Type 1 diabetes (T1D) risk testing

www.jdrf.org/t1d-resources

Several studies have established that screening for risk of type 1 diabetes will:

1. Reduce the chance of diabetic ketoacidosis (DKA), a potentially deadly condition. DKA renders the blood acidic, potentially causing organ damage. In rare cases, some people with DKA may enter into a coma that they may not recover from.
   Reference: www.ncbi.nlm.nih.gov/pmc/articles/PMC3198296
2. Improve a person’s metabolic control. If a person discovers that they have type 1 diabetes as early as possible they can have an enhanced opportunity to control their blood sugar better and thereby prevent or reduce damage to multiple body organs including the kidneys, heart, blood vessels and brain.
   Reference: www.ncbi.nlm.nih.gov/pmc/articles/PMC4190091
3. Support vital scientific research and trials for treatments that can delay or prevent T1D.
   Reference: www.nejm.org/doi/full/10.1056/NEJMoa1902226

The overall risk for type 1 diabetes in the general population is low. The absence of autoantibodies means that a person has a very low risk of developing type 1 diabetes at the time of testing. However, this does not exclude the possibility that an individual will develop autoantibodies later in childhood or as an adult. While the best testing frequency policy has not yet been established across the medical community, annual testing should be considered.

An individual's overall risk is influenced by many factors, including environmental influences, a history of enterovirus infections and the presence of certain genetic markers.

Currently, there are no approved therapies to delay or prevent T1D. However, several promising therapies are in clinical testing and one, Teplizumab, is being considered by the FDA.

After logging in, click the My Account button on the left upper side of the screen. Select Profile and input your changes on the page. Click Save on the middle right side of the screen.

As the legal adult guardian, you must create the Parent account using your own personal information and then agree to our terms and conditions, which includes consenting on behalf of your minor children. Multiple kits can then be ordered from your account and all results tracked for each recipient from your Parent account.

If you are the legal guardian of your grandchildren, you can create the Parent account using your own personal information and then agree to our terms and conditions, which includes consenting on behalf of your minor grandchildren. Multiple kits can then be ordered from your account and all results tracked for each recipient from your Parent account.

If you are not the legal guardian of your grandchildren, their parent or legal guardian will have to create the account and place orders for them.

Yes, an adult child should register an account in their own name.

Please email clinical@enablebiosciences.com to request cancellation of an order and a refund. Please keep in mind that you may still receive a kit in the mail if it is already on its way.

All information is handled in accordance with the Terms and Condition, Privacy Policy and Authorization for Use of Personal Health Information (PHI) listed on the site. A copy of these documents can be found at www.enablebiosciences.com/legal. A primary use of information gathered is to assist in advancing and accelerating both basic science and clinical research towards a cure for type 1 diabetes. You can opt out of sharing all or some of your information at any time by emailing us at privacy@enablebiosciences.com.

Yes we can! Please email us at clinical@enablebiosciences.com and we will forward your inquiry to our business development team.

Yes. We will follow up with everyone who has created an account but not ordered a test.

The cost, including shipping and handling, is $55 plus tax. JDRF is also providing an opt-in subsidy if you require financial assistance. If you choose this option, the cost of the subsidized test is reduced to only $10 plus tax. Once you click through from the account creation page to the order page, you will have the opportunity to choose which payment pathway is best for your family.

We use a payments processing company called Stripe to process our payments. They accept all major credit and debit cards including Visa, Mastercard, American Express, Discover, and many more.

Yes, you can pay for the test using your has or FSA.

Most insurers do not currently cover screening for type 1 diabetes in the absence of signs or symptoms of type 1 diabetes even though our ADAP test is the identical one used for diagnosing it. Some insurers may decide to cover it for screening and we and others will be encouraging more to do this. Individuals will need to contact their insurance company to see if they will cover the test for screening or you can submit the receipt you receive after ordering the test as a claim to your insurance company to see if they will reimburse you for it.

This test can be currently covered by insurance if designated by a doctor that it is being done for diagnostic purposes.

If an insurer will cover the test for screening and there is a need for one of our physicians/clinicians to approve the order, we can have one of our authorized clinicians do this for you. Please email us at clinical@enablebiosciences.com. We will set up a secure email communication to guide you as to how to complete your order in this regard.

Yes. You should create an account, but not order your kit yet. If you decide to pay out of pocket, the cost of the test is only $55 plus tax, or $10 plus tax if you are not able to afford that amount and utilize the JDRF subsidy option.

Sales tax on ecommerce products originating in the State of California have the California State tax levied, regardless of their destination.

Enable Biosciences Inc. uses Antibody Detection by Agglutination PCR (ADAP), a proprietary and highly validated immunoassay technology. Each sample is analyzed for three antibodies (GAD65, IA2, and INS) at our lab in South San Francisco using a custom Enable-Hamilton Assay-Ready workstation and a Bio-Rad CFX Quantitative PCR analyzer. This original screen is set at three standard deviations above the average as determined through the analysis of healthy negative controls. The lab and methodology are certified under the Federal and State CLIA lab law.

The test is appropriate for children that are older than 6 months.

However, the lancet in the kit is not intended for infants less than one year old. We are happy to work with you and your physician to have the sample collected at their office with an age-appropriate lancet and sent to our lab for analysis. Please contact us directly at clinical@enablebiosciences.com for more information.

The performance of the test has been extensively validated using thousands of clinical samples across diverse patient types and cohorts. Its performance has been shown to be equivalent or better than gold standard testing methods for type 1 diabetes antibodies that require large volumes of blood to be drawn by a phlebotomist.

No. Pregnancy does not affect the results.

Insurance discrimination based on pre-existing conditions is illegal. However, you can also choose to exclude results from any external use per the Terms and Conditions on the site. Just send us an email at privacy@enablebiosciences.com.