NCT05074342

Brief Summary

Early detection through regular diabetic retinopathy screening (DRS) is an effective method of preventing vision loss by enabling earlier intervention and timely treatment. It is recommended that all people with diabetes receive regular DRS, either annually or bi-annually. Current DRS practice in Canada, however, falls remarkably short of recommended DRS rates resulting in preventable vision loss. In this project the investigators use population health-based approach to diabetes care. Linked provincial administrative data will be leveraged to consistently identify all those that have not had DRS in 425 days with the goal to improve outcomes, equity and potentially reduce the cost of care delivery.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 1, 2025

Status Verified

March 1, 2025

Enrollment Period

3.9 years

First QC Date

September 29, 2021

Last Update Submit

March 26, 2025

Conditions

Keywords

Administrative dataScreening

Outcome Measures

Primary Outcomes (1)

  • The provision of a DRS status list to primary health care settings will increase the rate of annual DR screening in patients with type 1 or type 2 diabetes who have attended the centres.

    To increase the screening rate of individuals who are at risk for DR within the primary care settings, and to refer to treatment those at risk of vision loss.

    425 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with type 1 or type 2 diabetes, who have attended a primary healthcare setting at CHCs, and through the use of provincial administrative data is identified as the patient who has not had their eyes screened within the past 425 days.

You may qualify if:

  • At least 18 years of age
  • Type 1 or type 2 diabetes as determined through linked provincial healthcare administrative datasets or primary care data using algorithms similar to provincial methods.
  • Attended the primary health care setting, with at least 1 visit to the centre within the past 10 years

You may not qualify if:

  • \. Individuals identified as having received DRS (in the previous 425 days) by an ophthalmologist and/or optometrist or tele-ophthalmology/Tele-Retina.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontarioa, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, FRCSC Principal Investigator -Clinical Lead

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 12, 2021

Study Start

February 1, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 1, 2025

Record last verified: 2025-03

Locations