Pediatric Type 1 Diabetes and Retinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02691312
Recruitment Status : Completed
First Posted : February 25, 2016
Last Update Posted : January 4, 2019
Information provided by (Responsible Party):
University of Florida

Brief Summary:

Diabetic retinopathy (DR) causes more new cases of blindness among young adults than any other disease. More than 90% of individuals with type 1 diabetes (T1D) will have some form of DR by 20 years after their diagnosis. DR is associated with long-term hyperglycemia and blood glucose variability, which induces vascular endothelial dysfunction and destruction in the retina, eventual retinal ischemia, and in the end, widespread neovascularization of the retina and optic disk. When these fragile vessels bleed, they can cause vitreous hemorrhage and loss of vision. Eventually the friable vessels fibrose and can result in retinal detachment or further retinal ischemia.

Major risk factors for the development of diabetic retinopathy are time since diagnosis, age at diagnosis, and severity of hyperglycemia. Retinopathy most commonly occurs at least three years after diagnosis and most cases are diagnosed more than five years after the onset of T1D. Current guidelines from the American Diabetes Association (ADA) and American Academy of Ophthalmology (AAO) recommend that patients with T1D undergo an initial comprehensive dilated fundoscopic evaluation once the individual has had diabetes for 3-5 years and has either reached puberty or 10 years of age, whichever is earlier. These patients should receive a yearly exam thereafter, or every two years based upon the recommendation of an eye care professional. However, the prevalence of retinopathy in children is unknown and adherence to these guidelines, especially in youth, has proven difficult. Thus, it is important to make these guidelines more evidence based, as retinopathy is often asymptomatic until vision loss occurs. The first step in this process is the determination of the prevalence of retinopathy in a general population of youth with diabetes. This should be followed by determining which children are most at risk, so the guidelines can provide realistic and pertinent guidance to practitioners.

Condition or disease Intervention/treatment
Diabetic Retinopathy Device: Digital Retinography System

Detailed Description:

The study will be a prospective cross-sectional study of pediatric participants who have had T1D for one year or more. Pediatric participants will be recruited at the Florida Diabetes Camps, the Children With Diabetes Friends for Life Orlando Conference, and the University of Florida Pediatric Endocrinology Clinics. The participants will be tested for diabetic retinopathy using a Digital Retinography System (DRS) ( The DRS is a portable non-mydriatic fundus camera in which the participants places their chins on the chin-rest and the device takes a digital image of their eyes for evaluation by an ophthalmologist remotely. These photographs will be examined by an ophthalmologist (specializing in retinal disease) to assess for evidence of diabetic retinopathy.

As part of their informed consent, all participants will be asked as part of their informed consent to allow study staff to contact their local ophthalmologist for their eye exam results following a positive or inconclusive portable retinal screening. Participants or their guardians will also be asked to fill out a study questionnaire during the screening visit. When available, the study subjects' medical record will be accessed to identify their BMI, time since T1D diagnosis, previous hemoglobin A1c (HbA1c) levels over the last 12 months (or longer if available), insulin regimen, Tanner staging, serum lipids, urine microalbumin:creatinine, presence or absence of hypertension, and previous diagnoses of diabetic retinopathy, microalbuminuria, hyperlipidemia or hypertension.

Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Prevalence and Characterization of Retinopathy in Children With Type 1 Diabetes Using a Non-mydriatic Fundus Camera
Actual Study Start Date : July 2016
Actual Primary Completion Date : January 20, 2018
Actual Study Completion Date : December 27, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Type 1 diabetes (T1D)
Pediatric patients with type 1 diabetes (T1D) will have an eye exam using the Digital Retinography System (DRS) taking non-mydriatic fundus images. If the test is positive or inconclusive, subjects will be notified and referred to an ophthalmologist for a dilated retinal exam. A chart review and questionnaire will be completed to evaluate for risk factors predisposing subjects to diabetic retinopathy.
Device: Digital Retinography System
The DRS is a portable non-mydriatic fundus camera in which children place their chin on a chin rest and the camera, after auto-focusing, takes photographs of their retinas. These photographs will be examined by an ophthalmologist (specializing in retinal disease) to assess for evidence of diabetic retinopathy.
Other Names:
  • CenterVue Digital Retinography System
  • DRS

Primary Outcome Measures :
  1. Number of participants diagnosed with retinopathy [ Time Frame: Baseline ]
    Using a CenterVue Digital Retinography System (DRS) the participants with a positive or inconclusive screen will be called with the results and recommended to undergo a dilated eye examination by a skilled ophthalmologist. The results from the ophthalmologist will be compared to the DRS results.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   9 Years to 26 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
People with type 1 diabetes and a duration of 1 year or greater will be asked to participate. Potential participants will be approached at the Pediatric Endocrinology clinic visits, Florida Diabetes Camp and the Children With Diabetes annual meeting.

Inclusion Criteria:

  • Diagnosis of type 1 diabetes
  • Duration of diabetes 1 year or greater

Exclusion Criteria:

  • Diabetes less than 1 year duration
  • Age < 9 years and >26 years of age

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02691312

United States, Florida
Florida Diabetes Camps
De Leon Springs, Florida, United States, 32130
Pediatrics Endocrinology/Diabetes at UF Health Medical Plaza and Children's Medical Services Building
Gainesville, Florida, United States, 32611
Children With Diabetes Friends For Life Conference
Orlando, Florida, United States, 32821
Sponsors and Collaborators
University of Florida
Principal Investigator: Janet H Silverstein, MD University of Florida

Study Data/Documents: FDA 501(k)  This link exits the site

Responsible Party: University of Florida Identifier: NCT02691312     History of Changes
Other Study ID Numbers: IRB201501086
First Posted: February 25, 2016    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
type 1 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Diabetes Mellitus
Diabetes Complications
Retinal Diseases
Diabetic Retinopathy
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases