Abbott 1Q15 - Global, US sales see single-digit growth; strong adoption of FreeStyle Libre in the EU; US pivotal trial completed - April 23, 2015

Early this morning, Abbott CEO Mr. Miles White led the company's 1Q15 financial update. The big news is that Libre is still exceeding expectations and Abbott is still very positive on the investment. As expected, no sales/trajectory numbers came during the call, nor were there updates on the US timing – anecdotally, we have heard that Abbott is beginning to reach out to customers on its waiting list … finally! Below, we bring you our top ten highlights from the call. There was no diabetes relevant Q&A.

Financial Highlights

1. Global Diabetes Care sales totaled $267 million in 1Q15, down 6% as reported and up 3% operationally year-over-year (YOY). We find it tough to read into this “growth,” given the easy comparison to 1Q14 (sales fell 11% as reported, 10% operationally). Global sales fell 15% sequentially from 4Q14, though management increased guidance slightly for 2Q15 to low-to-mid single-digit operational growth YOY.

2. US Diabetes Care sales grew 5% YOY to total $102 million in 1Q15. This came on an especially easy comparison to 1Q15 when US sales declined an unprecedented ~27%. Management was strikingly positive on the business, commenting on a desire to “segment our products and our commercial strategies to drive profitable growth.” We were glad to hear it and the success of this in our view hinges on getting FreeStyle Libre approved and reimbursed in the US.

3. Internationally, Diabetes Care revenue totaled $165 million, falling 12% as reported and 1% operationally YOY; this reflects the significant strengthening of the US dollar (negative 13% currency impact) as opposed to major underlying weakness in the business’ fundamentals.

4. Combined global 1Q15 revenue for J&J, Roche, and Abbott totaled ~$1.3 billion, falling 7% YOY relative to pooled revenue in 1Q14. Notably, US sales of ~$414 million actually grew 3% YOY (vs. an easy comparison to 1Q14, when sales were down 22%). Sequentially, global pooled revenues fell a dramatic 18% relative to 4Q14, while US/North America sales declined 6%.

Pipeline Highlights

5. CEO Mr. Miles White shared clear enthusiasm for FreeStyle Libre, which has seen “strong consumer and physician adoption” and a “very positive early response” – this is similar to what we heard at 4Q14. There were no specifics on revenue/trajectory or patient adds. Anecdotally, we have heard that Abbott is beginning to reach out to customers on its long EU waiting list.

6. Notably, Abbott has completed its pivotal trial of FreeStyle Libre at six sites in the US – study results have not yet been posted. Management did not comment on the US timeline.

7. Abbott has partially turned its focus on FreeStyle Libre to growing the portfolio – both geographically and strategically. Both prepared remarks and the press release highlighted the launch of the professional version of Libre in India.

8. FreeStyle Libre is very popular on EU social media sites – see our appendix for a look at what patients are saying. As we noted at 3Q14, patients have been overwhelmingly wowed by the simplicity and form factor of the device, the discretion, the ease of a ~1 second reading, and the convenience of unlimited readings. See the diaTribe experience here.

9. Prepared remarks highlighted the recent US launch of Abbott’s newest BGM, the FreeStyle Precision Neo. The meter is on the basic side in terms of features, but brings a slim profile thinner than an iPhone. The marketing message is one of accessibility: “Skip the Copay.”

10. There were no additional pipeline updates on FreeStyle Libre or other Abbott meters.

Financial Highlights

1. Global Diabetes Care totaled $267 million in 1Q15, down 6% as reported and up 3% operationally year-over-year (YOY). It tough to read into this “growth” considering the easy comparison to 1Q14 when sales fell 11% as reported and 10% operationally. Indeed, sequential global sales fell 15% from 4Q14, marking the second-steepest sequential decline we have seen for Abbott since we began reporting their quarterly results in 2003. Performance was in-line with management guidance from 4Q14 – which anticipated low-single-digit operational improvement – though we find it disappointing to see global sales fall below $300 million yet again – see Figure 1 below. Prior to 1Q14, the last single quarter of sales under $300 million came in 2010 – sales have now come in under this mark in three of the past five quarters ($283 million in 1Q14; $294 million in 2Q14).

