Top Type 1 Research Breakthroughs to Watch in 2024

New and improved insulin pumps and continuous glucose monitors (CGMs), artificial pancreas systems, beta cell regeneration, encapsulation, bionic pump therapy—plus clinical trials happening right now that render individuals insulin independent. 

These trailblazing discoveries alone should be reason enough to commemorate this time in history and hope for even broader breakthroughs on the T1D horizon. 

Type 1 Diabetes Research in 2024

When someone is diagnosed with type 1 diabetes, the first question they and their loved ones ask is how close are scientists to finding a cure? Since the discovery of insulin in 1921 (over 100 years ago!), diabetes treatment and technological advancements for the chronic disease have come in waves. Now, finally, the pendulum appears to be swinging with upward momentum.

Thanks to the American Diabetes Association (ADA), Breakthrough T1D (formerly JDRF), Diabetes Research Institute and continued government funding for the Special Diabetes Program (SDP), exploration into a cure continues to grow. More specifically, treatments to reverse, slow down and aid individuals with type 1 diabetes seem to have had a resurgence of late.

What's more, StartUp Health's T1D Moonshot Program offers opportunities to entrepreneurs, scientists and philanthropists to accelerate innovation toward managing the disease and finding a cure for T1D.

T1D Advances on the Horizon

When someone thinks of a cure – they expect the illness or disease to cease from being. There is hope for a biological cure for T1D. Ideally, concerning type 1 diabetes care, a cure requires the body to start producing its own insulin again and normalizing blood sugar levels without the added risk of immunosuppression drug side effects.

Here are some diabetes breakthroughs to watch for - that keep improving.

Diabetes Devices

High Tech Insulin Pump Therapy

The science behind automated insulin delivery (AID) systems using algorithms to determine the precise amount of insulin the body requires is growing exponentially. Minimalizing the need even to count carbs is revolutionary—a true artificial working pancreas.

Here are a few exciting artificial pancreas (AP) systems and algorithms:

 iLet®Bionic Pancreas System (approved for ages 6+)

This truly amazing insulin delivery system works with the Dexcom G6 or G7 CGM and only needs your weight. The Beta Bionics’ iLet ACE Pump and iLet Dosing Decision Software do all of the work for you—no more carb counting, correction factors, carb ratios, or pre-set basal rates to worry about. These additional factors can be burdensome and time-consuming which is why this bionic pump stands out.

Medtronic MiniMed™ 780G (AP system approved for ages 7+)

The new Medtronic MiniMed 780G is the only system with Meal Detection™ technology, real-time insulin adjustments, and auto-bolus corrections all day and night. If you miss a meal dose or underestimate a carb count, the MiniMed automatically delivers correction boluses of insulin without any work from you, as quickly as five minutes.

Tidepool Loop

Tidepool Loop is the first fully interoperable automated insulin dosing app, cleared by the U.S. Food and Drug Administration (FDA). The algorithm that allows for interoperability for CGMs and insulin pumps originated as a patient-led initiative. This advanced sensor-enabled insulin pump system has three key components: a CGM sensor sends glucose data through a “controller.” The controller then calculates how to adjust your insulin and sends a command to your insulin pump to change how much insulin is delivered.

Dexcom G7 CGM system (available for ages 2+)

The new enhanced CGM system to improve diabetes control is the Dexcom G7. The small wearable sensor sends real-time glucose readings every five minutes to your smartphone or watch to adjust your insulin output easily. The Dexcom G7’s improvement over the Dexcom G6 is the G7’s sensor is 60% smaller than the G6’s and has a simpler setup and faster warm-up – the G7 sensor warms up in 30 minutes, which is the shortest time of any CGM system. ‍

CGMs are known to improve a patient's blood sugar level, protecting against severe hypoglycemic episodes and the threat of diabetic ketoacidosis.

Interesting Fact: One would expect Dexcom’s popularity to reach both the T1D and T2D communities, but did you know that even individuals without diabetes are using CGMs to observe the impact of food on their glucose levels to make more informative nutritional choices?

Top Diabetes Therapies

Stem Cell Therapy Implantation

Stem cell therapy introduces stem cells into diseased tissue to stimulate the body’s self-healing. The incredible ability of stem cells is that they can multiply exponentially and transform into other cell types, like insulin-producing cells.

Islet Cell Transplantation & Islet Replacement Therapy

Islets are clusters of beta cells in the pancreas that produce insulin, the hormone needed to regulate blood sugar. In one type of islet replacement therapy treatment, doctors take healthy islets from an organ donor and inject them into an individual with T1D. In some cases, patients have reduced or completely stopped insulin injections. In June 2023, the FDA approved Lantidra, the first allogenic (deceased donor) islet cell therapy for type 1 diabetes.

CellTrans’s Lantidra cell therapy is currently used in adults suffering from severe hypoglycemic episodes. The therapy takes deceased donor islets and, with the aid of immunosuppressive drugs, renders the individual insulin-independent.

Vertex Pharmaceuticals is developing stem cell-based therapies for diabetes. Its islet replacement therapy for T1D is used in human clinical trials and has shown remarkable results. The cells used in Vertex Pharmaceuticals VX-880 are grown in a laboratory, where they can morph into islet cells.

As of June 21, 2024, Vertex Pharmaceuticals' VX-880 is being evaluated in a phase 1/2 clinical trial for patients with type 1 diabetes who have severe hypoglycemia and impaired hypoglycemic awareness.

The VX-880 therapy is administered with infusions into the hepatic portal vein and requires chronic immunosuppressive therapy to protect the islet cells from immune system rejection.

Interesting Fact: One patient from the Vertex clinical trial is 100% insulin-independent 270 days after receiving the therapy with an A1C of 5.2%. He is on immunosuppressive therapy but does not need insulin.

