Thanks to Breakthrough T1D supporters like you, the power of the type 1 diabetes (T1D) community actively works to improve the lives of people living with the disease. This top 10 list reflects recent advances across T1D research, with many funded by Breakthrough T1D or the Breakthrough T1D T1D Fund. Others were advanced by the National Institutes of Health’s Special Diabetes Program, The Leona M. and Harry B. Helmsley Charitable Trust, or by the private sector that made T1D a priority in their research and development programs:
1. The second artificial pancreas system approved by the FDA
In December 2019, the Food and Drug Administration (FDA) authorized an algorithm that enables the second artificial pancreas system: The Tandem Control-IQ™ advanced hybrid closed loop technology. It’s the first algorithm authorized as an interoperable automated glycemic controller, which means the algorithm could be a component of any open protocol, or interoperable, artificial pancreas system (for now, though, the algorithm can be used with Tandem’s t:slim X2™ insulin pump and Dexcom’s G6 continuous glucose monitor (CGM)). Data came from the International Diabetes Closed Loop Protocol-3 (iDCL) trial, funded by the Special Diabetes Program. The study met all of its primary and secondary endpoints, including time-in-range and HbA1c, with no fingersticks and no severe low blood sugar events—a dangerous event for people with T1D.
Breakthrough T1D has been a leader in artificial pancreas systems for 15 years, from developing a roadmap for artificial pancreas development and partnering with the FDA and the Helmsley Charitable Trust to create a regulatory pathway for approval and commercialization of this technology. Industry experts have said that Breakthrough T1D’s involvement cut five years off the approval process for the Medtronic 670G artificial pancreas system in 2016, the first approved system.
This is a win for the T1D community, and it provides people with T1D another option to improve daily blood-sugar management.
2. Teplizumab delays T1D for more than two years
For the first time ever, an immune therapy treatment, called teplizumab, was able to significantly delay—for over two years—the onset of T1D in participants with a high risk of developing the disease. Breakthrough T1D funded one of the first clinical trials of this drug, and funds TrialNet, who conducted the study. Teplizumab is now being tested in a phase III clinical trial in people recently diagnosed with T1D, headed by Provention Bio, a company with an investment from the Breakthrough T1D T1D Fund. The FDA has also granted Breakthrough Therapy Designation to teplizumab in individuals at-risk of developing the disease.
3. European approval of two adjunct therapies
The European Commission has approved two medications that help in glucose management by preventing the kidneys from reabsorbing glucose back into the blood. The Commission approved SGLT inhibitors for T1D: Forxiga® (dapagliflozin and marketed in the United States as Farxiga) and Zynquista™ (sotagliflozin), when used in conjunction with insulin to improve glycemic control.
4. FDA approves two treatments for low blood sugar
The FDA approved Baqsimi, the first non-injectable emergency treatment for severe episodes of low blood sugar (hypoglycemia). Severe hypoglycemia means that another person has to administer treatment because the person with T1D has impaired or lost consciousness or may be having a seizure. Injectable glucagon has been approved in the United States for several decades, but this is the first non-injectable treatment. The FDA also recently approved a glucagon pre-filled syringe and auto-injector created by Xeris Pharmaceuticals, which is also funded by Breakthrough T1D to develop a bi-hormonal pump with insulin and glucagon. The GVOKE line of products features the first pre-mixed, pre-filled liquid glucagon formulation on the market.
5. Pharma makes a landmark investment in T1D research
In the largest deal to date of a T1D cure-based therapeutic program, Vertex Pharmaceuticals acquired Semma Therapeutics for $950 million. Semma was founded in 2015 with the goal of commercializing research to make beta cells from human-derived stem cells. The research team, led by Douglas Melton, Ph.D., had support from Breakthrough T1D since 2000 and, in 2017, the Breakthrough T1D T1D Fund provided an important investment in the company.
6. Recommendation: Pregnant women with T1D use continuous glucose monitors (CGMs) to monitor blood sugar
The United States has joined Australia and the United Kingdom in recommending that CGMs be used to improve HbA1c outcomes in pregnant women with T1D. Breakthrough T1D funded the CONCEPTT trial, which showed that using a CGM during and prior to pregnancy improves the health outcomes for both mothers and babies. It was the CONCEPTT trial that made the American Diabetes Association revise its clini