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
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Condition or disease |
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Type 1 Diabetes |

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 |
Actual Primary Completion Date : | April 2007 |
Actual Study Completion Date : | April 2007 |

- Glucose level at which counter-regulatory hormone response is achieved [ Time Frame: 90 minutes ]
- Accuracy of the Guardian-RT continuous glucose monitoring device [ Time Frame: 1 week ]
Biospecimen Retention: Samples Without DNA

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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 |
Inclusion Criteria:
- 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.
- Age 3.0 to <7.0 years or 12.0 to <18.0 years
- 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)
- Hemoglobin A1c <10.0%
- Subject currently uses an insulin pump
- Parent/guardian and subject understand the study protocol and agree to comply with it
- Informed Consent Form signed by the parent/guardian and Child Assent Form signed by the subject
Exclusion Criteria:
- 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.
- Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
- A severe hypoglycemic event resulting in seizure or loss of consciousness in the last month
- Use of systemic or inhaled corticosteroids in the last month
- Cystic fibrosis

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 |
Study Director: | Roy W Beck, MD, PhD | Jaeb Center for Health Research |
Responsible Party: | Jaeb Center for Health Research |
ClinicalTrials.gov Identifier: | NCT00607139 |
Other Study ID Numbers: |
DirecNet 009 |
First Posted: | February 5, 2008 Key Record Dates |
Last Update Posted: | September 5, 2016 |
Last Verified: | September 2016 |
Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases |