Effect of Diabetes Education During Retinal Ophthalmology Visits on Diabetes Control

NCT01323348 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1875

Last updated 2016-08-26

No results posted yet for this study

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 complications of diabetes.

Conditions

Interventions

BEHAVIORAL

Diabetes Education

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

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH
  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Lloyd P Aiello, M.D. · Joslin Diabetes Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2014-07-31
Completion
2015-01-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01323348 on ClinicalTrials.gov