Diabetotech Branded App, Now Available for Download! 50% OFF for the first 1000 downloads.
Hospitals Courses Blog About Us
Free Resources
E-Book For Healthcare Providers E-Book For People With Diabetes AID Systems CheatSheet AID Systems Diagram CGM Data Guide
Become An Expert
Log In

Diabetes Technology Updates – Fall 2024

Nov 21, 2024

 

As we embrace the advancements of Fall 2024, the landscape of diabetes technology continues to evolve at an unprecedented pace. 

This comprehensive update is tailored for diabetes experts keen on staying at the forefront of automated insulin delivery (AID) systems and continuous glucose monitoring (CGM) innovations. 

Below, you'll find the latest developments from leading companies, pivotal trial outcomes, and what to anticipate in the near future.

 

 

Medtronic

MiniMed 780G: Userbase and Performance

  • Estimated Userbase: Approximately 600,000 individuals.
  • Pivotal Trial with Guardian Sensor  (n=59): Time In Range (TIR) 70%, Time Below Range (TBR) 2.1%
  • Real-World Data with Guardian Sensor (n=100 000): TIR 72%, TBR 2%
  • Pivotal Trial with Simplera Sync Sensor (n=250): TIR 80%, TBR 1.5% in adults
  • Link to latest quarterly update

 

Sensor Updates

Medtronic is transitioning their Guardian sensor to the Simplera Sync CGM, already available in select European countries and submitted to the FDA. Upcoming enhancements include:

  1. Simplera Plus Sensor:
    • Extended wear time to 10+ days (from 7 days).
  2. "Next-Gen CGM":
    • Wearable for 14+ days.
    • New sensor chemistry minimizing acetaminophen interference.
    • Improved adhesive comfort and performance of the tape.

Medtronic is also collaborating with Abbott to develop a CGM probably resembling the FreeStyle Libre 3 Plus. Updates to the MiniMed Mobile and Simplera apps will enable scanning and initiation of the FreeStyle Libre sensor.

 

Hardware Updates

Upcoming Insulin Pumps:

  1. 8-Series Pump:
    • Smaller, tubed pump controllable via new Android and iOS apps.
    • Compatible with existing Extended reservoirs and infusion sets.
    • CE Mark Submission: Completed.
    • Pivotal Study: Planned for 2025.
  2. Modular Patch Pump:
    • Medtronic is working on their own patch pump.
    • Insulin Capacity: 300 units.
    • Wear Duration: 7 days with Extended wear infusion set.

Additionally, Medtronic is developing a combined patch pump and sensor device using MiniMed Duo technology.

 

Algorithm Updates

  • SmartGuard Enhancements:
    • Recent trials with Simplera Sync sensor show TIR up to 80% in adults.
    • Algorithm updates will be available via future software updates.
  • Novel Medtronic Experimental Automated Insulin Delivery (NMX-AID):
    • Features aggressive basal insulin adaptation through adaptive learning.
    • Pump Start Feature: Bypasses 48-hour warm-up for SmartGuard activation.
    • Automatic Meal Boluses: Without user input or acknowledgment.
    • Expected Results Presentation: @ATTD2025.
    • Users will be able to choose between carb announcements, meal announcements, or no meal announcements.

Note: Development of wristband-based automatic meal detection seems to be paused due to the success of algorithm updates.

 

Expanding Indications

  • Preschoolers (2–6 years):
    • CE Submission: Completed based on positive interim results of LENNY Trial.
    • FDA Submission: Planned in first half of 2025.
  • Pregnancy:
    • CE Submission: Completed based on positive results of CRISTAL Trial.
    • FDA Submission: Planned in first half of 2025.
  • Type 2 Diabetes:
  • Dialysis Patients:
    • Ongoing Study: In both type 1 and type 2 diabetes patients on hemodialysis.

 

Newer Insulins

  • Current Approval: NovoRapid®, NovoLog®, or Humalog® 100 U/mL.
  • CE Approval: Fiasp® and Lyumjev®. 
  • FDA Submission for biosimilar insulin: Planned in first half of 2025.
  • Recent study using Lyumjev® in the MiniMed 780G showed improved postprandial glucose control in children and adolescents with type 1 diabetes.
  • Ongoing Studies: Evaluating Fiasp® and Lyumjev® in type 1 diabetes patients using MiniMed 780G. 

 

Want to learn more? Check out our updated course on the MiniMed 780G pump and AID system, Guardian 4, and Simplera CGM.

