Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

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. Identifier: NCT01586065
Recruitment Status : Completed
First Posted : April 26, 2012
Last Update Posted : June 14, 2016
Information provided by (Responsible Party):
Larry Fox, Nemours Children's Clinic

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Device: Continuous Glucose Monitor (CGM) Other: Fingerstick BGs only Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. A1c [ Time Frame: 6 months ]

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

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

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

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 identifier (NCT number): 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

Responsible Party: Larry Fox, Physician, Nemours Children's Clinic Identifier: NCT01586065     History of Changes
Other Study ID Numbers: R03HD067329-01A1 ( U.S. NIH Grant/Contract )
First Posted: April 26, 2012    Key Record Dates
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
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