Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy

Diabetes Mellitus Clinical Trial

Official title:

KNOC OUT DIABETES: Combined Effects of Diabetes Self-Management Education and Nutritional Supplementation on Visual Function and Retinopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04120077
• Other study ID #: KNOC-001
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: April 2021
• Source: ZeaVision, LLC
• Contact: Paula R. Newsome, OD
• Phone: (704) 375-3935
• Email: paulanews[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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™).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2022
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• diagnosed prediabetes, type 1 or type 2 diabetes

• no diabetic retinopathy (DR), mild DR or moderate DR without center-involved macular edema

• age > 18 years

• ability to give informed consent

• best corrected visual acuity > 20/30 in each eye.

Exclusion Criteria:

• no formal diagnosis of prediabetes or diabetes

• age < 18 years

• inability to give informed consent

• best corrected visual acuity < 20/30 in either eye

• center-involved DME by spectral domain optical coherence tomography * evidence of severe non-proliferative or proliferative diabetic retinopathy

• evidence of other serious ocular disease (age-related macular degeneration, glaucoma, significant media opacity)

• history of intraocular surgery, including macular or panretinal photocoagulation or prior intra-ocular injection of anti-Vascular endothelial growth factor (anti-VEGF) drugs (except uncomplicated cataract or keratorefractive surgery more than 6 months prior to enrollment)

• pregnant and nursing women

• known sensitivity to any of the supplement ingredients.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Dietary Supplement:
• EyePromise DVS, EyePromise DVS plus EyePromise EZTears
Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements

Locations

Country	Name	City	State
United States	Advantage Vision Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
ZeaVision, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Chous AP, Richer SP, Gerson JD, Kowluru RA. The Diabetes Visual Function Supplement Study (DiVFuSS). Br J Ophthalmol. 2016 Feb;100(2):227-34. doi: 10.1136/bjophthalmol-2014-306534. Epub 2015 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Macular pigment optical density (MPOD) in relative density units	measurement of macular pigment optical density (MPOD) using heterochromic flicker photometry with a commercially available device (QuantifEye, ZeaVision, LLC, Chesterfield, MO). Subjects are asked to respond when they detect a flickering stimulus .	Change comparing Baseline and 12 months
Primary	full-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	Change from baseline to 12 months
Primary	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	Change from baseline to 12 months
Primary	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.	Change from baseline to 12 months
Secondary	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	Change comparing Baseline to 12 months
Secondary	body mass index (BMI) Kg/meter(squared)	patient height and weight will be assessed to calculate BMI at baseline and 12 months	Change comparing Baseline to 12 months
Secondary	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	Change comparing Baseline score and score at 12 months
Secondary	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);	Change comparing Baseline and 12 months