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Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic Identifier:
First received: April 25, 2012
Last updated: June 10, 2016
Last verified: June 2016
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
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 ]

Secondary Outcome Measures:
  • Frequency of hypoglycemia [ Time Frame: 6 months ]

Enrollment: 10
Study Start Date: February 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGM Device: Continuous Glucose Monitor (CGM)
Use of CGM for 6 months
Fingerstick BGs only, no CGM
Other: Fingerstick BGs only
No CGM - fingerstick BGs only


Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01586065

United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Sponsors and Collaborators
Nemours Children's Clinic
Principal Investigator: Larry A Fox, MD Nemours Children's Clinic
  More Information

Responsible Party: Larry Fox, Physician, Nemours Children's Clinic Identifier: NCT01586065     History of Changes
Other Study ID Numbers: R03HD067329-01A1 ( US NIH Grant/Contract Award Number )
Study First Received: April 25, 2012
Last Updated: June 10, 2016
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases processed this record on April 26, 2017