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

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.

Inclusion Criteria:

- Age 18 or older

- Newly diagnosed with pre-diabetes (within the previous 6 months) with a FPG of > or =
110-125mg/dl or an A1c > or = 6% - 6.4%

- Able to independently measure and read finger stick blood glucose levels

- Willing to wear the CGM device for up to 12 weeks during the study period

- Willing to test blood sugar by fingerstick twice per day while wearing the CGM

- DEERS eligible

Exclusion Criteria:

- Using medication for pre-diabetes

- Women who are pregnant, lactating, planning to become pregnant, or without a safe
contraceptive method; all female subjects will undergo pregnancy testing via a serum
HcG with their initial blood testing.

- Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing
agents during the course of the study.

- Active Duty service members likely to be deployed during the 18-month study period.