Hey readers! Here's something you don't hear often in T1D care: a treatment gap that's sat mostly untouched for three decades just got a new tool. This week we lead with Kerendia's FDA nod for kidney disease in type 1, then walk through what the fine print actually says, plus a fresh crop of research and device news worth your attention.
🫘 Kerendia gets a green light for T1D kidney disease
Bayer's Kerendia Wins FDA Approval As First New CKD Treatment For Type 1 Diabetes In 30 Years reports that the FDA approved Kerendia (finerenone), a once-daily non-steroidal mineralocorticoid receptor antagonist, for adults with chronic kidney disease associated with type 1 diabetes. Bayer describes it as the first new CKD treatment in more than 30 years for this population. – RTTNews
Why this lands: the article notes that 20-30% of people with T1D in the U.S. also have CKD, and for years clinicians have leaned on blood pressure drugs and off-label SGLT2 inhibitors to slow kidney decline. The label centers on reducing urinary albumin-to-creatinine ratio (UACR), a marker of kidney damage, with the expectation of slowing progression and lowering the risk of sustained eGFR decline and end-stage kidney disease.
"Kerendia (finerenone) is a non-steroidal mineralocorticoid receptor antagonist designed to reduce urinary albumin-to-creatinine ratio (UACR), a key marker of kidney damage, and is expected to slow CKD progression and reduce the risk of sustained eGFR decline and end-stage kidney disease in this population."
Dr. Janet McGill of Washington University School of Medicine, who co-chaired the study's executive committee, said the approval gives patients an important new option after decades of limited choices for managing CKD progression in T1D.
🔍 What the approval does and doesn't prove
This looks like AI…
Before anyone reshuffles their medication plan, the Syenza News breakdown is worth reading closely. It points out that this is not a conventional "hard outcomes" approval: the main supporting study, FINE-ONE, was a 242-patient, six-month albuminuria trial. The harder renal and cardiovascular event data in type 1 were inferred from the type 2 diabetes program (FIDELIO-DKD and FIGARO-DKD). – Syenza News
"The decision is clinically meaningful and commercially useful, but it is not a conventional outcomes approval."
That framing matters for how you and your care team think about expectations and coverage. Syenza notes U.S. payers are expected to lean on surrogate endpoints, including a possible 30% UACR reduction threshold, and to require monitoring such as potassium and eGFR checks. It also flags that outside the U.S., there was no type 1 CKD authorization as of September 17, 2026.
On availability, Next Edition reports that Bayer says Kerendia has started reaching eligible patients through U.S. pharmacies, calling it the first oral mineralocorticoid receptor antagonist indicated for people with T1D experiencing kidney decline. That piece also underscores the monitoring point: because this drug class carries a known hyperkalemia risk, specialists and patient-organization guidance recommend regular serum potassium and kidney function checks when starting finerenone. – Next Edition
💙 The advocacy angle
Breakthrough T1D Celebrates Approval of First New Treatment for People with Type 1 Diabetes and Chronic Kidney Disease in 30 Years traces the organization's role in getting here. Breakthrough T1D says it collaborated with Bayer to support the FINE-ONE phase 3 trial and notes finerenone was already approved for type 2 diabetes CKD since 2021 and for certain heart failure since July 2025. – Breakthrough T1D
"Today there are few treatments available for chronic kidney disease, a common complication of type 1 diabetes. The approval of finerenone is a huge win for the T1D community," said Jonathan Rosen, Ph.D., Breakthrough T1D Research Director.
The throughline across all four reports is the same: CKD affects nearly a third of people with T1D, and until now the toolkit was mostly borrowed from other conditions. This is a modest but genuine addition, best discussed with your nephrologist or endocrinologist alongside potassium monitoring.
🩸 Screening moves earlier
The New Global Type 1 Diabetes Screening Schedule covers international consensus guidance, published September 10, 2026 in Diabetologia, that lays out a three-stage childhood schedule for islet autoantibody testing: ages 2-4, 6-8, and 10-15, with catch-up and a one-time screen after age 15. A positive result needs a second confirmatory test, and two or more autoantibodies suggest stage 1 or stage 2. – Type1Strong
The motivation is stark. As the piece notes:
"Approximately 40% of children with type 1 diabetes aren't discovered until they're in DKA, a serious complication that causes coma, brain swelling and sometimes death."
The companion write-up of the consensus paper adds the implementation reality check: this needs referral pathways to pediatric endocrinology, provider education, psychosocial support for families, and reimbursement frameworks before it's routine.
🔬 Research worth watching
Gut microbiome development may help predict type 1 diabetes in children at high risk: a study in Nature Metabolism followed 887 high-genetic-risk children across four countries and found those whose microbiome development "plateaued early" had about three times the risk of developing T1D or its preceding immune attack. The signal only showed up through repeated sampling, and the authors are clear it's association, not cause. – EurekAlert!
UF Study Identifies Immune Cells That May Help Sustain Type 1 Diabetes Attack: University of Florida researchers identified self-renewing "stem-like" T cells in human pancreatic lymph node tissue that may explain why the autoimmune attack persists for years, pointing to possible new therapeutic targets. – UF Diabetes Institute
SAB BIO to Present SAB-142 Data at EASD: SAB Biotherapeutics will share Phase 1 data on SAB-142, a fully human anti-thymocyte globulin, at EASD (September 28 to October 2, 2026), highlighting mechanism of action, potential safe redosing, and early C-peptide preservation in Stage 3 T1D. It's also in the Phase 2b SAFEGUARD study. – GlobeNewswire
Diasome to Present HDV-Insulin Phase 2b Data: OPTI-2, a 25-week study in 226 adults, suggests HDV-insulin lispro may hold glycemic control while cutting clinically meaningful hypoglycemia versus standard lispro; new analyses come at EASD and the inaugural Breakthrough T1D Congress (October 9-11, 2026). – Markets Insider
🛠️ Devices and daily life
Mint Patch Pump for Type 1 Kids - Cleared, Not Shipping is a useful expectations-setter. Beta Bionics got FDA clearance on September 14, 2026 for Mint, a tubeless patch pump for adults and children ages six and up, but the full U.S. launch is targeted for Q1 2027, pharmacy channel only. It pairs a reusable controller with a disposable 200-unit patch worn about three days, with listed compatibility for Dexcom G7, Dexcom G7 15 Day, and Abbott FreeStyle Libre 3 Plus. – Diabetes Amigo
"Mint is a real FDA clearance for a kid-age tubeless pump, with a launch target in early 2027. That is news. It is not a household change."
The author also stresses that pump hardware clearance is separate from clearance for the next-generation dosing algorithm, so don't assume automated insulin delivery from this headline alone.
On the lifestyle front, an eight-hour eating window may improve blood sugar control in adults with T1D and obesity, per a 32-person randomized trial from the University of Illinois Chicago in Diabetes Care. Participants eating noon to 8 p.m. saw HbA1c fall by about 0.5% over six months with no reported rise in dangerous highs, lows, or DKA. It's small and single-site, and the researchers urge working with your endocrinologist before changing meal timing. – Health.News
That's the issue. The Kerendia approval is the headline, but the recurring lesson is the same: read the fine print, talk to your care team, and mind the monitoring. Take care of yourselves.