The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes (CGM PreDM)

Walter Reed National Military Medical Center

Status: Completed

Conditions: Impaired Glucose Tolerance; Pre-diabetes

Treatments: Behavioral: RT-CGM

Study type: Interventional

Funder types: Other U.S. Federal agency; Industry

Identifiers

NCT01741467

369196

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

110 participants in 1 patient group

RT-CGM

Experimental group

Description:

Patients using the RT-CGM for the intervention portion of the study.

Treatment:

Behavioral: RT-CGM