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

This study is currently recruiting participants.
Verified November 2012 by Walter Reed National Military Medical Center
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Robert Vigersky, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01741467
First received: July 19, 2012
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Pre-diabetes
Impaired Glucose Tolerance
Behavioral: RT-CGM

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes

Resource links provided by NLM:


Further study details as provided by Walter Reed National Military Medical Center:

Primary Outcome Measures:
  • Differences in blood glucose [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    Changes in A1c and fasting blood glucose over time and between the intervention and control groups.


Secondary Outcome Measures:
  • Impact of lifestyle changes [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.

  • Changes in Glucose dynamics [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    Comparison of intervention and control group on standard measures of glucose dynamics.

  • Differences in blood pressure. [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    Objective comparison between the control and experimental group in changes in blood pressure.

  • Differences in lipids. [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    Objective comparison between the control group and the experimental group on changes in lipids.

  • Differences in weight [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    Objective comparison between the control group and the experimental group on changes in weight.

  • Changes in medication use [ Time Frame: baseline, 18 months ] [ Designated as safety issue: No ]
    An objective comparison between the control and experimental group on changes in medication use.


Estimated Enrollment: 130
Study Start Date: May 2012
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RT-CGM
Patients using the RT-CGM for the intervention portion of the study.
Behavioral: RT-CGM
Dexcom Seven+

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01741467

Locations
United States, Maryland
Walter Reed National Military Medical Center Recruiting
Bethesda, Maryland, United States, 20889-5600
Contact: Sherri D Senicki, BSN    301-319-3402    sheri.senicki@med.navy.mil   
Contact: Mary Chellappa, MD    301-319-2871    mary.chellappa@med.navy.mil   
Principal Investigator: Robert Vigersky, MD         
Sub-Investigator: Nicole Ehrhardt, MD         
Sub-Investigator: Susan Walker, PhD         
Sub-Investigator: Stephanie Fonda, PhD         
Sponsors and Collaborators
Walter Reed National Military Medical Center
DexCom, Inc.
Investigators
Principal Investigator: Robert Vigersky Walter Reed National Military Medical Center
  More Information

Additional Information:
Publications:

Responsible Party: Robert Vigersky, COL, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier: NCT01741467     History of Changes
Other Study ID Numbers: 369196
Study First Received: July 19, 2012
Last Updated: November 30, 2012
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Intolerance
Prediabetic State
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia

ClinicalTrials.gov processed this record on April 17, 2014