DRC & Research News

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Exploring Challenges with Hybrid Closed-Loop Insulin Delivery Systems

There are many different options for managing diabetes from manually checking blood sugar and administering insulin to using a hybrid-closed loop insulin delivery system that does the work automatically with some human input. This type of insulin delivery system, also referred to as an artificial pancreas, was designed to improve diabetes management and blood sugar control without as much demand on patients.

However, a recent study found that nearly one-third of children and young adults stopped using the hybrid closed-loop system within six months. Some of them even discontinued use of a continuous glucose monitoring (CGM) system. The study involved 92 participants with type 1 diabetes who had an average age of 16. Each participant began using the Medtronic 670G system in manual mode for two weeks before switching to auto mode. They received follow-up training via phone within one month after starting auto mode, then were seen in a clinic every three months during the next six months.

The Medtronic 670G system uses CGM data to automatically control basal insulin delivery. This can help manage changes in blood sugar more quickly and administer the correct amount of insulin without patient input. If boluses are needed, however, the individual must enter their carb count and blood glucose number manually.

Researchers found that use of auto mode continued to decrease over the 6-month trial period, dropping from 65.5% during the first month to 51.2% by the sixth month. In total, 28 youth stopped using the hybrid closed-loop system within the first six months, and 21 of those 28 stopped using CGM as well. This raises the question as to whether CGM use posed some barriers to success and continued use of the hybrid closed-loop system.

The study did show that while participants used the artificial pancreas, their time spent within range for blood glucose improved from 50.7% to 56.9%, and their HbA1c levels decreased from 8.7% to 8.4%.

Understanding the strengths and challenges of artificial pancreas use in children and young adults can help researchers to make improvements and adjust systems for better results and continued use. Hybrid closed-loop therapy is just one option for managing type 1 diabetes, and it is important for individuals to find what works best for their situation.

Diabetes Research Connection is committed to providing early-career scientists with the funding necessary to support research designed to prevent, cure, and better manage type 1 diabetes. Funding is critical to continue advancing understanding and therapies for the disease. To learn more about current projects and donate, visit https://diabetesresearchconnection.org.

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Could Closed-Loop Systems Improve Blood Glucose Management?

One of the latest technologies being tested for managing type 1 diabetes is a closed-loop system. This system uses a continuous glucose monitor (CGM) to measure blood glucose levels. When blood sugar begins to rise outside of the target range, it sends information to an insulin pump to automatically administer insulin. When blood sugar begins to fall, insulin is not administered. It is a closed loop because the patient is not deciding when to inject insulin or how much, but rather the system does so automatically.

A recent study involving 168 individuals with type 1 diabetes between the ages of 14 and 71 were part of a six-month trial using a closed-loop system. One hundred and twelve people were randomly assigned to the closed-loop group while the remaining 56 people used a sensor-augmented pump and were considered the control group. All 168 participants completed the trial. There were no incidences of hypoglycemia and only one incidence of diabetic ketoacidosis, which occurred in the closed-loop group.

The results showed that the closed-loop group remained in the target range for glucose levels (70-180 mg/dL) a greater percentage of time than those in the control group. On average, their time in the target range increased from 61% to 71%, while the control group remained around 59%. In addition, the closed-loop group spent less time with glucose levels above 180 mg/dL or below 70 mg/dL. Throughout the duration of the six-month trial, participants in the closed loop group remained in closed-loop mode (with the system automatically managing glucose monitoring and insulin administration) a median of 90% of the time.

While the closed-loop system is not perfect, these findings show that it improved time spent in the target glucose range, which is desirable in diabetes management. It also reduces the manual tracking and input from individuals with type 1 diabetes in managing the disease. While more research and testing are needed, it is a step in the right direction toward developing what many refer to as an “artificial pancreas.”

Diabetes Research Connection (DRC) is interested to see how this system will continue to advance and improve diabetes management in the future and continues to follow its progress.  These types of devices play an integral role in supporting individuals with T1D and helping them to maintain more normal blood glucose levels. The DRC supports early career scientists in pursing novel research studies geared toward improving understanding, diagnosis, and treatment of T1D with the goal of one day finding a cure. Learn more about these efforts and how to help by visiting http://diabetesresearchconnection.org.

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Pumps and CGMs Help to Manage A1C Levels for Individuals with Type 1 Diabetes

A1C tests show an average blood sugar level over the past two to three months. This is important not only for helping to diagnose type 1 and type 2 diabetes but also for managing the disease. Healthy individuals without diabetes should have an A1C level below 5.7%. For those with diabetes, a level of 7% or less while using insulin is the target and considered being well controlled. If A1C levels are higher, it may mean that changes are needed to the person’s treatment regimen.

A recent study of participants in the T1D Exchange Clinic Network found that even with high quality care, many people are still not meeting A1C goals. Out of more than 20,000 participants, only 21% of adults had an A1C below 7%, and only 17% of youth had an A1C below 7.5%. These statistics are likely to be even lower for the general U.S. population with T1D who do not participate in the T1D Exchange Clinic Network.

On a positive note, the study found that those who use continuous glucose monitors (CGMs) and insulin pumps tended to have better outcomes. Since the 2010-2012 study, use of CGMs increased by 30%, and use of insulin pumps increased by 6%. Compared to non-CGM users, those who used the device had A1C levels that were about 1% lower.