• On the other hand, the 6% YOY decline in sales improved on three quarters of double-digit declines in 2014 (3Q14 was the exception when sales fell 6%) suggesting at a very high level that the business’ declines are attenuating. After all, the segment has experienced significant challenges in the recent past with only two quarters of Diabetes Care growth in the past 13 quarters (since 1Q12).
• Management raised its guidance for 2Q15 forecasting low-to-mid single-digit operational growth for the quarter. (For all of 2015, management previously guided for low-single-digit operational growth.)  It’s encouraging to see a bit of optimism and speaks to some internal confidence in the business. That said, revenue will continue to be assessed relative to particularly easy comparisons (2Q14: down 10%; 3Q14: down 6%; 4Q14: down 10%) – it will be some time until a new normal is reached.

Figure 1: Global, US, OUS Quarterly Sales (1Q11 – 1Q15)

2. US Diabetes Care sales grew 5% YOY, totaling just $102 million in 1Q15. While this came on an especially easy comparison to 1Q15 – when US sales declined an unprecedented ~27% – it does mark the first quarter of growth in the US business since 4Q12. It is tough not to notice the positive trend considering how bleak this environment has been – for context, the 5% growth breaks a string of five consecutive quarters of double-digit declines (stretching back to 4Q13). That too, sequential US sales fell “only” 6% – less steep than the double-digit declines between 4Q and 1Q seen over the past two years (down 11% and 25%, respectively). Still, it is difficult to read too far into the sequential numbers considering the very low base in 4Q14 ($108 million), and for now, we are keeping the expectations low. Deeper analysis of the financials also reveal a concerning trend as the quarterly performance ties 1Q15 US revenue for the third lowest ever recorded for Abbott’s US business in our financial model (which stretches back over a decade). With easy comparisons coming up as well (2Q14: down 27%; 3Q14: down 16%; 4Q14: down 16%), we assume the remainder of 2015 will see some low-to-modest growth.

• Management was somewhat positive on the US business, remarking on a desire to “segment our products and our commercial strategies to drive profitable growth” – certainly, this is always the goal, though the delivery was definitely less negative on the US business than we’ve perhaps heard in the past. Indeed, the stance somewhat mirrors what we heard from J&J last week. Commentary on the “challenging” stateside market has been a near certainty at Big Four quarterly updates over the past 18 months, and it continues to be notable NOT to hear this raised.

3. Internationally, Diabetes Care revenue totaled $165 million, falling 12% as reported and 1% operationally YOY; the comparison was moderately challenging (especially in this BGM environment) with revenue in 1Q14 growing 2% as reported and 4% operationally. The financials reflect the significant strengthening of the US dollar (negative 13% currency impact) as opposed to underlying weakness in the business’ fundamentals. As just one example, the dollar strengthened significantly vs. the Euro in late February/Early March, rising from an exchange rate of 0.88 Euros to 0.95 Euros.

• One might raise two concerning trends regarding the international business, though it’s hard to know how real they are given the currency impact. First, the 1Q15 performance marks a second consecutive quarter of reported YOY decline – a pattern we have not seen since 2012 (3Q – 4Q). Secondly, the sequential decline of 20% marks the largest sequential quarter-to-quarter drop ever recorded for Abbott’s international business in our financial model. However, we would note that latter comes relative to a high base in 4Q14, as sales hit $205 million; for context, this is not too far down from record high quarter of $217 million in 4Q13. It’s hard to be too negative on the international business considering how it has carried the Diabetes franchise during tough US times, as well as upside for FreeStyle Libre.

