Deciding to allow Tanner to participate in the Start Thymoglobulin trial was by far one of the most difficult decisions our family has ever made. Our lives were upside down with a new diagnosis, our son was recovering from his close call with mortality, we were learning a whole new language (diabetenese) and trying to figure out how to ever be okay knowing that our son's life now relied on a little bottle of insulin and our math skills. (I barely pulled a C- in math all through school, thank goodness the kids inherited Sams math skills) Including a clinical trial the magnitude of the thymo trial into the mix felt daunting at best. Through soul searching and scientific research a final decision was reached we all agreed on. To read about the process and details of the trial here.
T1 is caused by the immune system attacking the cells in the pancreas that produce insulin. Thymoglobulin is a drug used in organ donation transplants to stop donor rejection in the recipient. The START trial is being done to see if thymo can stop the immune system from attacking the pancreatic islet cells still functioning in a newly diagnosed Type 1 person.
To be honest, the trial was much more difficult than I had imagined. The infusions T went through left him feeling like he had the worst flu EVER. I wrote several blogs in May documenting the trial. The side effect continued for weeks after including side effects we didn't expect. I had moments I seriously doubted our decision and judgment. Moments I wondered if it would ever be worth it. There were so many unknowns, all I knew at the time was how miserable our son felt, and how amazingly positive he remained.
Part of the trial protocol involves very strict diabetes management, keeping logs, and multiple appointments that include extensive blood work and follow up testing. In order to have a full understanding of the results so far, you must have some background information in order to understand the significance of the tests. T has appointments every three months for blood work and questions, and every six months for the next two to five years for a test called a Mixed Meal Tolerance Test (MMTT). An MMTT requires T to eat at least 150 carbs for three days prior to testing. Then fast with nothing but water for the last 16 hours. Except for his basal insulin, he can not have bolused or have any active insulin for at least two hours before the test begins. An IV is placed and blood is taken. T tests his blood sugar. He then drinks a supplement drink called Boost that has a determined amount of carbohydrates and protein. He does not bolus (administer through his pump) any insulin for the Boost. His blood sugar is tested and drawn every fifteen minutes for four hours. All data is collected and evaluated. This test helps measure how well his pancreas is producing insulin.
I will do my best to keep this as brief and as understandable as possible. Bear with me. First I will describe some terms, definitions and values and how they apply to a person without Type 1 Diabetes. Then I will relate the the same values for a person with Type 1 that would be typical for someone T's age and last I will reveal how T's values measure up.
People without Type 1Diabetes:
Blood Sugar Value: the amount of glucose (sugar) present in a persons body to provide energy for all organ systems.
Value for someone without diabetes- 70-120 on average, children can be as high as about 140.
A1C: Is a numerical value average of the last three months of a persons blood sugar. A person without diabetes will have an A1C of between- 4-5.9
A Person with Type 1 Diabetes that is T's age (13) and in puberty.
There are thousands of factors that change blood sugar values in people with T1. Puberty is notorious for wreaking havoc with blood sugars in kids with T1. Boys produce testosterone, a steroid hormone, which makes the body very insulin resistant. It can cause blood sugar values to be stubbornly high, even with large amounts of insulin present. Our Dr. explained today that it is typical for a boy in T's stage of puberty to need 25 units of basal insulin for 24 hours (insulin needed to maintain basic body function) and have to take 1 unit of insulin for every 5 carbohydrates eaten. These numbers vary drastically from person to person.
A T1 teen blood sugar values vary depending on the person but most goals are set at having a blood sugar of between 80-180. Because people are not perfect manual pancreas's, despite frequent testing, carb counting and testing at night, it is almost impossible to always remain in those value ranges. T1 is a constant balancing act that requires continually factoring in multiple factors that are never static and can't be predicted. How to you predict hormones? a pending virus? the pancreas suddenly over-achieving and kicking out extra insulin? a set (catheter that administers insulin under the skin) becoming plugged? predict how fast or slow insulin injected into the skin will work? a growth spurt? how much sugar the body burned running in PE? how many carbs are in the cupcake that Johnny's mom unexpectedly brought to school that you are carb counting by your childs description over the phone?You can't!! Resulting in numbers that are out of range and require more insulin or carbohydrates to correct.
An A1C goal for a T1 teen in puberty is 6.0-8.5. Multiple factors have to be taken into consideration between a doctor and the family to create a target A1C. It varies greatly and should not be the only criteria when determining how well a teens T1 is being managed. Even teens that diligently test and work hard at managing T1 can still struggle with A1C's. Sometimes an A1C can be well below this, which at first glance may seem great, but can be a result of devastating low blood sugars which can be dangerous-even fatal. Having a lot of low blood sugars can lower an A1C and insulin adjustments have to be made to prevent lows.
T's results so far:
T did his MMTT today. He did not bolus or inject any insulin for this test. He does continue to use his basal insulin which maintains his body's basic insulin needs for metabolic function. His blood sugar before starting the test was 94. At half an hour after drinking the Boost he was 125. At an hour and a half he was 150. At two hours he was 186. At three hours he was 143. At four hours he was 100. A half hour after the test ended he was 78. T's blood sugars are rarely below 65 and seldom above 150. His average blood sugar value is 103. He uses about 8.5 units of insulin over 24 hours for his basic metabolic needs (basal insulin) and he takes 1 unit of insulin for every 18 carbs.
His A1C was 5.1 today. His lowest blood sugar over the last three months was a 64. Even for someone in his "honeymoon" phase of Type 1 diabetes his A1C is rare. His Dr. walked in today toward the end of the MMTT and said jokingly, "Do you have Type1? Why are you here? With this A1C and these blood sugars you don't qualify for this trial!"
We have no way of knowing how long this will last. T has never once regretted the trial and what he went through. Many of the "what if's" and worries, while warranted at the time, have faded now. T's T1 still requires work, diligence, testing, carb counting and worrying. And we realize how different his T1 is from families and people struggling with this disease. We also know that it can change anytime and and there is no way to predict that. We are just so happy to have been presented with an opportunity and for having a son brave enough to seize it.