NCT01741467

The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Walter Reed National Military Medical Center · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.

Detailed description

The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a "wash-in" phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.

Conditions

• Pre-diabetes
• Impaired Glucose Tolerance

Interventions

Type	Name	Description
BEHAVIORAL	RT-CGM	Dexcom Seven+

Timeline

• Start date: 2012-05-01
• Primary completion: 2015-08-01
• Completion: 2016-08-01
• First posted: 2012-12-05
• Last updated: 2016-10-19

Locations

1 site across 1 country: United States