\n
Dexcom: Strong growth and the next CGM generation<\/h3>\n\n\n\n
Dexcom has raised its revenue outlook for fiscal year 2026, contributing to a 7% increase in the company\u2019s share price.<\/p>\n\n\n\n
The rollout of the G7 15-Day<\/strong> appears to be progressing well, with positive feedback on the updated algorithm, extended wear time and improved adhesive performance. By the end of fiscal year 2026, Dexcom aims to transition around 50% of its US user base to the 15-day sensor.<\/p>\n\n\n\nLooking further ahead, the G8<\/strong> is expected to launch in late 2027 or early 2028. According to Dexcom, the next-generation sensor will be around 50% smaller than the G7 and is designed to further improve accuracy. A new silicon chip and updated algorithm are intended to enable a more adaptive sensor start-up and potentially reduce inaccurate glucose readings during the early wear period. Clinical validation studies are currently underway.<\/p>\n\n\n\nThe first G8 version will measure glucose only, but multi-analyte versions<\/strong> capable of measuring ketones and potassium are expected to follow.<\/p>\n\n\n\nAnother major strategic priority is expanding CGM use among the approximately 25 million people with type 2 diabetes in the US who do not use insulin<\/strong>. Dexcom has submitted the results of the CONNECT randomized controlled trial for publication. Presented at ADA 2026, the study showed that non-insulin-treated users of the G7 achieved a mean HbA1c reduction of 1.6 percentage points after 26 weeks<\/strong>, representing a 0.9 percentage-point greater reduction<\/strong> than in the control group receiving usual care with SMBG.<\/p>\n\n\n<\/div>\n\n\n\n\n
Dexcom selected for FDA TEMPO pilot program<\/h3>\n\n\n\n
The FDA has selected Dexcom as the first participant<\/strong> in its new Technology-Enabled Meaningful Patient Outcomes (TEMPO)<\/strong> pilot program. TEMPO is designed to evaluate innovative digital health technologies that can improve chronic disease management while generating real-world evidence.<\/p>\n\n\n\nThrough the program, Dexcom plans to introduce an AI-powered glucose health platform<\/strong> that combines data from the Dexcom G7 and Stelo with additional health information such as nutrition, physical activity, sleep and stress. The aim is to provide healthcare professionals and eligible users with more personalized and actionable insights.<\/p>\n\n\n\nThe platform is also intended to support earlier identification of prediabetes and type 2 diabetes<\/strong>. An estimated 115 million people in the US are affected by prediabetes or diabetes, while many remain unaware of their metabolic status.<\/p>\n\n\n<\/div>\n\n\n\n\n
Diabeloop launches smartphone-controlled DBLG2 AID system in Germany<\/h3>\n\n\n\n
Diabeloop and ViCentra have announced that the DBLG2 AID system<\/strong> is now available on prescription in Germany. The system combines Diabeloop\u2019s adaptive DBLG2 algorithm with the Kaleido patch pump<\/strong> and Dexcom G7 CGM<\/strong>.<\/p>\n\n\n\nA key feature is that the algorithm runs directly on the user\u2019s Android smartphone<\/strong>, eliminating the need for a separate controller. The launch follows CE marking of the DBLG2 algorithm in August 2025.<\/p>\n\n\n\nDBLG2 analyzes glucose data continuously and adjusts insulin delivery every five minutes. Users can select from 29 predefined activity profiles<\/strong> to proactively adapt insulin delivery during exercise. Additional features include a Fat Meal mode<\/strong> designed to improve glucose management after higher-fat meals and a customizable Night Mode<\/strong> aimed at reducing overnight alerts and sleep disruption.<\/p>\n\n\n\nAccording to Diabeloop, real-world data from Kaleido users running this algorithm showed a Time in Range above 77%<\/strong> and a Time Below Range below 0.2%<\/strong>.<\/p>\n\n\n\nDiabeloop is also pursuing international expansion: earlier this year, the company announced plans to integrate DBLG2 into Sequel\u2019s twiist AID system<\/strong>, with a US launch targeted for 2027.<\/p>\n\n\n<\/div>\n\n\n\n\n
Medtrum launches 300-unit patch pump in Germany<\/h3>\n\n\n\n
Medtrum is preparing to launch its 300-unit tubeless patch pump<\/strong> in Germany; the device is already available in selected international markets.<\/p>\n\n\n\nThe pump is part of the TouchCare Nano system<\/strong>, which also includes Medtrum\u2019s Nano CGM, the Artificial Pancreas GO (APGO)<\/strong> automated insulin delivery algorithm and the EasyPatch app.<\/p>\n\n\n\nOne notable feature is Auto Meal Handling<\/strong>, which allows users to select a meal type instead of performing a full carbohydrate calculation. The concept follows a broader trend towards simplifying meal management in AID systems, similar to approaches used in systems such as Beta Bionics\u2019 iLet and Medtronic\u2019s MiniMed 780G.<\/p>\n\n\n\nThe pump is already listed in the German statutory health insurance medical aids directory, supporting access and reimbursement in Germany.<\/p>\n\n\n\n
