Latest news with #MiniMed780G
Yahoo
23-07-2025
- Health
- Yahoo
Medtronic's MiniMed 780G system gains CE Mark for expanded indications
Medtronic's MiniMed 780G system has received European CE Mark approval to expand the indications for use by people aged two years and above, during pregnancy, and for those with type 2 insulin-requiring diabetes. The approval follows a review of published clinical data encompassing two to six-year-olds, pregnant women, and those with type 2 diabetes (T2D). The LENNY trial highlighted the efficacy and safety of the MiniMed 780G system in children aged two to six years with type 1 diabetes (T1D). Subjects who used the system in auto mode achieved a 0.6% reduction in HbA1C and a 9.9% increase in time in range against manual mode. An improved sleep quality and reduced fear of hypoglycaemia in the auto mode were reported by parents and caregivers. The company noted that the pregnancy poses distinct challenges for glucose management in women with T1D. The MiniMed 780G system's ability to address lower glucose levels offers a potent tool for maintaining tighter control, the company added. Additionally, a European study showed that women using the system during pregnancy achieved an average Pregnancy Time in Range (TIRp) of 66.5%, against traditional insulin therapy. The system has also proved beneficial for individuals with T2D. A pivotal trial reported a 0.7% decrease in HbA1c and an 80% increase in TIR. Real-world data from 26,427 T2D users of the system indicated good glycaemic control, with TIR exceeding international consensus targets. The company is working with the US Food and Drug Administration (FDA) to expand the system's use to a broader population, including individuals with T2D and young children. The SmartGuard algorithm within the system is said to automate insulin delivery based on continuous glucose monitoring (CGM) readings. The system is tailored to be used at an adjustable target glucose of 100mg/dl (5.5mmol/L) and customised on an individual basis. This month, Medtronic obtained CE mark approval for LigaSure RAS, a vessel-sealing instrument for use with the company's Hugo robotic-assisted surgery (RAS) system. "Medtronic's MiniMed 780G system gains CE Mark for expanded indications" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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.
Yahoo
21-06-2025
- Health
- Yahoo
Studies show promising results for individuals with type 2 diabetes and young children with type 1 diabetes on MiniMed™ 780G system
Data supports the potential of future indication expansion for the MiniMed™ 780G system. LENNY trial results published in Lancet Diabetes & Endocrinology. GALWAY, Ireland and CHICAGO, June 20, 2025 /PRNewswire/ -- Medtronic, a global leader in healthcare technology, will present data at the American Diabetes Association (ADA) 85th Scientific Sessions in Chicago, highlighting improved glycemic outcomes for individuals with insulin-intensive type 2 diabetes on the MiniMed™ 780G* system under investigational use. Participants in a clinical trial achieved an average 8.6% increase in Time in Range (TIR), reaching 84.9%, well above the ADA goal of 70%, and a HbA1C reduction from 7.7% to 6.9%, meeting ADA targets for diabetes management. Separately, results from the Medtronic LENNY trial were publishedi in The Lancet Diabetes & Endocrinology. This multi-center, randomized controlled, crossover trial evaluated the MiniMed™ 780G system in young children (ages 2-6 years) with type 1 diabetes in a home setting. Results showed those using the MiniMed™ 780G system with SmartGuard™ achieved a 0.6% lower HbA1C and 9.9% higher Time in Range when compared to a baseline therapy of manual mode or hybrid closed loop without autocorrections. Parents and caregivers also reported improved sleep quality and lower fear of hypoglycemia when the system was used in auto mode (with SmartGuard™) compared to manual mode. Benefits of automated insulin delivery (AID) systems for type 2 diabetesWhile the standard of care for type 2 diabetes often includes lifestyle modifications