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

Pre-diabetes Clinical Trial

— CGM PreDM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741467
• Other study ID #: 369196
• Status: Completed
• Phase: N/A
• First received: July 19, 2012
• Last updated: October 18, 2016
• Start date: May 2012
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: Walter Reed National Military Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Impaired Glucose Tolerance
• Pre-diabetes
• Prediabetic State

Intervention

Behavioral:
• RT-CGM
Dexcom Seven+

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Walter Reed National Military Medical Center	DexCom, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (13)

American Diabetes Association. Standards of medical care in diabetes--2011. Diabetes Care. 2011 Jan;34 Suppl 1:S11-61. doi: 10.2337/dc11-S011. — View Citation

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. — View Citation

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. — View Citation

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. Erratum in: N Engl J Med. 2011 Jul 14;365(2):189. N Engl J Med. 2011 Sep 1;365(9):869. — View Citation

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. Erratum in: Diabetes Care. 2013 Dec;36(12):4173-5. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in blood glucose	Changes in A1c and fasting blood glucose over time and between the intervention and control groups.	baseline, 18 months	No
Secondary	Impact of lifestyle changes	Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups.	baseline, 18 months	No
Secondary	Changes in Glucose dynamics	Comparison of intervention and control group on standard measures of glucose dynamics.	baseline, 18 months	No
Secondary	Differences in blood pressure.	Objective comparison between the control and experimental group in changes in blood pressure.	baseline, 18 months	No
Secondary	Differences in lipids.	Objective comparison between the control group and the experimental group on changes in lipids.	baseline, 18 months	No
Secondary	Differences in weight	Objective comparison between the control group and the experimental group on changes in weight.	baseline, 18 months	No
Secondary	Changes in medication use	An objective comparison between the control and experimental group on changes in medication use.	baseline, 18 months	No