Why it matters<\/strong> Medtrum is re-entering one of Europe\u2019s most competitive patch-pump markets, currently led by Insulet. Competition is likely to intensify further, with companies including MiniMed, Tandem, Beta Bionics, Modular Medical and ViCentra also developing or expanding patch-pump offerings.<\/p>\n\n\n<\/div>\n\n\n\n\n
MiniMed Flex now available with Abbott\u2019s Instinct CGM in the US<\/h3>\n\n\n\n
The MiniMed Flex<\/strong> insulin pump is now available in the US with Abbott\u2019s Instinct CGM<\/strong>, expanding beyond the Simplera Sync sensor previously used with the system. The launch is accompanied by a new marketing campaign emphasizing discretion, smartphone control and 24\/7 automation.<\/p>\n\n\n\nThe screenless MiniMed Flex holds up to 300 units of insulin<\/strong> and is compatible with MiniMed\u2019s Extended infusion set, which can be worn for up to seven days. Compared with Simplera Sync, the Instinct sensor is substantially smaller and offers a longer wear time of 15 days versus 6 days<\/strong>. Reported MARD is also lower at 8.2% versus 10.2%<\/strong>. Existing Flex users can enable Instinct compatibility through a software update.<\/p>\n\n\n\nBoth MiniMed Flex and Instinct are FDA-cleared for people with type 1 diabetes aged seven years and older, as well as adults with insulin-requiring type 2 diabetes.<\/p>\n\n\n\n
For now, Flex continues to use MiniMed\u2019s current SmartGuard AHCL algorithm<\/strong>. Its next-generation fully closed-loop algorithm, Vivera<\/strong>, is in late-stage development, with the NEXUS and GATEWAY studies underway. A further study is planned to compare Flex combined with Vivera against commercially available AID systems.<\/p>\n\n\n\nMiniMed is also preparing to submit its Fit patch pump<\/strong> to the FDA by autumn 2026, potentially extending the company\u2019s reach into the rapidly growing tubeless pump market.<\/p>\n\n\n<\/div>\n\n\n\n\n
Modular Medical begins US rollout of Pivot patch pump<\/h3>\n\n\n\n
San Diego-based startup Modular Medical<\/strong> has started a limited US rollout of its Pivot patch pump<\/strong> following FDA clearance in April 2026. A broader commercial launch is planned for October 2026, while CE marking is expected around late 2026 or early 2027.<\/p>\n\n\n\nPivot\u2019s main differentiator is its two-part, detachable design<\/strong>. The pump itself can be reused for up to 90 days, while the cartridge and adhesive patch are replaced every three days. According to the company, this could reduce waste by up to 40%. Unlike fully disposable patch pumps such as Omnipod, Pivot can also be temporarily removed for activities such as showering or exercise.<\/p>\n\n\n\nModular Medical is targeting what it calls the \u201cAlmost Pumper\u201d<\/strong> population \u2013 insulin-treated adults who remain on multiple daily injections despite potentially benefiting from pump therapy.<\/p>\n\n\n\nThe company also emphasizes affordability. Its own cost analysis suggests that patch-pump therapy could be less expensive over four years than more complex AID systems.<\/p>\n\n\n\n
Why it matters<\/strong> Pivot enters an increasingly crowded patch-pump market with a strategy focused on simplicity, reusability and lower cost. Whether this positioning will be sufficient to gain meaningful market share remains to be seen.<\/p>\n\n\n<\/div>\n\n\n\n\n
mylife reservoir refill option: sustainability in everyday use<\/h3>\n\n\n\n
Ypsomed has shared survey data from mylife Loop users on the use of the refill option for mylife YpsoPump reservoirs<\/strong>.<\/p>\n\n\n\nAmong 238 respondents, 84% were aware<\/strong> that the reservoir can be refilled. Of those actively using reservoirs, 78% reported using the refill option<\/strong>, suggesting that the feature is not only known but is also being adopted in everyday practice.<\/p>\n\n\n\nWhen asked about the main benefit, respondents most frequently mentioned resource conservation (35%)<\/strong> and sustainability (25%)<\/strong>. Other reasons included reducing reservoir use and maintaining flexibility in insulin choice. Overall, 86% saw benefits in the refill option<\/strong>.<\/p>\n\n\n\nWhy it matters<\/strong> Although based on a relatively small user survey, the results suggest that practical sustainability features can be relevant to people with diabetes \u2013 particularly when they allow users themselves to reduce material consumption without changing their therapy.<\/p>\n\n\n<\/div>\n\n\n\n\n
