A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes

NCT00674986 | Completed Results

• 2 other identifiers: RD000590RDC-MI&A-01-2007
• Study Type: interventional
• Target: 522
• Locations: 1 country
• Sites: 29

Brief Summary

This randomized, parallel group study will determine whether the use of episodic, intensive glucose monitoring via the Accu-Chek 360 view blood glucose analysis system has a positive effect on overall glycemic control. Patients will be randomized into either the 'usual care' group, or the 'interventional group' supplemented with the Accu-Chek 360 view blood glucose analysis system. The effect of each treatment regimen on glycemic control will be assessed by measurement of change in baseline HbA1c values at 12 months. The anticipated time on study treatment is 1 year, and the target sample size is 504 individuals.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12

  Blood was collected at Baseline and Month 12 and analyzed at a central laboratory for HbA1c. Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline HbA1c, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.

  Baseline, Month 12

Secondary Outcomes (7)

• Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations

  12 Months

• Change From Baseline in Depression Severity (PHQ-8)

  Baseline, Month 12

• Change From Baseline in the Diabetes Distress Scale (DDS)

  Baseline, Month 12

• Change From Baseline in the World Health Organization (WHO-5) Well-being Index

  Baseline, Month 12

• Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2)

  Baseline, Month 12

Study Arms (2)

Active Control Group (ACG)

OTHER

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.

Device: Accu-Chek Aviva Glucose Meter

Structured Testing Group (STG)

EXPERIMENTAL

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.

Device: Accu-Chek 360° View Blood Glucose Analysis Tool; Device: Accu-Chek Aviva Glucose Meter

Interventions

Accu-Chek 360° View Blood Glucose Analysis Tool DEVICE

Structured Testing Group (STG)

Accu-Chek Aviva Glucose Meter DEVICE

Active Control Group (ACG); Structured Testing Group (STG)

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \>= 25 years of age
• 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

You may not qualify if:

• Type 1 diabetes
• On any type of insulin therapy at start of study

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (29)

Unknown Facility

Mobile, Alabama, AL 36608, United States

Location

Unknown Facility

Pell City, Alabama, AL 35125, United States

Location

Unknown Facility

Chipley, Florida, 32428, United States

Location

Unknown Facility

Marianna, Florida, 32446, United States

Location

Unknown Facility

Pembroke Pines, Florida, FL 33028, United States

Location

Unknown Facility

Tampa, Florida, 33613, United States

Location

Unknown Facility

Tampa, Florida, 33624, United States

Location

Unknown Facility

Atlanta, Georgia, GA 30312, United States

Location

Unknown Facility

Atlanta, Georgia, GA 30342, United States

Location

Unknown Facility

Chicago, Illinois, 60616, United States

Location

Unknown Facility

O'Fallon, Illinois, IL 62269, United States

Location

Unknown Facility

Fishers, Indiana, IN 46038, United States

Location

Unknown Facility

Indianapolis, Indiana, 46256, United States

Location

Unknown Facility

Indianapolis, Indiana, In 46217, United States

Location

Unknown Facility

Flint, Michigan, 48504, United States

Location

Unknown Facility

Hickory, North Carolina, NC 28602, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Wilmington, North Carolina, 28401, United States

Location

Unknown Facility

Winston-Salem, North Carolina, 27103, United States

Location

Unknown Facility

Cuyahoga Falls, Ohio, OH 44223, United States

Location

Unknown Facility

Zanesville, Ohio, OH 43701, United States

Location

Unknown Facility

Pottstown, Pennsylvania, 19468, United States

Location

Unknown Facility

Pottstown, Pennsylvania, PA 19464, United States

Location

Unknown Facility

High Point, South Carolina, SC 29720, United States

Location

Unknown Facility

Lancaster, South Carolina, SC 29720, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Bristol, Tennessee, 37620, United States

Location

Unknown Facility

Crossville, Tennessee, TN 38555, United States

Location

Unknown Facility

Abingdon, Virginia, VA 24210, United States

Location

Related Publications (3)

• 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.

  PMID: 21916532 DERIVED

• 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.

  PMID: 21270183 DERIVED

• 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.

  PMID: 20482765 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffman-LaRoche

800-821-8590

Study Officials

• Bettina Petersen

  Roche Diagnostics GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2008
• First Posted: May 8, 2008
• Study Start: March 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: October 21, 2013
• Results First Posted: October 21, 2013

Record last verified: 2013-08

Locations

US (29)