Emerging Players in Diabetes Tech: Small but ImpactfulAug 18, 2023
The field of diabetes technology is undergoing rapid transformation, marked by a flurry of groundbreaking partnerships, novel applications, and cutting-edge closed-loop systems.
In this blog post, we will delve into the world of emerging players in this dynamic field, spotlighting companies such as Tidepool Loop, Modular Medical, SFC Fluidics, Pharmasens, and OneTwenty.
- Tidepool Loop Partners with new Insulin Pump for T2D of Embecta
- Expanding Accessibility: Tidepool Loop for Android Devices
- Innovative Collaboration for Insulin Delivery: Modular Medical and Philips-Medisize
- SFC Fluidics: Pioneering the Gemini Dual Hormone Artificial Pancreas Pod with a Game-Changing Grant
- Introducing the Niia Pump by PharmaSens: A Glimpse into Innovative Diabetes Technology
- Elevating Closed-Loop Algorithms with Digital Twin Innovation: OneTwenty's Breakthrough
Join us in unraveling the tapestry of advancements that are reshaping the landscape of diabetes technology.
1. Tidepool Loop partners with new insulin pump for T2D of Embecta
"Embecta is developing an ACE pump and their goal is to deliver a version of Tidepool Loop for the type 2 diabetes community so we're super excited about that because it really brings the technology that you know in Loop in a much broader and more accessible form." - Howard Loop, CEO Tidepool, Interview Diabetech July 2023
What is Tidepool Loop?
Tidepool Loop is Tidepool's version on the open-source do-it-yourself Loop closed-loop system:
- They've added a whole section of onboarding features to help people learn about Loop.
- They've also taken steps to improve safety and quality,
- and they've run the whole thing through a regulatory quality management system, and sent it off to the FDA.
As of January 2023, Tidepool Loop is the first-ever FDA-approved interoperable Automatic Glycemic Controller (iAGC), which essentially means it is an app that can talk to multiple devices.
Loop and Tidepool's philiosphy is to be interoperable with as many CGMs as possible and as many pumps as possible, so people with diabetes have more choice.
Connecting with sensors
Tidepool Loop has the ability to link up with all sorts of iCGMs (integrated continuous glucose monitors).
Right now, they've teamed up with Dexcom G6 and they're in the process of integrating the Dexcom G7.
They're also aiming to establish connections with other iCGMs down the road, like the FreeStyle Libre3.
Evolving Pump Partnerships
Originally, the Tidepool Loop project had set its sights on collaborating with Medtronic and Insulet pumps.
However, due to shifts in business strategies of Medtronic and Insulet, Tidepool Loop will not to launch with their pumps after all.
Currently, Tidepool Loop has established working relationships with two pump partners.
While they're keeping one partner's identity under wraps for now, the other was officially revealed in a press release on May 12th, 2023 – Embecta.
Embecta, born out of a spin-off from BD in March 2022, announced its mission to develop a patch pump tailored for individuals with type 2 diabetes (T2D).
- This focus on a T2D-specific insulin pump has been in the works at BD since 2016.
- The patch pump earned FDA Breakthrough Device Designation, but its initial FDA submission was withdrawn in 2019 without publicly shared plans for resubmission.
- The patch pump is expected to come in two main forms: open-loop and closed-loop.
- Embecta anticipates first obtaining FDA-approval for the open loop patch pump through a 510(k) pathway, followed by a clinical trial for the closed loop patch pump.
In a recent investor call on August 8th, 2023, Mr. Kurdikar, CEO of Embecta, shared exciting updates.
- Embecta, in partnership with the Jaeb Center, is launching a small observational study for adults with T2D using Tidepool’s algorithm (NCT05951569).
- This study, commencing in September with a target of 100 participants, aims to generate data that will contribute to the development of a closed-loop system with Tidepool.
- Notably, this data won't be the submission material for FDA's closed-loop 510(k) clearance.