 

 

Tandem Diabetes Care

Control-IQ: Userbase and Performance

 

Sensor Updates

  • t:slim X2 Pump Compatibility:
    • Dexcom G6 and G7
    • FreeStyle Libre 2 Plus: Available in the U.S.
    • FreeStyle Libre 3 Plus: Expected in 2025.
  • Mobi Pump Compatibility:
    • Dexcom G6 and G7
    • FreeStyle Libre 3 Plus: Expected in 2025.

 

Hardware and App Updates

  • t:slim X2 Pump:
    • t:connect Mobile App: Includes phone bolus feature (only in US).
    • European Launch of t:connect Mobile App and Tandem Source Readout Platform: Beginning in 2025 (without phone-bolus option).
  • Mobi Pump:
    • Availability: Only in U.S. market, expected in Europe in 2025.
    • Mobi Mobile App: Currently iOS only.
  • Future Developments:
    • Mobi:tubeless and Sigi Pump: Under development.
    • SteadiSet Infusion Set: 7-day wear; pivotal trial completion by end of year.

 

Algorithm Updates

  • Control-IQ 1.5 Upgrade:
    • Expanded Approved Insulin Dose Range: From 5–200 U/day (previously 10–100 U/day).
    • Expanded Approved Weight: For broader user accessibility.
    • Timeline: Originally planned for 2024.
  • Freedom (fully closed-loop) Algorithm:

 

Expanding Indications

  • Preschoolers:
    • FDA Approval: From 2 years and up.
    • Outside U.S.: From 6 years and up.
  • Pregnancy:
  • Type 2 Diabetes:

 

Newer Insulins

 

Interested in updates? Explore our courses on the Tandem t:slim X2 pump & AID system, and the Mobi pump & AID system.

 

 

Insulet

 

Omnipod 5: Userbase and Performance

 

Sensor Updates

  • Current Compatibility: Dexcom G6 and FreeStyle Libre 2 Plus.
  • Dexcom G7 Compatibility:
    • U.S.: Available.
    • International Markets: Expected in the first half of 2025.
  • FreeStyle Libre Compatibility:
    • Libre 2 Plus: Available in U.S., the Netherlands and UK.
    • Libre 3 Plus: Under development.

 

Product Updates

  • Geographical Expansion:
    • Current Availability: U.S., Germany, UK, Netherlands, France.
    • 2025 Launches: Australia, Belgium, Canada, Israel, Italy, Switzerland and the Nordics.
  • Omnipod 5 Smartphone App:
    • Android: U.S. only.
    • iOS App: Launched in U.S. for Dexcom G6; G7 compatibility expected in first half of 2025.
    • Features: Custom food library within SmartBolus Calculator (iOS only).

 

Algorithm Updates

 

Expanding Indications

 

Newer Insulins

  • Approved Insulins: NovoRapid®, NovoLog®, Trurapi®, Kirsty®, Humalog®, Admelog® 100 U/mL.
  • Off-Label Use: Humalog® 200 U/mL is being used off-label.

 

Want to dive deeper? Check our updated course on the Omnipod 5 pump and AID system.

 

 

mylife Loop

 

Mylife Loop: Userbase and Performance

 

Sensor Updates

  • Compatibility:
    • Dexcom G6
    • FreeStyle Libre 3 (Plus)
  • Canada: Dexcom G6 only.

 

Product Updates

  • Geographical Expansion:
    • Current Markets: Australia & Europe with significant uptake in Germany (30% market share).
    • 2025 Launches: Canada, Norway, New Zealand.
    • FDA: CamAPS FX Algorithm is FDA approved, mylife YpsoPump is submitted to the FDA.
  • App Availability:
    • Current: Android only.
    • iOS Version: In the first half of 2025 in selected countries.
  • Data Management:
    • Integration with Glooko.
    • Developing Dedicated Platform: Ypsomed working on own system.

 

Algorithm Updates

 

Expanding Indications

  • Preschoolers and Pregnancy: CamAPS FX algorithm is CE-approved for both.
  • Type 2 Diabetes: CamAPS HX is CE-approved for type 2 diabetes based on this trial, post-market study is ongoing.
  • In-Patient Use: Trial with CamAPS HX showed good results during complex surgery.
  • Dialysis: CamAPS HX showed positive results in people with type 2 diabetes on dialysis.

 

Newer Insulins

  • Approved Insulins: All U100 rapid-acting and ultra-rapid-acting insulins.
  • Recent Studies: Lyumjev® may improve postprandial glucose excursions.

 

Learn more: Access our courses on the mylife YpsoPump and mylife Loop system.

