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Diabetes Mellitus, Type 2NCT00674986

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

A study testing Accu-Chek 360° View Blood Glucose Analysis Tool and Accu-Chek Aviva Glucose Meter in people with Diabetes Mellitus, Type 2, run by Hoffmann-La Roche at 29 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 25 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Accu-Chek 360° View Blood Glucose Analysis Tool and Accu-Chek Aviva Glucose Meter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
522 participants
Where
29 sitesUnited States
Study dates
Mar 2008to Feb 2010
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Study site

    Abingdon, Virginia, VA 24210

  • Study site

    Atlanta, Georgia, GA 30312

  • Study site

    Atlanta, Georgia, GA 30342

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Chicago, Illinois, 60616

  • Study site

    Chipley, Florida, 32428

  • Study site

    Crossville, Tennessee, TN 38555

  • Study site

    Cuyahoga Falls, Ohio, OH 44223

  • Study site

    Fishers, Indiana, IN 46038

  • Study site

    Flint, Michigan, 48504

  • Study site

    Hickory, North Carolina, NC 28602

  • Study site

    High Point, South Carolina, SC 29720

  • Study site

    Indianapolis, Indiana, 46256

  • Study site

    Indianapolis, Indiana, In 46217

  • Study site

    Lancaster, South Carolina, SC 29720

  • Study site

    Marianna, Florida, 32446

  • Study site

    Mobile, Alabama, AL 36608

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    O'Fallon, Illinois, IL 62269

  • Study site

    Pell City, Alabama, AL 35125

  • Study site

    Pembroke Pines, Florida, FL 33028

  • Study site

    Pottstown, Pennsylvania, 19468

  • Study site

    Pottstown, Pennsylvania, PA 19464

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Tampa, Florida, 33613

  • Study site

    Tampa, Florida, 33624

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Zanesville, Ohio, OH 43701

Other trials in United States

About this study

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.

Being tested
Accu-Chek 360° View Blood Glucose Analysis Tool, Accu-Chek Aviva Glucose Meter
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Accu-Chek 360° View Blood Glucose Analysis ToolDevice

  • Accu-Chek Aviva Glucose MeterDevice

Study groups in NCT00674986
Study groupRoleWhat they receive
Active Control Group (ACG)OtherParticipants 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.
Receives: Device: Accu-Chek Aviva Glucose Meter
Structured Testing Group (STG)ExperimentalParticipants 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.
Receives: Device: Accu-Chek 360° View Blood Glucose Analysis Tool; Device: Accu-Chek Aviva Glucose Meter

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, Month 12

Secondary outcomes (7)

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

    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.)

    Measured: 12 Months

  2. Change From Baseline in Depression Severity (PHQ-8)

    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.

    Measured: Baseline, Month 12

  3. Change From Baseline in the Diabetes Distress Scale (DDS)

    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.

    Measured: Baseline, Month 12

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

    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.

    Measured: Baseline, Month 12

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

    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.

    Measured: Baseline, Month 12

  6. Mean Number of Subject Monitored Blood Glucose (SMBG) Tests Per Day

    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.

    Measured: 12 Months

  7. Glycemic Variability Pre and Post-Prandial Excursions at Each Meal

    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.

    Measured: Month 1, Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 May 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionFeb 2010
  4. Study completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
522 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00674986
Sponsor's protocol ID
RD000590
Other IDs
RDC-MI&A-01-2007
Status last verified
Aug 2013
First submitted
7 May 2008
Last updated
21 Oct 2013

Publications

  • 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.

    PubMed 21916532

  • 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.

    PubMed 21270183

  • 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.

    PubMed 20482765

Questions about this trial

What is this clinical trial studying?

A study testing Accu-Chek 360° View Blood Glucose Analysis Tool and Accu-Chek Aviva Glucose Meter in people with Diabetes Mellitus, Type 2, run by Hoffmann-La Roche at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Hemoglobin A1c (HbA1c) at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00674986, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2013.

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