Latest news with #glycemiccontrol
Medscape
5 days ago
- Health
- Medscape
Diabetes Tech Use On the Rise But A1c Reductions Still Lag
Use of diabetes technology has dramatically increased and glycemic control has improved among people with type 1 diabetes (T1D) in the US over the past 15 years, but at the same time, overall achievement of an A1c level < 7% remains low and socioeconomic and racial disparities have widened. These findings came from an analysis of national electronic health records of nearly 200,000 children and adults with T1D by Michael Fang, PhD, of the Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, and colleagues. The study was published online on August 11, 2025, in JAMA Network Open . Use of continuous glucose monitors (CGMs) increased substantially from 2009-2011 to 2021-2023, from less than 5% in both children and adults to more than 80% and over half, respectively. While A1c levels did drop over the 15 years, just 1 in 5 children and slightly over a quarter of adults achieved a level < 7%. The average A1c level stayed above 8%, with ethnic minorities and low-income patients seeing the smallest gains. 'Additional opportunities for individualized patient and clinician education can help optimize the use of technologies. In our analyses, the increase in CGM and insulin pump use substantially outpaced gains in glycemic control,' Fang and colleagues wrote. In an accompanying editorial, Diana Soliman, MD, of the Division of Endocrinology at the University of Miami Miller School of Medicine in Miami, and colleagues wrote, 'As technological innovation continues to accelerate, it is encouraging to see signs of progress in glycemic management. Ensuring that these advances benefit all individuals with T1D must remain a priority.' Asked to comment, Anne L. Peters, MD, professor of clinical medicine and director of Clinical Diabetes Programs at the Keck School of Medicine of USC, Los Angeles, told Medscape Medical News that a key component is having staff to help with prior authorization paperwork and certified diabetes care and education specialists (CDCES) to help train patients and troubleshoot. 'These health disparities are real but fixable. However, it takes staff to make it happen.' Tech Use On the Rise But A1c Level Hasn't Dropped Much Fang and colleagues used the OptumLabs Data Warehouse to identify 186,590 eligible individuals with T1D, of whom 26,853 were younger than 18 years. Three quarters were White, 12% were Black, and 7% were Hispanic individuals. Few previous studies of T1D have included such representative population-based data, the authors noted. From 2009-2011 to 2021-2023, among youths, the use of CGMs rose from 4% to 82%, insulin pumps from 16% to 50%, and the combination from 1% to 47% ( P for trend < .001 for all). Such use in 2021-2023 was higher among White youths and those with commercial insurance. During the same period, among adults, the use of CGM rose from 5% to 57%, insulin pumps from 11% to 29%, and the combination from 1% to 22% ( P for trend < .001 for all). Throughout, adults who were White, younger, and commercially insured were more likely to use CGMs. Overall, mean A1c levels dropped from 8.9% to 8.3% in youths and from 8.2% to 8.0% in adults from 2009-2011 to 2021-2023. Among youths, the prevalence of achieving glycemic control, defined as an A1c level < 7%, rose from about 7% in 2009-2011 and 2014-2017 to 19% in 2021-2023 ( P for trend < .001). Glycemic control improved for all youth subgroups except for Black youths. Differences by race, ethnicity, and insurance type increased after 2018-2020. During 2021-2023, 21% of White youths vs 17% of Hispanic and 12% of Black youths achieved glycemic control. Those with commercial health insurance also had higher rates of glycemic control than those with Medicaid insurance (22% vs 13%). For adults with T1D, glycemic control rose from 21% in 2009-2011 to 28% in 2021-2023 ( P for trend < .001). Again, the prevalence of achieving glycemic control was higher among those who were White (30% vs 20% of Hispanic and 21% of Black patients in 2021-2023) and those who had commercial insurance (30% vs 19% of those who had Medicaid insurance). Implications for Clinical Practice These findings have important implications for clinical practice and policy, Soliman and colleagues said. 'Barriers to diabetes technology access, including financial costs, lack of clinician prescription, and inadequate clinical communication, continue to disproportionately affect medically underserved populations. While the increase in diabetes technology may be attributed to expanded insurance coverage, incorporation into guidelines, and improved technology, there remains a crucial need to extend this technology more widely.' Addressing these challenges, they said, 'requires coordinated efforts that combine reduced financial barriers with clinician training, shared decision-making, and culturally competent communication to promote equitable and effective use of technology.' Peters has one practice in the relatively wealthy west side of Los Angeles and another in an underserved area in East Los Angeles. On the west side, she has a full-time staffer who exclusively handles prior authorizations for diabetes devices and a CDCES who trains patients and follows them weekly. The patients there all speak English and have high health literacy. On the east side, there aren't any educators and no classes on advanced technology. A prescription for an automated insulin delivery device can take months to get filled. Non-English speaking patients may have difficulty accessing manufacturer assistance and may lack smartphones compatible with their devices. Even when patients are able to start using the technology, they may not have the support they need to continue. 'The systems of care often lack what it takes to provide adequate care for under-resourced people with T1D. When we've had research funding to provide a CDCES, my patients in East LA do great. The training often takes longer than in those who are starting at a higher knowledge level, but technology is very useable by under-resourced people,' Peters said. The study was funded by the National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. Fang had no other disclosures. Soliman had no disclosures. Peters reported recording videos for Medscape Medical News, being on the advisory board for Vertex, and having stock options for Omada Health.
