On June 17, Tandem Diabetes announced FDA clearance of an expanded pediatric indication for the Tandem t:slim X2™ insulin pump with Control-IQ™ technology in children ages six and older. This device was initially only authorized for use in people 14 and older. Simply put: more people now have access to this life-changing technology.

“Today’s clearance by the U.S. Food and Drug Administration (FDA) extending the pediatric indication of the t:slim X2 Insulin Pump with Control-IQ Advanced Hybrid Closed-Loop Technology is another big win for the T1D community and especially for our youngest members,” said Sanjoy Dutta, Ph.D., Breakthrough T1D Vice President, Research. “With this technology now available to children ages six and above, families have an additional option to explore as they seek to find the system that best suits their needs.”

The data for the clearance came from the International Diabetes Closed Loop Protocol-5 (DCLP5), a six-month study of children ages 6-13. This study was funded by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with funds from the Special Diabetes Program (SDP), for which Breakthrough T1D is the primary advocate. The results are definitive: Control-IQ™ helps children with T1D do better.

Per Tandem’s announcement, children in the six-month trial experienced:

Control-IQ™ first received FDA authorization for people 14 and older on December 13, 2019. Critically, at the time, it became the first algorithm authorized as an interoperable automated glycemic controller, meaning the algorithm could be a component of an open protocol, or interoperable, artificial pancreas system.

Breakthrough T1D has been a leader in the development of artificial pancreas systems since starting the Artificial Pancreas Project over 15 years ago. Through years of research funding, collaboration with regulatory agencies and leadership in the field, Breakthrough T1D has helped accelerate the development of transformative therapies that make life better for people living with T1D. Breakthrough T1D has also been a leading advocate for coverage, affordability and choice for diabetes technology and the insulin people need through our Coverage2Control campaign. People with T1D need options, which is why Breakthrough T1D continues to call upon United Healthcare to lift its restrictions on insulin pump coverage, and cover all FDA authorized devices.

Today is a big win for the T1D community that will help a lot of children (and their parents!) sleep better at night.

PhysioLogic Devices, a Breakthrough T1D-funded company that is dedicated to transforming the treatment of type 1 diabetes (T1D), wants to develop the ThinPump™—a fully implantable automated insulin delivery system—in the next four years. We think it’s not only possible, but doable. PhysioLogic has two things going for it:

Gore is well known for developing GORE-TEX Products, the waterproof and breathable laminates used in outerwear. But that’s not all the company creates. It also makes air filters, headlight vents, heart stents and more. Gore was established more than 60 years ago, and generates annual revenues of $3.7 billion. Recently, Gore has started investing in the development of novel diabetes management technologies.

The standard of care for people with T1D involves insulin injections under the skin, known as the subcutaneous route. There are several known problems with this route of insulin delivery. First, the absorption of insulin from under the skin is slow, causing spikes in blood sugar after a meal. Second, the absorption of insulin from under the skin may continue for several hours after an injection, long after a meal has been fully absorbed. This causes blood sugar to fall to low levels hours after a meal. Slow insulin absorption and slow insulin clearance together cause blood glucose to alternately go high and low, outside of the normal range, in a roller-coaster manner that is well-known to people with T1D. It also makes it challenging to manage blood sugar levels during and after exercise.

But both of these problems can be corrected by delivering insulin into the abdominal space—via the intraperitoneal route. This route allows insulin to be processed in a manner that more closely resembles what happens in the body of someone without diabetes and the advantages of intraperitoneal insulin delivery over subcutaneous insulin delivery have been established in multiple clinical studies.

PhysioLogic’s mission is to create a fully implantable automated insulin delivery system—the ThinPump™—using intraperitoneal insulin delivery and an accurate and reliable glucose sensor, which could enable fully automated blood sugar control with no required user input. In addition, users would no longer have to worry about on-body devices or managing infusion set insertion sites. It’s a lofty goal, to be sure, but PhysioLogic is aggressively working towards starting the first-in-human clinical studies in less than four years.

In Europe, a similar product, Medtronic MiniMed™ Insulin Pump, has been used since the early 1990s. But translation of the MiniMed™model intraperitoneal insulin pump into the wide population has been small, due to several factors. The MiniMed™ model shows a bulge in the abdomen after transplantation, making it less attractive. And, manufacturing costs were too high. The ThinPump™ is predicted to be half the thickness of the MiniMed™ model, making it inconspicuous and significantly reducing manufacturing costs. Breakthrough T1D’s investment is bringing more dollars to T1D, and we celebrate this new line of funding for PhysioLogic Devices, which may lead to commercialization of this innovative technology. You can learn more about PhysioLogic Devices by visiting their website: PhysiologicDevices.com

Earlier this week, Beta Bionics announced that the Food and Drug Administration (FDA) has granted breakthrough device designation to the company’s iLet Bionic Pancreas System, a wearable pocket-sized device used for blood sugar control in people with diabetes. The device can be adjusted to work as an insulin-only, glucagon-only or bi-hormonal artificial pancreas using both insulin and glucagon.

Breakthrough T1D funded Ed Damiano, Ph.D., CEO of Beta Bionics, for his early research testing the safety and efficacy of a novel closed-loop system that incorporated the use of glucagon in addition to insulin. The results of this work helped to inform the development of the iLet bionic pancreas, which includes a configuration with a dual-chamber pump containing insulin in one chamber and glucagon in the other.

How is the iLet bionic pancreas system different than other artificial pancreas systems? Well, unlike most closed-loop systems on the market and in development, which use only insulin to normalize blood sugar levels, iLet has the ability to pump two hormones: insulin and glucagon. Glucagon, a key hormone whose response is impaired in type 1 diabetes (T1D), can help raise blood sugar levels when they become too low. This dual-hormone approach may enable the device to achieve tighter blood sugar control while minimizing low blood sugar, called hypoglycemia.

The Breakthrough Device Program is an FDA platform for more effective treatments of serious diseases, like T1D, and enables timely access to these devices by speeding their development, assessment, and review. Other companies that have received the FDA Breakthrough Device designation for T1D technologies include Breakthrough T1D partners EOFlow, Medtronic and Bigfoot.

What’s more, the iLet is designed to have the users enter only their weight for the iLet to initialize therapy. Immediately thereafter, the iLet begins controlling blood sugar levels automatically, without requiring the user to count carbohydrates, set insulin delivery rates, or deliver additional insulin for meals or corrections.

 The iLet, if results are positive, would be a welcomed additional approach to help people manage their T1D.

The Food and Drug Administration (FDA) today authorized an algorithm that enables the second artificial pancreas system: The Control-IQ™ advanced hybrid closed loop technology.

For now, the algorithm can be used with Tandem’s t:slim X2™ insulin pump and Dexcom’s G6 continuous glucose monitor (CGM). Though this is not the first algorithm approved for an artificial pancreas system, it is 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. Formerly, there was only one FDA approved artificial pancreas system on the market: The Medtronic 670G, approved in 2016.

Enabling open systems is a priority for Breakthrough T1D—meaning that insulin pump, a CGM and an algorithm can “talk” to each other, regardless of the manufacturer. This gives the T1D community more choice and flexibility to select the technology that works best for them.

Breakthrough T1D has been a leader in the development of artificial pancreas systems for 15 years, since starting the Breakthrough T1D Artificial Pancreas Project in 2005 and the Breakthrough T1D Artificial Pancreas Consortium, which have dramatically accelerated progress by bringing academic researchers, government agencies, industry and the Helmsley Charitable Trust together to pursue artificial pancreas technology.

Through these efforts, Breakthrough T1D developed a roadmap for artificial pancreas development with increasingly advanced versions of the device. Manufacturers embraced the roadmap to guide their own research and development programs.

Data for the submission to FDA came from the International Diabetes Closed Loop Protocol-3 (iDCL) trial, a six-month closed loop study, funded by the NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) with funds from the Special Diabetes Program (SDP). The clinical trial, with 168 participants ages 14+, which was recently published in the New England Journal of Medicine, met all of its primary and secondary endpoints, including time-in-range and HbA1c, with no fingerpricks and no severe low blood sugar events—a dangerous event for people with T1D, which, if not caught early, can lead to seizures, coma or, in extreme cases, death.

This important development is also a testament to the importance of the Special Diabetes Program (SDP), which has been renewed by Congress numerous times thanks to leadership by Breakthrough T1D.

The Special Diabetes Program (SDP) is up for renewal, so if you haven’t done so already, please sign up to be an advocate, and encourage friends and family to do the same. You’ll receive timely updates and actions you can take to turn Type One into Type None.

This is the latest example of how Breakthrough T1D research and advocacy work together to make T1D management better and safer. This is a win for the T1D community, and provides people with T1D another option to improve daily blood-sugar management, until cures are found.

Maribeth Stent was diagnosed with type 1 diabetes (T1D) in the fall of 1997. “It was right around my second birthday,” said Maribeth. She is now a senior coordinator of community engagement at Breakthrough T1D, and she took part in a clinical trial of a hybrid closed loop artificial pancreas system at Yale University in Connecticut. It was an Insulet Omnipod insulin pump and the Dexcom G6 continuous glucose monitor (CGM), which were FDA-approved, plus an algorithm provided by Insulet, which wasn’t FDA approved—yet.

