The purpose of this study is to evaluate the combined effects of diabetes self-management education (DSME) and nutritional supplementation on visual function and retinopathy incidence \& progression in patients with type 1 diabetes, type 2 diabetes and pre-diabetes.
This will be an investigator initiated, multi-center, double-blinded prospective study of 150-200 adult subjects with established prediabetes or diabetes. Subjects will be identified and enrolled with informed consent from 4 private optometric practices in the Southeastern and Central United States. Enrollment in the diabetes self-management education (DSME) component of the study will be requisite for participation in the trial and DSME will be provided by designated study investigators trained to deliver AADE7™ curricula in individual and/or group settings. Subjects will be randomized to DSME in isolation or in combination with one of two nutritional supplementation arms of the trial (described below). Supplements will be provided by ZeaVision, LLC of Chesterfield, MO. Subjects will undergo initial KNOC out Diabetes™ visits with assessment of current diabetes status and provision of DSME curriculum, with follow-up DSME assessments and goal reporting at 1-month, 3-months, 6-months, 9-months and 12-months. Subjects will receive comprehensive dilated eye examinations with additional tests of visual function (described below) at baseline, 3 months, 6 months and 12 months. KNOC out Diabetes™ is a 10-session, diabetes self-management education program designed to improve patient behaviors and blood glucose over a 12 month period and delivered by doctors of optometry. KNOC is an acronym for "Knowledge, Nutrition, Ocular Health and Coaching. The program features weekly internet learning, experiential learning focused on solving specific, individualized patient diabetes management problems, weekly phone coaching Test nutritional supplements will be: (1) a multi-component formula (EyePromise DVS™) (2) a high-potency marine-sourced omega-3 polyunsaturated fatty acid supplement (EyePromise EZTears™).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
150
Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements
Advantage Vision Center
Charlotte, North Carolina, United States
RECRUITINGfull-field flicker electroretinogram (ffERG) implicit time (milliseconds)
The Flicker ERG will be recorded using a commercially available system, (RetEval, Konan Medical, Irvine, CA). The test will be performed in an illuminated room, free of visual and audible distractions. Subjects will be instructed to fixate on a target using the fellow eye (eye not been tested) and results will be consecutively recorded from both eyes by means of skin electrodes
Time frame: Change from baseline to 12 months
full-field flicker electroretinogram (ffERG) amplitude (microvolts)
The Flicker ERG will be recorded using a commercially available system, (RetEval, Konan Medical, Irvine, CA). The test will be performed in an illuminated room, free of visual and audible distractions. Subjects will be instructed to fixate on a target using the fellow eye (eye not been tested) and results will be consecutively recorded from both eyes by means of skin electrodes
Time frame: Change from baseline to 12 months
glycosylated hemoglobin (HbA1c) percentage
HbA1c is a measure of mean blood glucose over a 8-12 week duration and requires a simple fingerstick blood draw.
Time frame: Change from baseline to 12 months
Diabetic Retinopathy Severity using International Diabetic Retinopathy Severity Scale (DRSS)
Photographic analysis of the retinal fundus will be conducted to assess severity at baseline and 12 months according to the DRSS: No retinopathy, mild non-proliferative retinopathy, moderate non-proliferative retinopathy, severe non-proliferative retinopathy, proliferative retinopathy
Time frame: Change comparing Baseline to 12 months
body mass index (BMI) Kg/meter(squared)
patient height and weight will be assessed to calculate BMI at baseline and 12 months
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Time frame: Change comparing Baseline to 12 months
Ocular Surface Disease Index Score (OSDI)
A validated questionnaire regarding symptoms of ocular dryness rated on a scale of 0 to 100, with higher scores representing more severe symptoms of dry eye
Time frame: Change comparing Baseline score and score at 12 months
Color Contrast Threshold Sensitivity (minimal percentage contrast detection for each pre-specified wavelength)
Extended color vision analysis yielding quantitative measurement of short, medium and long wavelength cone photoreceptor function will be obtained by having subjects ascertain the direction of a Landolt C target (up, down, left, right) of decreasing contrast, using a commercially available color vision testing device (ColorDx Chromatic Contrast Threshold testing, Konan Medical, Irvine, CA);
Time frame: Change comparing Baseline and 12 months