Podcast Summary: Diabetes Connections | Type 1 Diabetes
Episode: G7 15-Day Approval: Dexcom’s Jake Leach Answers Your Questions
Date: April 22, 2025
Host: Stacey Simms
Guest: Jake Leach, Chief Operating Officer, Dexcom
Episode Overview
This episode dives into the FDA’s approval of Dexcom’s G7 continuous glucose monitor (CGM) for 15-day wear (adults only). Stacey Simms interviews Jake Leach, exploring the technical, clinical, and user-experience aspects of this update. They cover why pediatric approval wasn't pursued, changes in device algorithms and adhesive, future plans for Dexcom products, insurance and sensor replacement concerns, collaborations with Aura sleep ring, and questions sourced directly from the diabetes community.
Key Discussion Points & Insights
1. Dexcom G7 15-Day Wear FDA Approval
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What’s new:
- The G7 sensor can now be worn for up to 15 days (plus 12-hour grace), up from 10 days, for adults only.
- Planned US launch for the second half of 2025, with international rollout to follow.
- Enhanced algorithm improves accuracy (now cited at 8% MARD) and sensor longevity.
“It takes the G7 10-day product, extends it out to 15 days. It still has the 12-hour grace period... raises the bar on accuracy and performance.”
— Jake Leach [04:23] -
Technical Details:
- Hardware remains physically the same, but the transmitter firmware is updated with the new algorithm and wear time parameters.
- Users won’t notice major changes in daily operations except for potential improvements in outlier sensor performance.
“...to continue the life of the sensor, you just kind of flip something on the software. But it is a change in that transmitter in the firmware.”
— Stacey Simms [06:27]
“It’s the software that’s in there... quite a bit of work that went into the new 15-day algorithm.”
— Jake Leach [06:34]
2. Accuracy and Sensor Replacement
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Sensor Longevity:
- About 74% of sensors last the full 15 days per clinical trial data; the remaining 26% may end early due to patch failures or sensor errors.
“Approximately 26% of sensors may not last for the full 15 days... there are sensors that last all the way up to 14 and a half and that would be one that would be counted as a sensor that didn’t last 15 days even though it went all the way up to 14.”
— Jake Leach [10:51] -
Replacement Policy:
- Dexcom maintains a robust sensor replacement program if sensors end prematurely.
- Concerns about insurance coverage—whether users will get two sensors a month or need three given possible early failures—are being discussed with insurers.
“Our goal is to ensure our users always have the sensors they need.”
— Jake Leach [13:01]
3. Interoperability & Prescriptions
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Pump Compatibility:
- Dexcom is coordinating with pump partners (e.g., Tandem, Insulet) to ensure seamless integration at launch.
- Differences in pump compatibility should be transparent to users; any gaps would be temporary.
“The goal is to get all this ready so that we can launch to all users that want to upgrade.”
— Jake Leach [08:23] -
Prescriptions:
- Whether a new prescription is needed is being worked out; details will be clear by launch.
“There’s some situations where we’re pretty clear it’s not required... but then there’s others where it’s a possibility.”
— Jake Leach [10:02]
4. Pediatric Approval and Use Cases
- Dexcom’s pediatric (Peds) approval is delayed due to adhesive performance and sensor longevity issues in children.
- Kids’ activity, sweat, and lower BMI can impact sensor adherence; clinical studies ongoing for better pediatric performance.
“We haven’t moved down to Peet’s yet because we do know that in PEDs... sometimes the adhesive performance, it’s not as good, because the kids are sometimes harder on their adhesives than the adults.”
— Jake Leach [13:01]
5. Adhesive and User Comfort
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The new 15-day G7 uses Dexcom’s updated adhesive, optimized for wear and skin comfort.
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Research ongoing for even better adhesives with a focus on balancing stickiness, breathability, and minimizing irritation.
"We’re still working on some that enhance it even further... balancing the breathability of the adhesive and how well it sticks, but also that it doesn’t irritate.”
— Jake Leach [16:46]
6. Dexcom’s User Base and Global Rollout
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Scale:
- Over 2.5 million daily active users globally.
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International Availability:
- 15-day G7 will roll out worldwide, not just in the US, and integrated into various Dexcom product lines over time.
