Informed Consent for Type 1 Diabetes Screening

The purpose of this Screening Test is to help identify early (presymptomatic) stages of Type 1 Diabetes (T1D). Research shows that T1D progresses through stages before symptoms appear:

• Stage 1: Two or more T1D-related autoantibodies, with normal blood sugar
• Stage 2: Multiple autoantibodies plus early sign(s) of dysglycemia
• Stage 3: Symptomatic diabetes requiring insulin (clinical diagnosis)

This Test may include:

• Measurement of T1D-related autoantibodies
• Genetic analysis to compute a Type 1 Diabetes polygenic risk score (PRS)
• Collection of personal and family health information

The purpose of this Screening Test is risk assessment, not diagnosis.

You will collect a biological sample at home (saliva, dried blood spot, or both) and return it to our CLIA-certified laboratory partners using prepaid materials.

Your sample may be used for:

• Autoantibody testing (e.g., GAD65, IA-2, ZnT8, IAA as applicable)
• Genetic analysis to compute a polygenic risk score
• Internal quality-control (QC) testing
• Repeat or confirmatory testing if needed

Results are delivered through your secure T1D Scout account and may include:

• Autoantibody status (Detected, Not Detected, or Indeterminate)
• Genetic risk classification
• Combined risk interpretation
• Recommendations for follow-up with a healthcare provider

• A “Detected” or “High Risk” result is not a diagnosis of Stage 3 diabetes.
• A “Not Detected” or “Low Risk” result does not guarantee the participant will never develop T1D.

All laboratory tests may produce:

• False positives (risk detected when none exists), and
• False negatives (missing existing risk).

A sample may fail due to:

• Insufficient collection
• Contamination
• Postal delays
• Degradation during transit

If the sample fails, you may be asked to submit a new sample.

Learning that a child may be at increased risk for a lifelong autoimmune condition can cause:

• Anxiety or worry
• Family stress or conflict
• Difficulty interpreting risk

T1D Scout is not responsible for emotional distress associated with learning screening results, and strongly encourages consultation with a pediatric endocrinologist.

T1D Scout does not provide medical diagnosis, treatment, or emergency services.
Screening results must be discussed with a licensed healthcare professional.

Potential benefits include:

• Early identification of elevated T1D risk
• Opportunity to engage healthcare providers earlier
• Access to confirmatory testing and monitoring
• Awareness of risk for other autoimmune conditions
• Qualifying for research studies or preventive therapies (e.g., Tzield)

Benefits are not guaranteed.

Your privacy is extremely important to us. More detail is available in our Privacy Policy, but key points include:

We collect Personal Information, health information, and biological data to:

• Process your sample
• Generate and deliver screening results
• Ensure laboratory and operational accuracy
• Provide product support

By agreeing to this Consent, you grant T1D Scout a perpetual, irrevocable, worldwide, royalty-free license to:

• De-identify your data using HIPAA “Safe Harbor” standards
• Use de-identified data for internal research
• Improve predictive algorithms (including PRS models)
• Publish scientific findings using aggregate or de-identified data only
• Share de-identified data with qualified research partners

You will not receive financial compensation for discoveries, publications, or commercial products resulting from such research.

No identifiable information will ever be disclosed for research without additional explicit consent.

We protect your information using:

• AES-256 encrypted data storage
• TLS 1.3 encrypted transmission
• HIPAA-equivalent administrative and technical safeguards
• Limited, role-based access controls
• Secure laboratory data pipelines

Identifiable information is only shared with:

• CLIA-certified laboratory partners
• Service providers essential for kit shipping, payment processing, or data storage
• Healthcare providers you explicitly request to receive your results
• Regulators or law enforcement when required by law

We never sell identifiable health or genetic information.

If genetic analysis is part of this Test:

• Under GINA, U.S. health insurers and employers are prohibited from requesting or using genetic information for coverage or employment decisions.
• GINA does not apply to life insurance, disability insurance, or long-term care insurance. These insurers may legally request genetic information.

Participation is voluntary. You may withdraw at any time by contacting info@t1dscout.com.

However:

• Sample destruction may not be possible once testing begins
• De-identified data already used in research cannot be withdrawn
• CLIA-regulated medical records (e.g., test results) must be retained for legally required durations

Withdrawal does not affect the validity of research already conducted.

T1D Scout provides:

• Access to your screening results
• Educational materials and resources
• Recommendations for discussing results with your healthcare provider
• Optional referral information for pediatric endocrinology groups

T1D Scout does not:

• Provide diagnosis or treatment
• Interpret laboratory findings beyond general guidance
• Offer medical advice or emergency care
• Monitor your child’s progression over time unless part of a separate, consented program

You are responsible for seeking all follow-up medical care.

The Screening Test may or may not be covered by insurance.
You are responsible for any applicable fees.

T1D Scout does not bill insurance providers unless explicitly stated.

Alternatives include:

• Discussing T1D risk with a pediatrician
  
• Testing through another laboratory
• Not undergoing screening

There are no penalties for choosing not to participate.

By providing consent for a minor, you confirm that you:

• Are the child’s parent or legal guardian
  
• Have legal authority to consent to medical screening
• Understand and accept all risks and limitations
• Will share results responsibly with the child when developmentally appropriate
• Will ensure appropriate medical follow-up occurs
• Understand that this screening is not a diagnosis

If you have questions about the Screening Test, please contact:

T1D Scout Screening Service
Email: info@t1dscout.com

For urgent medical questions, contact your healthcare provider or local emergency services. T1D Scout cannot respond to medical emergencies.

By checking the consent box or signing electronically, you acknowledge and agree that:

• You have read and understood this Informed Consent
  
• You understand the risks, benefits, and limitations
• You agree to allow processing of your or your child’s biological sample
• You authorize T1D Scout to return screening results through your secure account
• You consent to the use of de-identified data for research and algorithm development
• You are the parent or legal guardian if consenting for a minor
• You understand that this Test is not diagnostic

You may request a copy of this Consent at any time.