4. Combined global revenue for J&J, Roche, and Abbott totaled ~$1.3 billion, falling 7% relative to pooled revenue in 1Q15 (~$1.4 billion); offhand, we were hoping this would be a bit better, though we think the decline has been driven by the significant strengthening of the US dollar as opposed to US weakness – see below. The performance does come against an easy comparison as combined revenue declined 7% a year ago. Sequentially, global pooled revenues fell a staggering 18% relative to 4Q14 (when sales reached ~$1.5 billion). For context, J&J, Roche, and Abbott all fell 6% YOY, breaking a streak of three consecutive quarters in which Abbott had the weakest performance. On an operational basis, J&J (up 4% YOY) outperformed Abbott and Roche (up 1% YOY). As a note, it is difficult to make direct comparisons between J&J, Abbott, and Roche, given that each company’s Diabetes Care business includes a fraction of non-BGM revenue (J&J and Roche have global insulin delivery and Abbott has CGM and FGM outside of the US). We look forward to adding the last of the Big Four – Bayer – to this comparison when the company reports on April 30.

Figure 2: Abbott/J&J/Roche Quarterly Global Revenue Comparison (1Q11 – 4Q14)

• A comparison of Abbott/J&J/Roche quarterly global sales illustrates unique revenue trends for each company. Roche is the most cyclical of the three with sales that vary distinctly with quarters (high in 2Q and 4Q; low in 1Q and 3Q). J&J revenue has declined substantially since 2011 (more of its business is from the US, and its stateside business has been harder hit), while Abbott sales have been surprisingly steady (two-thirds of its sales are OUS).
• Notably, pooled declines were not driven by US weakness, where combined sales of ~$414 million actually grew 3% YOY – of course, this comes against a strikingly easy comparison to pooled sales in 1Q14 (down 22%) so the numbers are tough to read into. However, 1Q15 does mark the first quarter that pooled revenues have grown since 4Q11, making us wonder what the rest of 2015 will look like. That said, we also know that revenues will continue to be assessed relative to particularly easy comparisons in 2014 – a reminder that the full effects of competitive bidding are only going to be known some time down the road.
  • Sequentially, pooled US revenues fell 6% relative to 4Q14 ($440 million). Ultimately, the US continues to be a challenging region for growth despite the fact that we are well past the annualization of competitive bidding –the big question is when the market will bottom out (or if it already has).

Figure 3: Abbott/J&J/Roche Quarterly US Revenue Comparison (1Q11 – 4Q14)

• A comparison of Abbott/J&J/Roche quarterly US sales illustrates how significantly J&J’s US business has suffered in the past four years; we would note that declines began even before the implementation of competitive bidding. Abbott and Roche have suffered more modest declines.
• Pooled declines were driven by international weakness, where combined sales of ~$876 million declined 12% YOY. This came against a modest comparison (for the BGM industry) as sales grew 2% in 1Q14. Sequentially, pooled international revenues fell a staggering 23% relative to 4Q14 (~$1.1 billion). As noted above, these negative trends seem to reflect the significant strengthening of the US dollar as opposed to underlying weakness in any of the business’ fundamentals. J&J, Roche, and Abbott have announced steep YOY reported declines in 1Q15 offset by stronger operational performance: for context, J&J sales were down 15% as reported and up 1% operationally YOY in 1Q15 while Roche sales were down 10% as reported and up ~5% operationally (we estimate the latter because Roche reports EMEA and RoW separately).
• Roche’s global revenues accounted for the majority (42%) of the three companies’ pooled revenues; this held steady relative to Roche’s share in 1Q14 (43%). Abbott and J&J revenues also held relatively constant at 21% (vs. 20%) and 38% (vs. 37%), respectively. (We note that the numbers do not add to 100% due to rounding.) Regionally, J&J holds the greatest percentage of revenue in the US at 51% (vs. 48% in 1Q15), while Roche holds the greatest share of international revenue at 50% (vs. 49% in 1Q14). Overall, we are impressed with how steady market share has been.

Pipeline Highlights

5. Once again, the highlight of the call was CEO Mr. Miles White’s commentary on FreeStyle Libre. We heard clear enthusiasm for the product, which has seen “strong consumer and physician adoption” and a “very positive early response” – this is similar to what we have heard at previous updates, and specifics on revenue/trajectory and patient adds were absent. At ATTD 2015, we learned that there is still capacity constraint on the manufacturing front, which is probably only adding to the enthusiasm. Management noted at 4Q14 that the company’s challenge was actually meeting demand and that Abbott was working to facilitate capacity expansion. There was no commentary on efforts to expand scale in this call, though we assume this is on track. Manufacturing factory calibrated sensors at scale is not easy, and we look forward to seeing how quickly Abbott can expand capacity.

