Diabetes Technology in the Spotlight: 10 EASD Highlights
Oct 21, 2023
From 2 to 6 October 2023, the EASD Congress took place in Hamburg, the largest diabetes congress in Europe.
There were more than 11 000 participants, including 9 621 on-site and another 1 597 online.
As usual, a feeling of FOMO (Fear of Missing Out) always overwhelms you when you review the programme as it is impossible to attend all the sessions.... Fortunately, we were able to rely on the comprehensive report from the Kelly Close team to keep abreast of key developments. 🙏
In this blog post, we will go through the 10 most notable diabetes technology highlights from the EASD:
- #1 Real-world Data from MiniMed 780G of >100,000 Users
- #2 Simplera Sensor Achieves CE label
- #3 Head-to-head Study of Automated Insulin Delivery (AID) Systems
- #4 Tandem Examines Algorithm to Simplify Tandem Control-IQ Settings
- #5 Real-world Data from Nearly 70,000 Omnipod 5 Users
- #6 AiDAPT Study Confirms Safety and Effectiveness of AID Systems for Pregnant Women with Type 1 Diabetes
- #7 CamAPS HX: Full AID System for Adults with Type 1 Diabetes
- #8 INREDA Shows Impressive Results with Bihormonal AID System
- #9 More Asian Glucose Sensors
- #10 The Future of Glycaemic Control: Time in Tight Range?
Keep reading if you want to be fully informed!
#1 Real-world Data from MiniMed 780G of >100,000 Users
At the EASD congress, once again real-world data were shared, this time of a whopping 101,629 users of the MiniMed 780G.
This data revealed an average
- Estimated HbA1c of 7.0%,
- Time in Range (TIR) of 72.3%
- and a Time Below Range (TBR) of just 1.6%.
The time in auto mode was slightly lower this time, only 90%.
Currently, the main reason for going out of auto mode is sensor issues with the Guardian 4 sensor.
Happily, a new sensor is coming next year, with initial reports indicating that there would be fewer sensor problems with it.
This is because the Instinct CGM is easier to apply, and that could prevent some of the "sensor update" notifications.
Looking across countries, the MiniMed 780G's performance remains remarkably stable from country to country.
This typical Medtronic slide always nicely shows how AID systems are a true "equalizer":
- not just between countries,
- but probably also between diabetes centres.
If you do zoom in on the countries, Poland seems to do best.
There, the researchers of Medtronic saw an association between the better TIR results and the slightly higher use of the "best settings",
- namely a target value of 100 mg/dl (5.6 mmol/l)
- and an active insulin time of 2 hours.
The message was therefore again to use these "most aggressive" settings as much as possible.
#2 Simplera Sensor Achieves CE label
The Simplera CGM had a week before the EASD gained a CE label, and was launched at the EASD.
This new sensor from Medtronic offers the advantage
- of a sensor and transmitter in one,
- with a 50% smaller size than the Guardian sensor (although slightly larger than the FreeStyle Libre 3 and Dexcom G7).
- In addition, the Simplera has a shorter warmup time of just 30 minutes.
Accuracy (MARD 10.8%), sensor life (7 days) and compatibility with both Android and iOS are similar to the Guardian 4.
Although CE marking currently only applies to the new "Simplera" sensor in combination with the InPen,
we also expect CE and FDA labelling for the "Instinct CGM" in the near future, which is the same sensor for use with the MiniMed 780G.
#3 Head-to-head Study of AID Systems
The EASD congress brought results from one of the first large-scale head-to-head studies with AID systems.
At a centre in Barcelona, 132 adults with type 1 diabetes were prospectively followed using Diabeloop, MiniMed 780G and Tandem Control-IQ technology.
The results were promising:
- the HbA1c dropped from an average of 7.5% to 6.6%.
- and the TIR increased from an average of 60% to 74%.
There seems to be a trend that the MiniMed 780G had the highest TIR and Diabeloop had a slightly lower TIR.
The question, of course, is whether this was possibly due to device allocation?
Indeed, the study was not randomised and the baseline HbA1c of the MiniMed 780G was also slightly lower.
These results do argue in favour of Medtronic, which has repeatedly stated that their SmartGuard algorithm is the most responsive algorithm .
#4 Tandem Examines Algorithm to Simplify Settings of Tandem Control-IQ Technology
Optimizing settings for Tandem Control-IQ can be a challenge for both caregivers and users.
At EASD, Tandem showed a study using an "Adaptive Therapy Settings Algorithm" developed to simplify this process.
How does it work?
