Ingestion of Fruit to Go (TM)
  • Active Comparator: Sucrose
    Skittles (TM) are taken PO in response to a hypoglycemic event by participants randomized to this arm
    Intervention: Dietary Supplement: Ingestion of Skittles (TM)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2008)
33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2006
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00706693
Other Study ID Numbers  ICMJE 17089-AH
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allison Husband, RN, MN, CDE, Alberta Children's Hospital
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE
  • Canadian Diabetes Association
  • LifeScan Canada
  • Becton, Dickinson and Company
Investigators  ICMJE
Principal Investigator: Allison Husband, RN, MN, CDE Alberta Children's Hospital
PRS Account University of Calgary
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP