In this week’s issue of The Savvy Diabetic:
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- Diabeloop’s DBLG2 cleared for automated insulin delivery without meal input
- Medtronic wins expanded FDA label for 780G insulin pump
- Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study
- The ISLET Act to Increase Support for Endocrine Transplantation Act
- TCOYD: The Diabetes Guide for Aging Well
- Why people living at higher altitudes are less prone to diabetes
- GLP-1 Receptor Agonists & Reduced Mortality after Diabetic Foot Ulcers
- The Microbiome – What We Know So Far – Sabine Hazan, MD
- Now We Know What a Type 1 Cure Could Look Like
Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input by PMGroup, 19 February 2026.
Diabeloop, a company developing AI-based diabetes management systems, has announced that its DBLG2 has become the first automated insulin delivery system for which meal announcements are no longer mandatory to obtain clearance from the US FDA, as well as a CE Mark, for patients with type 1 diabetes.
A lack of meal announcements can potentially lead to lower glycaemic control. However, Diabeloop’s approach offers people living with diabetes greater choice and autonomy. With DBLG2’s advanced adaptive algorithm, users benefit from an automatic correction mechanism, even when a meal is not announced. This innovation offers a new user experience that prioritises daily quality of life by reducing the cognitive workload associated with diabetes management, though it may result in a reduction in glycemic control compared to fully announced meals.
Read more: Diabeloop’s DBLG2 receives FDA and CE clearance for automated insulin delivery without meal input
Medtronic wins expanded FDA label for 780G insulin pump by Nick Paul Taylor for MedTEchDive.com, 5 February 2026.
FDA has cleared the 780G system for use with the ultra-rapid-acting insulins Fiasp and Lyumjev. Sanofi’s Merilog is not named on the expanded label. Medtronic said using 780G with Fiasp and Lyumjev could cut the impact of inexact carbohydrate counts and missed or delayed mealtime doses of insulin. The products act faster than other insulins to reduce the impact of late or missed meal doses. Medtronic said the clearance will allow individuals to choose the insulin that best matches their physiology and lifestyle.
The CGM clearance enables further integration with the Instinct sensor, a product that was the focus of a label expansion in September and a launch in December. Medtronic said the clearance covers the use of its SmartGuard algorithm as an interoperable automated glycemic controller and the 780G pump as an alternate controller enabled for insulin-requiring Type 2 diabetes. Medicare and Medicare Advantage beneficiaries can now access MiniMed 780G with the Instinct sensor. Medtronic said customers who previously placed orders for the device combination will follow the standard Medicare billing and fulfillment process.
Read more; Medtronic wins expanded FDA label for 780G insulin pump
Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study by Portal Diabetes, reported on PRNewsWire.com, 17 February 2026.
Portal Diabetes, Inc. announced receipt of the Food and Drug Administration’s Breakthrough Device Designation for its implantable insulin pump system, the “Portal Pump,” and the start of a Phase 1 study of its proprietary temperature-stable insulin.
The Breakthrough Device Designation will facilitate priority interactions with the FDA as Portal plans clinical trials and navigates regulatory approvals, and the designation establishes eligibility for the Transitional Coverage for Emerging Technologies (TCET) pathway, expediting Medicare coverage for FDA-designated breakthrough devices. Under an Investigational New Drug application, the first two patients recently received Portal Insulin by intraperitoneal injection at a clinical site in San Diego, California, marking a major milestone for the Portal Pump Combination System.
“We believe patients will achieve much better glycemic control for a dramatically reduced mental burden with the Portal Pump,” expressed Stacy Chambliss, Chief Executive Officer (CEO). “No more meal announcements, no more exercise announcements, no more night wakings; that is our goal. Step by step, we are working diligently to bring long-awaited technology to patients living with type 1 diabetes. Today, we celebrate the first clinical injections of Portal Insulin, a momentous occasion for the combination system.”
Read more: Portal Diabetes Gets FDA Breakthrough for Pump, Starts Insulin Study
The ISLET Act to Increase Support for Life-saving Endocrine Transplantation Act was introduced in the 119th Congress to regulate the use of human cadaveric islets for transplantation as organs.
This bill, known as the Increase Support for Life-saving Endocrine Transplantation (ISLET) Act, aims to regulate human cadaveric islets (specialized cells in the pancreas that produce insulin) as organs for transplantation. The bill amends the Public Health Service Act to explicitly include human cadaveric islets in the definition of transplantable organs. It also clarifies that human cadaveric islets are not considered drugs, biological products, or human cells, tissues, or cellular products under existing regulations.
This is somewhat controversial … I’ve included a few resources.
According to Devin Holt, a nurse anesthetist and father to a T1D daughter and an advocate for the Islet Act, “the United States is the ONLY developed Nation that BANs donor derived Islet cell transplant to cure Type 1 Diabetes. Our own National organization Breakthrough T1D has done NOTHING to support the Islet Act Legislation that would greatly accelerate the United States to an approved curative therapy for 2 million Americans (10 million worldwide) suffering from Type 1 Diabetes! The very organization that we give MILLIONS to every year to cure Type 1 diabetes! We have a solution and cure right in front of us and they are doing NOTHING to support this legislation that would allow 2 million Americans ACCESS to the CURE!
We are throwing away pancreases every day that could be used to cure people like Katie Beth Hand! She is patient #9 and has been CURED of Type 1 Diabetes using donor-derived Islet cells in the very exciting trial using Eledon Pharmaceuticals, Inc.’s new miracle drug Tegoprubart!”
Read more:
The Diabetes Guide for Aging Well with Dr. Steve Edelman, Dr. Athena Philis-Tsimikas and Joanne Milo for TCOYD.com, 19 February 2026.
Dr. Steve Edelman was diagnosed with Type 1 diabetes at 15 and told he might not live past 40. He’s still here — and so are thousands of others who were given the same prognosis. In this conversation, Steve sits down with Dr. Athena Philis-Tsimikas, endocrinologist at Scripps Whittier, and Joanne Milo, a 61-year T1D veteran and founder of https://t1dto100.com, to talk about what aging with Type 1 actually looks like — the physiology, the fears, the technology, and how to keep living a long, happy, and healthy life!
Why people living at higher altitudes are less prone to diabetes by Ezzy Pearson for ScienceFocus.com, 19 February 2026.
High altitudes could compel red blood cells to act as ‘glucose sponges’, helping to keep blood sugar levels in check, a new study has found. The team hopes the discovery will lead to new therapies to manage diabetes and has already developed a medication that reproduces the effect in mice.
Scientists have long known that diabetes rates are lower among people living at higher altitudes, where oxygen levels are lower. In the US, people living 4,920ft above sea level are 12 per cent less likely to have diabetes than those living at altitudes below 1,640ft.
In a new study, published in Cell Metabolism, Dr. Yolanda Martí-Mateos, a postdoctoral scholar from Gladstone Institutes, reported, “red blood cells born in hypoxia are special, as they possess more glucose transporters than regular blood cells.” The team hopes the discovery will serve as a ‘proof of concept’ that will inspire new diabetes treatments.
“We’re excited about a small molecule our lab developed called HypoxyStat, which mimics the effects of low oxygen without actually reducing the oxygen you breathe,” said senior author Dr. Isha Jain, also from Gladstone Institute, to BBC Science Focus. When they gave mice the drug, it completely reversed their high blood sugar levels and did so far more effectively than existing medications.
Read more: Why people living at higher altitudes are less prone to diabetes
GLP-1 Receptor Agonists Are Associated With Reduced Mortality Following Diabetic Foot Ulcers by Jean-Baptiste Connect et al, for DiabetesJournals.org, 30 January 2026.
This nationwide study aimed to identify factors associated with 1-year mortality following a first diabetic foot ulcer (DFU) using the French National Health Data System (SNDS). A secondary objective was to analyze mortality after major lower-limb amputation within the same timeframe.
One-year mortality after DFU remains high and is strongly linked to age and comorbidities. Community-based identification highlights the vulnerability of these patients, even outside hospital settings. Glucagon-like peptide 1 receptor agonists and structured, multidisciplinary follow-up are associated with better survival and should be prioritized.
