Simultaneous Measurement and Responsive Treatment (SMART01): A Feasibility Study of the SynerG TM CGM sensor Integrated with the Niia Essential Insulin Patch Pump System in Persons with Type 1 Diabetes.

开始日期2025-03-24

申办/合作机构-

NL-OMON57171

/ SuspendedN/A

Phoenix: Clinical evaluation of the Medtronic Implantable Insulin Pump System (MIIPS 2020) in adult subjects with Type 1 Diabetes - Phoenix

开始日期2024-11-06

申办/合作机构-

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122,296

项与 NNC0268-0965 相关的文献（医药）

2025-12-31·ANNALS OF MEDICINE

Bioengineering and omics approaches for Type 1 diabetes practical research: advancements and constraints

Review

作者: Li, Ling ; An, Zhenmei ; Peng, Yihua ; Peng, Xi ; Zhou, Guangju

Insulin dependency arises from autoimmunity that targets the β cells of the pancreas, resulting in Type 1 diabetes (T1D). Despite the fact that T1D patients require insulin for survival, insulin does not provide a cure for this disease or prevent its complications. Despite extensive genetic, molecular, and cellular research on T1D over the years, the translation of this understanding into effective clinical therapies continues to pose a significant obstacle. It is therefore difficult to develop effective clinical treatment strategies without a thorough understanding of disease pathophysiology. Pancreatic tissue bioengineering models of human T1D offer a valuable approach to examining and controlling islet function while tackling various facets of the condition. And in recent years, due to advances in high-throughput omics analysis, the genotypic and molecular profiles of T1D have become finer tuned. The present article will examine recent progress in these areas, along with their utilization and constraints in the realm of T1D.

2025-12-31·Journal of Pharmaceutical Policy and Practice

Emergency medicine pharmacists’ interventions in the tertiary hospitals’ emergency departments in Malaysia

Article

作者: Teh, Lih Jiuan ; Tan, Shirlyn ; Tan, Sherene Su Ann ; Bhuvanendran Pillai, Anaanthan ; Sia, Rosalind Guen Lin ; Guee, Xin Nee ; Selvaratanam, Manimegahlai ; Koh, Hock Peng ; Wong, Wai Kit ; Koo, Yee Ping ; Chen, Mary Siew Yng ; Ab Jalal, Haliza

Background:

The emergency medicine (EM) pharmacist is an integrated part of the Emergency Department (ED) interdisciplinary team in many countries, including Malaysia. The presence of EM pharmacists in the ED has positively impacted patient outcomes. Data on EM pharmacists' interventions is scarce in the Asian region. In Malaysia, data on interventions done by EM pharmacists in the EDs was unavailable. This study aimed to assess the type of interventions done by EM pharmacists in the ED of tertiary public hospitals in Malaysia.

Methods:

This cross-sectional, multicenter study involved EM pharmacists from 14 tertiary hospitals in Malaysia. All accepted interventions done by EM pharmacists in the ED for patients admitted to the Red (critical) and Yellow (semi-critical) zones from January to June 2022 were extracted from the Clinical Pharmacy Report Form. All data were analyzed descriptively.

Results:

The EM pharmacists documented 1659 accepted interventions on 1584 patients during the study period. Inappropriate regimens (n = 1117, 67.3%) and incomplete prescriptions (n = 339, 20.4%) were the main categories of accepted interventions in ED. Inappropriate drug (n = 574, 34.6%), dose (n = 292, 17.6%), and frequency (n = 176, 10.6%) were the top three subcategory interventions documented under inappropriate regimens. Antimicrobials, antihypertensives, and proton pump inhibitors were the commonest drug intervened under the categories of inappropriate drug intervention. There were 272 (16.4%) accepted interventions on high-alert medications (HAMs). Insulin, enoxaparin, and noradrenaline were the most intervened HAMs.

Conclusion:

Inappropriate treatment regimens were the most common intervention category done by EM pharmacists in Malaysia. The significant number of interventions done by EM pharmacists demonstrated the importance of EM pharmacists as integral members of the EM team. This data can help improve the quality of clinical pharmacy services in the ED and is important for the future expansion of clinical pharmacy services in all EDs across Malaysia, neighbouring countries, and other developing countries.

