Endocrinology Update – September 16, 2025: Gestational Diabetes Review, PED-TAE Promise, CPAP Survival Benefit and More
From a comprehensive gestational diabetes playbook and FDA clearance of OsteoSight for opportunistic BMD to Plixorafenib’s promising thyroid cancer data—this week’s signals are strong. We span diabetes, endocrinology, oncology, diagnostics, and more, with clinical insights and regulatory milestones across areas, underscoring innovation and improved patient outcomes.
In Today’s Newsletter
🤰 Gestational diabetes review: molecular to clinical playbook [1] [05 Sep 2025]
https://www.mdpi.com/1422-0067/26/17/8719
Context: Narrative review (Int. J. Mol. Sci., 2025) on GDM pathophysiology, biomarkers (exosomes, miRNAs, metabolomics), and management.
Key point: Synthesizes emerging early-prediction markers and precision strategies; current screening (OGTT) remains late and imperfect.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧠 Learning disabilities & new T2D: faster to insulin, higher mortality [2] [UK • 08 Sep 2025]
Context: UK CPRD cohort (n=280,300) of adults with incident T2D (2004–2021).
Key point: Lower odds of poor 5-yr glycemic control but faster insulin initiation; all-cause and diabetes-related mortality roughly doubled vs. no learning disability.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
💉 Pressure-enabled thyroid embolization (PED-TAE) shows promise [3] [09 Sep 2025]
Context: Retrospective cohort (n=22) using PEDD device via inferior thyroid arteries; 6-mo follow-up in 18.
Key point: Technical/clinical success in all; 71% hyperthyroid → euthyroid; mean thyroid volume ↓ ~73% at 6 mo; no neurovascular complications reported.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 DHEA-S aids MACS diagnosis [4] [10 Sep 2025]
Context: Systematic review/meta-analysis (7 MACS studies; 2 adrenal insufficiency).
Key point: DHEA-S cutoff 60–70 mcg/dL yields ~82% sensitivity/82% specificity for MACS; limited data suggest added value in adrenal insufficiency; overall certainty low.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🦴 OsteoSight gets FDA 510(k) for opportunistic BMD from X-rays [5] [US • 11 Sep 2025]
https://www.itnonline.com/content/fda-grants-510k-clearance-osteosight
Context: AI software analyzes routine hip/pelvis X-rays (≥50 yrs) to flag low BMD; prior Breakthrough Device (2023).
Key point: 510(k) clearance enables US commercialization; aims to catch undiagnosed low BMD within ortho workflows.
Implication: Introduces competition that may affect pricing and formulary access.
🚭 Smoking ups risk across all T2D subtypes; strongest for SIRD [6] [EU • 13 Sep 2025]
https://medicalxpress.com/news/2025-09-diabetes-characteristics.html
Context: Scandinavian datasets; EASD 2025 presentation.
Key point: Ever-smokers had higher risk for all T2D subtypes; ~2.15× risk for SIRD; heavy smoking increased risks further; genetic predisposition amplified effects.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧬 Plixorafenib at ATA: durable benefit in BRAF-altered thyroid cancer [7] [US • 13 Sep 2025]
https://finance.yahoo.com/news/fore-biotherapeutics-presents-phase-1-210000516.html
Context: Phase 1/2a subset (n=21 thyroid; PTC/ATC); compared to historical benchmarks; FORTE Phase 2 ongoing.
Key point: MAPKi-naïve BRAF V600 PTC: mPFS ~63.9 mo; CBR 85.7%; ATC mPFS 16.1 mo; favorable safety consistent with prior reports.
Implication: May influence prescriber choice and payer reviews pending full data.
🌙 ZT-01 aims to prevent nocturnal hypoglycemia in T1D (Phase 2) [8] [14 Sep 2025]
Context: Zucara Therapeutics; somatostatin-targeting approach to restore glucagon counter-regulation; US/Canada sites recruiting.
Key point: Phase 1/1b showed safety and proof-of-concept; Phase 2 focuses on overnight lows; effect designed to taper ~90 mg/dL.
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 CPAP linked to 26% lower mortality in T2D with OSA [9] [EU • 15 Sep 2025]
https://www.medicalrepublic.com.au/cpap-therapy-delivers-survival-edge-in-type-2-diabetes/119871
Context: Swedish registry comparison (12,388 CPAP vs 737,911 non-CPAP; ≤14 yrs follow-up); EASD 2025.