Moreover, researchers at the Massachusetts General Hospital in Boston, MA, are testing immune system medication and cell regeneration. The clinical trial incorporates the BCG vaccine (used to treat T.B.), which is believed to balance the autoimmune attack while regenerating insulin-producing cells.

Encapsulation of Islet Cells

Vertex is also involved in a trial using encapsulated stem cell-derived islets as replacement therapy and exploring gene-edited stem cell-based therapies to eliminate the need for immunosuppressive drugs. The body must not attack the insulin-producing islet cells for islet transplantation to work.

The idea behind islet cell encapsulation is to protect the threatened cells, therefore eliminating the immunosuppressive drugs that sometimes have adverse side effects. This strategy allows nutrients, oxygen and secreted hormones to enter a capsule while blocking immune cells from entering.

The VX-264 trial does not require immunosuppressive therapy as the device protects cells from the immune system’s attack.

CRISPR Therapeutics’ VCTX-211 clinical trial at the University of Alberta, Canada, is a gene-edited, stem cell-derived investigational therapy incorporating encapsulation and additional gene edits to enhance cell fitness. The durable, removable device is designed to protect and maintain the PEC211 cells.

Beta Cell Regeneration Research

Funding beta cell regeneration is one of Breakthrough T1D’s key research initiatives. Internally regenerating and protecting beta cells would essentially cure type 1 diabetes. Scientist Bridget Wagner, Ph.D. from the Broad Institute, believes they can use chemicals to induce beta cells to replicate. Preferably, they could develop a drug given to patients with type 1 diabetes to repopulate their beta cells to increase their number and function.

The trial PlpepToIDC at the City of Hope Medical Center in Duarte, CA, uses immune system medication and cell regeneration. This immunotherapy uses a patient’s immune cells and a beta cell protein to teach the immune system to stop attacking the insulin-producing beta cells. 

Also, the Umbilical T Cells Plus Liraglutide clinical trial study at the Second Xiangya Hospital in Hunan, China, uses cell regeneration and immune system modification. Regulatory T cells pulled from umbilical cord blood ex-vivo have shown the capacity to control immune responses in autoimmune diseases like T1D. 

Beta Cell Replacement Therapy

Beta cell replacement therapy is islet transplantation, where infused working beta cells are transferred into the liver’s portal vein. ViaCyte, a beta cell replacement company supported by Breakthrough T1D, has shown that its PEC-Direct therapy helps T1Ds produce insulin again. These PEC-01 cells are implanted under the skin to produce C-peptide, a biomarker for insulin. In July 2022, Vertex purchased ViaCyte for $320 million and, in turn, eliminated its main competition.

Taking this major player out of the game, Vertex gained rights to PEC-Direct, an implantable device infused with progenitor cells, developed inside the body, and PEC-Encap, a device in which the developed cells are protected from immune rejection by a semi-permeable membrane.

Additionally, Sernova, a regenerative medicine company, participated in a Breakthrough T1D-funded clinical trial showing that its cell replacement therapy, the Cell Pouch System™, can produce insulin in T1D patients. Sernova's immune protection technology protects the cells using medications that prevent immune system attacks.

Gene-Edited Replacement Therapy

To cure T1D, the body must regain the ability to make insulin, and the cells must be protected from the immune system’s assault. ViaCyte and CRISPR’s gene-edited precursor cells were the first to accomplish this feat. These genetically modified precursor cells are immune-evasive, which means they can function inside the body without the threat of an immune system attack.

Immunosuppressive therapy is not required to keep the cells alive in these cases. Clinical trials for VCTX210 are underway.

In 2023, Vertex brokered a deal with Lonza Bioscience, a global pharmaceutical biotech partner, to build a stem cell supply factory. The endeavor hopes to optimize an ample supply of stem cells at a commercial level. This powerhouse initiative to produce insulin-producing cells began construction late last year and will be solely for developing cells tested in Vertex’s VX-264 and VX-880 clinical trials. Operated by Lonza, the manufacturing building is expected to span over 130,000 square feet upon completion.

Diabetes Treatments

Tzield™

The immunotherapy drug Tzield, approved by the FDA in 2022, can delay the onset of T1D in a patient for up to three years. It's the first disease-modifying therapy to delay the onset of type 1 diabetes in at-risk individuals aged eight years and older. Since this drug can slow down the progression and halt the disease in some cases for up to three years, it’s optimistic that similar drugs can reverse and permanently stop the progression altogether.

Verapamil

In another Breakthrough T1D-funded study, researchers discovered that Verapamil, a drug approved to treat high blood pressure, could, in some cases, assist diagnosed T1D teens and children to produce more insulin, thereby stabilizing the insulin-producing beta cells. More studies are needed to validate the results and explore the potential side effects of the drug.

Diabetes Testing

The misdiagnosis of T1D in young adults with type 2 diabetes is an increasingly dangerous problem, which is why testing is so vital to assist those who might have a family history or who are experiencing symptoms. Breakthrough T1D and IQVIA partnered to develop an algorithm using artificial intelligence to identify individuals diagnosed with T2D who actually have T1D. Enable Biosciences also has a simple blood test to determine the correct type of diabetes accurately.

Fun Fact: Humans aren't the only species benefitting from high tech devices. Man's furry best friends, who happens to develop diabetes, can also partake in the wonder of medical science.

A Cure for All

Undoubtedly, it’s an exciting time in history with giant strides and milestones for diabetes mellitus research. Scientists have connected the dots and concentrated their efforts on diabetes management. Moving past simply controlling blood glucose levels with pumps and CGMs to patients participating in clinical trials to reverse T1D—is monumental. When these great ideas come together, a breakthrough cure is sure to follow.