Latest news with #insulintherapy
Medscape
03-07-2025
- Health
- Medscape
Automated Insulin Delivery Shows Promise in Young Children
TOPLINE: In children aged 2-6 years with type 1 diabetes (T1D) who required at least six units of insulin daily, using the auto mode of the MiniMed 780G hybrid closed-loop insulin delivery system improved glycemic control compared to the system's manual mode — without increasing insulin requirements — and maintained an acceptable safety profile. METHODOLOGY: Poor glycemic control during childhood can adversely affect both brain development and plasticity. Automated insulin delivery systems have shown promising results in children younger than 15 years. Researchers conducted a prospective, multinational trial to investigate the efficacy and safety of automated insulin delivery with the MiniMed 780G system, recruiting 98 children aged 2-6 years with T1D (mean hemoglobin A1c level, 7.53%; 49% girls) between March and September 2023, all of whom required at least six units of insulin daily. The trial began with a 2-week run-in phase, in which the MiniMed 780G system was used in manual mode along with the suspend-before-low (SBL) feature, with the low glucose threshold set at 65 mg/dL. This was followed by a 26-week randomly assigned crossover phase, where patients received either 12 weeks of the auto mode, a 2-week washout, and 12 weeks of the manual + SBL mode or the reverse sequence (manual + SBL mode, washout, and then auto mode). The primary endpoint was the adjusted difference in the percentage of time in range (70-180 mg/dL) between the auto and manual + SBL modes, with noninferiority defined as an absolute margin of 7.5 percentage points. Secondary endpoints included the adjusted difference in mean hemoglobin A1c levels at the end of each 12-week period, tested for noninferiority against an absolute margin of 0.4 percentage points; safety outcomes were also evaluated. TAKEAWAY: The mean time in range of the patients was 58.1% during the run-in phase and 68.3% and 58.3% when using the auto and manual + SBL modes, respectively; the adjusted difference in the time in range between the auto and manual + SBL modes was 9.9 percentage points (95% CI, 8.0-11.7). The adjusted difference in mean hemoglobin A1c levels between the auto and manual + SBL modes was −0.61 percentage points (95% CI, −0.76 to −0.46). The mean total daily insulin dose requirement was similar between the two modes. No severe hypoglycemia events or serious adverse events related to the device or procedure were reported. IN PRACTICE: 'These important findings add to the existing evidence on the safety and efficacy of hybrid closed-loop systems in this vulnerable population and, pending regulatory approval, will increase the options for young children and caregivers to choose their preferred hybrid closed-loop system,' Charlotte K. Boughton, MD, PhD, from the University of Cambridge, Cambridge, England, wrote in a related comment. SOURCE: This study was led by Tadej Battelino, MD, University of Ljubljana, Ljubljana, Slovenia. It was published online in The Lancet Diabetes & Endocrinology. LIMITATIONS: Each center managed its own hemoglobin A1c testing, potentially introducing variations. Excluding children who required fewer than six units of insulin per day may have limited the generalizability of the findings. This study did not capture data on food intake or physical activity, and its sample size was insufficient to assess safety events that occurred infrequently. DISCLOSURES: This study was funded by Medtronic. Four authors reported being employees of Medtronic. Several other authors reported receiving consultant or speaker fees, advisory board fees, research grants, and travel grants from Medtronic and various other pharmaceutical and healthcare companies. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
02-07-2025
- Health
- Medscape
Glucose Monitoring Shows Dysglycaemia in Premature Infants
TOPLINE: In very low birth weight (VLBW) infants, continuous glucose monitoring (CGM) at 36 weeks of postmenstrual age (PMA) revealed subclinical dysglycaemia; male infants showed prolonged hyperglycaemia, and prior insulin therapy predicted extended hypoglycaemia. METHODOLOGY: Researchers evaluated the prevalence of dysglycaemia in VLBW infants at 36 weeks of PMA through CGM and investigated associated risk factors. The prospective cohort included 35 VLBW infants (mean gestational age, 27.3 weeks; 65.7% female infants; mean birth weight, 929 g) who were assessed at 36 weeks from 2016 to 2019. CGM was performed at 36 weeks of PMA using a blinded Dexcom G4 sensor for 48 hours, with dysglycaemia defined as glucose concentrations > 8 mmol/L (hyperglycaemia) or < 2.6 mmol/L (hypoglycaemia) sustained for at least 30 minutes. Researchers analysed risk factors (sex and prior