Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Nemours Children's Health

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Continuous Glucose Monitor (CGM)

Study type: Interventional

Funder types: Other

Identifiers

NCT01586065

R03HD067329-01A1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

CGM in adolescents with poorly-controlled T1D

Experimental group

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.

Treatment:

Device: Continuous Glucose Monitor (CGM)