Diabetes, Diabetic Macular Edema, Diabetic Retinopathy
Conditions
Keywords
diabetes, diabetic macular edema, diabetic retinopathy, optical coherence tomography
Brief summary
The purpose of this protocol is to determine whether point of care optical coherence tomography (OCT) imaging combined with an OCT-guided retinal referral algorithm at primary diabetes care visits increases rates of retina specialist eye care for patients with diabetic macular edema. The hypothesis is that OCT imaging with an automated OCT-guided referral algorithm will enable identification of patients at risk for vision loss from diabetic macular edema and facilitate direct referral to retina specialists for more timely evaluation and treatment.
Interventions
DEVICEOCT imaging
Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
Sponsors
Genentech, Inc.
Juvenile Diabetes Research Foundation
Optovue
Joslin Diabetes Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Caregiver, Investigator)
Masking description
Primary diabetes care specialists masked to results of OCT intervention
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes mellitus as evidenced by: * Current regular use of insulin or oral anti-hyperglycemia agents for the treatment of diabetes OR * Documented diabetes by American Diabetes Association and/or World Health Organization criteria * Age greater than or equal to 18 years old * Diabetes duration of 10 more years OR last measured HbA1c of 10% or more * Able and willing to participate in study procedures and comply with study follow-up visits * Able to give informed consent for study participation * Not moving out of the study area during the 1 year follow-up period
Exclusion criteria
* Unable to cooperate with the OCT image acquisition procedure or other study procedures * Unable or unwilling to comply with the study follow-up visits * Unable or unwilling to sign form for release of retinal medical records
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Retina Care Referral for Patients With Diabetic Macular Edema | Baseline visit | Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Retinal Referral Rates for Patients With DME | Baseline visit | Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm |
| Rates of Retinal Treatment for Patients With DME | One month | Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment |
| Rates of Retinal Treatment Over 1 Year for Patients With DME | 9 months | Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OCT Imaging All study participants will undergo optical coherence tomography imaging and will be referred to a retina specialist for further standard care evaluation and management if they are identified as having diabetic macular edema or the scan quality is not sufficient to evaluate macular status.
OCT imaging: Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina. | 385 |
| Total | 385 |
Baseline characteristics
| Characteristic | OCT Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 91 Participants |
| Age, Categorical Between 18 and 65 years | 294 Participants |
| Age, Continuous | 54.8 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment United States | 385 Participants |
| Sex: Female, Male Female | 193 Participants |
| Sex: Female, Male Male | 192 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 385 |
| other Total, other adverse events | 0 / 385 |
| serious Total, serious adverse events | 0 / 385 |
Outcome results
Primary
Rates of Retina Care Referral for Patients With Diabetic Macular Edema
Percentage of participants who are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Time frame: Baseline visit
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retina Specialist Care | Rates of Retina Care Referral for Patients With Diabetic Macular Edema | 44 Participants |
Secondary
Rates of Retinal Treatment for Patients With DME
Percentage of participants are referred by OCT-guided algorithm who are confirmed to have vision threatening retinopathy at first visit with retina specialist after study enrollment
Time frame: One month
Population: This is the subgroup of participants who were referred for retinal care by the OCT guided referral algorithm
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retina Specialist Care | Rates of Retinal Treatment for Patients With DME | 14 Participants |
Secondary
Rates of Retinal Treatment Over 1 Year for Patients With DME
Percentage of participants who are referred by OCT guided algorithm to a retina specialist who receive treatment for DME over the course of 9 months follow-up by retina specialist
Time frame: 9 months
Population: This is the subgroup of participants who were referred for retina care by the OCT guided referral algorithm.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Retina Specialist Care | Rates of Retinal Treatment Over 1 Year for Patients With DME | 18 Participants |
Secondary
Retinal Referral Rates for Patients With DME
Count of eyes that are referred to a retina specialist for evaluation and management of DME after OCT imaging and OCT-guided referral algorithm
Time frame: Baseline visit
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Retina Specialist Care | Retinal Referral Rates for Patients With DME | 59 eyes |