About GleeT1D

The goal of the GleeT1D research study is to preserve beta cells so that your body can continue to produce some of its own insulin.

Even modest amounts of naturally-produced insulin can improve overall blood sugar control, make daily management of T1D easier, and reduce the risk of long-term complications.

Based on previous research, medical researchers think that giving medications that affect the immune system soon after diabetes is diagnosed may stop or delay the destruction of beta cells, resulting in better blood sugar control.

Read more about background on What is Gleevec?.

Eligibility

Participants were eligible for the study if they:

  • Were 18 to 45 years old; and
  • Diagnosed with T1D less than three months before screening; and
  • Tested positive for at least one diabetes-related autoantibody (a blood test will determine this)

Participation

Participation in the Gleevec study for type 1 diabetes will last up to 2 years and involves:

  • Taking a pill (either Gleevec or a placebo) once a day for 6 months.
  • Coming to one of the Study Locations for follow up visits and additional lab tests (approximately once a month the first year, and every 6 months the second year).

Participants will be randomly assigned to one of two groups. One group will be given the study drug, Gleevec, and the other group will receive an inactive substance made to look like the study drug, called a placebo. A computer randomly picks who gets the study drug and who get the placebo. You will have a 2 out of 3 chance of being randomized to the Gleevec group, and 1 out of 3 chance of being randomized to the placebo group.

All participants will receive close monitoring and education by a diabetes team, with advice on how to optimize blood sugar control. Tighter blood sugar by itself has been shown to help preserve beta cell function.

Follow up

During the study visits, the study doctors will review medications, check for possible side effects, evaluate diabetes control, and assess participants’ overall health.

All study participants with receive intensive diabetes management from expert medical staff, with the goal to keep blood sugar levels as close to normal as possible.

The study doctors will also periodically check for how much insulin participants produce after an assessment called a mixed meal tolerance test (MMTT). We will measure a break down product, or metabolite, of naturally produced insulin, called C-peptide. The study team will track how much C-peptide your beta cells produce and monitor how your response changes over time to determine how many functioning, insulin-producing beta cells you have.

Gleevec may help people continue to make insulin, but there is no guarantee that this will happen. Even if Gleevec does protect the beta cells, study participants may still need to take insulin injections and actively manage their diabetes. However, the total amount of insulin needed may be less, and overall blood sugar control may be better, if the beta cells are preserved.

Participating Medical Centers

Currently there are 8 medical centers where you can come for study visits. They include:

  • Atlanta – Emory University
  • Boston – Joslin Diabetes Center
  • Denver – Barbara Davis Center, University of Colorado, Denver
  • Indianapolis – Indiana University, Indianapolis
  • Iowa City – University of Iowa
  • Philadelphia – Children’s Hospital of Philadelphia, University of Pennsylvania
  • San Francisco – University of California, San Francisco
  • Melbourne (Australia) – Royal Melbourne Hospital/Walter and Eliza Hall Institute

See Study Locations for more detail. Note: The study covers travel expenses. The study staff will go over this in detail.

Compensation

Compensation for time, effort, travel and related expenses is available for eligible participants. The study staff will go over this in detail.