Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control (CGM-Teens)
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|ClinicalTrials.gov Identifier: NCT00945659|
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: Continuous Glucose Sensor Other: Standard Care Behavioral: CGS + Behavior Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||121 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||3 group (Standard Care: Continuous Glucose Monitor; Continuous Glucose Monitor + Behavior Therapy) X 4 time points (0, 3, 6, and 9 months) Repeated measures randomized treatments design.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control|
|Study Start Date :||August 2009|
|Actual Primary Completion Date :||February 7, 2017|
|Actual Study Completion Date :||February 7, 2017|
Active Comparator: Standard Care
Standard Care constitutes intensified diabetes management, an enrollment criterion for the study, consisting of either continuous subcutaneous insulin infusion (insulin pump) or multiple daily injections using a "basal-bolus" approach. All patients must be using carbohydrate counting and have prescribed correction factors for targeted insulin bolus dose adjustments.
Other: Standard Care
Intensified diabetes management based on either insulin pump or multiple daily injection insulin regimen, employing carbohydrate counting and a bolus dose correction factor for adjusting insulin doses.
Active Comparator: Continuous Glucose Sensor
Patients will have the same diabetes management regimen as those in the Standard Care group. In addition they will be given a continuous glucose sensor, receive expert instruction in its use, and be guided by a physician and diabetes educator in achieving glycemic benefits through retrospective and real-time interpretation of CGS results and by learning to respond judiciously to the various CGS alarms.
Device: Continuous Glucose Sensor
Education and medical management to promote optimal therapeutic benefit from adding use of a continuous glucose sensor to daily diabetes management.
Experimental: CGS + Behavior Therapy
Patients in the use group will receive the same medical management as the Continuous Glucose Sensor group above. In addition, they will have 6 scheduled encounters with a behavior therapist that are designed to reduce or eliminate typical behavioral and/or psychological barriers to optimal use of CGS as part of diabetes care.
Behavioral: CGS + Behavior Therapy
Patients in this group will receive 6 scheduled encounters with a behavior therapist who will assist the adolescent and parent in reducing or eliminating common behavioral and psychological barriers to achieving optimal benefit from CGS use in diabetes care.
- Glycated hemoglobin (HbA1c) [ Time Frame: 9 months ]
- Diabetes Technology Questionnaire [ Time Frame: 9 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945659
|United States, Florida|
|Nemours Children's Clinic|
|Jacksonville, Florida, United States, 32207|
|Principal Investigator:||Tim Wysocki, Ph.D.||Nemours Children's Clinic Jacksonville|