Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Nemours Children's Clinic.
Recruitment status was  Recruiting
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:


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
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: 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 August 28, 2014