Senseonics advances implantable CGM portfolio<\/h3>\n\n\n\n
Senseonics reports continued uptake of its Eversense 365<\/strong> implantable CGM system, which can be used for up to one year. Around 60% of new-patient growth is currently being driven by direct-to-consumer channels, while the number of active prescribers is also increasing. Integration with Sequel\u2019s twiist AID system<\/strong> is another important step in expanding the role of implantable CGM within automated insulin delivery.<\/p>\n\n\n\nLooking ahead, Senseonics is targeting approval of its Gemini<\/strong> system next year. Gemini is designed to offer two user experiences on a single platform: a smartphone-based flash monitoring mode without a continuously worn transmitter, and a real-time CGM mode using an optional on-body transmitter.<\/p>\n\n\n\nDevelopment of the Freedom<\/strong> system is also progressing, with a feasibility study expected to begin later this year. Freedom is intended to be a fully implantable CGM system with integrated Bluetooth communication, eliminating the need for any externally worn transmitter. At ADA 2026, Senseonics presented data showing reliable Bluetooth connectivity within approximately three meters of the implanted sensor.<\/p>\n\n\n\nSenseonics is also working on an enhanced Eversense 365 app<\/strong>, including improved integration with Apple Health and Google Health Connect and future AI-supported diabetes management features based on Welldoc\u2019s healthcare-focused AI platform. An EU launch of the updated app is planned for early 2027.<\/p>\n\n\n\nWhy it matters<\/strong> Senseonics is moving implantable CGM beyond longer sensor wear alone. Gemini and Freedom point toward a future in which users may have greater flexibility in how \u2013 or whether \u2013 they wear an external transmitter at all.<\/p>\n\n\n<\/div>\n\n\n\n\n
Tandem expands CGM compatibility and European footprint<\/h3>\n\n\n\n
Tandem\u2019s t:slim X2<\/strong> insulin pump is now compatible with Abbott\u2019s FreeStyle Libre 3 Plus CGM<\/strong> in the UK, Switzerland, Sweden, Finland and Italy. The Netherlands, Germany and Belgium are expected to follow later this year. Tandem has also announced compatibility with the Dexcom G7 15 Day<\/strong>.<\/p>\n\n\n\nThe Libre 3 Plus sensor can be worn for up to 15 days and transmits glucose values every minute. Data can be viewed both on the pump and in the Tandem t:connect mobile app. The t:slim X2 uses Control-IQ+<\/strong>, Tandem\u2019s hybrid closed-loop algorithm, which adjusts insulin delivery every five minutes based on predicted glucose levels.<\/p>\n\n\n\nTandem continues to expand internationally. In Q1 2026, the company reported $86 million in international revenue<\/strong>, its highest quarterly international revenue to date.<\/p>\n\n\n\nAt the same time, Tandem is broadening its pump portfolio. A US regulatory submission has been filed for Mobi Tubeless<\/strong>, while the company is also beginning the international rollout of Tandem Mobi, with launches planned in more than ten countries by the end of 2026. A future Mobi generation is expected to incorporate technology from the Sigi patch pump<\/strong> platform.<\/p>\n\n\n\nTandem also plans to start a pivotal study of a fully closed-loop system<\/strong> later this year.<\/p>\n\n\n\nWhy it matters<\/strong> Tandem is pursuing a dual strategy: increasing sensor choice for existing AID users while expanding into smaller and increasingly tubeless pump formats.<\/p>\n\n\n<\/div>\n\n\n\n\n
Trinity Biotech targets false nighttime hypoglycemia alerts with CGM+ algorithm<\/h3>\n\n\n\n
Dublin-based Trinity Biotech<\/strong> has presented study results on an algorithm designed to detect compression-related false hypoglycemia readings<\/strong> during sleep. These can occur when pressure on the tissue around a CGM sensor temporarily distorts glucose readings.<\/p>\n\n\n\nAccording to the company, identifying such events could help reduce unnecessary nighttime alarms and carbohydrate intake, while also providing healthcare professionals with more meaningful context when interpreting Time Below Range<\/strong>. No detailed quantitative accuracy data from the study have yet been published.<\/p>\n\n\n\nThe feature is being developed as part of Trinity Biotech\u2019s CGM+ platform<\/strong>, a 15-day, calibration-free system with a compact sensor and reusable applicator. The company is positioning the platform as a multimodal system combining glucose data with additional physiological signals such as heart activity, body temperature and physical activity, supported by AI-based analytics.<\/p>\n\n\n\nPrevious study data indicated that no fingerstick calibration was required during the 15-day wear period. A commercial launch is currently expected later this year.<\/p>\n\n\n\n