and oral medications, many individuals require intensive insulin therapy to achieve optimal glucose management. The ADA's 2025 Standards of Careii now endorse the use of AID systems for adults with insulin-intensive type 2 diabetes, recognizing their potential to significantly improve clinical outcomes — an important validation of the growing role of diabetes technology in transforming chronic disease management. A 31-site single arm trial evaluated the MiniMed™ 780G system paired with the Simplera Sync™ sensor in a cohort of 236 individuals with type 2 diabetes. Results were promising across all clinical outcome metrics including Time in Range (TIR), Time in Tight Range (TITR), Time Above Range (TAR) compared to the run-in period where hybrid closed loop (auto basal only) or open-loop delivery was used. Time below range (TBR) remained stable. "As the industry moves toward broader indications of automated insulin delivery systems, we see tremendous potential to improve outcomes and quality of life for millions of people managing type 2 diabetes with insulin," said Dr. Robert Vigersky, Chief Medical Officer, Medtronic Diabetes. "Our teams are committed to advancing smart, connected technologies that reduce the daily burden of care and bring precision to insulin therapy like never before."Baselinea Studyb Change (Study - Baseline) P Participants, N 236 232 -- -- Time in AHCL, % -- 92.4 ± 15.7 -- -- A1C, % 7.7 ± 0.9 6.9 ± 0.7c -0.8 ± 0.9c <0.0001 Mean SG, mg/dL 152.9 ± 21.2 140.7 ± 13.3 -12.3 ± 19.5 <0.0001 CV of SG, % 25.1 ± 4.8 25.6 ± 4.8 0.4 ± 3.3 0.073h TBR <54 mg/dL, % 0.0 ± 0.1 0.0 ± 0.1 -0.0 ± 0.1 0.277 TBR <70 mg/dL, % 0.3 ± 0.5 0.3 ± 0.4 0.0 ± 0.5 0.056 TITR 70-140 mg/dL, % 45.3 ± 19.7 58.1 ± 13.6 13.0 ± 18.8 <0.0001h TIR 70-180 mg/dL, % 76.4 ± 15.9 84.9 ± 9.7 8.6 ± 14.4 <0.0001 TAR >180 mg/dL, % 23.4 ± 15.9 14.8 ± 9.7 -8.6 ± 14.5 <0.0001 TAR >250 mg/dL, % 3.5 ± 5.2 1.7 ± 2.5 -1.8 ± 4.6 <0.0001 TDD, U 61.0 ± 36.1 76.1 ± 44.1 14.5 ± 25.1 <0.0001 Basal and bolus insulin Total basal, U 34.6 ± 21.3 39.8 ± 23.9 4.9 ± 16.8 <0.0001 Total bolus, U 26.5 ± 20.7 36.3 ± 23.8 9.6 ± 15.1 <0.0001 Auto bolus, U -- 13.7 ± 11.1 -- -- Auto bolus, %TDD -- 17.2 ± 8.5 -- -- Auto bolus, %Total bolus -- 39.3 ± 21.8d -- -- System-initiated insulin Automated insulin, U 0.5 ± 3.4 51.2 ± 33.4 50.7 ± 33.7 <0.0001 Automated insulin, %TDD 0.9 ± 5.8 65.9 ± 17.3 65.0 ± 17.8 <0.0001 Daily carbohydrate, g 119.1± 87.4 127.7 ± 88.9 7.7 ± 84.6 0.571 ICR 7.6 ± 4.0d 6.9 ± 3.8e -0.6 ± 1.5f <0.0001 Weight, kg 98.0 ± 22.8g 98.4 ± 23.0c 0.7 ± 4.7c 0.006 BMI, kg/m2 34.0 ± 7.3g 34.2 ± 7.4c 0.2 ± 1.7c 0.006 Table 1. Glycemic outcomes, insulin delivery and weight during MiniMed™ 780G system use with the Simplera Sync™ sensor in adults with type 2 diabetes Data are shown as mean± loop (with or without predictive low glucose management) or HCL. AHCL was inadvertently (temporarily) enabled on 13 represent the last 6 weeks of the study period with glucose target set at the investigator's dN=231, eN=228. fN= two-sided t-test; otherwise, Wilcoxon signed-rank Body mass index; CV, Coefficient of variation; ICR, Insulin-to-carb ratio; SG, Sensor glucose; TAR, Time above range; TBR, Time below range; TIR, Time in range; TITR, Time in tight range; TDD, Total daily dose; U, MiniMed™ 780G system has not been approved for use in type 2 diabetes by U.S. FDA or other regulatory bodies. Impact on families of young children with diabetesManaging type 1 diabetes in young children and toddlers can be challenging for families. Data from the Lenny trial, published in The Lancet Diabetes & Endocrinology, highlighted how young children aged 2-6 years old achieved improved glycemic outcomes using the MiniMed™ 780G system. "To preserve brain development and minimize long-term diabetes complications, it is essential that blood glucose concentrations are maintained close to healthy ranges from disease onset in early life," said Prof. Tadej Battelino, MD, Head of Department of Pediatric and Adolescent Endocrinology, UMC Ljubljana, Slovenia. "We are hopeful that if the data continues to be strong, the