Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Continuous Glucose Monitor (CGM)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM in adolescents with poorly-controlled T1D<br>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. | Device: Continuous Glucose Monitor (CGM)<br>* CGM during 24-hr CRC stay.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, adolescents, poor control, CGM