After the user has worn Tandem Control-IQ for 3 days, the new algorithm adjusts settings on day 3, day 7 and then weekly, based on patterns in glycaemia.
In a study of adults with type 1 diabetes who switched to Tandem Control IQ technology,
this new algorithm led to a Time in Range increase of 19% after just 30 days.
This new algorithm can thus automatically calculate the necessary adjustments to the settings and promises to make Tandem Control-IQ easier to use.
The integration of this new algorithm into Control-IQ is planned for 2025 at the earliest, at the launch of "Control-IQ 2.0".
In the coming months, Tandem will be busy with other launches:
- Integration of the Dexcom G7 sensor into Tandem Control-IQ (already launched in a small group in US)
- Integration of the FreeStyle Libre sensor
- Launch of Tandem Source (the update of the t:connect platform)
- Launch of the t:connect app with bolus function in Europe
- Launch of Control-IQ 1.5 where especially the limits of total daily insulin dose and weight will be more comprehensive
Currently, the total daily insulin dose and weight at Control-IQ (1.0) are set to respectively 10-100 U per day and 25-140 kg.
At Control IQ 1.5, the limits will be extended to 5-200 U per day and >10 kg, based in part on the PEDAP study.
#5 Real-world Data from Nearly 70,000 Omnipod 5 Users
Insulet presented real-world data from 69 994 users in the United States.
This data shows the increasing use of the Omnipod 5.
The results were slightly less rosy than expected, partly because many users did not choose the lowest target value.
- With a target value of 110 mg/dl (6.1 mmol/l) they achieved a TIR of 69%,
- while other targets yielded lower TIR values (61% and 54%).
- The Time Below Range did remain consistently low at less than 2%.
Insulet has also announced that The Netherlands will be allowed to launch with the Omnipod 5 early next year,
and that afterwards France, Italy, Sweden, Denmark, Norway and Finland will have their turn.
A lot of people are waiting for this system in our country too, but the people in Belgium will unfortunately have to be patient for a little while longer.
With regard to the integration of new sensors, it was stressed that Insulet's goal is to offer Omnipod 5 with a sensor of your choice,
and so this involves the Dexcom G6, Dexcom G7 and FreeStyle Libre (2 or 3) sensor.
A more concrete timeline for this was not given.
#6 AiDAPT Study Confirms Safety and Effectiveness of AID Systems for Pregnant Women with Type 1 Diabetes
At EASD, the results of the AiDAPT study, the largest study using AID systems during pregnancy, were discussed.
Simultaneously to the EASD, the results were also published in the NEJM.
In this study, 124 pregnant women with type 1 diabetes were included in a few centres in the UK,
and randomised to the CamAPS FX AID system or their usual therapy (i.e. a manual insulin pump or insulin pens).
As expected, the results were very good.
- Those on CamAPS FX had a TIR of 68%
- compared to a TIR of 56% in those without AID.
(The TIR here was 63-140 mg/dl or 3.5-7.8 mmol/l, adjusted for pregnancy)
Although the study was not powered to look at pregnancy outcomes,
it was noted that this better glycaemic control also had a good effect on maternal and child health:
- the mother's weight was 3.5 kg lower
- mothers had less hypertension and pre eclampsia
- and the babies were smaller (macrosomia at 39% compared with 50%).
The presentation of these results drew a huge applause from the audience.
and it was decided that "AID systems should be offered to every pregnant woman with type 1 diabetes".
#7 CamAPS HX: Full AID System for Adults with Type 1 Diabetes
At EASD, we also saw one of the first studies with a full AID system in adults with type 1 diabetes.
A full AID system means you no longer have to declare your meals, something we all naturally want to move towards.
This algorithm was tested in people with a poorer HbA1c, i.e. >8%, as it is suspected that this is likely to be the population that will benefit most.
- People with an HbA1c of <8% are probably people who already bolus very well before meals,
- and we also know that a system with meal boluses will always do better than one without meal announcements.
This was a small study, namely only in 26 adults,
and in them, the system in open-loop was compared with the system in closed-loop, for 8 weeks.
The results were reasonably OK:
- HbA1c dropped from 8.8% to 8.2%
- TIR increased from 36% to 50%
- And the TBR remained low: from 0.6% in open-loop to 0.9% in closed-loop
An HbA1c of 8.2% and a TIR of 50% is obviously not yet spectacular,
but it is clearly better than from where these people come without automated insulin delivery ("closed-loop").
#8 INREDA Shows Impressive Results with Bihormonal AID System
INREDA's bihormonal AID system is being actively investigated in the Netherlands, and the results of one of their larger studies (FREE1) was shared at EASD.