Key point: Adjusted analysis associates CPAP with 26% reduction in all-cause mortality; adherence/severity data limited; residual confounding possible.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🤝 Hanmi × Silanes: diabetes combo supply deal in Mexico [10] [MX • 15 Sep 2025]
https://www.koreabiomed.com/news/articleView.html?idxno=28974
Context: Licensing/supply agreement; Silanes to license/distribute/sell; builds on 2019 partnership.
Key point: Hanmi supplies combo therapies leveraging formulation/production tech; expands portfolio in Mexico’s diabetes market.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Opportunistic AI BMD screening may shift fracture prevention upstream within ortho workflows [5].
- Precision endocrine diagnostics (DHEA-S for MACS) could streamline workups if validated prospectively [4].
- Sleep care is emerging as a survival lever in cardiometabolic disease (CPAP in T2D+OSA) [9].
- Targeted oncology (plixorafenib) continues to push durability in BRAF-altered thyroid tumors [7].
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FAQ
What cutoff for DHEA-S is supported to screen for MACS?
A 60–70 mcg/dL DHEA-S threshold showed ~82% sensitivity and ~82% specificity in pooled analyses, though overall certainty was low and cutoffs varied across studies [4].
How durable is plixorafenib activity in BRAF V600 PTC?
In MAPKi-naïve PTC, median PFS was ~63.9 months with a clinical benefit rate of 85.7%; several patients remained on therapy >5 years. Data are from a small Phase 1/2a subset vs historical controls [7].
Does CPAP improve survival for people with T2D and OSA?
A Swedish registry analysis associated CPAP with a 26% reduction in all-cause mortality over ≤14 years, but limitations include incomplete adherence/severity data and potential residual confounding [9].
Is PED-TAE ready for broad use in symptomatic thyroid disease?
A 22-patient retrospective study reported 100% technical/clinical success, ~73% mean volume reduction at 6 months, and 71% hyperthyroid → euthyroid conversion, warranting further multi-center validation [3].
What’s new about OsteoSight’s FDA clearance?
It enables opportunistic BMD assessment from routine hip/pelvis X-rays within orthopedic workflows, potentially identifying undiagnosed low BMD at scale [5].
What does the Hanmi–Silanes deal change in Mexico?
Silanes will license, distribute, and sell Hanmi’s diabetes combo drugs locally, expanding access and reinforcing both firms’ regional footprint [10].
Entities / Keywords
Gestational diabetes mellitus (GDM); exosomes; microRNAs; metabolomics;
Learning disabilities; type 2 diabetes (T2D); insulin initiation; mortality;
Pressure-enabled thyroid artery embolization (PED-TAE); euthyroid conversion; gland volume;
Dehydroepiandrosterone sulfate (DHEA-S); mild autonomous cortisol secretion (MACS); adrenal insufficiency;
OsteoSight; opportunistic BMD; osteoporosis screening; FDA 510(k);
Smoking; snus; T2D subtypes (SIRD, SIDD, MOD, MARD); genetic risk;
Plixorafenib (FORE Biotherapeutics); BRAF V600; BRAF fusions; PTC; ATC; ATA;
ZT-01 (Zucara Therapeutics); nocturnal hypoglycemia; somatostatin; glucagon;
Continuous positive airway pressure (CPAP); obstructive sleep apnea (OSA); mortality;
Hanmi Pharmaceutical; Laboratorios Silanes; Mexico; combo therapies.
References
- https://www.mdpi.com/1422-0067/26/17/8719
- https://www.psychiatryadvisor.com/news/adults-learning-disabilities-new-diabetes-shorter-time-insulin-initiation/
- https://www.endocrine.org/journals/journal-of-the-endocrine-society/pressure-enabled-thyroid-embolization
- https://www.endocrinologyadvisor.com/news/dehydroepiandrosterone-sulfate-demonstrates-utility-in-macs-diagnosis/
- https://www.itnonline.com/content/fda-grants-510k-clearance-osteosight
- https://medicalxpress.com/news/2025-09-diabetes-characteristics.html
- https://finance.yahoo.com/news/fore-biotherapeutics-presents-phase-1-210000516.html
- https://www.type1strong.org/blog-post/zucaras-new-drug-aims-to-prevent-overnight-lows-in-type-1-diabetes
- https://www.medicalrepublic.com.au/cpap-therapy-delivers-survival-edge-in-type-2-diabetes/119871
- https://www.koreabiomed.com/news/articleView.html?idxno=28974