Catch up on this week’s endocrinology highlights—from major developments and new regulations to exciting progress across the biopharma industry.
In Today’s Newsletter
Dive deeper
🧪 Microbial TMA blocks IRAK4-linked inflammation in diabetes models [1] [08 Dec 2025]
https://medicalxpress.com/news/2025-12-microbial-molecule-inflammation-diabetes-treatment.html
Context: Nature Metabolism study from UCLouvain, Imperial, Ottawa Heart Institute.
Key point: Trimethylamine (TMA) from gut microbes binds IRAK4, dampens diet-induced inflammation, restores insulin sensitivity in preclinical models (endpoint not specified).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📰 Media coverage of TMA–IRAK4 finding highlights therapeutic angle [2] [08 Dec 2025]
Context: News recap of the Nature Metabolism paper and prior inflammation–insulin resistance work.
Key point: Positions TMA as a nutritional microbiome-derived inhibitor of IRAK4 with potential to counter diet-driven insulin resistance (metrics not specified).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📘 ADA issues Standards of Care in Diabetes, 2026 [3] [US • 08 Dec 2025]
Context: Multidisciplinary PPC, endorsements from ACC, NKF, AGS, ISPAD, others.
Key point: Updates span CGM at diagnosis, AID access, obesity pharmacotherapy individualization, CKD therapy including dialysis, and BP targets.
Implication: May influence prescriber choice and payer reviews pending full data.
📱 Abbott Lingo OTC CGM now on Android, shares RWD on protein use [4] [US • 08 Dec 2025]
Context: Lingo for adults not on insulin; RWD presented at diabetes and obesity meetings.
Key point: Android launch expands reach; internal analyses associate protein supplementation with lower glucose exposure in users (observational).
Implication: Could streamline initiation and adherence via remote prescribing and logistics.
😮 GLP-1 RA use associated with chronic cough in EMR study [5] [08 Dec 2025]
Context: Observational multicenter EMR analysis; JAMA Otolaryngology publication.
Key point: Higher risk of new chronic cough vs several non–GLP-1 comparators after adjustment; design is observational.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🌬️ Inhaled Technosphere insulin in youth misses HbA1c noninferiority [6] [08 Dec 2025]
https://www.endocrinologyadvisor.com/news/inhaled-insulin-noninferiority-hba1c-youth/
Context: INHALE-1 RCT, 26 weeks, youth with predominantly type 1 diabetes.
Key point: TI did not meet pre-specified HbA1c noninferiority vs rapid analog; safety and satisfaction favored TI, with less weight gain.
Implication: May influence prescriber choice and payer reviews pending full data.
🏪 Wellgistics launches Brenzavvy to independent pharmacy network [7] [US • 08 Dec 2025]
https://ca.finance.yahoo.com/news/wellgistics-health-announces-launch-diabetes-124000459.html
Context: Uses EinsteinRx AI prompts for pharmacist-led education to drive access.
Key point: Distribution push for bexagliflozin into 6,500 pharmacies, emphasizing cash price vs branded SGLT2s.
Implication: Introduces competition that may affect pricing and formulary access.
🧠 Meta-review: AI-enhanced wearables for T2D/prediabetes care [8] [08 Dec 2025]
https://medicalxpress.com/news/2025-12-explores-ai-wearable-devices-diabetes.html
Context: npj Digital Medicine meta-review of 60 studies.
Key point: AI-CGMs can predict glucose changes 1–2 hours ahead; gaps include explainability, validation, and workflow integration.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
👧 EMA clears tirzepatide for T2D in children ≥10 years [9] [EU • 12 Dec 2025]
https://www.medscape.com/viewarticle/mounjaro-cleared-type-2-diabetes-eu-children-2025a1000yz4
Context: CHMP backs indication extension; pediatric RCT showed A1c reduction and BMI improvement vs placebo.
Key point: EU label extended to adolescents and children 10+, as adjunct to diet and exercise, monotherapy or add-on.
Implication: May influence prescriber choice and payer reviews pending full data.
⚖️ CHMP positive opinion for Wegovy 7.2 mg dose, ~20.7% loss [10] [EU • 15 Dec 2025]
Context: STEP UP and STEP UP T2D trials; higher-dose semaglutide vs placebo and 2.4 mg.
