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

Primary Purpose

Pre-diabetes, Impaired Glucose Tolerance

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
RT-CGM
Sponsored by
Walter Reed National Military Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Walter Reed National Military Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RT-CGM

Arm Description

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

Outcomes

Primary Outcome Measures

Differences in blood glucose
Changes in A1c and fasting blood glucose over time and between the intervention and control groups.

Secondary Outcome Measures

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

Full Information

First Posted
July 19, 2012
Last Updated
October 18, 2016
Sponsor
Walter Reed National Military Medical Center
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01741467
Brief Title
The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Acronym
CGM PreDM
Official Title
The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Walter Reed National Military Medical Center
Collaborators
DexCom, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes, Impaired Glucose Tolerance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RT-CGM
Arm Type
Experimental
Arm Description
Patients using the RT-CGM for the intervention portion of the study.
Intervention Type
Behavioral
Intervention Name(s)
RT-CGM
Intervention Description
Dexcom Seven+
Primary Outcome Measure Information:
Title
Differences in blood glucose
Description
Changes in A1c and fasting blood glucose over time and between the intervention and control groups.
Time Frame
baseline, 18 months
Secondary Outcome Measure Information:
Title
Impact of lifestyle changes
Description
Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.
Time Frame
baseline, 18 months
Title
Changes in Glucose dynamics
Description
Comparison of intervention and control group on standard measures of glucose dynamics.
Time Frame
baseline, 18 months
Title
Differences in blood pressure.
Description
Objective comparison between the control and experimental group in changes in blood pressure.
Time Frame
baseline, 18 months
Title
Differences in lipids.
Description
Objective comparison between the control group and the experimental group on changes in lipids.
Time Frame
baseline, 18 months
Title
Differences in weight
Description
Objective comparison between the control group and the experimental group on changes in weight.
Time Frame
baseline, 18 months
Title
Changes in medication use
Description
An objective comparison between the control and experimental group on changes in medication use.
Time Frame
baseline, 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Vigersky
Organizational Affiliation
Walter Reed National Military Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States

12. IPD Sharing Statement

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

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