 

 

Diabeloop

 

Diabeloop: Userbase and Performance

  • Estimated Userbase: Approximately 12,000 users.
  • Pivotal Trial (n=63): TIR 69%, TBR 2.0%
  • Real-World Data (n=3706): TIR 72%, TBR 0.9%
  • No quarterly update available

 

Sensor Updates

  • Current Compatibility: Dexcom G6.
  • Future Plans: Potential Dexcom G7 compatibility; timelines unclear.

 

Product Updates

  • Availability:
    • Diabeloop-Kaleido: Netherlands, Germany, France.
    • Future Rollout: Unclear.
  • Pump Compatibility: Exploring integration with Dana-i and MEDISAFE WITH insulin pumps.
  • App Development:
    • Android App: Planned.
    • iOS App: To follow Android release.

 

Algorithm Updates

 

Expanding Indications

  • Children:
    • Approval: Anticipated for ages 6+ in 2025.
  • Pregnancy:
    • Usage: Off-label.
  • Type 2 Diabetes:

 

Newer Insulins

  • Approved Insulins: NovoRapid®, Humalog® 100 U/mL.
  • Virtual Simulator Study: Safe use with Lyumjev® and Fiasp®; Lyumjev showed better TIR.

 

Interested in Diabeloop? Explore our courses on the Accu-Chek Insight pump, Kaleido pump, Diabeloop-Insight and Diabeloop-Kaleido system.

 

 

iLet Bionic Pancreas

 

iLet Bionic Pancreas: Userbase and Performance

  • Estimated Userbase: Approximately 10,000 users.
  • Pivotal Trial (n=219): TIR 65%, TBR 1.8%
  • Real-World Studies (n=3675): HbA1c: 7.0%–7.6%. TIR/TBR: Data not specified.
  • No quarterly update available

 

Sensor Updates

 

Product Updates

 

 Algorithm Updates

  • Bihormonal (fully closed-loop) Algorithm: 
    • Feasibility Trial: Great results
    • Pivotal Trial: Start date not announced.

 

Expanding Indications

  • Preschoolers and Pregnancy: No data available.
  • Type 2 Diabetes: Preliminary, unpublished studies show potential benefits.
  • Cystic Fibrosis-Related Diabetes: Feasibility trial showed positive results, a larger trial is ongoing.

 

Newer Insulins

  • Approved Insulins: U100 NovoRapid®, Humalog®, Fiasp® PumpCart.

 

Want more information? Check out our course on the iLet Device and System.

 

 

TouchCare Nano System

 

TouchCare Nano System: Userbase and Performance

  • Estimated Userbase: Approximately 300 users.
  • Feasibility Trial (n=20): TIR 73%, TBR 2.2%.
  • Pivotal Trial (n=160): Ongoing.

 

Sensor Updates

  • Current CGM: TouchCare Nano CGM.
  • New CGMs: S9 CM, S9 Pro CGM, S10 CGM showcased; connectivity with TouchCare Nano Pro expected in 2025.

 

Product Updates

  • Availability: UK, Czech Republic, Croatia, Estonia, Greece, Slovenia, Sweden, Denmark, Italy, Hungary.
  • Pump Options:
    • 200 U Patch Pump
    • 300 U Patch Pump
    • 400 U Patch Pump: In development

 

Algorithm Updates

  • APGO Algorithm: Can be used with carb counting or simple meal announcements.
  • Not clear wether a fully closed-loop algorithm is in development.

 

Expanding Indications

  • Data Unavailable: For preschoolers, pregnancy, or type 2 diabetes.

 

Newer Insulins

  • Approved Insulins: U100 NovoRapid®, Humalog®, Fiasp®, Lyumjev®.

 

 

Open-Source AID Systems

 

Open-source AID systems: Userbase and Performance

  • Estimated Userbase: Approximately 25,000 users.
  • Key Studies:
    • AndroidAPS Randomised Trial (n=44): TIR 71%, TBR 1.6% (New Zealand).
    • DIY Loop Real-World (n=558): TIR 73%, TBR 2.9% (U.S.).
    • Supported Open-Source AID (n=248): TIR 80%, TBR 2.5% (Canada).
    • Ongoing Study: 500 participants in China.

 

Sensor and Pump Updates

  • AndroidAPS v3.3: Pending release; supports Equil pump and Ottai CGM.
  • DIY Loop v3.4: Released July 2024; supports FreeStyle Libre 1 with third-party transmitter and European FreeStyle Libre 2 CGM.
  • iAPS v5.4: Released October 2024; concerns over safety due to frequent updates.
  • Trio: In development.