Yahoo
05-08-2025
- Business
- Yahoo
Biomea Fusion Reports Second Quarter 2025 Financial Results and Corporate Highlights
Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health: In patients with type 2 diabetes (T2D) not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and improved beta-cell function subsequent to the dosing period In a rodent model of T2D, icovamenib in combination with low-dose semaglutide, promoted enhanced glycemic control and weight loss with complete lean mass preservation Icovamenib promoted healthy myotube morphology and reduced drug-induced atrophy in ex-vivo human myotube cultures Next-generation oral GLP-1 receptor agonist (RA) candidate, BMF-650, demonstrated robust, dose-dependent weight loss and appetite suppression in obese non-human primates; planned Investigational New Drug (IND) submission remains on track for the second half of 2025 Raised approximately $42.8 million in gross proceeds through a public offering, extending projected cash runway into the second half of 2026 Reduced the workforce and quarterly expenses to support the advancement of the ongoing core programs SAN CARLOS, Calif., Aug. 05, 2025 (GLOBE NEWSWIRE) -- Biomea Fusion, Inc. ('Biomea' or 'Biomea Fusion' or 'the Company') (Nasdaq: BMEA), a clinical-stage diabetes and obesity company, today reported its financial results for the second quarter ended June 30, 2025, and provided a business update. 'In the second quarter, we presented clinical and preclinical results with icovamenib that support its unique role as a novel, potentially first-in-class investigational agent for the treatment of type 2 diabetes as well as in obesity, while further strengthening our BMF-650 program with robust data in non-human primates,' said Mick Hitchcock, Ph.D., Interim Chief Executive Officer and Board Member of Biomea Fusion. 'At ADA 2025, we showed in preclinical models that our menin inhibitor, icovamenib, in combination with low-dose semaglutide not only drove superior glycemic control but also considerably boosted weight reduction, while fully preserving lean mass and outperforming semaglutide alone. Furthermore, icovamenib promoted myotube health and reduced drug-induced atrophy in a human cell model, highlighting its potential to support muscle health. We look forward to engaging with FDA and further evaluating icovamenib in this patient setting. Our next-generation investigational GLP-1 RA, BMF-650, showed encouraging results in a 28-day study in obese cynomolgus monkeys, achieving up to 15% weight reduction and robust dose-dependent appetite suppression. These findings reinforce BMF-650's potential as an oral GLP-1 RA. With these clinical advances and the completion of our $42.8 million equity financing, we now have the necessary resources to advance these high-priority diabetes and obesity programs.' Second Quarter Highlights: Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and Type 1 Diabetes (T1D)) Three presentations at ADA 2025 highlighted the therapeutic potential of icovamenib across multiple aspects of metabolic health: In patients with T2D not achieving glycemic targets, icovamenib demonstrated durable HbA1c reduction and enhanced beta-cell function three months subsequent to the dosing period, particularly in severe insulin deficient patients enrolled in its Phase II trial; icovamenib was well tolerated across the dosing arms. In a Zucker Diabetic Fatty (ZDF) rat model of T2D, treatment of icovamenib in combination with low-dose semaglutide delivered superior metabolic benefits compared to low-dose semaglutide alone: 60% lower fasting blood glucose and 50% lower glucose OGTT AUC Greater HbA1c decline of >1% by Day 28 and >2% by Day 39 Greater improvement in insulin sensitivity with a 75% lower HOMA-IR (marker of insulin resistance) 2-fold increase in C-peptide to glucose ratio indicating enhanced beta cell function Superior appetite suppression with a 10% greater body weight reduction than low-dose semaglutide alone The observed body weight loss was primarily due to fat mass reduction with complete preservation of lean mass Icovamenib also promoted healthy myotube morphology and diminished drug-induced atrophy in ex vivo human myotube cultures. BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity) In a 28-day study in obese cynomolgus monkeys, BMF-650 achieved rapid, dose-dependent reductions in food intake and significant weight loss, with average weight reductions of 15% at the higher dose of 30 mg/kg/day. BMF-650 was generally well tolerated across all dose levels and showed no aminotransferase elevations. These preclinical results compare favorably to published preclinical data from other leading oral GLP-1 RA candidates in development and support BMF-650's potential as a best-in-class oral small-molecule GLP-1 RA. BMF-500 (Oral Small Molecule FLT3 Inhibitor in Acute Myeloid Leukemia (AML)) Presented updated Phase I data at EHA 2025, showing sustained antileukemic responses, deep bone marrow blast