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Primary Intervention with Mucosal Insulin for Prevention of Type 1 Diabetes: Pre-POINT

Principle Investigator: Dr. Georgeanna Klingensmith, COMIRB #05-1043

  • The Pre-Point study is looking for children aged 2-7.0 years old who do not have diabetes, but have a first degree family member with type 1 diabetes.
  • The goal of the study is to prevent or delay the onset of diabetes in those who are genetically at high risk by taking oral insulin or placebo.

Why you should participate?

  • You will be part of a study to see if we can slow or prevent the development of auto-antibodies and diabetes.
  • You will have close follow-up and regular testing for diabetes.
  • If diabetes develops we will be able to detect the onset before symptoms and/or complications occur.
  • The information from this study may help other people with diabetes.

Who can participate?

  • Children who do not have diabetes; ages 2 to 7.0 years old.
  • Have at least one brother or sister or both parents with type 1 diabetes.

What will happen in this study?

  • You will be assigned to take a capsule filled with oral insulin or placebo, or spray with intranasal insulin or placebo.
  • You will also be asked to answer questionnaires, monitor blood sugar at home, have additional blood tests and attend study visits.
  • You will be followed in this study up to 18 months.

Whom should I contact with questions or to schedule an appointment?