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Hormone Responses During Hypoglycemia and the Accuracy of Continuous Glucose Monitors

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ClinicalTrials.gov Identifier: NCT00607139
Recruitment Status : Completed
First Posted : February 5, 2008
Last Update Posted : September 5, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
The primary objective of this study will be to compare the glucose level at which counter-regulatory hormone responses occur during hypoglycemia in young children with diabetes, with the glucose level counter regulatory hormone responses that occur in older children with diabetes.

Condition or disease
Type 1 Diabetes

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Counter-regulatory Hormone Responses During Hypoglycemia and the Accuracy of Continuous Glucose Monitors in Children With T1DM
Study Start Date : December 2006
Primary Completion Date : April 2007
Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Glucose level at which counter-regulatory hormone response is achieved [ Time Frame: 90 minutes ]

Secondary Outcome Measures :
  1. Accuracy of the Guardian-RT continuous glucose monitoring device [ Time Frame: 1 week ]

Biospecimen Retention:   Samples Without DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Approximately 30-50 subjects will be enrolled in this study at five clinical centers with approximately 6-10 enrolled at each center.

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  2. Age 3.0 to <7.0 years or 12.0 to <18.0 years
  3. Weight >12.8 kg (28.2 lbs) for reinfusion centers (centers that employ reinfusion of blood drawn to clear the dead space in intravenous catheters) and >17.4 kg (38.3 lbs) for discard centers (centers that discard the blood drawn to clear the dead space)
  4. Hemoglobin A1c <10.0%
  5. Subject currently uses an insulin pump
  6. Parent/guardian and subject understand the study protocol and agree to comply with it
  7. Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject

Exclusion Criteria:

  1. The presence of a significant medical disorder or use of any medication that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
  2. Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
  3. A severe hypoglycemic event resulting in seizure or loss of consciousness in the last month
  4. Use of systemic or inhaled corticosteroids in the last month
  5. Cystic fibrosis
Contacts and Locations

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): NCT00607139

United States, California
Division of Pediatric Endocrinology and Diabetes, Stanford University
Stanford, California, United States, 94305
United States, Colorado
Barbara Davis Center for Childhood Diabetes, University of Colorado
Aurora, Colorado, United States, 80010
United States, Connecticut
Department of Pediatrics, Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Jaeb Center for Health Research
Tampa, Florida, United States, 33647
United States, Iowa
Department of Pediatrics, University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Jaeb Center for Health Research
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director: Roy W Beck, MD, PhD Jaeb Center for Health Research
More Information


Responsible Party: Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00607139     History of Changes
Other Study ID Numbers: DirecNet 009
First Posted: February 5, 2008    Key Record Dates
Last Update Posted: September 5, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs