DRC & Research News

Glycemic Control Among Youth with Type 1 Diabetes

Scientists have come a long way in their understanding of type 1 diabetes and in not only treatments used to manage the disease, but also technology. From continuous glucose monitors and insulin pumps to smart apps, there is a lot of diabetic technology that exists to support patients. But that does not mean that all patients are taking advantage of it or necessarily have access.

In a recent study by SEARCH, individuals with type 1 diabetes between the ages of 10 and 24 showed poorer levels of glycemic control between 2014 and 2019 than the study cohort from 2002 to 2007, despite improvements in treatment and management options. The SEARCH study encompasses more than 20,000 participants from sites in California, Colorado, Ohio, South Carolina, and Washington.

This particular study evaluated data from 6,492 participants and divided them into cohorts from 2002 to 2007, 2008 to 2013, and 2014 to 2019. Information was also categorized based on the duration of diabetes and whether the participant had type 1 diabetes or type 2 diabetes, with the majority of participants having type 1. Researchers then analyzed HbA1c levels over time, adjusting data for “site, age, sex, race, health insurance status and disease duration, both overall and for each duration group.”

Although average HbA1c levels remained consistent across cohorts (8.7% for 2014-2019, 8.9% for 2008-2013, and 8.6% for 2002-2007), when broken down by individual age ranges, those between the ages of 10 and 24 had poorer glycemic control in 2014-2019 than in 2002-2007.

These findings highlight the need for improved access to and use of diabetic technology as well as other interventions to support youth and young adults in enhancing glycemic control. Maintaining tight glycemic control and staying within target ranges can help reduce potential complications from the disease and promote better health.

Diabetes Research Connection (DRC) is committed to advancing research related to T1D and improving prevention, treatment, and management efforts as well as one day finding a cure. Early-career scientists can receive up to $50K in funding to support their peer-reviewed, novel research studies. Learn more about current projects and how to donate by visiting https://diabetesresearchconnection.org.

Immunosuppression for Islet Grafts

One of the approaches scientists have been testing for reversing or better controlling type 1 diabetes is the use of allogeneic pancreatic islet transplants. By reintroducing healthy insulin-producing islets, they aim to support the body in naturally regulating and stimulating insulin production to manage blood glucose levels.

A major challenge to this technique, however, is the immune system’s rejection of the graft following transplantation. As with organ transplants, scientists were forced to suppress the immune response in order to keep cells from attacking and destroying the islets. But immunosuppression is not a long-term solution for islet graft transplantation because the potential risks and health effects can outweigh the benefits.

In a recent study, scientists explored the possibility of controlling a localized immune response rather than a systemic one. They designed a synthetic platform that contains microgel made of biomaterials that can deliver checkpoint proteins to regulate cell death.  They used a chemeric streptavidin/programmed cell death-1 (SA-PD-L1) protein. In addition to this protein, they added a short, two-week administration of rapamycin to help the body adjust to the transplant while curbing rejection risk. This approach enabled the sustained survival of allogeneic islet grafts without the need for chronic systemic immunosuppression.

These results demonstrate the potential benefits of using synthetic microgels in combination with immunomodulatory ligands and specific antibodies to manage the immune response to allogeneic pancreatic islet grafts. While additional research is needed, this is a step toward improving therapeutic modalities for treating or potentially reversing type 1 diabetes.

The Diabetes Research Connection (DRC) is interested to see how this study influences future work on islet transplantation as an option for managing type 1 diabetes. The DRC is committed to advancing research within the field by providing critical funding to early-career scientists pursuing novel research studies focused on all aspects of type 1 diabetes. Learn more about current projects and how to help by visiting https://diabetesresearchconnection.org.

Maintaining Beta-Cell Function with T1D

In healthy individuals, pancreatic beta cells respond to glucose levels in the blood and automatically increase or decrease the production and release of insulin. This occurs without individuals ever knowing it happened. But in those with type 1 diabetes (T1D), the immune system mistakenly attacks and destroys insulin-producing beta cells leaving the body unable to naturally regulate blood sugar levels. Instead, individuals must do this on their own by continually monitoring their blood sugar and administering the appropriate amount of insulin via injection or an insulin pump.

However, in the early stages of type 1 diabetes, the pancreas continues to produce insulin, just not enough to keep blood sugar entirely under control. Eventually, this function ceases and individuals become insulin-dependent. Researchers have been investigating potential treatment options to preserve beta-cell function and slow the progression of type 1 diabetes.

A recent study found that the drug golimumab has shown positive results when used to treat individuals newly diagnosed with T1D. When administered every two weeks, this anti-tumor-necrosis-factor (TNF) therapy helped preserve beta-cell function and reduced the amount of additional insulin required by patients.

After 52 weeks of treatment, “41.1% of participants receiving golimumab had an increase or less than 5% decrease in C-peptide compared to only 10.7% in the placebo group.” C-peptide only measures the amount of insulin produced naturally by the pancreas, not injected insulin. Participants receiving the drug were able to maintain better blood sugar control with less insulin and also experienced a decrease in incidences of hypoglycemia where blood sugar was less than 54 mg/dL.

Another treatment that has shown potential is the combination of anti-interleukin (IL)-21 and liraglutide. Participants were randomly assigned to one of four groups: anti-IL-21, liraglutide, anti-IL-21 and liraglutide, or a placebo. Anti-IL-21 targets IL-21-mediated inflammation while liraglutide may reduce cell stress and apoptotic cell death. Treatment was administered every six weeks for 54 weeks.

At the end of the trial, those participants who received the combination treatment showed statistically better beta-cell function than those receiving only liraglutide or the placebo. Beta-cell function was nonsignificant when compared to those receiving only anti-IL-21. In addition, results showed that “combination therapy resulted in the lowest on-treatment glucose levels, although this was not statistically significant, and a significant 32% reduction in insulin dose relative to placebo.”

A third treatment of note was the use of ladarixin, a CXCR1/2 inhibitor that blocks IL-8. Although this therapy did not slow beta-cell function decline during the three-month trial period, it did achieve a statistically significant decline after six months. However, these effects had disappeared again by 12 months. But individuals taking ladarixin did experience better HbA1c levels than those in the placebo group. More research is needed on potential uses and effectiveness of ladarixin.

In addition, researchers also conducted a study involving individuals who were not yet diagnosed with T1D, but who were at high risk due to family history and the presence of at least two autoantibodies. They wanted to see if they could preserve beta-cell function and delay onset of T1D through the use of an Fc receptor-nonbinding anti-CD3 monoclonal antibody called teplizumab.

In this trial, 44 participants received teplizumab, and 32 received a placebo. Treatment was administered for 14 days. The results showed that “the medium time to the diagnosis of type 1 diabetes was 48.4 months in the teplizumab group and 24.4 months in the placebo group.” Overall, T1D was eventually diagnosed in 43% of the teplizumab group and 72% of the placebo group, demonstrating that the treatment may have helped slow the progression of the disease and preserve beta-cell function in individuals at high risk of developing T1D.

All of these therapies are continuing to undergo research to determine their effectiveness and potential use in delaying or preventing the onset of T1D. Diabetes Research Connection (DRC) is dedicated to ensuring that this type of work continues and provides critical funding to early-career scientists pursuing novel, peer-reviewed studies related to type 1 diabetes. Dr. Kevan Herold, a Yale researcher and member of the DRC’s scientific review committee (SRC), was involved in the study regarding teplizumab. Learn more about how the DRC supports scientists and current research projects by visiting https://diabetesresearchconnection.org.

Benefits of CGM Use

Individuals with type 1 diabetes (T1D) have multiple options for managing their blood sugar, ranging from traditional finger sticks and insulin injections to continuous glucose monitors (CGM) and insulin pumps. Scientists are also continuing to work on more advanced technology including artificial pancreas systems.

CGMs are a popular device for individuals with T1D because they automatically measure and track blood glucose levels and send alerts when they begin to rise or fall too far. They tend to be worn most often by young children and adults ages 26 to 50. However, there are barriers to access for these devices including eligibility requirements and insurance coverage. Furthermore, not all primary care providers are well-versed in how to effectively manage care using these systems.

