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Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01586065
First Posted: April 26, 2012
Last Update Posted: June 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic
  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
Intervention Model: Parallel Assignment
Masking: None (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 Larry Fox, 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
Control
Fingerstick BGs only, no CGM
Other: Fingerstick BGs only
No CGM - fingerstick BGs only

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

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): NCT01586065


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

Responsible Party: Larry Fox, Physician, Nemours Children's Clinic
ClinicalTrials.gov Identifier: NCT01586065     History of Changes
Other Study ID Numbers: R03HD067329-01A1 ( U.S. NIH Grant/Contract )
First Submitted: April 25, 2012
First Posted: April 26, 2012
Last Update Posted: June 14, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Larry Fox, 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