Following this observational study, Embecta anticipates conducting further research to obtain FDA clearance for their closed-loop system designed for individuals with T2D.
While concurrently working on this closed-loop system, Embecta is also diligently pursuing FDA 510(k) clearance for their open-loop system.
"We're currently conducting a small observational study with Tidepool. Simultaneously, we're working on integrating the Tidepool algorithm into our system. While our focus remains on achieving FDA 510(k) clearance for our open-loop system, it's clear that we're making parallel progress towards our closed-loop aspirations." - Mr. Kurdikar, CEO of Embecta, Investor call August 8th, 2023
2. Expanding Accessibility: Tidepool Loop for Android Devices
"We're very very pleased to announce that a very generous anonymous donor has given us a grant to bring Tidepool Loop to Android so we have now begun the planning and development effort to bring what is known today as Tidepool Loop to Android devices. [...] Bringing Tidepool Loop to Android is one way that we can do that, so we're really really excited about that project." - Howard Loop, CEO Tidepool, Interview Diabetech July 2023
More exciting news from the Tidepool Loop team!
A kind and anonymous donor has stepped forward with a generous grant that's set to propel Tidepool Loop onto Android devices.
While the specifics of which Android phones and even watches it'll be compatible with are still under exploration, the team is determined to make it a seamless experience for users.
This development comes at a crucial time, with the acknowledgment that Android stands as the most popular mobile platform globally, accounting for around 70% of users worldwide.
Interestingly, Android shines particularly bright among those relying on public assistance insurance.
The Tidepool team's dedication to making diabetes technology accessible to these vulnerable populations aligns perfectly with their nonprofit mission.
We're excited to see Tidepool Loop making strides towards reaching not only the Apple Store but also the Android Play Store,
bringing advanced closed-loop systems to even more people who can benefit from them.
3. Innovative Collaboration for Insulin Delivery: Modular Medical and Philips-Medisize
"This partnership has not only accelerated our development process but has also set the stage for substantial scalability and readiness for market launch." - Kevin Schmid, COO of Modular Medical, press release August 16th, 2023
A new partnership is on the horizon as Modular Medical, a company dedicated to advancing insulin delivery technology, joins forces with Philips-Medisize.
This dynamic duo is set to pave the way for the MODD1 Insulin Delivery System, an innovative solution that promises user-friendliness and affordability.
With an eye on revolutionizing insulin pump technology, Modular Medical is taking the lead in creating the next generation of insulin delivery devices.
- The collaboration with Philips-Medisize, announced through a press release on August 16th, 2023, is a significant step towards achieving this goal.
- Philips-Medisize's expertise will play a pivotal role in the design, development, manufacturing, and assembly of the MODD1 Insulin Delivery System.
The results speak for themselves, as the announcement triggered a notable increase in Modular Medical's shares on the following day.
4. SFC Fluidics reveives grant to develop Gemini Dual Hormone Artificial Pancreas Pod
A remarkable stride in diabetes technology has emerged from US-based SFC Fluidics, the brains behind the Panda pump.
Their dedicated efforts have been recognized through the award of a substantial $2 million Small Business Innovation Research (SBIR) Phase II grant. (press release July 20th, 2023)
This grant is set to propel the advanced development of SFC's Gemini™ Dual Hormone Artificial Pancreas Pod (Gemini-DHAP):
- With this financial boost, SFC Fluidics is poised to obtain an Investigational Device Exemption (IDE) for their Insulin and Glucagon delivery system.
- This IDE will pave the way for initiating clinical trials, a crucial step towards securing FDA approval for their groundbreaking technology.
This endeavor reaffirms SFC Fluidics' commitment to driving innovation in diabetes care, pushing boundaries, and ultimately enhancing the lives of individuals managing diabetes.
5. Introducing the Niia Pump by PharmaSens: A Glimpse into Innovative Diabetes Technology
PharmaSens, a pioneering diabetes technology company based in Switzerland, has been making waves in the industry.