But recent studies show that CGMs may be especially beneficial for the groups that tend to wear them the least – teens and young adults, and older adults. When these devices are consistently used, they can help to improve glycemic control and reduce instances of hypoglycemia. These factors are essential for continued well-being.

One study followed a group of 153 adolescents and young adults between the ages of 14 and 24 for 26 weeks, then followed up at one year. All of the participants had HbA1c levels of at least 7.5% but not more than 11.0%. The control group contained 79 individuals who did not wear a CGM and conducted finger sticks four times per day to measure their blood glucose levels. The test group contained 74 individuals who wore a CGM and conducted finger sticks twice per day.

At the end of 26 weeks, HbA1c levels for the CGM group dropped from 8.9% to 8.5%, while levels for the control group remained steady at 8.9% throughout. In addition, the CGM group’s time in target glucose range increased from 9 hours per day to 10.3 hours per day, whereas the control group actually dropped from 8.7 hours per day to 8.3 hours per day. However, over time, the CGM group wore their devices less frequently, going from 82% to 68% of participants wearing the device at least five days per week.

At the end of one year, the results remained relatively consistent. Within the CGM group, HbAc1 levels improved slightly from 8.5% to 8.3%, while time in target range decreased slightly from 43% to 41%. There was a noticeable difference when it came to low blood sugar, with the average time spent below 70 mg/dL improving from 49 minutes per day to just 16 minutes per day.

On the other end of the spectrum, adults ages 60 and older also saw positive results when it came to CGM use. This study involved 203 adults split into the same type of test and control groups as the adolescents/young adults. The older adults in the CGM group were more consistent with their device use with 81% wearing it continuously and 89% wearing it at least five days per week.

The focus of this study was on hypoglycemia and time spent with a glucose level below 70 mg/dL. After 26 weeks, the CGM group went from 73 minutes per day to just 39 minutes per day, while the control group saw very minimal change. These rates stayed approximately the same at the one-year mark. In addition, the CGM group spent an average of 2.1 hours per day more in the target blood glucose range than the control group at 26 weeks.

The findings from both studies are encouraging when it comes to helping individuals with T1D to better manage their blood sugar and reduce the risk of hypoglycemia. It is important to educate patients on the benefits of using a CGM while also working to reduce barriers and improve access to this technology.

Though not involved in these studies, the Diabetes Research Connection supports early-career scientists in conducting research related to preventing and curing type 1 diabetes, minimizing complications, and improving quality of life for those living with the disease. From an increasing understanding of how and why the disease develops to improving treatment and management options, scientists are working hard every day. Learn more about current projects funded by the DRC and how to support these efforts by visiting http://diabetesresearchconnection.org.

In many patients, there is a slight delay between the time when type 1 diabetes (T1D) is first diagnosed, and when they become dependent on insulin. This is known as the “honeymoon phase” and often lasts for a few months or up to a year. During this time, insulin-producing beta cells continue to function relatively normally and are supported by a small amount of insulin. Over time, these cells stop functioning and patients become insulin-dependent.

A recent study reveals that scientists have developed a breakthrough drug that may delay the onset of clinical T1D by up to three years. The drug, teplizumab, was used to treat patients who were identified at high risk of developing T1D due to the presence of at least two autoantibodies. The drug was administered for two weeks, and following this treatment, insulin secretion rates and C-peptide levels remained higher than for those participants who received a placebo.

During the preliminary trial, patients who took teplizumab showed a delayed onset of T1D of two years, but during the latest phase 2 drug trial, this was extended to three years. Participants who took a placebo continued to experience decreased insulin and C-peptide production as the disease progressed. As a result of these findings, the drug was awarded Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) and PRIority MEdicines (PRIME) Designation by the European Medicines Agency (EMA) in 2019.

More than 18 million people around the world are living with type 1 diabetes, and this drug has the potential to make a positive difference in the lives of millions more who are at-risk for the disease. Diabetes Research Connection (DRC) is excited to see how clinical trials continue to progress for teplizumab and whether it eventually becomes an approved prevention therapy for type 1 diabetes.

The DRC is committed to growing understanding and improving treatment and prevention of type 1 diabetes through providing critical funding for early-career scientists so they can advance and execute their research. Learn more about current projects and how to help by visiting https://diabetesresearchconnection.org.