reductions, and survival benefit in relapsed/refractory FLT3-mutant AML patients, all of whom had failed FLT3 inhibitor gilteritinib. The Company concluded its oncology efforts and is now exploring strategic partnerships for BMF-500. Financing & Operations In June 2025, Biomea closed its previously announced underwritten public offering and in July 2025 the underwriters partially exercised their over-allotment option to purchase additional shares of common stock. The aggregate gross proceeds from the offering, including the over-allotment option, were approximately $42.8 million, before deducting underwriting discounts and commissions and offering expenses payable by Biomea. During the first half of 2025 Biomea also reduced its workforce and operational expenses and anticipates future quarterly operational expenses to be approximately 40% lower than the most recent quarter, depending on study enrollments and expansion. Key Anticipated 2025 Milestones: Icovamenib (Oral Small Molecule Menin Inhibitor for T2D and T1D) 52-week data from the Phase II COVALENT-111 study in T2D expected in the second half of 2025. Initiation of Phase II study of icovamenib in T2D patients currently uncontrolled on a GLP-1 based therapy in the second half of 2025. Preliminary data from the Phase II COVALENT-112 study in T1D anticipated in the second half of 2025. BMF-650 (Next-generation Oral Small Molecule GLP-1 RA for Obesity) Submission of the IND application for BMF-650 is planned for the second half of 2025. Phase I study initiation in obese, otherwise healthy volunteers anticipated by late 2025, pending regulatory clearance. Second Quarter 2025 Financial Results Cash, Cash Equivalents, and Restricted Cash: As of June 30, 2025, the Company had cash, cash equivalents and restricted cash of $56.6 million. The Company expects its cash, cash equivalents, and restricted cash to be sufficient to fund planned operating activities into the second half of 2026. Net Loss: The Company reported a net loss attributable to common stockholders of $20.7 million for the three months ended June 30, 2025, which included $2.6 million of stock-based compensation, compared to a net loss of $37.3 million for the same period in 2024, which included $4.8 million of stock-based compensation. Net loss attributable to common stockholders was $50.0 million for the six months ended June 30, 2025, which included $5.7 million of stock-based compensation, compared to a net loss of $76.3 million for the same period in 2024, which included $9.9 million of stock-based compensation. Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended June 30, 2025, compared to $31.8 million for the same period in 2024. The decrease of approximately $15.3 million was primarily driven by a decrease of $9.1 million related to clinical activities, a decrease of $2.0 million related to preclinical and exploratory programs, a decrease of $0.1 million of manufacturing costs and a decrease of $0.2 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $3.8 million, including stock-based compensation, due to a decrease in headcount. R&D expenses were $39.5 million for the six months ended June 30, 2025, compared to $65.6 million for the same period in 2024. The decrease of $26.1 million was primarily driven by a decrease of $16.4 million related to clinical activities, a decrease of $3.0 million related to preclinical and exploratory programs and a decrease of $1.9 million of manufacturing costs. This decrease in external costs was partially offset by an increase of $0.7 million in other external costs related to consultants, advisors and other professional services to support our clinical studies. Personnel-related expenses decreased by $5.5 million, including stock-based compensation, due to a decrease in headcount. General and Administrative (G&A) Expenses: G&A expenses were $4.7 million for the three months ended June 30, 2025, compared to $7.1 million for the same period in 2024. The decrease of $2.4 million is primarily driven by a decrease of $1.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount and a decrease of $0.4 million related to professional and legal services. G&A expenses were $11.5 million for the six months ended June 30, 2025, compared to $14.4 million for the same period in 2024. The decrease of $2.8 million is primarily driven by a decrease of $2.9 million related to personnel-related expenses, including stock-based compensation, due to a decrease in headcount. About Biomea FusionBiomea Fusion is a clinical-stage diabetes and obesity medicines company focused on the development of its oral small molecules, icovamenib and BMF-650, both being developed to significantly improve the lives of patients with diabetes, obesity, and metabolic diseases. We aim to cure. Visit us at and follow us on LinkedIn, X and Facebook. Forward-Looking Statements Statements we make in this press release may include statements which are not historical facts and are considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the 