This is a before-and-after study in 82 adults with type 1 diabetes, who have worn the system for as much as 1 year .
As in their previous smaller study, the results were very good!
- HbA1c dropped from 7.8% to 6.9%
- The TIR increased from 56% to 80%!
- And the TBR fell from 3.2% to 1.5%.
The time in auto mode was 95%, which argues for good portability of the system.
- As you may know, one of the biggest drawbacks of the INREDA AP is that it is a very large pump, and there is quite a lot of work to keep the system running.
- This is because the AP has 2 catheters, 2 infusion sets and 2 sensors, and the glucagon has to be manually dissolved every day.
- Nevertheless, the participants in this study appeared to succeed in doing so.
A TIR of 80% with a closed-loop system where you have to declare both no meals and no sports is obviously spectacular!
Unfortunately, we will still have to wait a while for the commercial availability of this, as it would not be before 2025 at the earliest.
#9 More Asian Glucose Sensors
At EASD, we saw surprisingly many Asian sensor manufacturers present at EASD's "technology fair" (the booths),
and they are getting ready to launch their product on the European market.
So these sensors already have a CE label or expect one soon,
which means they have some evidence to proof their accuracy and reliability.
The MARD quoted by these firms is indeed often below 10%.
It should be noted here, however, that sometimes there are doubts about the reliability of these studies,
and that the results are often not public, making it difficult to check their specific methods.
Some general features of these sensors are:
- they can remain 10-15 days on site,
- they do not require finger pricks for calibration,
- and they send their glycaemia data to an associated app on your mobile phone.
In addition, we naturally expect a price difference with current US-origin sensors (Abbott, Dexcom and Medtronic).
#10 The Future of Glycaemic Control: Time in Tight Range?
One of the themes of this year's EASD was the call to start looking more at the "Time in Tight Range" rather than "Time in Range":
- Time in Tight Range (TITR): 70-144 mg/dl (4-8 mmol/l)
- Time in Range (TIR): 70-180 mg/dl (4-10 mmol/l)
One of the reasons to aim for a higher TITR is that a glucose level between 70-144 mg/dl (4-8 mmol/L) better matches the glucose levels of people without diabetes.
- People without diabetes in fact, 96% of the time have a glycaemia between 70-140 mg/dl (4-8 mmol/l),
- and only 2.4% of the time a glycaemia between 140-180 mg/dl (8-10 mmol/l).
It is also cited that current diabetes care is not good enough.
- Currently, girls with type 1 diabetes diagnosed before the age of 10, experience a loss of 17 life years,
- and boys with the same diagnosis before the age of 10, lose 14 life years.
So there is every reason to aim for better glycaemic control comparable to peers without diabetes.
Another argument is that since the emergence of AID systems, it is actually possible to aim for a higher TITR to begin with, rather than just looking at the TIR.
Last year, the ISPAD guidelines were already updated to incorporate this "new concept":
- "A reasonable treatment goal after the initial remission period in insulin-treated children younger than 7 years can be >50% of time in target (TIT) 3.9-7.8 (70-140 mg/dL) or >70% time in range (TIR) 3.9-10 mmol/L (70-180 mg/dL). Soon after diagnosis, during the remission period, a higher TIT or TIR is preferable."
- ISPAD Clinical Practice Consensus Guidelines 2022: Managing diabetes in preschoolers
At EASD, Medtronic presented data showing how an AID system can improve TITR.
- They examined Carelink data from more than 10,000 people with type 1 diabetes older than 15 years, who also had sensor data from before the MiniMed 780G was commissioned.
- TITR increased from 37% for auto mode to 49% in auto mode.
Striking was the significantly better TITR in the 530 people who used "the optimal settings" (a target value of 100 mg/dl (5.6 mmol/l) and an active insulin time of 2 hours).
Their TITR was 57%.
While it would already be a step forward if the majority of people with type 1 diabetes met the international TIR targets (which is still not the case at the moment),
it might not hurt to look further?
- Perhaps we should indeed strive for even better results?
- Or is TITR indeed a better parameter than TIR in reducing complications?
At the EASD congress, people in the audience did comment directly that the pursuit of a higher TITR might well trigger additional diabetes burden.
We also often hear from people with diabetes themselves that we should not forget the "Time in Happiness" in particular.
The next few years will certainly reveal the importance of TITR,
and how we can use this as a parameter without adding further stress to people with diabetes.
These developments in diabetes technology promise a better future for people with (type 1) diabetes.
Hopefully, we can soon achieve all our new Time in Range and Time in Tight Range goals without too much extra effort!
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Kind regards,