Their showcase at ATTD2023 and participation in the ADA 2023 technology fair gave a sneak peek into their innovative creation, the niia essential insulin pump.
- This new patch pump is "semi-reusable" and holds up to 300 units of insulin.
- Although currently wearable for up to three days, PharmaSens envisions stretching this wear time in the future.
- It has a bolus button for easy dosing, and you can fill and start the pump without needing a syringe or separate inserter.
- This user-friendly patch pump is particularly designed for individuals who pesently manage their diabetes through multiple daily injections (MDI).
PharmaSens is preparing to seek FDA approval for the niia essential system in 2023.
Exploring their website reveals an exciting roadmap, featuring not one, but two other insulin patch pumps in the works:
- The niia advanced pump, which offers smartphone control and seamless integration with a glucose sensor.
- And the niia signature pump, a combination of an insulin patch pump and a glucose sensor, united in a single device
The potential of these developments is undeniably impressive!
Anticipation is high, and the hope remains that further funding will expedite the transformation of this artificial pancreas into a reality in the near future.
6. Elevating Closed-Loop Algorithms with Digital Twin Innovation: OneTwenty's Breakthrough
Introducing OneTwenty, a relatively new entrant to the scene, having emerged in 2022 with a distinct focus on pioneering digital twin algorithms.
They've developed an advanced closed-loop algorithm (medicAID) that has the potential to be taken to new heights through the integration of digital twin technology (BioX® neoAP).
- While their portfolio may not yet boast published materials, a recent interview with the company unveiled remarkable outcomes.
- Their closed-loop algorithm achieved an impressive Time in Range (TIR) of 90% within a diverse diabetes population, validated extensively using the FDA-approved UVA simulator in a wide range of realistic scenarios. The company further conducted an initial pilot study that cofirmed the in-silico performance.
This groundbreaking closed-loop algorithm will become available as an interoperable Automatic Glycemic Controller (iAGC) at a later point when US and EU regulations have been aligned.
OneTwenty's approach involves integrating the algorithm within the microchip of the insulin pump to enable maximum autonomy for the user.
The company is currently immersed in dialogues with potential pump partners, although the precise details of these collaborations remain confidential at this stage.
But that's not all; OneTwenty is steering innovation in more directions:
- bioX® sensAI is an additional digital twin algorithm that transforms raw sensor data into heightened accuracy. This has the potential to enhance the precision of (non-invasive) Continuous Glucose Monitors (CGMs).
- Delving into web-based digital twin technology, OneTwenty is crafting Newton i/O – a web platform geared towards analyzing CGM and insulin pump data. Operating somewhat like an Autotune, it aims to provide insights for individuals as well as healthcare providers and data driven recommendations for basal insulin rates. A clinical study to validate this decision support software is slated for 2024.
OneTwenty's innovative journey holds the promise to incorporate digital twin technology into decision support software for diabetes management.
With an emphasis on precision, integration, and data-driven insights, they are poised to impact the lives of individuals managing diabetes in profound ways.
As we conclude this insightful exploration into the ever-evolving landscape of diabetes technology,
it's evident that innovation knows no bounds in the quest to enhance the lives of those managing diabetes.
From groundbreaking partnerships to novel applications and cutting-edge algorithms,
the potential for transformative change is palpable.
If you're eager to delve even deeper into the intricacies of this dynamic field,
we invite you to download our "Overview of Diabetes Technology 2023".
This comprehensive guide provides an overview of all current and future
- glycemic sensors,
- smart insulin pens,
- insulin pumps
- and closed-loop systems,
so you will gain valuable insights into the groundbreaking advancements shaping diabetes management.
Don't miss out – seize this opportunity now to embark on an illuminating journey of discovery and empowerment.
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Be at the forefront of diabetes technology understanding and download your copy today.