'Securities Act'), and Section 21E of the Securities Exchange Act of 1934, as amended (the 'Exchange Act'). These statements may be identified by words such as 'aims,' 'anticipates,' 'believes,' 'could,' 'estimates,' 'expects,' 'forecasts,' 'goal,' 'intends,' 'may,' 'plans,' 'possible,' 'potential,' 'seeks,' 'will,' and variations of these words or similar expressions that are intended to identify forward-looking statements. Any such statements in this press release that are not statements of historical fact, including statements regarding the expected benefits resulting from the implementation of the cost saving measures and potential ability to fund key value drivers; clinical and therapeutic potential of our product candidates and development programs, including icovamenib, BMF-500, and BMF-650, the potential of icovamenib as a treatment for T1D and T2D, the potential of BMF-650 as a treatment for diabetes and obesity; our research, development and regulatory plans; the mechanism of action of our product candidates and development programs; the progress and initiation of our ongoing and upcoming clinical trials, including our Phase I/II COVALENT-111 study of icovamenib in T2D, our Phase II COVALENT-112 study of icovamenib in T1D, and our planned IND submission for the BMF-650 program; the anticipated availability of data from our clinical trials; our planned interactions with regulators, and the timing of such events; and our expected cash runway may be deemed to be forward-looking statements. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act and are making this statement for purposes of complying with those safe harbor provisions. Any forward-looking statements in this press release are based on our current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including the risk that preliminary or interim results of preclinical studies or clinical trials may not be predictive of future or final results in connection with future clinical trials and the risk that we may encounter delays in preclinical or clinical development, patient enrollment and in the initiation, conduct and completion of our ongoing and planned clinical trials and other research and development activities. These risks concerning Biomea Fusion's business and operations are described in additional detail in its periodic filings with the U.S. Securities and Exchange Commission ('SEC'), including its most recent periodic report filed with the SEC and subsequent filings thereafter. Biomea Fusion explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact: Meichiel Jennifer WeissSr. Director of Investor Relations and Corporate Development mweiss@ BIOMEA FUSION, INC. Condensed Statement of Operations and Comprehensive Loss (Unaudited) (in thousands, except share and per share data) Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Operating expenses: Research and development (1) $ 16,566 $ 31,825 $ 39,463 $ 65,601 General and administrative (1) 4,710 7,073 11,525 14,356 Total operating expenses 21,276 38,898 50,988 79,957 Loss from operations (21,276 ) (38,898 ) (50,988 ) (79,957 ) Interest and other income, net 536 1,622 986 3,620 Net loss and comprehensive loss $ (20,740 ) $ (37,276 ) $ (50,002 ) $ (76,337 ) Net loss per common share, basic and diluted $ (0.51 ) $ (1.03 ) $ (1.29 ) $ (2.12 ) Weighted-average number of shares used to compute basic and diluted net loss per common share 40,630,403 36,043,561 38,639,834 35,966,965 (1) Includes stock-based compensation as follows (non-cash operating expenses): Three Months Ended Six Months Ended June 30, June 30, 2025 2024 2025 2024 Research and development $ 1,568 $ 2,448 $ 3,488 $ 4,994 General and administrative 1,005 2,392 2,254 4,868 Total stock-based compensation expense $ 2,573 $ 4,840 $ 5,742 $ 9,862 BIOMEA FUSION, INC. Condensed Balance Sheet Data (Unaudited) (in thousands) June 30, December 31, 2025 2024 Cash, cash equivalents, and restricted cash $ 56,593 $ 58,648 Working capital 47,095 46,659 Total assets 73,163 79,938 Stockholders' equity 27,510 51,573
Medscape
04-08-2025
- Health
- Medscape
Add-On Lobeglitazone Boosts Glycemic Control in T2D
TOPLINE: Patients with type 2 diabetes (T2D) who responded inadequately to sitagliptin plus metformin experienced improvements in glycemic control and insulin sensitivity after lobeglitazone was added to their regimen. METHODOLOGY: Metformin and DPP-4 inhibitors such as sitagliptin are widely used for glycemic control in patients with T2D; however, the choice of which agent to add when these therapies fail to achieve target blood glucose levels remains unclear. Researchers in Korea conducted a phase 3 trial from April 2018 to December 2021 to evaluate the efficacy and safety of adding lobeglitazone to the dual therapy regimen of metformin (≥ 1000 mg/d) and sitagliptin (100 mg/d). The study included 231 patients with T2D (mean age, 58.65 years; 56.52% men) whose A1c ranged from 7.0% to 10.0% despite receiving the dual therapy. After