Hormone Responses During Hypoglycemia and the Accuracy of Continuous Glucose Monitors

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00607139
First received: January 22, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted
  Purpose

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
Type 1 Diabetes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Glucose level at which counter-regulatory hormone response is achieved [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Accuracy of the Guardian-RT continuous glucose monitoring device [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum


Enrollment: 28
Study Start Date: December 2006
Study Completion Date: April 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   3 Years to 17 Years
Genders Eligible for Study:   Both
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.

Criteria

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00607139

Locations
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
Investigators
Study Director: Roy W Beck, MD, PhD Jaeb Center for Health Research
  More Information

Publications:

Responsible Party: Roy W. Beck, MD, PhD, Jaeb Center for Health Research
ClinicalTrials.gov Identifier: NCT00607139     History of Changes
Other Study ID Numbers: DirecNet 009
Study First Received: January 22, 2008
Last Updated: January 22, 2008
Health Authority: United States: Federal Government
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014