Why it matters<\/strong> Compression-related false lows remain a practical problem in CGM use, particularly at night. If reliably detected, such algorithms could improve sleep, reduce unnecessary interventions and make CGM data more clinically meaningful.<\/p>\n\n\n<\/div>\n\n\n\n\n
Ypsomed continues to expand its injection-device business<\/h3>\n\n\n\n
Following the divestment of its diabetes business in 2025, Ypsomed<\/strong> continues to expand its broader injection-device activities. The company currently has 14 new customer projects, mainly involving autoinjectors for biosimilars and infectious disease therapies, and has recently received several new product approvals.<\/p>\n\n\n\nYpsomed is also investing in additional manufacturing capacity. Recent milestones include the commissioning of its first high-capacity YpsoMate<\/strong> production line in Solothurn, Switzerland, and the completion of a fully automated high-bay warehouse at its Schwerin site in Germany.<\/p>\n\n\n\nWhy it matters<\/strong> The update illustrates Ypsomed\u2019s strategic shift away from diabetes care towards large-scale manufacturing of injection systems for the broader pharmaceutical market.<\/p>\n\n\n<\/div>\n\n\n<\/div>\n\n\n\n\n
For debate<\/h2>\n\n\n\nMeasuring ketones is not the same as managing ketones<\/h3>\n\n\n\n
Continuous ketone monitoring could become an important addition to diabetes technology. But simply adding a ketone value to a CGM does not automatically create a useful clinical product.<\/p>\n\n\n\n
The real question is not \u201cCan we measure ketones continuously?\u201d but \u201cWhat should a person with diabetes do with that information?\u201d<\/p>\n\n\n\n
Glucose is already linked to relatively well-established therapeutic actions: insulin dosing, carbohydrate intake, exercise adjustments, or automated insulin delivery. For continuous ketone values, this decision framework is much less developed. What does a mildly elevated ketone level mean when glucose is normal? At what level should someone take additional insulin, drink fluids, stop exercise, change an infusion set, or seek medical help? And importantly, how should the trend and rate of change influence these decisions?<\/p>\n\n\n\n
This becomes particularly relevant with SGLT2 inhibitors, illness, fasting, exercise, or pump failure, where the relationship between glucose and ketones can be complex and diabetic ketoacidosis may occasionally develop without marked hyperglycemia.<\/p>\n\n\n\n
More data are therefore not automatically better care. A sensor provides a measurement. A useful diabetes technology must translate that measurement into validated, understandable and actionable guidance.<\/p>\n\n\n\n
As we add more biomarkers to wearable devices, we should be careful not to overload people with diabetes with numbers and alarms that do not support a meaningful therapy decision. The next challenge is not only continuous ketone sensing. It is building the clinical evidence, thresholds, algorithms and guidelines that tell people what to do with the data.<\/p>\n\n\n<\/div>\n\n\n\n
\n
And finally\u2026<\/h2>\n\n\n\n
CGM speaks in arrows, AID in algorithms, AI in probabilities \u2013 and Europe in many languages. Our job is to translate at least some of it.<\/p>\n\n\n\n
See you next month \u2014 diateam and Diabetes Center Berne<\/p>\n\n\n<\/div>","protected":false},"excerpt":{"rendered":"Welcome to the first edition of dt monthly: a concise monthly overview of important developments in diabetes technology, digital health and related innovation.","protected":false},"featured_media":0,"template":"","class_list":["post-1885","dt_issue","type-dt_issue","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/dt-report.de\/en\/wp-json\/wp\/v2\/monthly-issues\/1885","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dt-report.de\/en\/wp-json\/wp\/v2\/monthly-issues"}],"about":[{"href":"https:\/\/dt-report.de\/en\/wp-json\/wp\/v2\/types\/dt_issue"}],"version-history":[{"count":1,"href":"https:\/\/dt-report.de\/en\/wp-json\/wp\/v2\/monthly-issues\/1885\/revisions"}],"predecessor-version":[{"id":1890,"href":"https:\/\/dt-report.de\/en\/wp-json\/wp\/v2\/monthly-issues\/1885\/revisions\/1890"}],"wp:attachment":[{"href":"https:\/\/dt-report.de\/en\/wp-json\/wp\/v2\/media?parent=1885"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}