Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Use of CGM in Adolescents With Poorly-controlled Type 1 Diabetes
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 25, 2012
CompletedFirst Posted
Study publicly available on registry
April 26, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
June 28, 2023
CompletedJune 28, 2023
June 1, 2023
2.3 years
April 25, 2012
April 18, 2023
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of High Glucose Correction Doses Administered.
Principal study outcome was comparing insulin doses using pre- and post-meal sensor versus plasma glucose values. All insulin dose calculations over a 24-hour period were made using sensor glucose concentrations; these doses were compared to the those calculated as if plasma glucose were to be used instead for dose calculations.
24 hrs
Secondary Outcomes (1)
Pre- and Post-meal (2-3 Hour) Glucose Levels
24 hours
Study Arms (1)
CGM in adolescents with poorly-controlled T1D
EXPERIMENTALAdolescents with poorly controlled type 1 diabetes on insulin pumps were admitted to the clinical research center (CRC) and a continuous glucose sensor was inserted. Sensor glucose (SG) values were compared to plasma glucose measured at least hourly using Yellow Springs Instrument's (YSI) glucose analyzer. SG rather than YSI was used for treatment decisions unless YSI was \<70 mg/dL or specific criteria indicating SG and YSI were very discordant were met.
Interventions
CGM during 24-hr CRC stay.
Eligibility Criteria
You may qualify if:
- to \<18 years old
- T1D for at least one year
- Treatment with insulin pump therapy
- A1c ≥9%
- Willingness to comply with study procedures
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Related Publications (1)
Fox LA, Balkman E, Englert K, Hossain J, Mauras N. Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly controlled type 1 diabetes mellitus: a pilot study. Pediatr Diabetes. 2017 Jun;18(4):271-276. doi: 10.1111/pedi.12404. Epub 2016 Jul 20.
PMID: 27435145RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Larry A Fox, MD
- Organization
- Nemours Children's Health
Study Officials
- PRINCIPAL INVESTIGATOR
Larry A Fox, MD
Nemours Children's Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physician
Study Record Dates
First Submitted
April 25, 2012
First Posted
April 26, 2012
Study Start
February 1, 2012
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
June 28, 2023
Results First Posted
June 28, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share