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

NCT01741467 | Completed DMC

• 1 other identifier: 369196
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes; Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (1)

• Differences in blood glucose

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

  baseline, 18 months

Secondary Outcomes (6)

• Impact of lifestyle changes

  baseline, 18 months

• Changes in Glucose dynamics

  baseline, 18 months

• Differences in blood pressure.

  baseline, 18 months

• Differences in lipids.

  baseline, 18 months

• Differences in weight

  baseline, 18 months

Study Arms (1)

RT-CGM

EXPERIMENTAL

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

Behavioral: RT-CGM

Interventions

RT-CGM BEHAVIORAL

Dexcom Seven+

RT-CGM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889-5600, United States

Location

Related Publications (13)

• 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. doi: 10.1111/j.1464-5491.2007.02043.x.

  PMID: 17257275 BACKGROUND

• 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. doi: 10.1056/NEJMoa012512.

  PMID: 11832527 BACKGROUND

• 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. doi: 10.2337/diacare.28.11.2780.

  PMID: 16249558 BACKGROUND

• 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. doi: 10.1016/j.amjmed.2007.09.016.

  PMID: 18261504 BACKGROUND

• 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. doi: 10.1056/NEJMoa1010949.

  PMID: 21428766 BACKGROUND

• 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. doi: 10.4158/EP.12.S1.25.

  PMID: 16627376 BACKGROUND

• 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. doi: 10.1002/14651858.CD005061.pub2.

  PMID: 17054235 BACKGROUND

• 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. doi: 10.1056/NEJMoa0805017. Epub 2008 Sep 8.

  PMID: 18779236 BACKGROUND

• 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. doi: 10.2337/dc10-1989. Epub 2011 Feb 19.

  PMID: 21335621 BACKGROUND

• 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. doi: 10.2337/dc09-0846. Epub 2009 Aug 12.

  PMID: 19675193 BACKGROUND

• 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. doi: 10.2337/dc11-1438. Epub 2011 Nov 18.

  PMID: 22100963 BACKGROUND

• 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. doi: 10.2337/dc11-1468.

  PMID: 22442395 BACKGROUND

• American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1(Suppl 1):S11-61. doi: 10.2337/dc11-S011. No abstract available.

  PMID: 21193625 BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Robert Vigersky

  Walter Reed National Military Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Diabetes Institute

Study Record Dates

• First Submitted: July 19, 2012
• First Posted: December 5, 2012
• Study Start: May 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: October 19, 2016

Record last verified: 2016-10

Locations

US (1)