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

October 18, 2016 updated by: Alicia L. Warnock, Walter Reed National Military Medical Center
This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20889-5600
        • Walter Reed National Military Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RT-CGM
Patients using the RT-CGM for the intervention portion of the study.
Behavioral: RT-CGM
Dexcom Seven+

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in blood glucose
Time Frame: baseline, 18 months
Changes in A1c and fasting blood glucose over time and between the intervention and control groups.
baseline, 18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Walter Reed National Military Medical Center

Collaborators

DexCom, Inc.

Investigators

  • Principal Investigator: Robert Vigersky, Walter Reed National Military Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

July 19, 2012

First Submitted That Met QC Criteria

November 30, 2012

First Posted (Estimate)

December 5, 2012

Study Record Updates

Last Update Posted (Estimate)

October 19, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 369196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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