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

Not Applicable

Completed

• Conditions: Pre-diabetes; Impaired Glucose Tolerance
• Interventions: Behavioral: RT-CGM

• Registration Number: NCT01741467
• Lead Sponsor: Walter Reed National Military Medical Center

Brief 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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-07-19
• Study First Submitted QC: 2012-11-30
• Study First Posted: 2012-12-05
• Primary Completion: 2015-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Differences in blood glucose	baseline, 18 months	Changes in A1c and fasting blood glucose over time and between the intervention and control groups.

Secondary Outcome Measures

Name	Time	Method
Differences in lipids.	baseline, 18 months	Objective comparison between the control group and the experimental group on changes in lipids.
Impact of lifestyle changes	baseline, 18 months	Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.
Differences in blood pressure.	baseline, 18 months	Objective comparison between the control and experimental group in changes in blood pressure.
Changes in medication use	baseline, 18 months	An objective comparison between the control and experimental group on changes in medication use.
Changes in Glucose dynamics	baseline, 18 months	Comparison of intervention and control group on standard measures of glucose dynamics.
Differences in weight	baseline, 18 months	Objective comparison between the control group and the experimental group on changes in weight.

Trial Locations

Locations (1)

Walter Reed National Military Medical Center; 🇺🇸 Bethesda, Maryland, United States