On Veterans Day, Stephanie Lolo loaded her two youngest kids into a minivan and drove half an hour to the Medial Office Building of Memorial Regional Hospital in Hollywood to have their blood tested for Type 1 diabetes.
No kid likes needles, but Lolo’s oldest child, 8-year-old Enzo, has had the chronic disease since he was a toddler. That means her other children, Alexander and Olivia, are at higher risk of developing the disease, which causes dependence on injected or pumped insulin for life, carries the threat of devastating complications and is extremely costly.
The free annual screening, conducted by researchers with Joe DiMaggio’s Children Hospital, is part of the “Pathway to Prevention Study” run by TrialNet, a federally funded, international network of 21 clinical centers that are researching people at increased risk for Type 1 diabetes.
Researchers are trying to learn more about how the disease occurs and then steer some participants who develop it into different TrialNet studies that are working on stabilizing or delaying the onset of diabetes, as well as helping to find a cure.
Stephanie Lolo said there are several reasons why she is having her two youngest kids take part in the study. For starters, it ensures that diabetes “does not sneak up” on Alexander and Olivia. This is important to prevent diabetic ketoacidosis, a life-threatening condition due to undetected, severely high blood sugar that often occurs at the onset of diabetes and requires hospitalization.
If either child does start to develop the disease, early diagnosis also enables doctors to try treatments that could stabilize or delay the onset.
The free screening for at-risk children and adults is available at seven other sites around South Florida (see box). So far, TrialNet has screened more than 155,000 people worldwide, said Dr. Jennifer B. Marks, a principal investigator of the Trial Net study.
“It is a very complex disease,” added Marks, a professor of medicine at the University of Miami School of Medicine and medical director of the diabetes management program at the Miami VA Medical Center. “Although we understand a great deal more than we did 20 years ago, there are things we don’t understand and things we are still discovering that will help us toward final prevention.”
Researchers have learned that Type 1 diabetes is caused because the immune system attacks the pancreas’ beta cells, which produce insulin. Insulin is a hormone that enables people to get energy from food. With the beta cells unable to produce enough or any insulin, glucose builds up in the bloodstream, creating a condition called hyperglycemia.
The disease also carries the threat of complications, including kidney failure, blindness, nerve damage, amputations, heart attack, stroke and pregnancy problems. And, of course, there is the lifelong high medical costs that come with managing a disease that results in death if it is not continuously dealt with.
Dr. Robin Nemery, a principal investigator of the TrialNet study and a pediatric endocrinologist at Joe DiMaggio Children’s Hospital, said it is especially important to try to get a handle on Type 1 diabetes now because the incidence of the disease is rising worldwide.
“And we don’t know why,” she said. “But whatever the why is, it’s causing more and more young people to develop Type 1 diabetes, particularly in the younger age group, under 5.”
Figures vary, but in 2012, about 1.25 million American children and adults had Type 1 diabetes, according to the Centers for Disease Control and Prevention. More than 200,000 of those living with the disease are children.
“It’s been frustrating,” Nemery said. “It was bad enough when we had some cases, but now we have a lot. Instead of curing the damn thing, we are getting more cases.”
But people like college student Enid Sosa are optimistic that a cure will be found. She was diagnosed with Type 1 diabetes a week before her 14th birthday. She earned the nickname “Miss Gadget” because of all the insulin pumps and glucose monitors she needed to keep her blood sugar under control.
She has learned how to live with the disease, but it has not been easy. She hopes to one day become a pediatric endocrinologist.
“We are trying to trick out nature, that’s the problem,” said Enid, who receives treatment at Nicklaus Children’s Hospital. “But we are looking at the cure. It’s very complicated, but we just got to break the last wall.”
It has been decades of frustration. “The immune system has proven to be a formidable opponent,” Nemery said.
But each failure helps better direct the research in the right direction. The screening is helping, and the more people who are screened, the better for them and for the researchers.
“Once we have a child diagnosed with Type 1 diabetes, then we get involved with the research,” said Paulette Smith, a researcher at Joe DiMaggio Children’s Hospital. “We reach out to the families to let them be aware that the federal government is doing this research for blood relatives.”
TrialNet screens first-degree relatives: parents and full-blooded siblings aged 1 to 45. It also screens second-degree relatives: half-siblings, nieces, nephews and cousins, aged 1 to 20.
“No one is saying you will get Type 1 diabetes, but the research is showing that the risk is higher in blood relatives and that risk can be 15 times greater than a person with no family history of the disease,” Smith said.
The blood test is looking for antibodies that are proteins that the immune system produces because it is reacting to something, possibly insulin or particular enzymes.
“You may be walking around with all these proteins in your blood and have the chance of developing Type 1 diabetes and have no clue,” Smith said. “If you go to your doctor and have a regular blood test, it won’t detect it. There’s research blood work involved.”
There are three possible outcomes. No antibodies are found and a letter is sent saying the test was negative and to please come back in a year to get another screening.
The second possibility is that one antibody is found and the person is asked to return for a confirmatory draw. If that is negative, the person is asked to return in a year. If still positive, they are monitored. But one antibody usually doesn’t lead to the development of diabetes.
The third scenario is that more than one antibody is found and the person is put into the monitoring phase. If the person begins to develop the disease, then he or she can be placed in studies to receive treatment to stabilize or delay the onset.
One TrialNet study using oral insulin is about to complete enrollment at the end of the year. The participants are followed for a year.
Julie Ford, clinical research administrator at TrialNet, said the results should be available by early 2017.
She said some of the studies are “promising, but until we do large-scale clinical trials we can’t really know.”
Each time her two youngest kids get screened, Lolo said she can’t wait to get the letter with the results. “I open it right at the mailbox and look at the first two lines for the word ‘negative,’ ” she said.
The research also gives her hope for her oldest child. Enzo’s diabetes has not kept him from being an active 8-year-old who does taekwondo, plays football and swims.
But life has been tough for him. Excitement, fear and growth spurts can cause his blood sugar to spike. Stephanie Lolo also is sad that diabetes may put limitations on her son, who would not be allowed to join the military or become a pilot, she said.
“To put restrictions on your child’s dreams is not something a parent wants to do,” she said. “But we have been following the research over the years and we have to remain optimistic. A lot of good people out there, and good foundations and organizations, are pushing for the end goal, which is a cure and not just better treatments and therapies. We pray for that.”
Free Screening Sites:
▪ Joe DiMaggio Children’s Hospital, 305-243-3781
▪ Genoma Research Group, Inc., 305-243-3781
▪ Life Research Investigation Center Corp., 305-243-3781
▪ Miami Children’s Hospital, 305-243-3781
▪ Paramount Public Health & Research Management Services, 305-243-3781
▪ South Florida Research Phase I-IV, 305-243-3781
▪ University of Miami, 305-243-3781
Palm Beach Gardens:
▪ Pediatric Endocrine and Diabetes Specialists, 305-243-3781