Key point: In obesity without diabetes, average 20.7% weight loss at 72 weeks; safety profile aligned with 2.4 mg.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Microbiome-derived small molecules are emerging as credible metabolic immunomodulators, creating drug-target options beyond incretins.
- ADA’s annual updates steer payer policy and clinic protocols across CGM, AID, and cardio-renal-liver comorbidity care.
- OTC CGM plus app ecosystems are pushing glucose literacy into wellness markets, potentially shifting demand and data flows.
- Safety signals around GLP-1s require balanced counseling as labels expand across age and obesity indications.
- EU regulatory momentum for tirzepatide and higher-dose semaglutide sets up 2026 access debates on pediatrics and dose escalation.
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FAQ
What is the TMA–IRAK4 finding and who led it?
A Nature Metabolism study from UCLouvain, Imperial College London, and Ottawa Heart Institute reports that microbial TMA binds IRAK4, dampens inflammation, and improves insulin sensitivity in models [1][2]. Details are preclinical and endpoints are not specified in news summaries.
What changed in ADA’s 2026 Standards of Care?
Guidance expands CGM initiation, relaxes prerequisites for AID/CSII, individualizes obesity pharmacotherapy, updates CKD therapy including dialysis use, and revises BP targets, with added sections on cancer care, transplant, and foot care tech [3].
What is Abbott Lingo and what new data were shared?
Lingo is an over-the-counter CGM and app now available on Android in the US and UK. Abbott shared observational analyses linking protein supplementation to lower glucose exposure among users [4].
Did inhaled insulin work as well as injections in youth?
In INHALE-1, Technosphere insulin did not meet the noninferiority margin for HbA1c vs rapid-acting analog over 26 weeks. Safety, satisfaction, and less weight gain favored TI, supporting it as an option with trade-offs [6].
What pediatric and obesity regulatory moves occurred in the EU?
EMA cleared tirzepatide for type 2 diabetes in children and adolescents 10+ [9]. CHMP gave a positive opinion for Wegovy 7.2 mg, showing ~20.7% weight loss at 72 weeks in adults without diabetes, pending EC decision [10].
Entities / Keywords
TMA; IRAK4; Université catholique de Louvain; Imperial College London; Ottawa Heart Institute; ADA Standards of Care 2026; Abbott Lingo; GLP-1 receptor agonists; chronic cough; JAMA Otolaryngology; Technosphere insulin; INHALE-1; bexagliflozin Brenzavvy; Wellgistics; AI-CGM; npj Digital Medicine; tirzepatide Mounjaro; EMA CHMP; Wegovy semaglutide 7.2 mg; STEP UP.
References
- https://medicalxpress.com/news/2025-12-microbial-molecule-inflammation-diabetes-treatment.html
- https://www.thenationalnews.com/health/2025/12/08/major-diabetes-breakthrough-as-scientists-disarm-inflammation/
- https://www.prnewswire.com/news-releases/the-american-diabetes-association-releases-standards-of-care-in-diabetes2026-302634515.html
- https://abbott.mediaroom.com/2025-12-08-Abbotts-Lingo-TM-Now-on-Android-TM-,-Expanding-Access-to-Real-Time-Glucose-Data
- https://www.endocrinologyadvisor.com/news/glp-1-receptor-agonist-use-linked-to-chronic-cough-among-adults-with-type-2-diabetes/
- https://www.endocrinologyadvisor.com/news/inhaled-insulin-noninferiority-hba1c-youth/
- https://ca.finance.yahoo.com/news/wellgistics-health-announces-launch-diabetes-124000459.html
- https://medicalxpress.com/news/2025-12-explores-ai-wearable-devices-diabetes.html
- https://www.medscape.com/viewarticle/mounjaro-cleared-type-2-diabetes-eu-children-2025a1000yz4
- https://www.biospace.com/press-releases/novo-nordisk-a-s-more-efficacious-dose-of-wegovy-recommended-by-the-european-medicines-agency-can-help-people-with-obesity-achieve-an-average-of-20-7-weight-loss