Read more: GLP-1 Receptor Agonists Are Associated With Reduced Mortality Following Diabetic Foot Ulcers
the(sugar)science T1D Th1nk Tank Presents: The Microbiome – What We Know So Far – Sabine Hazan, MD Zoom presentation, 24 February 2026. Discussion: How might microbiome and FMT inform autoimmune diseases, with Sabine Hazan, MD
As the first woman accepted into the University of Florida as a Clinical Gastroenterology Fellow and a specialist in gastroenterology, internal medicine, and hepatology, Dr. Sabine Hazan is a pioneer in medicine. She is also a speaker for the World Congress of Digestive Disease, MAGI, Microbiome Congress, ILADS, TACA, International Drug Discovery Science and Technology Conference, and NIST (National Institute of Standards and Technology).
Dr. Hazan is the CEO of Ventura Clinical Trials, where she has 20+ years of experience leading clinical trials for cutting-edge research on various medical issues and has conducted over 300 clinical trials for pharmaceutical companies. She is also the founder & CEO of Progenabiome, a genetic sequencing research laboratory, and she leads 35+ studies investigating the role of the gut flora in various diseases.
To Register: The Microbiome – What We Know So Far
Now We Know What a Type 1 Cure Could Look Like by Tim Street for Diabettech.com, 14 February 2026.
For the first time, the cure conversation is no longer built mostly on hope, extrapolation, and mouse data. It’s being shaped by human evidence — and that evidence is starting to converge on a surprisingly coherent blueprint. It isn’t a single breakthrough. It’s an engineered architecture: a combination of strategies that each solve a different part of the immune problem that makes Type 1 diabetes uniquely difficult. And crucially, those components are no longer hypothetical. We now have human evidence for each part of the cure puzzle.
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- Vertex settled the first argument: the cells can work. Can we make insulin-producing cells that behave like real human islets? Vertex has now answered that, and the answer is yes.
- Type 1 diabetes is not one immune problem. It is two. The problem is that Type 1 diabetes isn’t only transplant rejection. It includes a second, disease-specific immune system: autoimmune memory against beta cells.
- VX-264 didn’t just fail. It taught the field what won’t be enough. VX-264 tested the simplest “no immunosuppression” concept: take the same proven cells, put them behind a protective device, and let glucose and insulin diffuse while blocking immune attack. In theory, it was the most intuitive next step.
- Sana is testing the next logical step: immune invisibility. Can we prevent immune destruction without systemic immunosuppression? Sana’s approach aims to engineer cells so they are less recognisable to the immune system — essentially reducing their visibility to it. If successful, this would allow cell replacement therapy to move beyond the narrow subset of people for whom the risk of immunosuppression is acceptable.
- ProTrans adds a different kind of evidence: autoimmunity can be reshaped for years. NextCell’s ProTrans is not a cell replacement therapy. It is a disease-modifying therapy designed to preserve endogenous beta cell function early in Type 1 diabetes through immune modulation. And that distinction matters, because it speaks directly to immune wall number two: autoimmune memory.
- The “Immune-First” What-If: Could modulation come before replacement? What if the cure pathway doesn’t start with cell replacement? What if it starts with immune preparation?
- Let’s be even more provocative: could immune modulation be enough for some people? ProTrans and other immune-modulating approaches are typically framed as “disease-modifying,” not “curative,” because they don’t replace lost beta cells. But a subtle possibility lies in that framing. Many people with long-duration Type 1 diabetes still have tiny traces of beta-cell function. Sometimes it’s so small that it doesn’t meaningfully change insulin dosing — but it can show up as a low but detectable C-peptide. The question is: what does that tiny residual function represent?
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The Three Milestones That Would Confirm the Blueprint:
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- 1st milestone: insulin independence without chronic systemic immunosuppression
- 2nd milestone: evidence that the autoimmune component of Type 1 diabetes can be durably suppressed, reshaped, or functionally neutralised without paying the price of broad immunosuppression.
- 3rd milestone: the combination moment: a therapy stack that explicitly treats Type 1 diabetes as a dual-immune problem, not a single obstacle
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