Type 1 Diabetes and COVID-19

As cases of COVID-19 continue to spread across the United States and the globe, scientists are especially interested in how it affects specific populations, such as those with type 1 diabetes (T1D). T1D is considered an underlying health condition and already puts individuals at greater risk when it comes to illness and potential complications.

One positive sign is that preliminary data from a recent study shows that many patients with T1D who also test positive for COVID-19 or have COVID-19-like symptoms are able to effectively manage their recovery at home. Less than 25% of patients were serious enough to require hospital admission. In addition, there were only two reported fatalities, and those individuals had existing comorbidities.

According to the preliminary data, it appears as though patients who have higher A1c levels and poorer glycemic management tend to be more negatively impacted by the disease. In addition, higher body mass index may also be a risk factor. When it comes to age, about 65% of cases were in individuals aged 18 or younger (though many had COVID-19-like symptoms, not confirmed diagnoses), and the average age of all 64 participants was 20.9 years. This is not an issue that is only facing older adults.

According to the study, “Overall, 34.9% of patients were able to manage COVID-19 entirely at home, with 27.3% of the confirmed and 43.3% of the suspected cases able to do so. At the other extreme, 22.2% of patients overall were admitted to the intensive care unit; 30.3% of the confirmed versus 13.3% of suspected cases.” Other patients were seen at an urgent care or hospital but not admitted.

Of those who managed their recovery at home, many received support virtually through telemedicine where they able to consult with endocrinologists and infectious disease specialists. There were also many who did not need to seek care and had their symptoms improve.

Since the initial study was conducted, more patient data has been submitted, and there are now 220 patients as opposed to 64. This data is still being analyzed and reviewed, but at first glance, researchers have found that results continue to be similar to the original group. Researchers are looking at A1c levels, glycemic management, comorbidities, mortality, telemedicine access and use, and more to better understand how COVID-19 is impacting individuals with T1D. They are also digging deeper into risk factors. A new paper reflecting this latest data is in the works.

There are still a lot of unknowns when it comes to COVID-19, but researchers are striving to understand how it may affect more vulnerable populations such as those with type 1 diabetes. The Diabetes Research Connection (DRC) continues to follow these studies and trends to stay up-to-date on the latest information. In addition, the DRC provides critical funding for early career scientists to conduct their own novel, peer-reviewed studies around T1D, whether related to COVID-19 or any other facet of the disease. To learn more and support current projects, visit http://diabetesresearchconnection.org.

High Costs of Diabetes

Discussions around type 1 diabetes care and affordability often focus on the cost of insulin. While insulin prices can be extremely high and add up quickly depending on how much is needed to effectively control blood sugar levels and what is covered by insurance, this is not the only diabetes-related expense that individuals incur.

Insulin is only one part of managing diabetes. Patients also must pay for the supplies necessary to test and monitor their blood glucose levels and to administer insulin. Many people use continuous glucose monitors and insulin pumps to assist, and even if they don’t, they need syringes and other testing supplies.

A national study of 65,199 patients between the ages of 1 and 64 who had private, employer-sponsored insurance coverage found that the average out-of-pocket cost for managing diabetes was $2,500 a year. But only 18% of that cost was insulin. The rest was other supplies like those aforementioned. Furthermore, families with children who had type 1 diabetes were more likely to use CGMs and insulin pumps to help manage their child’s condition, and their annual out-of-pocket costs exceeded those of adults at $823 versus $445 respectively.

While steps have been taken to reduce the cost of insulin in recent years, and especially during the coronavirus pandemic, not as much has been done to improve the affordability and access of other diabetes-related supplies. CGMs and insulin pumps can play an integral role in helping patients better manage their diabetes and reduce complications, especially for children; in turn, this may help decrease additional medical expenses.

More focus is needed on the overall costs of diabetes management and how to better support patients in affording the care they need for improved health. The Diabetes Research Connection (DRC) stays abreast of the latest changes in the industry and advancements in research and treatment to help individuals with type 1 diabetes. Scientists are always working on ways to improve care and reduce the burden of the disease, and the DRC provides critical funding for these efforts. Learn more about current projects and how to support early-career scientists by visiting https://diabetesresearchconnection.org.