“When I arrived the first day of the trial….we each had our pump sites and sensors set up and inserted,” says Maribeth. “Right away, I was in closed loop! Every few minutes, the system would use the CGM data and other factors such as meal boluses and activity to adjust insulin dosing. It was so neat to watch the system automatically make decisions that I normally would have had to make on my own.”

Some people think that being in a clinical trial is scary or unpleasant. But Maribeth feels differently. “The clinical team made me feel super comfortable and safe from the very first day in the enrollment visit. They kept me informed every step of the way, and reminded me that I could end the trial at any time.”

She added: “I would encourage everyone living with type 1 diabetes to explore clinical trials that they may be eligible for. Studies like the one I participated in make more options for the type 1 diabetes community available faster.”

Great idea! One way to search for clinical trials is to use the Breakthrough T1D online, easy-to-use tool called the Clinical Trials Connection. It asks users simple questions—about where they live, the distance they can travel and other characteristics—to match them with trials for which they are eligible. Currently, there are more than 300 clinical trials for people at-risk of, living with or that have complications of T1D. Start the clinical trials matching process here.

Anything else you want to add, Maribeth? “When you’ve had T1D for so many years, it can feel frustrating how slowly new technology and therapies become available. I have a new perspective and an understanding of the process—these things take time!”

Yes, they do, but having people like you, Maribeth, who will take part in a clinical trial, make the process much quicker. You are my champion, and I hope that others will follow your lead.

Two leading innovators in the type 1 diabetes (T1D) space have announced a collaborative partnership aimed at enabling those with T1D to select favorite devices, knowing they all work together, even if made by different companies.

The nonprofit company Tidepool announce that it is partnering with leading pump manufacturer Medtronic to create an interoperable automated insulin pump system.

Breakthrough T1D is an early supporter of Tidepool and a strong advocate for Open Protocol, which calls for T1D technologies to all work together, even if made by different manufactures.

Through the partnership, Medtronic will develop a future Bluetooth-enabled MiniMed™ pump that would be compatible with Tidepool Loop, an open-source automated insulin delivery app for iPhone and Apple Watch currently in development.

“In an era of empowered health consumers, this collaboration opens up new opportunities for people with diabetes to choose the technology that’s right for them,” said Howard Look, Tidepool Founder and CEO.

The two companies announced their partnership at the 79th Scientific Sessions of the American Diabetes Association (ADA) being held in San Francisco.

Tidepool Loop is an automated insulin delivery app for iPhone that connects to an insulin pump and CGM using Bluetooth LE. It runs an algorithm every five minutes to adjust your basal rate for the next 30 minutes, helping you reduce or avoid high and low blood glucose.

As part of the agreement, Medtronic will contribute financial support to Tidepool for the integration development effort and develop a software development kit to enable iPhone to pump communication.

Read more here.

A new artificial pancreas system that both doses and takes away insulin is showing critical benefits in helping those with type 1 diabetes maintain more consistent, and healthier, glucose levels.

Two studies, shared this weekend, showed that the t:slim X2™ insulin pump with Control-IQ™ advanced hybrid closed-loop technology by Tandem® Diabetes Care resulted in more time in range—less highs, less lows—with no severe hypoglycemic events.

“Fantastic results, showing the potential for another system for the T1D community in sight,” said Breakthrough T1D President and CEO Aaron Kowalski, Ph.D.

The t:slim X2 insulin pump with Control-IQ technology utilizes Dexcom G6 continuous glucose monitoring (CGM) sensor values to predict glucose levels and adjust insulin delivery to prevent highs and lows, while still allowing the user to manually bolus for meals. The system also automates correction boluses, which is a feature not commercially available today on automated insulin delivery devices.

The results of the first large-scale, 6-month closed-loop study, were presented at the 79th Scientific Sessions of the American Diabetes Association (ADA) being held in San Francisco. Company leaders say they will now share the study results with the FDA, hoping approval would lead to a commercial launch in the second half of 2019.

Critical in determining potential benefits of the technology, the study was funded by the U.S. Special Diabetes Program. Breakthrough T1D is a leading advocate for the annual renewal of the SDP program, as it supports critical T1D research such as this study.

Breakthrough T1D also has been an early and long-term funder of research that helped lead to the development of this new technology.

“Combining Tandem’s t:slim X2 pump with Control-IQ technology and the exceptional accuracy of our Dexcom G6 CGM—which requires zero fingersticks for operation—has delivered what promises to be the most advanced, simple-to-use hybrid closed-loop system to date,” said Kevin Sayer, president and CEO of Dexcom. “The impressive data released today, combined with our iCGM classification, will help to accelerate innovation and bring powerful insulin delivery tools to people with diabetes more quickly.”

To learn more, read Tandem’s media release here.

