Trial record 14 of 80 for: Open Studies | "Prediabetic State"

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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

History of Changes

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:

MedlinePlus related topics: Diabetes Pre-diabetes

U.S. FDA Resources

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:

County Level Estimates of Diagnosed Diabetes — U.S. Maps This link exits the ClinicalTrials.gov site

Publications:

Diabetes Prevention Program Research Group. The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the Diabetes Prevention Program. Diabet Med. 2007 Feb;24(2):137-44.

Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403.

Yamaoka K, Tango T. Efficacy of lifestyle education to prevent type 2 diabetes: a meta-analysis of randomized controlled trials. Diabetes Care. 2005 Nov;28(11):2780-6.

Salpeter SR, Buckley NS, Kahn JA, Salpeter EE. Meta-analysis: metformin treatment in persons at risk for diabetes mellitus. Am J Med. 2008 Feb;121(2):149-157.e2. Review.

DeFronzo RA, Tripathy D, Schwenke DC, Banerji M, Bray GA, Buchanan TA, Clement SC, Henry RR, Hodis HN, Kitabchi AE, Mack WJ, Mudaliar S, Ratner RE, Williams K, Stentz FB, Musi N, Reaven PD; ACT NOW Study. Pioglitazone for diabetes prevention in impaired glucose tolerance. N Engl J Med. 2011 Mar 24;364(12):1104-15.

Chiasson JL. Acarbose for the prevention of diabetes, hypertension, and cardiovascular disease in subjects with impaired glucose tolerance: the Study to Prevent Non-Insulin-Dependent Diabetes Mellitus (STOP-NIDDM) Trial. Endocr Pract. 2006 Jan-Feb;12 Suppl 1:25-30. Review.

Van de Laar FA, Lucassen PL, Akkermans RP, Van de Lisdonk EH, De Grauw WJ. Alpha-glucosidase inhibitors for people with impaired glucose tolerance or impaired fasting blood glucose. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD005061. Review.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Tamborlane WV, Beck RW, Bode BW, Buckingham B, Chase HP, Clemons R, Fiallo-Scharer R, Fox LA, Gilliam LK, Hirsch IB, Huang ES, Kollman C, Kowalski AJ, Laffel L, Lawrence JM, Lee J, Mauras N, O'Grady M, Ruedy KJ, Tansey M, Tsalikian E, Weinzimer S, Wilson DM, Wolpert H, Wysocki T, Xing D. Continuous glucose monitoring and intensive treatment of type 1 diabetes. N Engl J Med. 2008 Oct 2;359(14):1464-76. Epub 2008 Sep 8.

Battelino T, Phillip M, Bratina N, Nimri R, Oskarsson P, Bolinder J. Effect of continuous glucose monitoring on hypoglycemia in type 1 diabetes. Diabetes Care. 2011 Apr;34(4):795-800. Epub 2011 Feb 19.

Juvenile Diabetes Research Foundation Continuous Glucose Monitoring Study Group; Bode B, Beck RW, Xing D, Gilliam L, Hirsch I, Kollman C, Laffel L, Ruedy KJ, Tamborlane WV, Weinzimer S, Wolpert H. Sustained benefit of continuous glucose monitoring on A1C, glucose profiles, and hypoglycemia in adults with type 1 diabetes. Diabetes Care. 2009 Nov;32(11):2047-9. Epub 2009 Aug 12.

Vigersky RA, Fonda SJ, Chellappa M, Walker MS, Ehrhardt NM. Short- and long-term effects of real-time continuous glucose monitoring in patients with type 2 diabetes. Diabetes Care. 2012 Jan;35(1):32-8. Epub 2011 Nov 18.

Diabetes Prevention Program Research Group. The 10-year cost-effectiveness of lifestyle intervention or metformin for diabetes prevention: an intent-to-treat analysis of the DPP/DPPOS. Diabetes Care. 2012 Apr;35(4):723-30.

American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1:S11-61. No abstract available.

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 June 17, 2013

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