insulin therapy) against capillary glucose correlations. TAKEAWAY: Overall, dysglycaemia was detected in 68.6% of infants; 28.6% of infants had hyperglycaemia alone, 17.1% had hypoglycaemia alone, and 22.9% had both. Male sex was linked to a longer duration of hyperglycaemia (B = 252.172; CI, 101.484-402.86; P = .002). Prior insulin treatment led to an increase in the duration of hypoglycaemia (B = 68.607; CI, 9.932-127.283; P = .023). Lower birth size and bronchopulmonary dysplasia were also associated with dysglycaemia. IN PRACTICE: "Male sex is associated with longer time spent in hyperglycemia and insulin treatment during the admission period is associated with longer time spent in hypoglycemia nearing term age. It is possible that these infants may require more rigorous monitoring of their glucose concentrations even when nearing term age," the authors wrote. SOURCE: This study was led by Itay Nilsson Zamir, Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden. It was published online on June 27, 2025, in the European Journal of Pediatrics. LIMITATIONS: The single-centre study design and small sample size may have limited generalisability. The CGM device used (Dexcom G4) had a higher-than-ideal mean absolute relative difference (18.8%). Calibrations relied on point-of-care glucometers rather than on laboratory-analysed values. DISCLOSURES: This study was supported by research grants from Umeå University and other sources. The CGM system was donated by Dexcom Inc., which had no role in the study design, data analysis, or publication. The authors declared having no competing interests. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
02-07-2025
- Health
- Medscape
Weekly IcoSema Matches Daily Insulin Therapy in T2D
TOPLINE: Once-weekly IcoSema — a combination of basal insulin icodec and the GLP-1 receptor agonist semaglutide — achieved a noninferior reduction in A1c levels compared with daily basal-bolus therapy in patients with type 2 diabetes (T2D) inadequately controlled with daily basal insulin. The treatment also led to greater body weight reduction, lower weekly insulin dose requirements, and fewer hypoglycemic episodes. METHODOLOGY: An unmet need exists for therapies that reduce injection burden while effectively controlling glucose levels, managing weight, and minimizing hypoglycemia risk. Researchers conducted a phase 3 trial (COMBINE 3) to evaluate the efficacy and safety of IcoSema vs basal-bolus therapy in adults with T2D inadequately controlled with daily basal insulin. A total of 679 patients (mean age, 59.6 years; 41% women; mean A1c levels, 8.3%) receiving daily basal insulin (20-80 U) were randomly assigned to receive either once-weekly IcoSema or once-daily basal-bolus therapy. The IcoSema group received the treatment once weekly via a pen device at a starting dose of 40 dose steps (equivalent to 40 U icodec and 0.114 mg semaglutide), while the basal-bolus group received once-daily insulin glargine U100 along with two to four daily injections of insulin aspart. The primary endpoint was the change in A1c levels from baseline to week 52, with a noninferiority margin of 0.3 percentage points; secondary endpoints included changes in body weight, episodes of clinically significant hypoglycemia through week 57, and a weekly total insulin dose during weeks 50-52. TAKEAWAY: At week 52, IcoSema was noninferior to basal-bolus therapy (estimated mean change in A1c levels, -1.47 vs -1.40 percentage points; estimated treatment difference [ETD], -0.06 percentage points; P for noninferiority < .0001). From baseline to week 52, mean body weight decreased by 3.56 kg with IcoSema but increased by 3.16 kg with basal-bolus therapy (ETD, -6.72 kg; P < .0001). IcoSema vs basal-bolus therapy also led to lower weekly total insulin doses (ETD, -270 U; P < .0001) and fewer clinically significant hypoglycemia episodes (0.21 vs 2.23 episodes per person-year of exposure; P < .0001). Serious adverse events were reported in 13% of patients receiving IcoSema vs 9% of those receiving basal-bolus therapy; gastrointestinal disorders were the most frequent adverse events with IcoSema. IN PRACTICE: 'Once-weekly IcoSema achieved noninferior A1c reduction and superiority in change in bodyweight, weekly total insulin dose, and hypoglycemia rates vs daily BBT [basal-bolus therapy], suggesting that there is a potentially beneficial treatment intensification option for adults with type 2 diabetes,' the authors concluded. SOURCE: This study was led by Liana K. Billings, MD, Endeavor Health/NorthShore Hospitals and the University of Chicago Pritzker School of Medicine, Chicago. It was published online in The Lancet Diabetes & Endocrinology. LIMITATIONS: This study was limited by its open-label design and the absence of information on adherence. DISCLOSURES: The study was funded by Novo Nordisk. Some authors reported receiving research support or consultant fees, serving on advisory panels, or having other ties with various pharmaceutical and healthcare companies, including the funding agency. Three authors reported being employees of Novo Nordisk and holding stock options. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Yahoo