MiniMed™ 780G system can help make this possible." After a run-in phase, subjects using the MiniMed™ 780G system with the Guardian™ 4 sensor were randomized into two sequences, consisting of a 12-week auto mode period (advanced hybrid closed loop), a 2-week wash-out phase and 12-week manual mode period (with suspend before low feature activated), or vice-versa. In total, there were 98 subjects across 12 centers in 4 countries. Results showed significantly** better glycemic management in auto mode, as shown in Figure 1 and Table 2 below. With no severe hypoglycemic events, the study showed an acceptable safety profile. Participants in auto mode spent on average 145 minutes per day more in range than those in manual mode. This improvement was primarily driven by a reduction in hyperglycemia, which is a major contributor to long-term complications. "We're hopeful that if the data continues to be strong, we will receive future indication expansion so the most vulnerable group, small children under 7 years, and their families can also benefit from this technology ", said Prof. Ohad Cohen, M.D., senior global medical affairs director, Medtronic Diabetes. Table 2: Glycemic metrics during the run-in phase, the manual mode period, and the auto mode Manual Mode Auto Mode HbA1c, % 7.53 ± 0.96 7.61 ± 0.91 7.00 ± 0.53 HbA1c, mmol/mol 58.8 ± 10.5 59.7 ± 9.9 53.0 ± 5.8 Mean glucose, mg/dl 169.6 ± 25.7 169.1 ± 23.1 150.2 ± 10.7 SD of SG, mg/dl 65.0 ± 14.7 65.4 ± 13.2 61.8 ±10.9 GMI, % 7.4 ± 0.6 7.4 ± 0.5 6.9 ± 0.3 Table 2: Glycemic metrics during the run-in phase, the manual mode period, and the auto mode period. During manual mode, the suspend before low (SBL) feature was activated. During run-in, the system was also used in manual mode with SBL activated. Data are shown as mean ± SD. The emotional toll of diabetes for parents and caregiversManaging type 1 diabetes in toddlers and young children can be emotionally stressful for parents and caregivers due to the need for constant blood sugar monitoring, dietary management, insulin administration and disrupted routines and sleep. A survey of caregivers in the LENNY trial indicated that when their child used auto mode, they experienced relatively low fear of hypoglycemia and high sleep Manual Mode Auto Mode Parent hypoglycemia fear survey (HFS-P) 44.75 ± 14.9 42.9 ± 13.3 40.9 ± 13.2 Pittsburgh Sleep Quality Index (PSQI) 7.1 ± 3.8 7.1 ± 4.0 5.9 ± 3.2 Table 3: Parent hypoglycemia fear survey and Pittsburgh Sleep Quality Index during the run-in phase, the manual mode period and the auto mode period. During manual mode, the suspend before low (SBL) feature was activated. During run-in, the system was also used in manual mode with SBL activated. Medtronic will seek future expansion of indications for a broader populationThe MiniMed™ 780G system currently is not indicated for use in in type 2 diabetes or young children under 7 years old by the U.S. Food and Drug Administration (FDA) or other regulatory bodies. Medtronic intends to work with global regulators towards expanding access to its diabetes technology for insulin-intensive type 2 diabetes, as well as a lower age indication for those with type 1 diabetes. About the Diabetes Business at Medtronic Medtronic Diabetes is on a mission to make diabetes more predictable, so everyone can embrace life to the fullest with the most advanced diabetes technology and always-on support when and how they need it. We've pioneered first-of-its-kind innovations for over 40 years and are committed to designing the future of diabetes management through next-generation sensors (CGM), intelligent dosing systems, and the power of data science and AI while always putting the customer experience at the forefront. About MedtronicBold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit and follow Medtronic on LinkedIn. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results. *MiniMed™ 780G system is for type 1 ages 7 years and over. Prescription required. WARNING: Do not use SmartGuard™ feature for people who require less than 8 units or more than 250 units of insulin/day. See the User Guide for a detailed list of information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. For details, see Significance was shown via confidence intervals§ Refers to SmartGuard™ feature. Individual results may vary.