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Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

This study is currently recruiting participants.
Verified April 2012 by Nemours Children's Clinic
Sponsor:
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic
ClinicalTrials.gov Identifier:
NCT01586065
First received: April 25, 2012
Last updated: NA
Last verified: April 2012
History: No changes posted
  Purpose

The purpose of this study is to see if children and adolescents with poorly controlled type 1 diabetes will benefit from using a continuous glucose monitor (CGM), a device that can be used to check blood sugars.


Condition Intervention
Type 1 Diabetes
 Device: Continuous Glucose Monitor (CGM)
Other: Fingerstick BGs only

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Use of CGM in Adolescents With Poorly-controlled Type 1 Diabetes

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Nemours Children's Clinic:

Primary Outcome Measures:
  • A1c [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 26
Study Start Date: February 2012
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGM Device: Continuous Glucose Monitor (CGM)
Use of CGM for 6 months
Control
Fingerstick BGs only, no CGM
 Other: Fingerstick BGs only
No CGM - fingerstick BGs only

  Eligibility

Ages Eligible for Study:   12 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 12 to <18 years old
  • T1D for at least one year
  • Treatment with either multiple daily injections (MDI) or insulin pump therapy
  • A1c ≥9%
  • Willingness to comply with study procedures

Exclusion Criteria:

  • Current diabetic ketoacidosis
  • Hypoglycemia unawareness
  • Chronic use of medications that affect recognition of hypoglycemia (e.g., beta blockers)
  • Chronic use of medications that mimic symptoms of high or low blood sugars (e.g., decongestants)
  • Recent or frequent severe hypoglycemia (2 episodes in the last year; 1 episode in the last 6 months)
  • Skin rashes or conditions that may affect CGM placement and wear
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01586065

Contacts
Contact: Larry A. Fox, MD 9046973674 lfox@nemours.org

Locations
United States, Florida
Nemours Children's Clinic Recruiting
Jacksonville, Florida, United States, 32207
Contact: Larry A Fox, MD     904-697-3674     lfox@nemours.org    
Principal Investigator: Larry A Fox, MD            
Sub-Investigator: Nelly Mauras, MD            
Sponsors and Collaborators
Nemours Children's Clinic
Investigators
Principal Investigator: Larry A Fox, MD Nemours Children's Clinic
  More Information

No publications provided

Responsible Party: Larry Fox, Physician, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01586065     History of Changes
Other Study ID Numbers: R03 HD067329-01A1
Study First Received: April 25, 2012
Last Updated: April 25, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Nemours Children's Clinic:
type 1 diabetes
adolescents
poor control
CGM

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013