"The US is one of the first to launch it, but our intent is to bring 15-day across the whole portfolio."
— Jake Leach [18:14]
7. Other Features, Tech, and Partnerships
- FDA warning letter:
- Involves regulatory process improvements, does not impact supply, approvals, or product safety.
“It's not impacting our ability to supply sensors. It's not impacting our ability to get products approved. You saw the 15-day approval.”
— Jake Leach [19:59] - Omnipod and iPhone app compatibility:
- Dexcom and Insulet are actively working to streamline G7 compatibility with the iPhone Omnipod 5 app and to reduce delays in future updates.
- Follow app and Clarity integration:
- Major UI/UX updates coming to the Follow app and Clarity data being folded into the primary G7 app.
"There is a whole host of updates coming this year to Follow... putting all of the Clarity functionality into the G7 app."
— Jake Leach [24:01] - New Analytes and Integration with Aura:
- Dexcom exploring ways to measure additional health metrics beyond glucose, like ketones.
- Partnership with Aura for integrating sleep and activity data into future reports.
“We're importing sleep and activity data already and using that within the insights report... But that’s just the tip of the iceberg when it comes to what these platforms are capable of.”
— Jake Leach [26:56]
8. Future Directions and Discontinuing Older Products
- G6 phase-out:
- G6 will eventually be discontinued, but only after G7 (and its variants) are fully integrated and compatible with pump systems.
- Access and Growth:
- Focus on affordability and access, including non-insulin using populations (e.g., Stelo platform).
“...continuing to lower the cost of the technology... access... advocating in the United States, but also globally.”
— Jake Leach [28:38] - Impact:
- CGM use is associated with measurable improvements in A1C and time in range for diabetes management.
“CGM in my opinion has been the most impactful in driving down A1Cs and also increased time in range.”
— Jake Leach [30:38]
Notable Quotes & Memorable Moments
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On advancing accuracy and user experience:
“As we improve the performance and accuracy, a lot of it is around tailoring in on those sensors that have been less accurate to really bring the whole group up.”
— Jake Leach [06:50] -
On insurance and replacement worries:
“Our goal is to ensure our users always have the sensors they need. And part of that is working with the insurance companies to make sure there’s coverage there.”
— Jake Leach [13:01] -
On collaborating with pump partners:
“The goal is to get all this ready so that we can launch to all users that want to upgrade.”
— Jake Leach [08:23] -
On pursuing pediatric approval:
“We want to make sure that PEDs performance is where it needs to be before we launch.”
— Jake Leach [13:01] -
On the mission of CGM:
"What gets me out of bed every morning is when I look at our active user base ... seeing so many more people using CGM ... there's still so much to do."
— Jake Leach [28:38]
Timestamps for Key Segments
- G7 15-Day Approval Announcement – [04:08]
- Technical Upgrades & Algorithm – [06:07]
- Pump Interoperability Details – [08:01]
- Sensor Replacement & Insurance – [10:51]
- Pediatric Use and Adhesive Concerns – [14:06], [15:40]
- Pregnancy Indication – [16:16]
- Adhesive Developments – [16:42]
- Global Rollout Plans – [18:14]
- FDA Warning Letter Explained – [19:29]
- Insulet Omnipod Compatibility – [21:44]
- Follow App & Clarity Updates – [24:01]
- Ketones/Other Metrics & Aura Partnership – [25:17], [26:36]
- G6 Discontinuation Plans – [27:54]
- Vision for the Future – [28:38]
Summary & Takeaways
- Dexcom’s G7 15-day CGM approval brings greater convenience, a new algorithm for improved accuracy, and a firm, patient-focused approach to interoperability and coverage.
- User experience and replacement needs are top priorities, with a commitment to work closely with both insurers and pump partners for a seamless transition.
- Pediatric patients will need to wait for further adhesive and longevity improvements.
- Major updates to Dexcom’s software suite are coming, including big changes to the Follow app and expanded integration of health data via Aura.
- Dexcom’s core mission remains centered on broadening access, reducing cost, and empowering people with diabetes through better technology.
For more updates, information on the 15-day G7, or upcoming Dexcom events, visit diabetes-connections.com. Got questions? Join their Facebook group or reach out for future listener Q&As!