† Refers to auto correct, which provides bolus assistance. Can deliver all auto correction doses automatically without user interaction, feature can be turned on and off. i Battelino et al. Efficacy and safety of automated insulin delivery in children aged 2–6 years (LENNY): an open-label, multicentre, randomised, crossover trial; Lancet Diabetes Endocrinol 2025ii American Diabetes Association Professional Practice Committee: Diabetes Care 2025;48(Supplement_1):S146–S166 Contacts:Ashley Patterson Ryan Weispfenning Global Communications Investor Relations +1-818-576-3025 +1-763-505-4626 View original content to download multimedia: SOURCE Medtronic plc
Yahoo
31-05-2025
- Business
- Yahoo
Does This Move Make Medtronic Stock a Buy?
Medtronic's diabetes care unit has grown faster than the rest of its business in recent years. However, the company decided to spin off this segment into a stand-alone corporation. Still, Medtronic has several growth avenues and an impeccable dividend program. 10 stocks we like better than Medtronic › Over the past few years, Medtronic (NYSE: MDT) has faced significant challenges, including a pandemic-induced slowdown, relatively slow revenue growth, and economic issues that impacted its financial results. Throughout it all, Medtronic's diabetes care business has consistently been one of its fastest-growing segments. However, the healthcare leader recently announced some news regarding this unit that might surprise some investors. Let's find out more about it and discuss what it means for Medtronic's prospects. Medtronic markets several products within its diabetes care segment. Perhaps its most important line is its insulin pump franchise. One of the latest iterations of this was the MiniMed 780G, which came with several nifty features, including automatic insulin dose corrections. Medtronic also markets continuous glucose monitoring (CGM) systems that allow diabetes patients to keep track of their blood sugar levels, with constant measurements every few minutes. Additionally, it offers insulin pens and a software that collects information from CGM devices, insulin pumps, and smart pens to create reports to inform patients' progress or share with medical professionals. There is considerable room for growth in the diabetes market. Of the half-billion adults worldwide with diabetes, only 1% had access to CGM technology as of the end of 2023. One might think Medtronic would seize the vast untapped opportunity, especially considering its diabetes care unit's faster growth. During the company's fiscal 2025, ended April 25, Medtronic reported revenue of $33.6 billion, up 3.6% compared to the previous fiscal year. The company's diabetes care segment generated $2.8 billion in sales, with year-over-year growth of 10.7%. True, it still makes up a small part of its business, but given the massive worldwide opportunity, it might have eventually become its biggest growth driver if it kept up its much faster growth pace for a long time. However, Medtronic announced that it would spin off its diabetes care unit, which will become a stand-alone, publicly traded corporation within the next 18 months. Medtronic wants to simplify its portfolio and focus its resources on core, high-margin growth opportunities. That's the rationale management gave for the separation. What does it mean for investors? Medtronic would likely struggle to catch up with the leaders in the diabetes care field. Abbott Laboratories and DexCom dominate the CGM market. In the insulin pump niche, Medtronic has had to compete with companies such as Tandem Diabetes Care. Perhaps Medtronic felt it would not be competitive in these and other niches of the diabetes market over the long run, hence its decision to focus on markets where it "has leading core competencies," to borrow the company's phrasing. While Medtronic will lose its