Status:
COMPLETED
Randomized Trial to Assess Efficacy and Safety of Continuous Glucose Monitoring in Children 4-<10 Years With T1DM
Lead Sponsor:
Jaeb Center for Health Research
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
4-9 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
On the day of enrollment, a hemoglobin A1c level will be obtained, and potential subjects will be evaluated for study eligibility through the elicitation of a medical history and performance of a phys...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00760526
Start Date
September 1 2010
End Date
January 1 2012
Last Update
October 19 2016
Active Locations (5)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
Yale University, School of Medicine
New Haven, Connecticut, United States, 06520
3
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
4
Children's Hospital of Iowa, Department of Pediatrics
Iowa City, Iowa, United States, 52242