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

August 19, 2013 updated by: Hoffmann-La Roche
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

522

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, AL 36608
      • Pell City, Alabama, United States, AL 35125
    • 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
    • Georgia
      • Atlanta, Georgia, United States, GA 30312
      • Atlanta, Georgia, United States, GA 30342
    • Illinois
      • Chicago, Illinois, United States, 60616
      • O'fallon, Illinois, United States, IL 62269
    • Indiana
      • Fishers, Indiana, United States, IN 46038
      • Indianapolis, Indiana, United States, 46256
      • Indianapolis, Indiana, United States, In 46217
    • Michigan
      • Flint, Michigan, United States, 48504
    • 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
    • Ohio
      • Cuyahoga Falls, Ohio, United States, OH 44223
      • Zanesville, Ohio, United States, OH 43701
    • Pennsylvania
      • Pottstown, Pennsylvania, United States, 19468
      • Pottstown, Pennsylvania, United States, PA 19464
    • South Carolina
      • High Point, South Carolina, United States, SC 29720
      • Lancaster, South Carolina, United States, SC 29720
      • Mount Pleasant, South Carolina, United States, 29464
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Crossville, Tennessee, United States, TN 38555
    • Virginia
      • Abingdon, Virginia, United States, VA 24210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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 Aviva Glucose Meter
Device: Accu-Chek 360° View Blood Glucose Analysis Tool

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.)
12 Months
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.
Baseline, Month 12
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.
Baseline, Month 12
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.
Baseline, Month 12
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.
Baseline, Month 12
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.
12 Months
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.
Month 1, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Investigators

  • Study Director: Bettina Petersen, Roche Diagnostics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

February 1, 2010

Study Registration Dates

First Submitted

May 7, 2008

First Submitted That Met QC Criteria

May 7, 2008

First Posted (Estimate)

May 8, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2013

Last Update Submitted That Met QC Criteria

August 19, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RD000590
  • RDC-MI&A-01-2007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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