NCT01083433

Study to Find Out if Intensive Diabetes Clinic and Continuous Glucose Monitors Help Teenagers With Diabetes

Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 68 (actual)
• Sponsor: University Hospitals Cleveland Medical Center · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.

Detailed description

Good glycemic control is critical in preventing chronic complications of type 1 diabetes. However, achieving good glycemic control remains elusive for many adolescents. This study evaluates two clinic-based approaches for improving glycemic control in adolescents with poorly controlled type 1 diabetes - an intensive diabetes support and education program alone and the same intensive diabetes support and education program together with continuous glucose monitoring - in comparison with standard diabetes care.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
BEHAVIORAL	Diabetes related psychological counseling and education	The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
DEVICE	Continuous Glucose Monitor	Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-09-01
• Completion: 2011-10-01
• First posted: 2010-03-09
• Last updated: 2022-01-13
• Results posted: 2022-01-13

Locations

1 site across 1 country: United States