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DiabetesPhase 3NCT01323348

Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

A Phase 3 study testing Diabetes Education in people with Diabetes and Diabetic Retinopathy, run by Jaeb Center for Health Research at 34 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

The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes, Diabetic Retinopathy
What is being tested?
Diabetes Education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,875 participants
Where
34 sitesUnited States
Study dates
Oct 2011to Jan 2015
Phase
Phase 3
Are there results?
None posted in the registry

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

Who may be able to join

  • Age >18 years
  • Diagnosis of type 1 or type 2 diabetes mellitus
  • Any one of the following will be considered to be sufficient evidence that diabetes is present:
  • Current regular use of insulin for the treatment of diabetes
  • Current regular use of oral anti-hyperglycemia agents for the treatment of diabetes
  • Documented diabetes by American Diabetes Associate and/or World Health Organization criteria
Show all 10Show fewer
  • Routine care follow-up is yearly or more frequent
  • English or Spanish speaking
  • Able and willing to provide informed consent
  • Willing to complete 24 months of study follow up

Who cannot join

  • Known HbA1c (patient report or available records at time of enrollment) <7.5% within prior 6 months
  • Active participation in any type of intervention study
  • Initiation of insulin treatment within 3 months from date of enrollment
  • Prior complete panretinal photocoagulation or prior diabetes-related vitrectomy in both eyes
  • Advanced visual acuity loss in both eyes which prohibits ability to read study materials (tested as needed with reading test using materials in appropriate size script)
  • Significant renal disease including use of erythropoietin (Procrit, Epogen, Eprex) or a history of chronic renal failure requiring dialysis or kidney transplant

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Retina Research Center

    Austin, Texas, 78705

  • Elman Retina Group, P.A.

    Baltimore, Maryland, 21237

  • Wilmer Ophthalmological Institute at Johns Hopkins

    Baltimore, Maryland, 21287-9277

  • Retina Associates of Cleveland, Inc.

    Beachwood, Ohio, 44122

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • University of North Carolina, Dept of Ophthalmology

    Chapel Hill, North Carolina, 27599-7040

  • Charlotte Eye, Ear, Nose and Throat Assoc., PA

    Charlotte, North Carolina, 28210

  • University of Illinois at Chicago Medical Center

    Chicago, Illinois, 60612

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Palmetto Retina Center

    Columbia, South Carolina, 29169

  • Carolina Retina Center

    Columbia, South Carolina, 29223

  • Henry Ford Health System, Dept of Ophthalmology and Eye Care Services

    Detroit, Michigan, 48202

  • Retina Vitreous Consultants

    Fort Lauderdale, Florida, 33334

  • Penn State College of Medicine

    Hershey, Pennsylvania, 17033

  • Retina and Vitreous of Texas

    Houston, Texas, 77025

  • Raj K. Maturi, M.D., P.C.

    Indianapolis, Indiana, 46280

  • University of Florida College of Med., Department of Ophthalmology

    Jacksonville, Florida, 32209

  • Central Florida Retina Institute

    Lakeland, Florida, 33805

  • Retina and Vitreous Associates of Kentucky

    Lexington, Kentucky, 40509-1802

  • Loma Linda University Health Care, Dept. of Ophthalmology

    Loma Linda, California, 92354

  • University of Wisconsin-Madison, Dept of Ophthalmology/Retina Service

    Madison, Wisconsin, 53705

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Retina Center, PA

    Minneapolis, Minnesota, 55404

  • John-Kenyon American Eye Institute

    New Albany, Indiana, 47150

  • The New York Eye and Ear Infirmary/Faculty Eye Practice

    New York, New York, 10003

  • Paducah Retinal Center

    Paducah, Kentucky, 42001

  • University of Pennsylvania Scheie Eye Institute

    Philadelphia, Pennsylvania, 19104

  • Casey Eye Institute

    Portland, Oregon, 97239

  • Retinal Consultants of San Antonio

    San Antonio, Texas, 78240

  • California Retina Consultants

    Santa Barbara, California, 93103

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Barnes Retina Institute

    St Louis, Missouri, 63110

  • Wake Forest University Eye Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

The purpose of this study is to assess whether glycemic control (assessed with HbA1c measurement) in individuals with type 1 or type 2 diabetes can be improved with a point-of-care measurement of HbA1c in the ophthalmologist's office combined with a personalized risk assessment for diabetic retinopathy and other complications of diabetes.

Read the detailed description

Although each patient with diabetes should be receiving diabetic education as part of their on-going routine medical care, it is likely that such education is delivered with different details and intensity. Motivating a patient with diabetes to become involved in his or her care is of primary importance in achieving better systemic control.

