Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Use of CGM in Adolescents With Poorly-controlled Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01586065
• Other study ID #: R03HD067329-01A1
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: June 2014

Study information

• Verified date: June 2023
• Source: Nemours Children's Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• Continuous Glucose Monitor (CGM)
CGM during 24-hr CRC stay.

Locations

Country	Name	City	State
United States	Nemours Children's Clinic	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Nemours Children's Clinic

Country where clinical trial is conducted

United States, 

References & 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: 10.111 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 hours

External Links

•   Safety of using real-time sensor glucose values for treatment decisions in adolescents with poorly-controlled type 1 diabetes mellitus: a pilot study