 

Algorithm Updates

  • Full Closed-Loop: AndroidAPS supports unannounced meals.
  • Pancres4All Trial: Demonstrated feasibility of AndroidAPS in full closed-loop mode over 3 days in 16 participants with type 1 diabetes.
  • CLOSE IT Trial: Investigating 12-week use of Lotus in full closed-loop mode in 37 participants with type 1 diabetes.

 

Expanding Indications

  • Preschoolers: Usage reported; data lacking.
  • Pregnancy: Limited literature but in use.
  • Type 2 Diabetes: Reports show mean TIR of 93% in small group.
  • Peri-Operative Use: Ongoing study in China with 54 patients.

 

Newer Insulins

  • Common Choices: Fiasp®, Lyumjev®.
  • Insulin Mixing: Some users mix different fast-acting insulins, no data available.

 

Want more information? Check out our course on AndroidAPS, DIY Loop and iAPS.

 

 

ISPAD Might Lower HbA1c Goal to <6.5%

 

The rapid advancements in diabetes technology have started a new era, prompting experts to rethink optimal glycemic control for young patients. 

Recognizing the profound impact of even mild hyperglycemia on cognitive function and long-term complications, the International Society for Pediatric and Adolescent Diabetes (ISPAD) has set more ambitious targets:

Proposed glycemic targets for children and adolescents with diabetes who have access to CGM and AID systems: (Clinical Practice Consensus Guidelines 2024, document in review):

  • HbA1c ≤ 6.5% (48 mmol/mol)
  • Time in Range (TIR) > 80%

 

Sweden stands out as a shining example of what can be achieved with dedicated effort and the right strategies.

At the ISPAD 2024 conference, Dr. Peter Adolfsson presented inspiring data revealing that Swedish children have reached a mean HbA1c of just 6.9%.

 

This remarkable achievement didn't happen by chance.

Dr. Adolfsson attributed this success to several key factors:

  • Continuous Education for Healthcare Professionals (HCPs): Sweden has implemented national courses focusing on the latest in insulin pump technology and diabetes care advancements. These are held regularly—an annual insulin pump course and technology updates offered three to four times a year.

  • Utilization of the National Diabetes Registry: The registry plays a crucial role in setting targets and providing continuous updates, enabling HCPs to monitor and improve patient outcomes effectively.

  • Widespread Access to Technology: An impressive 98% of children in Sweden have access to Continuous Glucose Monitoring (CGM), and a significant number are using Automated Insulin Delivery (AID) systems.

 

The results speak for themselves.

  • Clinics like Sachsska, Uddevalla, and Kungsbacka have surpassed national averages, achieving mean HbA1c levels of 6.8%, 6.5%, and 6.4%, respectively.
  • Over 1,000 HCPs have participated in these educational initiatives, equipping them with the knowledge and skills to provide personalized and effective care.

 

This collective effort has not only improved individual patient outcomes but has set a new standard for what's possible in diabetes management.

 

 

 

Conclusion

 

The integration of Automated Insulin Delivery (AID) systems is truly transforming diabetes management, enabling us to aim for lower glycemic targets with confidence.

However, despite the progress and proven benefits, only about 12% of people with type 1 diabetes worldwide are currently utilizing an AID system.

This gap highlights the need for continuous education to keep pace with swift technological advancements.

 

Education is the key to bridging this gap.

Regular training is essential for every member of the diabetes care team.

 

It ensures that everyone is up-to-date with the latest tools and techniques, reinforcing existing knowledge through repetition.

Understanding and effectively using new technologies can make a profound difference in patient care.

 

 

Join Our Free Webinar

 

To support this need for ongoing education, we're hosting a free webinar titled "Diabetes Tech Update" next Tuesday on November 26, 2024.

This event will delve into the latest developments in diabetes technology, and will prepare you for the AID systems and CGMs that are coming our way.

 

>>> Register for the Webinar Here <<<

 

Don't let the fast-paced evolution of diabetes technology leave you behind.

Stay informed and enhance your expertise by joining our webinar and exploring our available courses.

 

By doing so, you'll be better equipped to make a real impact

—initiating people with diabetes on new AID systems and transforming their lives for the better.

 

 

Kind regards,

 



Diabetes Technology Updates – Fall 2024

CGM for People Without Diabetes

Hoe AI de diabeteszorg hervormt

 

Lees meer hier
Schrijf je in op de nieuwsbrief

 

Read more here
Subscribe to the newsletter