fastest-growing segment, its business should remain robust. The company still markets dozens of products across several other areas that generate consistent revenue and profits. In today's challenging environment, investors tend to gravitate toward steady and stable corporations like Medtronic. Furthermore, the healthcare leader recently announced important news. The company is requesting U.S. clearance for its Hugo robotic-assisted surgery (RAS) system in urologic procedures after the device delivered strong clinical trial results. Approval of Medtronic's RAS Hugo system in the U.S. should unlock massive opportunities, given the industry's underpenetration and significant runway for growth. Finally, Medtronic remains an excellent dividend stock, and it recently announced yet another payout hike. The medical device specialist has increased its dividends for 48 consecutive years -- just two more and it will join the exclusive rank of Dividend Kings. Even with the potential impact of tariffs, Medtronic has performed relatively well this year compared to broader equity markets. In the long run, it should be able to mitigate the effects of tariffs, given its diversified business and consistent earnings, which can enable it to shift its manufacturing around. Medtronic remains a top pick for long-term, income-oriented investors despite spinning off its fastest-growing unit. Before you buy stock in Medtronic, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Medtronic wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $638,985!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $853,108!* Now, it's worth noting Stock Advisor's total average return is 978% — a market-crushing outperformance compared to 171% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of May 19, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Abbott Laboratories. The Motley Fool recommends DexCom and Medtronic and recommends the following options: long January 2026 $75 calls on Medtronic, long January 2027 $65 calls on DexCom, short January 2026 $85 calls on Medtronic, and short January 2027 $75 calls on DexCom. The Motley Fool has a disclosure policy. Does This Move Make Medtronic Stock a Buy? was originally published by The Motley Fool Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Time of India
21-05-2025
- Business
- Time of India
Medtronic to separate diabetes business into standalone company
Bengaluru: Medical device maker Medtronic said on Wednesday it plans to separate its diabetes business, which houses its insulin pumps and other wearable devices, into a stand-alone company. The new company will be headed by Que Dallara, the current chief of Medtronic's diabetes division , and will house about 8,000 employees and be headquartered in Northridge, California. The diabetes unit has recently struggled after a 2021 warning by regulators about the company's MiniMed 600 insulin pumps. The spin off would allow Medtronic to focus on more profitable businesses such as heart devices , its biggest revenue driver. The spin off is expected to be complete within the next 18 months through a series of capital markets deals, with a preferred path of an initial public offering and subsequent split-off. The separation was first reported by the Wall Street Journal earlier on Wednesday. In 2022, the U.S. Food and Drug Administration flagged a cybersecurity risk for the MiniMed 600 Series insulin pump system, cautioning that the device was susceptible to cyberattacks that could potentially disrupt insulin delivery. The decision to separate the diabetes business follows years of restructuring efforts, which included a delay in the FDA clearance for the MiniMed 780G insulin pump until 2023. Separately, the company posted an adjusted profit of $1.62 per share for the fourth quarter ended April 25, ahead of Wall Street estimates of $1.58 per share, according to LSEG data. Its revenue of $8.93 billion also beat estimates of $8.82 billion, driven by sales of both heart devices and diabetes devices. Shares in the Ireland-based company were up marginally in pre-market trading.