Ocular complications from diabetes remain the most common cause of blindness among American adults 20-74 years of age. A recent survey reported that loss of vision is the most feared of all diabetic complications. Thus, it is possible that an educational intervention at an ophthalmology office may have additional impact beyond the current standard of diabetes education at a primary care or diabetologist/endocrinologist office alone. This study will determine whether diabetes education in the ophthalmology office (which includes same-visit feedback of HbA1c levels, combined with standardized education regarding same-visit blood pressure, retinopathy status and overall diabetes education) can improve subsequent HbA1c as compared with current standard care in an ophthalmology office.

Materials used in this research setting must be applicable for use in ophthalmology practices. Therefore, the materials and procedures for this study have been developed with the goal of easy translation to this audience.

Being tested
Diabetes Education
Keywords
Diabetes, Diabetes Education, Diabetic Retinopathy, HbA1c
Medical subject headings
Diabetes Mellitus, Diabetic Retinopathy

What participants receive

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

  • Diabetes EducationBehavioural

    The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks):

    • Measurement of HbA1c in office with immediate feedback
    • Measurement of blood pressure with immediate feedback
    • Assessment of retinopathy risk with immediate feedback
    • Personalized risk assessment reports based on current HbA1c
    • Brief assessment of patient understanding of key issues with immediate feedback
    • Supplemental diabetes management educational materials (provided at baseline only)
    • Feedback to primary care provider
    • Email reminder to study participants with email access of individualized risk assessment findings
Study groups in NCT01323348
Study groupRoleWhat they receive
Diabetes Educational InterventionExperimentalStudy participants in the intervention group will receive a diabetes management educational intervention at baseline and at follow-up visits. For those on an annual follow-up schedule, educational intervention will take place at baseline and 12 months. For those whose standard care involves more frequent, than annual, visits the educational intervention will take place no more than once every 12 weeks.
Receives: Behavioral: Diabetes Education
Standard CareNo interventionUsual care

What is being measured

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

  1. Change in HbA1c

    Mean change in HbA1c from baseline to 12 months in intervention versus control for study participants being seen for standard care more frequently than every 12 months

    Measured: 12 Months

Secondary outcomes (3)

  1. Diabetes Care Knowledge

    At baseline and at annual visits, study participants in all treatment groups will complete self-assessment questionnaires in order to assess perception of emotional problems frequently reported in type 1 and type 2 diabetes and to measure perceived adherence to diabetes self-care recommendations. At the annual visits, summary statistics will be presented on the responses as appropriate to the distribution and the treatment groups will be compared controlling for baseline responses.

    Measured: 12 Months/24 Months

  2. Blood Pressure

    For analyses, systolic and diastolic blood pressure will be converted to an overall mean blood pressure according to the following calculation: diastolic blood pressure + 1/3 (systolic blood pressure - diastolic blood pressure). Blood pressure will be analyzed as the change in the weighted mean blood pressure from baseline to 12 months adjusted for the baseline weighted mean blood pressure. Treatment group comparisons will be made using ANCOVA to adjust for the baseline blood pressure, with GEE to adjust for the correlation within subjects of the same cluster.

    Measured: 12 Months/24 Months

  3. Body Mass Index

    Treatment group comparisons will be made using analysis of covariance (ANCOVA) to adjust for the baseline HbA1c, with generalized estimating equations (GEE) to adjust for the correlation within subjects of the same randomization cluster.

    Measured: 12 Months/24 Months

Timeline

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

  1. First posted25 Mar 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionJul 2014
  4. Study completionJan 2015

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,875 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01323348
Sponsor's protocol ID
DRCR.net-Protocol M
Status last verified
Aug 2016
First submitted
24 Mar 2011
Last updated
26 Aug 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Aiello LP, Ayala AR, Antoszyk AN, Arnold-Bush B, Baker C, Bressler NM, Elman MJ, Glassman AR, Jampol LM, Melia M, Nielsen J, Wolpert HA; Diabetic Retinopathy Clinical Research Network. Assessing the Effect of Personalized Diabetes Risk Assessments During Ophthalmologic Visits on Glycemic Control: A Randomized Clinical Trial. JAMA Ophthalmol. 2015 Aug;133(8):888-96. doi: 10.1001/jamaophthalmol.2015.1312.

    PubMed 25996273

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Diabetes Education in people with Diabetes and Diabetic Retinopathy, run by Jaeb Center for Health Research at 34 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 10 inclusion and 6 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 26 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 in HbA1c (time frame: 12 Months). 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 NCT01323348, which also lists 1 linked publication.

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 26 Aug 2016.

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