Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Device: Continuous Glucose Monitor (CGM)

• Registration Number: NCT01586065
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-25
• Study First Submitted QC: 2012-04-25
• Study First Posted: 2012-04-26
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Results First Submitted: 2023-04-18
• Status Verified: 2023-06
• Results First Submitted QC: 2023-06-05
• Last Update Submitted: 2023-06-05
• Results First Posted: 2023-06-28
• Last Update Posted: 2023-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM in adolescents with poorly-controlled T1D	Continuous Glucose Monitor (CGM)	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.

Primary Outcome Measures

Name	Time	Method
Number of High Glucose Correction Doses Administered.	24 hrs	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

Name	Time	Method
Pre- and Post-meal (2-3 Hour) Glucose Levels	24 hours	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.

Trial Locations

Locations (1)

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States