Clinical trial NCT01741467: The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Official title: The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-diabetes
Impaired Glucose Tolerance
Lead sponsor: Walter Reed National Military Medical Center
Sponsor class: FED
Collaborators: name: DexCom, Inc.
First posted: 2012-12-05
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Differences in blood glucose
timeFrame: baseline, 18 months
Secondary outcomes:
measure: Impact of lifestyle changes
timeFrame: baseline, 18 months
measure: Changes in Glucose dynamics
timeFrame: baseline, 18 months
measure: Differences in blood pressure.
timeFrame: baseline, 18 months
measure: Differences in lipids.
timeFrame: baseline, 18 months
measure: Differences in weight
timeFrame: baseline, 18 months
measure: Changes in medication use
timeFrame: baseline, 18 months
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
Study officials:
affiliation: Walter Reed National Military Medical Center
name: Robert Vigersky
role: PRINCIPAL_INVESTIGATOR
References:
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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. doi: 10.1002/14651858.CD005061.pub2.
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.
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.
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.
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.
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