Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor (CGM)
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, adolescents, poor control, CGM
Eligibility 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
Sites / Locations
- Nemours Children's Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CGM in adolescents with poorly-controlled T1D
Arm Description
Adolescents 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Pre- and Post-meal (2-3 Hour) Glucose Levels
Mean sensor and plasma pre- and post-meal glucose concentrations for all dinner (n=8), bedtime snack (n=8), and breakfast (n=10) during the study period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01586065
Brief Title
Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
Official Title
Use of CGM in Adolescents With Poorly-controlled Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nemours Children's Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Adolescents with type 1 diabetes, HbA1c ≥9% on insulin pumps were admitted to the clinical research center 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, adolescents, poor control, CGM
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CGM in adolescents with poorly-controlled T1D
Arm Type
Experimental
Arm Description
Adolescents 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.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor (CGM)
Intervention Description
CGM during 24-hr CRC stay.
Primary Outcome Measure Information:
Title
Number of High Glucose Correction Doses Administered.
Description
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.
Time Frame
24 hrs
Secondary Outcome Measure Information:
Title
Pre- and Post-meal (2-3 Hour) Glucose Levels
Description
Mean sensor and plasma pre- and post-meal glucose concentrations for all dinner (n=8), bedtime snack (n=8), and breakfast (n=10) during the study period.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
12 to <18 years old
T1D for at least one year
Treatment with 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry A Fox, MD
Organizational Affiliation
Nemours Children's Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27435145
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5250611/
Description
Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly-controlled type 1 diabetes mellitus: a pilot study
Learn more about this trial
Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes
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