23-06-2025
- Health
- Yahoo
New Treatment May Cure Severe Type 1 Diabetes, Study Finds
A dozen volunteers with severe type 1 diabetes showed clear improvements in their condition 12 months after receiving a revolutionary stem cell treatment, with all but two dropping their insulin therapy altogether. The phase 1/phase 2 clinical trial results provide hope for the 8.4 million people around the world with type 1 diabetes; an autoimmune condition where the immune system damages insulin-producing cells. While more extensive studies are required to see how long the benefits of the treatment can last, the new therapy developed by Boston-based Vertex Pharmaceuticals provides strong evidence that it's possible to replace the body's lost insulin production using infusions of stem cells. Related: People with type 1 diabetes are dependent on a precarious balance of insulin therapy for their whole lives. If their insulin drops too low, cells are unable to make use of the sugar in their bloodstream, leading to a buildup that can damage organs. If insulin is too high, patients are plunged into hypoglycemia, which can result in a loss of consciousness, seizures, coma, or death. The pancreas's islet cells are responsible for maintaining most of our bodies' insulin levels. Donor transplants of healthy versions of these cells have shown promise in treating type 1 diabetes in the past, but multiple donors are required, and donors are rare. So University of Toronto surgeon Trevor Reichman and colleagues infused 12 patients with islet cells derived from human stem cells in a treatment known as zimislecel. The patients also received immunosuppressive treatment before and after their zimislecel infusion. The islets not only produced insulin inside their bodies, but they did so at safe levels, reducing the patients' dependence on costly doses of insulin. "These findings showed that zimislecel islet cells were functional and self-regulated appropriately," the researchers write in their paper. The mild to moderate side-effects, including decreased kidney function and the anticipated drop in immune cells, were all linked with the immunosuppressive therapy. Sadly, two additional participants died during the trial; one from an infection arising from surgery and the other from complications due to an unrelated condition. As there were no serious adverse events attributed to the new islet cell therapy, the clinical trials are have progressed into phase 3. "These findings provide evidence that pancreatic islets can be effectively produced from pluripotent stem cells and used to treat type 1 diabetes," Reichman and team conclude. This research was published in NEJM. Scientists Identify New Blood Group, And It's The World's Rarest Extreme Heat Wave Scorches The US: Here's How You Can Stay Safe Your Brain Has a Hidden Rhythm, And It May Reveal How Smart You Are
Globe and Mail
18-06-2025
- Health
- Globe and Mail
Biodexa Hits Key Milestone For Its Type 1 Diabetes Candidate Tolimidone, Enrolls First Patient In Phase 2a Study
CARDIFF, UNITED KINGDOM / ACCESS Newswire / June 18, 2025 / When it comes to type 1 diabetes, treating this chronic condition can be difficult. After all, with this type of diabetes, the body's immune system attacks and destroys the beta cells that produce insulin. Without the natural ability to produce insulin, glucose from the bloodstream isn't absorbed into cells to provide energy. Since there is no cure, patients with type 1 diabetes need lifelong insulin therapy, typically via injections or a pump. Although type 1 diabetes typically develops in childhood or adolescence, it can happen at any age and is more likely to occur in individuals who are obese or inactive, or both. 1.7 million adults aged 20 or older - or 5.7% of U.S. adults - have the disease and are receiving insulin via shots or a pump. As it stands, the global market for treating type 1 diabetes is $16.97 billion and projected to reach $26.22 billion by 2032, growing at a CAGR of 6.9% from now until then. Biodexa Believes It Has The Answer That's why a handful of companies, including Biodexa Pharmaceuticals PLC (NASDAQ:BDRX), a clinical stage biopharmaceutical company developing treatments for unmet medical needs, are working on next-generation drugs and therapies to treat this insidious disease. Biodexa is developing Tolimidone to treat type 1 diabetes and has recently enrolled its first patient in a phase 2a trial. Tolimidone was first discovered by Pfizer