2025-12-31·Journal of Pharmaceutical Policy and Practice

Effect of statins and antihyperglycemics on chronic kidney disease in patients with type 2 diabetes mellitus: a retrospective cohort study with a 12-year follow-up

Article

作者: Mohammed, Khuloud Jamal ; El-Dahiyat, Faris ; Al Jaberi, Asma Khaled ; Shahwan, Moyad ; Al Jawamis, Dina Farhan ; Jairoun, Ammar Abdulrahman ; Ping, Chong Chee ; Ibrahim, Baharudin ; Dawoud, Tasnim

Background:

Chronic Kidney Disease (CKD) represents a significant worldwide health challenge, with far-reaching implications for both patients and healthcare systems. This study aimed to identify the incidence of CKD at stages 3-5, analyzed the impact of statin and other antihyperglycemic interventions, on the CKD progression in individuals with T2DM.

Methods:

This was a single-center retrospective cohort study based on data derived from electronic medical records (EMR) of UAE populations with diabetes mellitus, registered at outpatient clinics at Tawam Hospital in Al Ain, UAE, between January 2011 and December 2021. T2DM patients aged ≥ 18 years who had serum HbA1c level ≥ 6.5% and using one of the statin therapies were inclusion criteria. Patients with T1DM, who had undergone permanent renal replacement therapy, with under 1 year of follow-up and missing or incomplete data were excluded from the study. The collected data encompassed socio-demographics, detailed medical history, anthropometric measurements, laboratory analyses, clinical parameters, disease characteristics, and medications.

Results:

Our study included a cohort of 1,003 individuals. We observed 388 subjects developed CKD stages 3-5 across an average monitoring duration of 11.7 years. This resulted in a cumulative incidence of 38.7%, translating to an incidence rate of 38 cases per 1000 person-years. There was a statistically significant difference in the cumulative incidence of CKD stages 3 ± 5 according to statin therapy (P = 0.047). High intensity statin users are more likely to develop a CKD stage 3-5 compared to low/moderate intensity users and to no statin users respectively (44.3% vs 37.9%), (44.3% vs 30.9%). Conversely, the use of Biguanides was associated with a decreased probability of CKD progression (37.9% vs. 52.8%; P = 0.001), whereas Insulin users demonstrated a heightened risk (54.2% vs. 34.1%; P < 0.001).

Conclusion:

The findings emphasise the pivotal role of personalised treatment strategies, particularly concerning statin therapy and other medications, in populations at high risk.

958

项与 NNC0268-0965 相关的新闻（医药）

2025-07-04

·GlobeNewswire-Health Care

Immuthera’s Scientific Advisory Board: World-Leading Expertise Driving Next-Generation Diabetes and Immunotherapy Solutions

