Hormone Responses During Hypoglycemia and the Accuracy of Continuous Glucose Monitors

NCT00607139 | Completed DMC

• 1 other identifier: DirecNet 009
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 6

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Glucose level at which counter-regulatory hormone response is achieved

  90 minutes

Secondary Outcomes (1)

• Accuracy of the Guardian-RT continuous glucose monitoring device

  1 week

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jaeb Center for Health Research: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (6)

Division of Pediatric Endocrinology and Diabetes, Stanford University

Stanford, California, 94305, United States

Location

Barbara Davis Center for Childhood Diabetes, University of Colorado

Aurora, Colorado, 80010, United States

Location

Department of Pediatrics, Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Jaeb Center for Health Research

Tampa, Florida, 33647, United States

Location

Department of Pediatrics, University of Iowa

Iowa City, Iowa, 52242, United States

Location

Related Publications (5)

• Tsalikian E, Mauras N, Beck RW, Tamborlane WV, Janz KF, Chase HP, Wysocki T, Weinzimer SA, Buckingham BA, Kollman C, Xing D, Ruedy KJ; Diabetes Research In Children Network Direcnet Study Group. Impact of exercise on overnight glycemic control in children with type 1 diabetes mellitus. J Pediatr. 2005 Oct;147(4):528-34. doi: 10.1016/j.jpeds.2005.04.065.

  PMID: 16227041 BACKGROUND

• Weinzimer SA, Beck RW, Chase HP, Fox LA, Buckingham BA, Tamborlane WV, Kollman C, Coffey J, Xing D, Ruedy KJ; Diabetes Research in Children Network Study Group. Accuracy of newer-generation home blood glucose meters in a Diabetes Research in Children Network (DirecNet) inpatient exercise study. Diabetes Technol Ther. 2005 Oct;7(5):675-80; discussion 681-3. doi: 10.1089/dia.2005.7.675.

  PMID: 16241867 BACKGROUND

• Diabetes Research in Children Network (DirecNet) Study Group. Impaired overnight counterregulatory hormone responses to spontaneous hypoglycemia in children with type 1 diabetes. Pediatr Diabetes. 2007 Aug;8(4):199-205. doi: 10.1111/j.1399-5448.2007.00248.x.

  PMID: 17659061 BACKGROUND

• Diabetes Research In Children Network (Direcnet) Study Group; Buckingham BA, Kollman C, Beck R, Kalajian A, Fiallo-Scharer R, Tansey MJ, Fox LA, Wilson DM, Weinzimer SA, Ruedy KJ, Tamborlane WV. Evaluation of factors affecting CGMS calibration. Diabetes Technol Ther. 2006 Jun;8(3):318-25. doi: 10.1089/dia.2006.8.318.

  PMID: 16800753 BACKGROUND

• Tansey MJ, Tsalikian E, Beck RW, Mauras N, Buckingham BA, Weinzimer SA, Janz KF, Kollman C, Xing D, Ruedy KJ, Steffes MW, Borland TM, Singh RJ, Tamborlane WV; Diabetes Research in Children Network (DirecNet) Study Group. The effects of aerobic exercise on glucose and counterregulatory hormone concentrations in children with type 1 diabetes. Diabetes Care. 2006 Jan;29(1):20-5. doi: 10.2337/diacare.29.1.20.

  PMID: 16373890 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Roy W Beck, MD, PhD

  Jaeb Center for Health Research

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2008
• First Posted: February 5, 2008
• Study Start: December 1, 2006
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: September 5, 2016

Record last verified: 2016-09

Locations

US (6)