Inc. and was developed to treat gastric ulcers. The drug made it through phase 2 trials, but Pfizer discontinued developing the drug because of a lack of efficacy for gastric ulcers. But for type 1 diabetes, it holds promise given Tolimidone is a selective activator of the enzyme Lyn kinase, which increases phosphorylation of insulin substrate-1, thereby amplifying the signaling cascade initiated by the binding of insulin to its receptor. In layman's terms, it can potentially help the body produce insulin. Lyn is a member of the Src family of protein tyrosine kinases, which is mainly expressed in hematopoietic cells, in neural tissues, liver, and adipose tissue. The use of Tolimidone in type 1 diabetes has been demonstrated in a number of preclinical studies conducted at the University of Alberta. The studies identified Lyn kinase as a key factor for beta cell survival and proliferation in in vitro and in vivo models, reports Biodexa. Very promising, noted the company, is the fact that Tolimidone was able to induce proliferation in beta cells isolated from human cadavers. Biodexa believes the drug has the potential to become a first-in-class blood glucose modulating agent. That would be welcome news to type 1 diabetes patients who are forced to take insulin shots or use an insulin pump. Taking just a pill to manage their disease could prove game changing. Phase 2a Trial Gets Its First Patient Currently, Biodexa is working with the University of Alberta on a phase 2a dose confirmation study, and the enrollment of the first person in that study is a big milestone for Biodexa. The dosing study was already approved by Health Canada and will be conducted by the University of Alberta, which will measure C-peptide levels (a marker for insulin) and HbA1c (a marker for blood glucose) after three months compared with baseline and the number of hyperglycemic events initially in 12 patients across three dose groups. The study may be expanded. "We are excited to initiate our clinical program in type 1 diabetes with the University of Alberta and build on the extensive tolimidone data package put together by Pfizer, Melior and Bukwang," said Stephen Stamp, CEO and CFO of Biodexa, when the study was first announced. The study is designed to build on the preclinical data that Biodexa said suggested Tolimidone could have a proliferative impact on pancreatic beta cells, the cells responsible for insulin production. Type 1 diabetes may not be the most common form of diabetes, but it can be among the most life-altering, requiring patients to rely on insulin for the rest of their lives. Biodexa is trying to make that easier for sufferers, taking a drug already developed and putting it to use in another form, one that the company believes holds a lot of potential. With the first patient enrolled in its phase 2a trial, Biodexa is much closer to bringing relief to type 1 diabetes patients. Stay tuned to hear more about Tolimidone and Biodexa's progress in fighting a disease that impacts millions of people in the U.S. and abroad. Featured image from Shutterstock. This post contains sponsored content. This content is for informational purposes only and is not intended to be investing advice. Click here for more information on Biodexa Pharmaceuticals. Contact: Stephen Stamp, CEO, CFO ir@ Important notice, please read: The information and statistical data contained herein may contain forward-looking statements that reflect the company's intentions, expectations, assumptions, or beliefs concerning future events, including, but not limited to, expectations with respect to FDA and other regulatory bodies approval of new products, technology, and product development milestones, the ability of the company to leverage its product development and negotiate favorable collaborative agreements, the commencement of sales, the size of market opportunities with respect to the company's product candidates and sufficiency of the company's cash flow for future liquidity and capital resource needs and other risks identified in the Risk Factor Section of the company's Annual Report and any subsequent reports filed with the SEC. We do not undertake to advise you as to any change in this information. The forward-looking statements are qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. In addition, significant fluctuations in quarterly results may occur as a result of varying milestone payments and the timing of costs and expenses related to the company's research and development programs. This is not a solicitation of any offer to buy or sell. Redington, Inc. is paid by Biodexa Pharmaceuticals PLC to provide investor relations services, and its employees or members of their families may from time to time own an equity interest in companies mentioned herein. View the original press release on ACCESS Newswire