Immuthera’s Scientific Advisory Board: World-Leading Expertise Driving Next-Generation Diabetes and Immunotherapy Solutions Distinguished experts Dr. Jay Skyler, Dr. Desmond Schatz, and Dr. Lawrence Steinman have joined Immuthera’s Scientific Advisory Board.Immuthera will continue expanding its Scientific Advisory Board over the coming months to build a truly world-class team.In collaboration with PolTREG and leading U.S. academic centers, Immuthera will be developing a pipeline of cutting-edge, clinically validated Treg cell therapies for autoimmune and neuroinflammatory diseases. 4 JULY 2025 - Immuthera, a pioneer in cell therapies for autoimmune diseases, and parent company, PolTREG (Warsaw Stock Exchange: PTG), are proud to highlight the exceptional caliber of the first three members of its Scientific Advisory Board (SAB)—a team whose collective expertise and groundbreaking achievements are shaping the future of diabetes and immunotherapy research. The support and guidance from these globally renowned scientists underscore Immuthera’s commitment to delivering innovative, safe, and effective therapies for patients worldwide. “The collective wisdom and leadership of Drs. Skyler, Schatz, and Steinman provide Immuthera and PolTREG with an unparalleled strategic advantage. Their guidance ensures that our research and clinical programs are aligned with the highest standards of scientific rigor and patient care. Immuthera plans on expanding our SAB over the next several months to build a truly world-class team that will guide our activities in the US and beyond. With their support, Immuthera is uniquely positioned to accelerate the development of transformative therapies for type 1 diabetes and other autoimmune diseases” - said Prof. Piotr Trzonkowski, CEO of Immuthera and PolTREG. Immuthera will be working closely with PolTREG, and US academic centers, to develop a pipeline of cutting edge and clinically validated Treg cell therapies for the treatment of autoimmune and neuroinflammatory diseases. “Regulatory T cells (Treg cells) play a crucial role in maintaining immune homeostasis. As such, Immuthera’s and PolTREG’s delivery of Tregs offers hope for curing or controlling autoimmune diseases, including type 1 diabetes” – said Dr. Desmond Schatz. "I am excited to provide advice as Immuthera and PolTREG test their exciting technology in the clinic" – add Dr. Lawrence Steinman. A Scientific Advisory Board of Visionaries: Unrivaled Leadership in Diabetes and Immunology Dr. Jay Skyler: Architect of Modern Diabetes Care Dr. Jay Skyler stands as one of the most influential figures in type 1 diabetes research. His visionary work has transformed patient care and set new standards for clinical excellence: Pioneering Intensive Insulin Therapy: Dr. Skyler’s development of patient self-monitoring and intensive insulin protocols revolutionized diabetes management, empowering millions to achieve better glycemic control.Leadership in Landmark Clinical Trials: As Chairman of the NIH-sponsored Diabetes Prevention Trial – Type 1 (DPT-1) and Type 1 Diabetes TrialNet, Dr. Skyler has overseen global efforts to prevent and delay the onset of type 1 diabetes.Trailblazer in Immune Intervention: He led the first NIH-funded studies using cyclosporine and monoclonal antibodies to preserve beta-cell function, paving the way for modern immune therapies.Editorial and Organizational Leadership: Founding Editor-in-Chief of Diabetes Care and past President of the American Diabetes Association, Dr. Skyler’s influence extends from laboratory to clinic, and from policy to patient advocacy.Recognition: His accolades include the Banting Medal for Service, the Distinction in Endocrinology Award, and the Mary Tyler Moore/S. Robert Levine Award from JDRF. Dr. Desmond Schatz: Champion of Prevention, Genetics, and Pediatric Care Dr. Desmond Schatz’s four-decade career has been dedicated to unraveling the mysteries of type 1 diabetes, particularly in children and adolescents: Pioneering Research: Dr. Schatz has led major NIH and JDRF-funded studies on the prediction, genetics, and immunopathogenesis of type 1 diabetes, including the TEDDY program for newborn genetic screening and the Human Islet Research Network (HIRN).Clinical Trial Leadership: As Principal Investigator for the University of Florida’s TrialNet Clinical Center and a founding member of DPT-1, Dr. Schatz has driven international efforts to prevent and manage type 1 diabetes.Mentorship and Advocacy: A prolific author with over 400 publications, Dr. Schatz is recognized for nurturing the next generation of diabetes researchers and clinicians.Honors: His distinguished service has been recognized with the Banting Medal, ISPAD Prize for Achievement, the George Eisenbarth Award, and the University of Florida College of Medicine Lifetime Achievement Award. Dr. Lawrence Steinman: Innovator in Neuroimmunology and Autoimmune Therapies Dr. Lawrence Steinman’s research has redefined the landscape of neuroimmunology and autoimmune disease treatment: Breakthrough Therapy Development: His work at Stanford University led to the creation of Natalizumab (Tysabri), the first approved monoclonal antibody for multiple sclerosis (MS), now a standard of care worldwide.Groundbreaking Discoveries: Dr. Steinman’s research unveiled the molecular link between Epstein-Barr virus and MS, earning him the 2023 Pioneer in Medicine Award.Expanding the Frontiers: His expertise in antigen-specific therapies and DNA vaccines spans MS, ALS, neuromyelitis optica, and type 1 diabetes.Recognition: Dr. Steinman is a recipient of the John Dystel Prize, the Charcot Prize for Lifetime Achievement, and is an elected member of both the US National Academy of Sciences and the National Academy of Medicine. About Immuthera: Immuthera is pioneering novel cell-based therapies for clinical development in the United States and Canada. Immuthera will be clinically developing assets initially developed by PolTREG under the US FDA regulatory framework. Immuthera will have full access to PolTREG’s Research and Development capabilities and asset pipeline along with the ability to explore novel modalities developed by US Institutions. Immuthera is currently seeking investment to pursue the manufacture and clinical development of these assets in the United States. About PolTREG: PolTREG is a global leader in developing autoimmune therapies based on T-regulatory cells (Tregs). Its lead product, PTG-007, autologous Treg treatment for early-onset Type-1 Diabetes (T1D) is ready for Phase 2/3 clinical testing, for which the company is seeking a partnership. PolTREG has established a robust platform encompassing a wide range of cell therapy approaches, including polyclonal TREG, CAR-TREG, allogeneic TREG, antigen-specific TREG, and TCR-TREG therapies.

免疫疗法上市批准高管变更临床研究细胞疗法

2025-06-28

·PRNewswire

ESOT Congress 2025: Scientists create functional human islets in 3D printing breakthrough for type 1 diabetes treatment

LONDON, June 28, 2025 /PRNewswire/ -- A team of international scientists has made a major leap forward in diabetes research by successfully 3D printing functional human islets using a novel bioink. Presented today at the ESOT Congress 2025, the new technology could pave the way for more effective and less invasive treatment for people living with type 1 diabetes. The breakthrough involved printing human islets – the insulin-producing clusters of cells in the pancreas – using a customised bioink made from alginate and decellularised human pancreatic tissue. This approach produced durable, high-density islet structures that remained alive and functional for up to three weeks, maintaining strong insulin responses to glucose and showing real potential for future clinical use. Traditional islet transplants are typically infused into the liver, a process that can result in significant loss of cells and limited long-term success. In contrast, the 3D-printed islets were designed to be implanted just under the skin, a simple procedure requiring only local anaesthesia and a small incision. This minimally invasive approach could offer a safer and more comfortable option for patients. "Our goal was to recreate the natural environment of the pancreas so that transplanted cells would survive and function better," explained lead author Dr. Quentin Perrier. "We used a special bioink that mimics the support structure of the pancreas, giving islets the oxygen and nutrients they need to thrive." The bioprinted islets stayed alive and healthy, with over 90% cell survival. They responded better to glucose than standard islet preparations, releasing more insulin when it was needed. By day 21, the islets showed a stronger ability to sense and react to blood sugar levels – an important sign that they could work well after being implanted. The constructs maintained their structure without clumping or breaking down, overcoming a common hurdle in earlier approaches. Additionally, the 3D-printed structures featured a porous architecture that enhanced the flow of oxygen and nutrients to the embedded islets. This design helped maintain cell health and promoted vascularisation, both of which are critical for long-term survival and function after transplantation. "This is one of the first studies to use real human islets instead of animal cells in bioprinting, and the results are incredibly promising," noted Dr. Perrier. "We're getting closer to creating an off-the-shelf treatment for diabetes that could one day eliminate the need for insulin injections." WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

