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Participating in T1D Trials; The Value of Knowing and Helping

TrialNet, TEDDY, and other trials take effort but you gain awareness and improve treatment while helping others

We spoke with Tavia Vital, BSN, BA, RN, CDE, who was diagnosed with T1D at age 2½ and is an Outpatient Certified Diabetes Educator, about the experience of her two sons participating in TrialNet, TEDDY, and the Oral Insulin Trial.  Each son tested positive for high-risk genes for T1D.

Tavia Vital, BSN, BA, RN, CDE, was diagnosed with T1D at age 2½ and is an Outpatient Certified Diabetes Educator. Her two sons participate in TrialNet, TEDDY, and the Oral Insulin Trial

“I started out on fingerstick glucose monitoring BEFORE digital meters. For me, the ‘guillotine’ lancet device was an upgrade to the manual lancet and pipette straws they used on me initially.”

Since genetic markers and antibody testing showed that either of my sons might develop T1D, I wanted to participate in all the monitoring studies that were available.  I lived in Denver at the time and worked at the University of Colorado Hospital’s Endocrinology, Diabetes, and Metabolism Clinic. The Barbara Davis Center was very nearby and where the closest sites for TrialNet and TEDDY studies are based.

T1D Parent Decisions

Every parent with T1D fears that their children will also get T1D.  Human nature is complex and sometimes you don’t want to know and just let life unfold.  For those T1D parents who do want to know, free screening and ongoing monitoring studies are available for children with 1st or 2nd-degree relatives with T1D.

TrialNet

TrialNet is easy because it is available to anyone, no matter where you live in the United States, Canada plus eight other countries.  They can mail you the tubes for the blood draws and you can get blood drawn at a local blood draw facility.  Screening is free and results are ready in 4-6 weeks. You can contact them or go to https://www.trialnet.org/participate to sign up.

TrialNet screens annually and will move you to the monitoring phase of TrialNet if antibodies become positive. The monitoring phase involves taking an Oral Glucose Tolerance Test and responding to questionnaires about food and physical activity.

TrialNet will let you know if there are any prevention trials enrolling near where you live.  Prevention trials are aimed at trying to keep T1D from officially happening. My kids’ antibodies appeared when they were newborns. My youngest son’s antibodies disappeared and have not (yet) returned. My oldest son’s antibody levels continued and additional antibodies appeared over the years. He is now considered to have Stage 2 Type 1 Diabetes.

TrialNet and studies like TEDDY have helped everyone better understand the progression of T1D.  Three stages of T1D development are now defined.  Source: UCSF

  • Stage 1: This is the start of type 1 diabetes. At this stage, individuals test positive for two or more diabetes-related autoantibodies. The immune system has already begun attacking the insulin-producing beta cells, although there are no symptoms and blood sugar remains normal.
  • Stage 2: This stage, like stage 1, includes individuals who have two or more diabetes-related autoantibodies, but now, blood sugar levels have become abnormal due to increasing loss of beta cells. There are still no symptoms.
  • Stage 3: This is when a clinical diagnosis has typically taken place. By this time, there is significant beta cell loss and individuals generally show common symptoms of type 1 diabetes, which include frequent urination, excessive thirst, weight loss, flu-like symptoms, and fatigue.

Once two or more antibodies are present the lifetime risk of developing type 1 diabetes approaches 100 percent.

The Oral Glucose Tolerance Test is an important tool.  A measured volume of glucose is consumed and then blood glucose levels are measured at baseline, then at timed intervals after the glucose drink is consumed.  A person is diagnosed with diabetes if their blood glucose level exceeds 200 mg after 120 minutes.

If you or your family member without T1D starts making antibodies, then TrialNet will alert you to any currently enrolling studies you may be eligible for in your area. Sometimes there are no studies that are enrolling.  For example, my oldest son isn’t old enough for any other preventative studies. So, at this time, we ‘watch and wait’. We check his fasting glucose and again 2 hours after supper. We also check his glucose if he displays symptoms of high blood glucose or reports he isn’t feeling well.

TEDDY, The Environmental Determinants of Diabetes in Youth, is no longer enrolling new people in their study. Nonetheless, you can learn more about TEDDY at https://teddy.epi.usf.edu/. The study is ongoing and they have a very large number of published papers from things they have learned about possible ‘triggers’ and things that are not likely the answer to everyone’s question: What causes T1D?  For example, they confirmed the bacterial flora of kids that go on to develop T1D differs from those kids who do not get T1D even if they have the same high-risk genetic markers. TEDDY study participants are scheduled for blood draws and questionnaires about food, physical activity, illnesses, medications, over the counter supplements, social groups, hospitalizations, fevers, signs/symptoms of Celiac Disease. Samples of toenails, tap water, snot, and even poop of TEDDY kids are collected by parents and sent into the study at scheduled intervals.

Since there are so many blood draws involved in the number of studies we participate in and the research study nurses are really great. They use IVs to just do one poke and draw multiple labs off of the one IV line. The studies provide kids with prizes like bubbles or coloring books or small toys. TEDDY gives the kids age-appropriate books about being a TEDDY Scientist and why they need the blood draws and other samples.

Tavia’s son’s Ixa and Caiden when they were much younger

T1D Delay

My oldest son participated in an Oral Insulin or Placebo study for about 7 years.  At the close of the study, they revealed he was on placebo the whole time. We thought he had been receiving oral insulin all along because his antibody levels slowly declined over time and some even went back to zero!  We could watch the antibody numbers due to being in the TEDDY study.

My sons do not yet have Stage 3 T1D after nine and eleven years of monitoring.  I think this is partially a result of the daily supplements that I give them. These supplements include Vitamin D (2000 IUs), Omega 3, a multivitamin and Probiotics. Until there is a prevention study my oldest son qualifies for, this is the only thing we feel we can do to help slow down the progression.

While watching and waiting is not a comfortable strategy, at least we will most likely be able to find out when my oldest son’s T1D officially becomes Stage 3 without needing to go through potentially life-threatening DKA and hospitalizations upon diagnosis.

Martin is the Founder of SelfRx Media and editor-in-chief of Insulin Nation. He's a passionate about sharing knowledge with those affected by Diabetes.

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