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

• ClinicalTrials.gov Identifier: NCT00674986
• Recruitment Status: Completed
• First Posted: May 8, 2008
• Results First Posted: October 21, 2013
• Last Update Posted: October 21, 2013
• Sponsor: Hoffmann-La Roche
• Information provided by (Responsible Party): Hoffmann-La Roche

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus, Type 2	Device: Accu-Chek 360° View Blood Glucose Analysis Tool; Device: Accu-Chek Aviva Glucose Meter	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 522 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Clinical Study to Evaluate the Use of Episodic, Intensive Blood Glucose Monitoring in Persons With Non-insulin Treated Type 2 Diabetes
• Study Start Date: March 2008
• Actual Primary Completion Date: February 2010
• Actual Study Completion Date: February 2010

Arms and Interventions

Arm	Intervention/treatment
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.	Device: Accu-Chek Aviva Glucose Meter
Experimental: 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.	Device: Accu-Chek 360° View Blood Glucose Analysis Tool; Device: Accu-Chek Aviva Glucose Meter

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 [ Time Frame: Baseline, 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.

Secondary Outcome Measures :

1. Number of Visits With Diabetic Medication and/or Lifestyle Change Recommendations [ Time Frame: 12 Months ]
   Treatment intensification was assessed at each clinic visit. The physician evaluated the patient and made recommendations of a change in two areas: changes in diabetic medication and/or changes in lifestyle (such as diet, exercise and education.)
2. Change From Baseline in Depression Severity (PHQ-8) [ Time Frame: Baseline, Month 12 ]
   The Patient Health Questionnaire-8 (PHQ-8) is an eight-item patient questionnaire to measure the severity of depression disorders over the previous 2 weeks. Each item is rated on a 4-point scale of: 0=not at all to 3=nearly every day. The total score for all items range from 0 (best) to 24 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline PHQ-8, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.
3. Change From Baseline in the Diabetes Distress Scale (DDS) [ Time Frame: Baseline, Month 12 ]
   Participants rated their level of diabetes distress by answering 17 questions in in the following areas: Regimen-related Distress, Emotional Burden, Diabetes-related Interpersonal Distress and Physician-related Distress (PD) on a 6-point scale: 1=Not a problem to 6=A very serious problem. The Average Total score ranged from 1 (best) to 6 (worst). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline DDS, gender, age, and race as fixed effects; and site and subject as random effects. A negative change from Baseline indicated improvement.
4. Change From Baseline in the World Health Organization (WHO-5) Well-being Index [ Time Frame: Baseline, Month 12 ]
   Participants used the WHO-5 to rate their well-being (feeling good and cheerful) for the past 2 weeks using a 6-point scale: 0=At no time to 5=All of the time for a total possible score of 0 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline WHO-5, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.
5. Change From Baseline in Confidence in Diabetes Self-Care (CIDS-2) [ Time Frame: Baseline, Month 12 ]
   Participants rated how confident they felt about managing each of 20 diabetes self-care tasks using the CIDS-2 questionnaire. Responses were given on a 5-point scale ranging from 1=not at all confident to 5=completely confident for a total possible score of 20 (worst) to 100 (best). Results were calculated using a Linear Mixed Model with study group, visit, group-by-visit interaction, baseline CIDS-2, gender, age, and race as fixed effects; and site and subject as random effects. A positive change from Baseline indicated improvement.
6. Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day [ Time Frame: 12 Months ]
   SMBG data for all participants was collected by the glucose meter and were uploaded directly to a web server. The mean number of SMBG tests/day was calculated for the entire study period.
7. Glycemic Variability Pre and Post-Prandial Excursions at Each Meal [ Time Frame: Month 1, Month 12 ]

   Glycemic Variability was evaluated in the STG group for each 3-day set that corresponded to the days the subjects completed the tool before each post-baseline clinic visit. Some parameters used to estimate glycemic variability over the 3-day profile included mean and maximum post-prandial glucose excursions (differences between pre- and post-meal blood glucose levels), mean blood glucose and mean amplitude of glycemic excursion.

   The calculation used a Linear mixed model with visit, Month 1 value, gender, age and race (White and Non-White) as fixed effects; and site and subject as random effects.

Eligibility Criteria

• Ages Eligible for Study: 25 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Contacts and Locations

Locations

United States, Alabama

Mobile, Alabama, United States, AL 36608

Pell City, Alabama, United States, AL 35125

United States, Florida

Chipley, Florida, United States, 32428

Marianna, Florida, United States, 32446

Pembroke Pines, Florida, United States, FL 33028

Tampa, Florida, United States, 33613

Tampa, Florida, United States, 33624

United States, Georgia

Atlanta, Georgia, United States, GA 30312

Atlanta, Georgia, United States, GA 30342

United States, Illinois

Chicago, Illinois, United States, 60616

O'fallon, Illinois, United States, IL 62269

United States, Indiana

Fishers, Indiana, United States, IN 46038

Indianapolis, Indiana, United States, 46256

Indianapolis, Indiana, United States, In 46217

United States, Michigan

Flint, Michigan, United States, 48504

United States, North Carolina

Hickory, North Carolina, United States, NC 28602

Raleigh, North Carolina, United States, 27609

Wilmington, North Carolina, United States, 28401

Winston Salem, North Carolina, United States, 27103

United States, Ohio

Cuyahoga Falls, Ohio, United States, OH 44223

Zanesville, Ohio, United States, OH 43701

United States, Pennsylvania

Pottstown, Pennsylvania, United States, 19468

Pottstown, Pennsylvania, United States, PA 19464

United States, South Carolina

High Point, South Carolina, United States, SC 29720

Lancaster, South Carolina, United States, SC 29720

Mount Pleasant, South Carolina, United States, 29464

United States, Tennessee

Bristol, Tennessee, United States, 37620

Crossville, Tennessee, United States, TN 38555

United States, Virginia

Abingdon, Virginia, United States, VA 24210

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

• Study Director: Bettina Petersen; Roche Diagnostics

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fisher L, Polonsky W, Parkin CG, Jelsovsky Z, Amstutz L, Wagner RS. The impact of blood glucose monitoring on depression and distress in insulin-naïve 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.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT00674986
• Other Study ID Numbers: RD000590; RDC-MI&A-01-2007
• First Posted: May 8, 2008
• Results First Posted: October 21, 2013
• Last Update Posted: October 21, 2013
• Last Verified: August 2013

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases