A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
NCT ID: NCT00674986
Last Updated: 2013-10-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
522 participants
INTERVENTIONAL
2008-03-31
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Active Control Group (ACG)
Participants in the Active Control Group received enhanced standard of care (more frequent clinic visits, free blood glucose meters and strips and point-of-care Hemoglobin A1c (HbA1c) test) for management of their Type 2 diabetes.
Accu-Chek Aviva Glucose Meter
Structured Testing Group (STG)
Participants in the Structured Testing Group in addition to enhanced standard of care for the treatment of their Type 2 diabetes used the ACCU-CHEK® 360° View blood glucose analysis system (Tool) to monitor glucose levels at least quarterly.
Accu-Chek 360° View Blood Glucose Analysis Tool
Accu-Chek Aviva Glucose Meter
Interventions
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Accu-Chek 360° View Blood Glucose Analysis Tool
Accu-Chek Aviva Glucose Meter
Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes for \>= 1 year
* Hemoglobin A1c \>= 7.5% and \<=11%
* Diabetes managed by exercise and diet, prescription oral medication or an injectable incretin mimetic
Exclusion Criteria
* On any type of insulin therapy at start of study
25 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Bettina Petersen
Role: STUDY_DIRECTOR
Roche Diagnostics GmbH
Locations
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Mobile, Alabama, United States
Pell City, Alabama, United States
Chipley, Florida, United States
Marianna, Florida, United States
Pembroke Pines, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
O'Fallon, Illinois, United States
Fishers, Indiana, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Flint, Michigan, United States
Hickory, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Winston-Salem, North Carolina, United States
Cuyahoga Falls, Ohio, United States
Zanesville, Ohio, United States
Pottstown, Pennsylvania, United States
Pottstown, Pennsylvania, United States
High Point, South Carolina, United States
Lancaster, South Carolina, United States
Mt. Pleasant, South Carolina, United States
Bristol, Tennessee, United States
Crossville, Tennessee, United States
Abingdon, Virginia, United States
Countries
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References
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Fisher L, Polonsky W, Parkin CG, Jelsovsky Z, Amstutz L, Wagner RS. The impact of blood glucose monitoring on depression and distress in insulin-naive patients with type 2 diabetes. Curr Med Res Opin. 2011 Nov;27 Suppl 3:39-46. doi: 10.1185/03007995.2011.619176. Epub 2011 Sep 14.
Polonsky WH, Fisher L, Schikman CH, Hinnen DA, Parkin CG, Jelsovsky Z, Petersen B, Schweitzer M, Wagner RS. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care. 2011 Feb;34(2):262-7. doi: 10.2337/dc10-1732.
Polonsky W, Fisher L, Schikman C, Hinnen D, Parkin C, Jelsovsky Z, Amstutz L, Schweitzer M, Wagner R. The value of episodic, intensive blood glucose monitoring in non-insulin treated persons with Type 2 Diabetes: design of the Structured Testing Program (STeP) study, a cluster-randomised, clinical trial [NCT00674986]. BMC Fam Pract. 2010 May 18;11:37. doi: 10.1186/1471-2296-11-37.
Other Identifiers
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RDC-MI&A-01-2007
Identifier Type: -
Identifier Source: secondary_id
RD000590
Identifier Type: -
Identifier Source: org_study_id