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Completed

NCT Number: NCT01586065

Continuous Glucose Monitoring in Adolescents With Poorly Controlled Type 1 Diabetes

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous Glucose Monitor (CGM)

Device

CGM during 24-hr CRC stay.

Primary outcomes

  1. Number of High Glucose Correction Doses Administered.

    Time frame: 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 outcomes

  1. Pre- and Post-meal (2-3 Hour) Glucose Levels

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Nemours Children's Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 26, 2012
Registry last updated
Jun 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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