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NCT00945659 · ClinicalTrials.gov registry record · NA

Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control

A NA study of Type 1 Diabetes Mellitus, sponsored by Nemours Children's Clinic.

Completed
Registry status
NA
Development phase
116
Enrollment target
1
Study location

NCT00945659 is a NA study of Type 1 Diabetes Mellitus that has completed, run by Nemours Children's Clinic. The registered enrollment target is 116 participants, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (17% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00945659, a NA study of Type 1 Diabetes Mellitus, has completed, sponsored by Nemours Children's Clinic.

COMPLETED
Registry status
NA
Development phase
116 participants
Enrollment target
1
Study location

Study Summary

The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. This study will randomize adolescents (11 to not yet 17 years old) with type 1 diabetes for at least 2 years who are not achieving targeted HbA1c levels (\> 7.5%) to continue in standard care (SC), to add continuous glucose monitoring (CGM) to their care with appropriate education and medical management (CGS) or to add CGM to their care as above but to also receive support and assistance from a behavior therapist who will assist the patient and family in optimizing the adolescents' therapeutic benefit from CGS (CGS+BT). A variety of outcomes will be measured, including blood glucose control, quality of life, and CGS satisfaction and impact. An enrollment criterion for this study is that the adolescent must have established consistent care for type 1 diabetes at a Nemours Children's Clinic location either in Wilmington, DE, Philadelphia, PA, Orlando, FL or Pensacola, FL for at least 12 months prior to enrollment in the study. Adolescents treated elsewhere are not eligible to enroll in the study.

Conditions Studied

Type 1 Diabetes Mellitus

Interventions

  • OTHER Standard Care
  • DEVICE Continuous Glucose Sensor
  • BEHAVIORAL CGS + Behavior Therapy

Study Locations (1)

Florida

  • Nemours Children's Clinic - Jacksonville

Trial Details

FieldValue
Enrollment Target 116 participants
Start Date 2009-08
Est. Completion 2017-06-30
Phase NA

Sponsor

Nemours Children's Clinic

108 total trials

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What the Registry Record Tells You About NCT00945659

The ClinicalTrials.gov registry entry for NCT00945659 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 116 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 139-participant average among 105 other Type 1 Diabetes Mellitus trials with a reported enrollment target (17% lower). The listed sponsor is Nemours Children's Clinic, which has 108 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Type 1 Diabetes Mellitus appearing as the primary indexed condition, and to 3 interventions - of which Standard Care is the first listed.

NCT00945659 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.

Frequently Asked Questions

What is clinical trial NCT00945659 about?

NCT00945659 is a clinical study titled "Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control". The incorporation of continuous glucose sensors (CGS) into management of type 1 diabetes in adolescence could improve treatment outcomes. But, behavioral barriers may prevent adolescents from enjoying optimal benefits from this new technology. This study will randomize adolescents (11 to not yet 17 ...

What is the current status of trial NCT00945659?

This trial is currently completed. It is a NA study. The enrollment target is 116 participants. The study started on 2009-08. Estimated completion is 2017-06-30.

What conditions does trial NCT00945659 study?

This clinical trial studies the following conditions: Type 1 Diabetes Mellitus.

What interventions are being tested in trial NCT00945659?

The interventions under investigation include: Standard Care (OTHER), Continuous Glucose Sensor (DEVICE), CGS + Behavior Therapy (BEHAVIORAL).

Who is sponsoring clinical trial NCT00945659?

This trial is sponsored by Nemours Children's Clinic, which has 108 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00945659 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.