Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM

Completed · Phase 3

Conditions studied: Diabetes Mellitus, Type 1

In brief

The purpose of this study is to determine the efficacy, tolerability, safety, and effect on quality of life of CGM in children 4 to less than 10 years of age with type 1 diabetes.

Key facts

Study ID

NCT00760526

Run by

Jaeb Center for Health Research

People needed

146

Starts

2010-09-01

Expected to finish

2012-01-01

Last updated by the study team

2016-10-19

Who can join

Age: 4 and older, up to 9. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least twelve months
• Age >4.0 to <10.0 years
• HbA1c >= 7.0%
• Current insulin regimen involves either use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day) for the last three months, with no plans to switch the modality of insulin administration during the next 6 months (e.g., injection user switching to a pump, pump user switching to injections, or the addition of Lantus (Glargine) insulin)

You may not qualify if…

• Diabetes diagnosed <6 months of age
• Use of a medication such as oral/inhaled glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
• The presence of any of the following diseases or another disease that the investigator believes to be a contraindication to participation in the protocol:
• Asthma if treated with systemic or daily inhaled corticosteroids in the last 6 months (Intermittent treatment with inhaled corticosteroids does not exclude subjects from enrollment)
• Cystic fibrosis (Celiac disease and adequately treated thyroid disease do not exclude subjects from enrollment)
• Home use of CGM in past 6 months.
• Participation in an intervention study (including psychological studies) in past 6 weeks.
• Another member of the same household is participating in this study.

Where it is running

• Stanford University Medical Center — Stanford, California, United States
• Yale University, School of Medicine — New Haven, Connecticut, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Children's Hospital of Iowa, Department of Pediatrics — Iowa City, Iowa, United States
• Washington University School of Medicine — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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