There was some really amazing results out here in San Francisco! Here is Dan Finan, Ph.D., head of the Breakthrough T1D’s artificial pancreas and glucose control programs, to recap the day:

What do Aaron Kowalski, Ph.D., president and CEO of Breakthrough T1D, and Jeremy Pettus, M.D., an endocrinologist at the University of California San Diego and a Breakthrough T1D grantee, have in common? Well, for one, they both have type 1 diabetes (T1D), an autoimmune disease in which the pancreas does not make enough insulin to control blood sugar levels. But I’m looking for something even rarer.

The answer: Both Kowalski and Pettus wear a DIY artificial pancreas system. An artificial pancreas system, or an automated insulin delivery device, is when a continuous glucose monitor (CGM)—which takes blood sugar levels every five minutes—and an insulin pump can “talk” to each other via an algorithm, giving the body the right amount of insulin at the right time, the way a normal pancreas would do naturally. And both are featured in the DIY artificial pancreas piece out this month in The Atlantic.

The article goes through the DIY artificial pancreas technology—from OpenAPS and Loop, which provide the algorithm to dose appropriately, to the aftermath of a DIY artificial pancreas system (warning: it involves sleep, and lots of it!). But it is also a “self-selecting bunch,” says the author, “as the systems require buying your own equipment out of pocket and following detailed setup instructions.” Still, the artificial pancreas system will be the future for T1D, and “might be all that kids today ever know.”

The end game, says Kowalski, “is to have multiple compatible pumps, glucose sensors, and algorithms, so that patients can mix and match what they prefer.” We hope that day comes quickly, and people with T1D have an artificial pancreas system that is preferred and useful, until a cure is found.

You can read the article, titled “People Are Clamoring to Buy Old Insulin Pumps,” in The Atlantic.

Happy reading!

Incredible strides have been made since the discovery of insulin almost 100 years ago. Insulin formulations have improved dramatically, blood-sugar levels can be measured continuously and first-generation artificial pancreas systems have reached the market. Yet only a small percentage of people with type 1 diabetes (T1D) achieve their blood sugar goals. In a review published online in Cell Metabolism, members of the Breakthrough T1D Research Team—including Aaron Kowalski, Ph.D., Esther Latres, Ph.D., and Dan Finan, Ph.D.—survey the road ahead for two of the most promising diabetes treatments: artificial pancreas systems, which can automate insulin delivery, and beta cell replacement therapies.

First-generation artificial pancreas systems combine a continuous glucose monitor (CGM) with an insulin pump and an algorithm that calculates and delivers an optimal amount of insulin based on current, and sometimes future predictions of, blood sugar trends. First-generation systems currently automate only insulin delivery, and they require users to deliver an extra dose of insulin at mealtimes. But Dr. Finan, lead of the Artificial Pancreas Program at Breakthrough T1D, notes the following pathway to getting more advanced and convenient artificial pancreas systems to users:

“Artificial pancreas systems are improving people’s lives today, and these systems will get significantly better over the foreseeable future, providing further benefits related to both glucose control and reduced burden,” says Dr. Finan. “While we are truly excited to realize the full potential these systems have to offer people who choose them, we also understand that they are not for everyone and that beta cell replacement therapies may drive even more value to the type 1 diabetes community.”

The replacement of insulin-producing cells by transplantation shows significant promise. It is limited, however, in application due to supply constraints and the need for chronic immunosuppression. Over the past decade, significant progress has been made to address these barriers to widespread implementation of a cell therapy.

A beta cell replacement therapy will require: (1) an unlimited cell source of highly functioning insulin-producing cells; (2) a strategy to protect the implanted cells from the immune-mediated destruction, which would eliminate the need for lifelong immunosuppression; and (3) an optimal implantation site that provides a nurturing niche in which it can release insulin to fluctuating blood sugar levels. At Breakthrough T1D, we are funding these three gaps in beta cell therapy, with the aim to develop a beta cell replacement treatment that works for a lifetime.

“Breakthrough T1D is at a unique crossroad to accelerate both artificial pancreas and cell-based therapies for the greatest benefit of people living with T1D,” says Dr. Latres, head of the Beta Cell Replacement Program at Breakthrough T1D. “While cell therapies may have a longer path to deliver a functional cure, we look up to emulate the visionary roadmap that the artificial pancreas field has successfully planned and achieved to improve the outcomes and management of type 1 diabetes.”

So, the authors ask, who wins: artificial pancreas systems or beta cell replacement therapies? They don’t divulge, but ultimately the winner is people living with diabetes.

“One hundred years after the discovery of insulin, we stand upon another potential major advance—perhaps the true cure that was envisioned in 1921,” says the final sentence.

We hope so.

If you want to hear more about what Breakthrough T1D is doing to bring type 1 into type none, go to jdrf.org.