a 2-week run-in period, patients were randomly assigned to receive either a 0.5 mg/d dose of lobeglitazone (n = 116) or placebo (n = 115) alongside metformin and sitagliptin for 24 weeks, followed by a 28-week open-label phase in which all patients received lobeglitazone. The primary endpoint was the change from baseline in mean A1c at 24 weeks. Secondary endpoints included changes in additional glycemic and lipid parameters and safety outcomes. TAKEAWAY: At week 24, mean A1c levels were 1.03% lower in patients who received lobeglitazone vs placebo (95% CI, -1.23% to -0.82%), with the reduction being maintained until 52 weeks; those who switched from placebo to lobeglitazone at week 24 also saw a reduction in A1c levels by week 52. Additionally, at week 24, a higher proportion of patients receiving lobeglitazone vs placebo achieved A1c levels < 6.5% (27.14% vs 0.87%) and < 7% (53.04% vs 13.04%; both P < .0001). The addition of lobeglitazone to dual therapy significantly improved insulin sensitivity markers compared with placebo at week 24, with effects sustained till week 52; additionally, administration of lobeglitazone reduced low-density lipoprotein cholesterol levels. The incidence of adverse events was not significantly different between the two groups; the incidence of edema and weight gain in some patients receiving lobeglitazone aligned with the known effects of thiazolidinediones. IN PRACTICE: 'The observed improvements in various glucose-related metabolic factors and lipid metabolism indicators with lobeglitazone coadministration may provide valuable evidence for long-term blood glucose management and cardiovascular risk reduction,' the authors of the study wrote. SOURCE: This study was led by Eun-Gyoung Hong, MD, Hallym University Dongtan Sacred Heart Hospital, Hwaseong, South Korea. It was published online in Diabetes, Obesity and Metabolism. LIMITATIONS: A longer follow-up might be needed to fully evaluate the sustained effects of the study outcomes and potential side effects. DISCLOSURES: This study received funding from Chong Kun Dang Pharmaceutical Company. The authors declared having no conflicts of interest. This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
Medscape
16-07-2025
- Health
- Medscape
Sesame Oil Boosts Glycemic Control in Women With MASLD
TOPLINE: In women with metabolic dysfunction-associated steatotic liver disease (MASLD), supplementing a calorie-restricted diet with unheated sesame oil, such as that used on salads or cooked meals, significantly improved biomarkers of glycemic control and insulin resistance. METHODOLOGY: Sesame oil contains compounds that attenuate inflammation by suppressing proinflammatory cytokines, potentially improving glucose and lipid metabolism; however, studies on its role in MASLD are limited. Researchers in Iran conducted a clinical trial to investigate whether sesame oil supplementation influenced glycemic, metabolic, and stress biomarkers in women with MASLD (aged 20-50 years; BMI, 25-40) who regularly consumed sunflower oil. After a 2-week run-in period on their usual diet, patients were randomly assigned to consume 30 g/d of either sesame oil or sunflower oil in unheated form for 12 weeks, alongside a weight-loss diet with a calorie deficit of 500 kcal/d. Blood markers for glycemic control, insulin sensitivity, inflammation, and oxidative stress were measured at baseline and at 12 weeks. TAKEAWAY: Of 60 patients enrolled, 53 completed the study, 27 in the sesame oil group (mean age, 38.89 years) and 26 in the sunflower oil group (mean age, 39.35 years). The sesame oil group experienced reductions in fasting blood glucose of 18.2 mg/dL, fasting serum insulin of 3.2 μIU/mL, and homeostatic model assessment for insulin resistance of 1.4 units; these reductions were significantly greater than in the sunflower oil group (P < .001 for all). Markers of pancreatic beta cell function and glucose regulation improved significantly in patients in the sesame oil group; however, markers of inflammation and oxidative stress did not differ between the two groups. Both groups achieved significant weight loss, with no differences between them. IN PRACTICE: 'While both groups achieved significant weight loss, the superior glycemic improvements in the [sesame oil] group indicate effects beyond calorie restriction,' the authors of the study wrote. SOURCE: This study was led by Masoumeh Atefi, Shahroud University of Medical Sciences in Shahroud, Iran. It was published online in BMC Nutrition. LIMITATIONS: The study did not measure serum vitamin E levels, red blood cell fatty acid content, or serum A1c levels. Self-reported dietary intake might have introduced bias. Enrollment was restricted to women aged 20-50 years with a specified BMI, limiting generalizability. DISCLOSURES: The study received a grant from Isfahan University of Medical Sciences. The authors reported 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
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.