Furthermore, these devices also had an impact on hypoglycemic episodes and diabetic ketoacidosis (DKA). Only about 5% of CGM and pump users experienced severe lows compared to 7% of non-CGM users and 9% of non-pump users. CGM and pump users also had fewer incidences of DKA.

While there is still more work to be done to better control diabetes and A1C levels, the use of CGMs and insulin pumps seem to be beneficial for many individuals using them. With increased awareness and education about these options, as well as improved access, there is the potential to benefit even more individuals with T1D and help manage A1C.

The Diabetes Research Connection is always looking for new and innovative research projects to fund that support advancement in understanding T1D as well as preventing and curing this disease and improving quality of life for those living with it. Early career scientists can receive a grant ranging from $25,000 to $75,000 for their research project.


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Could Real-Time Continuous Glucose Monitoring Reduce Incidences of Hypoglycemia?

Managing type 1 diabetes can be tricky. Many people rely on self-monitoring throughout the day by periodically testing their blood sugar and administering the proper dose of insulin as needed. Individuals with T1D often inject themselves with insulin multiple times per day. However, food, beverages, physical activity, illness, and other factors can all impact blood sugar levels making them more difficult to effectively manage.

But with advances in technology, continuous glucose monitoring (CGM) devices are now available to help those with T1D track and manage their blood sugar. These devices have a tiny sensor that is inserted under the skin which automatically measures blood glucose levels and transmits the information to a monitoring device. The system can also alert when blood sugar becomes too high or falls below a specified level allowing individuals to respond accordingly.

A recent study conducted across 12 diabetes centers in Germany aimed to determine whether the use of real-time CGM (rtCGM) systems could reduce the number and severity of incidences of hypoglycemia in patients with T1D who had a history of impaired hypoglycemia awareness or severe hypoglycemia within the previous 12 months. The study involved 149 participants, and 141 successfully completed the trial in its entirety.

All participants wore a masked rtCGM system for 28 days before being randomly assigned to one of two groups: the first group wore an unmasked rtCGM system for the next 26 weeks, and the second group was a control group that self-monitored blood glucose levels during this time. The results of the study found that the group that wore the rtCGM system had a 72% decrease in the number of hypoglycemic events (10.8 to 3.5 per 28 days), while the control group saw no significant reduction (14.4 to 13.7 per 28 days). Therefore, the rtCGM system was able to reduce the number of hypoglycemic events that occurred in individuals with a history of severe hypoglycemia or impaired hypoglycemia awareness.

The Diabetes Research Connection (DRC) is encouraged to see the difference these types of devices can make in the lives of individuals living with type 1 diabetes. It is through innovative research studies and technology development that these advances are possible. The DRC supports early career scientists in pursuing novel research geared toward diagnosing, treating, or curing T1D, as well as improving quality of life for those living with the disease. Learn more about the incredible projects that are taking place and find out how you can be a part of supporting these initiatives by visiting http://diabetesresearchconnection.org.

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Medicare to Reimburse for Dexcom G5 Mobile CGM for Type 1 and Type 2 Diabetes

Frequent blood glucose testing can be expensive, especially for individuals who must intensively manage their insulin and adjust dosages. The cost of supplies can add up, but they are a necessity for good health. Some individuals may soon see some relief as Medicare recently agreed to cover therapeutic continuous glucose monitoring (CGM) systems and provide reimbursement. The Dexcom G5 Mobile CGM is currently the only system approved by the FDA for making treatment decisions that falls under this coverage.

Reimbursement would be available for individuals on intensive insulin therapy (either through multiple daily injections or a CSII pump) with Type 1 or Type 2 diabetes. Given current estimates of the number of intensive insulin users receiving Medicare, this could mean that more than 1 million people could be eligible for CGM coverage.  Reimbursement would include not only the G5 receiver, but also sensors, transmitters, and BGM and related supplies.

Dexcom CEO Kevin Sayer explains, “This is a new era and a huge win for people with diabetes on Medicare who can benefit from therapeutic CGM. This decision supports the emerging consensus that CGM is the standard of care for any patient on intensive insulin therapy, regardless of age.”

The broad scope of coverage criteria could mean that even more individuals may be eligible for coverage than previously thought. According to Dexcom, criteria includes:

  • Have diabetes;
  • Have been using a home BGM and performing at least four checks per day;
  • Are insulin-treated with MDI or a pump; and
  • Have an insulin treatment regimen that requires frequent adjustment on the basis of therapeutic CGM testing results.

The Dexcom G5 Mobile is categorized as “Durable Medical Equipment” under Medicare Part B, and qualifies as therapeutic CGM because it can be used to make treatment decisions. In addition, the system’s non-adjunctive label claim was approved in December. The ruling regarding coverage moved forward very quickly, and is a step forward for individuals living with diabetes.

There are currently other CGM systems on the market, but they have not yet been approved by the FDA as therapeutic CGM, therefore are not subject to coverage at this time.

The Diabetes Research Connection is excited to see how this will impact patients with diabetes moving forward. The organization strives to enhance research into the prevention, treatment, and cure of Type 1 diabetes through donor-driven funding. To learn more and support emerging research, visit www.diabetesresearchconnection.org.

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