2025-06-28

·ETPharma

Novo Nordisk's semaglutide may help some with type 1 diabetes

London: People with type 1 diabetes who need to lose weight can benefit from the blockbuster GLP-1 drug semaglutide currently approved only for type 2 diabetes, according to results from a small trial. Semaglutide is the active ingredient in Novo Nordisk 's diabetes drugs Ozempic and Rybelsus, as well as its weight-loss treatment Wegovy. In the first clinical trial testing the Novo drug in people with type 1 diabetes and obesity, the 36 patients who received weekly semaglutide injections along with their usual insulin spent more time in their target blood sugar range and lost more weight than 36 similar patients who got a placebo along with their insulin, study leader Dr. Viral Shah of Indiana University School of Medicine reported at the American Diabetes Association meeting in Chicago. All of the patients were using automated insulin delivery systems and had a body mass index of 30 or higher, which is considered obese. One-third of the patients in the semaglutide group achieved all three of the study's goals: blood sugar in the target range of 70 to 180 mg/dL more than 70% of the time, dangerously low blood sugar less than 4% of the time, and body weight reduction of at least 5%. The average weight loss with semaglutide was 20 pounds (9 kg). No one in the placebo group achieved all three of these milestones, according to a report of the study published in NEJM Evidence. "We hope that our trial will encourage the industry to conduct a regulatory approval trial so that this drug could be available as an adjunct to insulin therapy to optimize type 1 diabetes management," Shah said in a statement. FASTING BEFORE SURGERY MAY BE POINTLESS The decades-old practice of having patients fast before surgery might not do what it's supposed to do, a new analysis suggests. Surgeons have patients stop eating hours before an operation in order to avoid so-called aspiration pneumonia, which happens when anesthesia causes vomiting and the vomit contents are inhaled into the lungs. The belief is that an empty stomach would lower that risk. For the analysis, researchers pooled data from 17 studies involving 990 patients who fasted before surgery and 801 who did not. Aspiration occurred in 0.5% of non-fasting patients and 0.7% of those who fasted, the researchers reported in Surgery. No particular fasting regimen was better than the others at preventing aspiration, the researchers found. "At some point, almost everybody will undergo a procedure and there are universal policies in every healthcare facility that require some degree of fasting before surgery," study leader Dr. Edward Livingston of the David Geffen School of Medicine at UCLA said in a statement. "Fasting for long periods of time is extremely uncomfortable and patients really don't like to do it. Our research suggests that long periods of fasting may not be necessary." (To receive the full newsletter in your inbox for free sign up here) (Reporting by Nancy Lapid; editing by Bill Berkrot)

临床结果上市批准

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适应症	最高研发状态	国家/地区	公司	日期
2型糖尿病	临床1期	德国	Novo Nordisk A/S	2019-10-29
1型糖尿病	临床1期	德国	Novo Nordisk A/S	2019-06-05

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


ADA2024	N/A	-	-	U-500 Insulin	淵選觸壓糧積憲簾顧遞(繭膚鏇選夢築淵範夢醖) = 觸獵選廠構簾鏇築鏇艱餘簾蓋淵廠壓鏇夢齋糧 (襯製憲構廠鹹簾構醖積 ) 更多	-	2024-06-14
				U-100 Insulin	淵選觸壓糧積憲簾顧遞(繭膚鏇選夢築淵範夢醖) = 襯遞鏇網鹽鏇鹽顧願鑰餘簾蓋淵廠壓鏇夢齋糧 (襯製憲構廠鹹簾構醖積 ) 更多
975-P (ADA2024)	N/A	1型糖尿病	49	Ultrarapid insulin analogs (FiAsp)Insulclock Connected Insulin Cap (Ultrarapid insulin analogs (FiAsp))	鑰遞繭蓋鑰齋蓋淵獵憲(憲選鏇鏇網繭艱壓網鬱) = 餘獵觸糧膚鹹糧襯範選鏇膚繭鹹餘範鏇膚醖夢 (餘夢網窪鏇襯積窪範繭 ) 更多	-	2024-06-14
				Rapid insulin analogs	鑰遞繭蓋鑰齋蓋淵獵憲(憲選鏇鏇網繭艱壓網鬱) = 鏇製壓齋遞鑰選範網鏇鏇膚繭鹹餘範鏇膚醖夢 (餘夢網窪鏇襯積窪範繭 ) 更多
967-P (ADA2024)	N/A	急性淋巴细胞白血病	5	Hybrid Closed-Loop Insulin Delivery (Tandem t:slim X2 insulin pump with Control-IQ technology and Dexcom G6 continuous glucose monitor)	夢襯鬱廠遞餘膚簾艱夢(繭構構築顧憲觸繭鹽夢) = One adverse event was related to bleeding at the CGM insertion site 鏇網襯衊積齋艱觸鬱網 (願觸鹹選夢獵衊鹹鑰窪 )	积极	2024-06-14
WSC2023	N/A	睡眠呼吸暂停综合征	-	Diabetic Patients on Insulin Therapy	膚餘夢餘廠顧壓廠願繭(網艱鏇衊齋襯夢壓遞窪) = 網構積製膚範願壓遞蓋構鏇願膚鹽糧壓遞選顧 (蓋鏇壓鬱選願廠願獵繭, 0.02) 更多	-	2023-10-23
STOP study (EASD2023)	N/A	2型糖尿病	93	IDegLira	鏇獵夢鬱願衊窪憲鹹構(醖獵網觸觸鬱顧築夢襯) = 壓顧鏇願憲憲築膚蓋顧獵鑰膚鏇鬱鬱餘積觸願 (願蓋鏇構衊構醖襯衊憲 ) 更多	积极	2023-10-05
EASD2023	N/A	2型糖尿病	514	insulin (Descending mode)	艱鏇糧網醖遞蓋築艱網(築蓋繭遞窪遞窪製選艱) = 鑰窪遞鹹築淵積壓襯鹹壓衊壓夢繭構鬱簾範窪 (網願顧蓋壓繭構選艱顧, (1.0 ~ 6.0)) 更多	积极	2023-10-05
				insulin (Ascending mode)	艱鏇糧網醖遞蓋築艱網(築蓋繭遞窪遞窪製選艱) = 鑰顧願鹽製壓選鑰廠醖壓衊壓夢繭構鬱簾範窪 (網願顧蓋壓繭構選艱顧, (0 ~ 4.0)) 更多
INSENODIAB (ESPE2023)	N/A	1型糖尿病	-	Insulin	鬱獵鏇艱艱網遞築製鏇(遞窪醖遞壓願艱鏇積遞) = 獵艱衊襯膚繭築願鬱齋繭簾鑰餘選醖襯夢憲廠 (鑰齋襯範壓鹽觸鏇艱餘, 0.5)	-	2023-09-21
				rINSENODIAB cohort	鬱獵鏇艱艱網遞築製鏇(遞窪醖遞壓願艱鏇積遞) = 製鹽鬱鹹糧選衊淵齋襯繭簾鑰餘選醖襯夢憲廠 (鑰齋襯範壓鹽觸鏇艱餘, 6.9)
ESPE2023	N/A	家族性乳糜微粒血症综合征 LPL deficiency	4	Insulin	觸觸選鑰鏇製醖憲鏇繭(憲鏇醖獵簾獵壓獵衊獵) = 憲窪齋製鏇淵糧網鏇積積醖顧獵觸願積築艱齋 (獵觸繭壓鹹鹹鬱顧憲鑰 )	-	2023-09-21
ADA2023	N/A	2型糖尿病	96	Basal insulin only	醖製廠構鹽餘艱齋簾鹽(遞觸憲構淵夢範鑰窪積) = 鑰齋醖範鹹艱憲蓋鹹獵網窪餘餘廠夢廠鬱鹹膚 (獵鑰鹹廠餘鬱衊鹹願範 ) 更多	-	2023-06-23
				Multiple daily injections (MDI)	醖製廠構鹽餘艱齋簾鹽(遞觸憲構淵夢範鑰窪積) = 遞醖願襯憲繭艱觸鹽窪網窪餘餘廠夢廠鬱鹹膚 (獵鑰鹹廠餘鬱衊鹹願範 ) 更多
ADA2023	N/A	怀孕	-	Concentrated insulin in continuous subcutaneous insulin infusion (CSII)	選餘觸壓醖範鏇餘壓鹽(艱製夢襯簾鏇築選鏇願) = 顧餘構繭鹽糧憲餘壓積壓廠鹹鹹艱餘廠積鬱鏇 (構獵糧廠構構顧壓願憲 ) 更多	-	2023-06-20