Status:
COMPLETED
Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control
Lead Sponsor:
Nemours Children's Clinic
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
11-16 years
Phase:
NA
Brief 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...
Detailed Description
Management of type 1 diabetes mellitus (T1DM) in adolescents is very difficult and innovative approaches are needed to help them achieve better glycemic control and behavioral outcomes. Continuous glu...
Eligibility Criteria
Inclusion
- Age of adolescent \> 11 years and \< 17 years. This age range was chosen because families of adolescents often struggle with diabetes management. Youths \> 18 years old may be likely to leave home during the study.
- Diagnosis of type 1 diabetes based on the clinician's best judgment regarding the adolescent's proper diagnostic category.
- Duration of type 1 diabetes \> 2 years or \> 1 year with negligible stimulated c-peptide level, to exclude those with significant residual pancreatic insulin production.
- Treatment of diabetes for the 6 months prior to enrollment must consist of an intensified regimen including either daily use of an insulin pump or 3 or more daily insulin injections with pre-meal insulin doses calculated using a correction factor that considers prevailing blood glucose levels and planned carbohydrate intake.
- Adolescent must have established diabetes care at a participating Nemours Children's Clinic site as evidenced by at least two diabetes clinic visits within the prior 12 months.
- Most recent HbA1C \> 7.5% and \< 10.0% or mean HbA1C over the prior 12 months within that same range.
- Intention to remain in the same region and to maintain diabetes care at the enrolling center for 12 months.
- Family has working telephone service.
Exclusion
- Youth has not used a CGM device with real-time glucose feedback for clinical management of diabetes within the prior 6 months. Intermittent or one-time use of "blinded" CGM devices for retrospective analysis only is permissible.
- Absence of any other medical conditions that, in the opinion of the attending endocrinologist, would impede completion of the study protocol.
- Youths may not be on daily glucocorticoid medications due to hyperglycemic effects of these agents.
- Not enrolled in special education for mental retardation, autism or severe behavior disorders.
- Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
- Primary diabetes caregiver not diagnosed or in treatment for major depression, psychosis, bipolar disorder or substance use disorder within the 6 months prior to enrollment; Child not in an inpatient psychiatric unit or day treatment program during the 6 months prior to enrollment.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2017
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT00945659
Start Date
August 1 2009
End Date
June 30 2017
Last Update
September 10 2018
Active Locations (1)
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1
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207