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

This study has been terminated.
(Recruitment difficulties)
Sponsor:
Collaborator:
DexCom, Inc.
Information provided by (Responsible Party):
Alicia L. Warnock, Walter Reed National Military Medical Center
ClinicalTrials.gov Identifier:
NCT01741467
First received: July 19, 2012
Last updated: November 19, 2015
Last verified: November 2015
  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.


Enrollment: 110
Study Start Date: May 2012
Estimated Study Completion Date: November 2016
Primary Completion Date: August 2015 (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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Maryland
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889-5600
Sponsors and Collaborators
Walter Reed National Military Medical Center
DexCom, Inc.
Investigators
Principal Investigator: Robert Vigersky Walter Reed National Military Medical Center
  More Information

Publications:

Responsible Party: Alicia L. Warnock, Director, Diabetes Institute, 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 19, 2015
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 July 26, 2016