Use of Continuous Glucose Sensors by Adolescents With Inadequate Diabetic Control (CGM-Teens)
|ClinicalTrials.gov Identifier: NCT00945659|
Recruitment Status : Completed
First Posted : July 24, 2009
Last Update Posted : February 9, 2017
|Condition or disease||Intervention/treatment|
|Type 1 Diabetes Mellitus||Device: Continuous Glucose Sensor Other: Standard Care Behavioral: CGS + Behavior Therapy|
|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|
|Primary Completion Date :||February 7, 2017|
|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 ]
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|