• Anecdotally, we have heard that Abbott is beginning to reach out to customers on its waiting list; we are awaiting official confirmation from the company on this front. As a reminder, we learned at ATTD 2015 that the company was only serving existing customers – e.g., they did not have the scale to meet the growing demand. Now, new customers are reportedly being pulled off the waiting list and will be sent two sensors – one month’s worth – at a time (same as for existing customers).
• Mr. White acknowledged that sales of Libre have been driven by a “successful direct-to-consumer campaign.” Abbott came out with an impressive, consumer-focused approach to marketing at launch – the “No more fingersticks” message, online ordering without a prescription, accessible pricing relative to CGM at 59.90 euros for the reader and 59.90 euros for each 14-day sensor – and reimbursement (should it come through; see below) will be a huge step forward in terms of accessibility. It’s been very impressive to see the warm reception for the current out-of-pocket price (~120 euros/month), and while it’s still cheaper than CGM, it is still more than BGM. This is particularly critical, as many European patients are not used to paying out-of-pocket for devices.
• Abbott is still in the process of conducting two six-month outcomes studies to support reimbursement; there were no specific updates on this front. REPLACE (n=210 type 2s on MDI, A1c>7.5%) and IMPACT (n=225 type 1s on MDI or pumps, A1c <7.5%) are both ongoing and not currently recruiting participants – this does not represent a change in status for REPLACE but is an update on IMPACT, which was still actively recruiting participants as of 4Q14. The goal of the type 2 study is to show a change in A1c at six months, while the type 1 study seeks to improve time spent in hypoglycemia at six months. Both trials will compare FreeStyle Libre to standard SMBG and both have an estimated completion date of June 2015. The A1c inclusion criterion is very smart in our view, and it’s good to see that both studies are quite large, especially for a glucose monitoring trial..

7. Notably, Abbott has completed its pivotal trial (ClinicalTrials.gov Identifier: NCT02283411) of FreeStyle Libre at six sites in the US – study results have not yet been posted. The trial had been recruiting in both type 1 and type 2 patients as of 4Q14 and had an estimated completion date of March 2015 – it is terrific to see Abbott hit its timeline, another signal this is a major priority. The purpose of the study (n= 164) was to evaluate the point and rate accuracy of the system against YSI and to characterize the safety through Adverse Device Effects and Serious Adverse Device Effects experience by participants.

• Management did not comment on the US timeline in the call. As a reminder, commentary during Q&A at 4Q14 hinted at ongoing struggles with the FDA regulatory path – “I’m frustrated with the pace of regulatory approval in the US.” The big question is whether the FDA will grant FreeStyle Libre a dosing claim; Dexcom has been wrestling with this for some time now (FDA clarity on an insulin dosing claim trial is expected by August, per its 4Q14 call).

8. Abbott has partially turned its focus on FreeStyle Libre to growing the portfolio – both geographically and strategically. Both the prepared remarks and press release highlighted the recent launch of the professional version of Libre in India – we thought it notable to see such a focus on the new product and region, which clearly reflects internal optimism in the investment. The launch was described in the context of a “logical target market” given the large target population and the relative under-penetration of SMBG in India. We are impressed to see Abbott investing in an area of such vast need (there is not the same safety net for patients in India). We don't think the approval is so much about introducing Libre for long-term full time patients use as it is about helping HCPs drive therapeutic change (and presumably dietary and exercise) more easily and more clearly. Patients using the Pro version of Libre would put the sensor on and come back to their provider in two weeks; they are not given a reader, a key difference from the consumer version.

• As a reminder, Abbott announced the approval of the Libre Pro earlier this month, marking India’s Central Drug Standard Control Organization as the first regulatory body to approve the professional-use device. The Pro is approved for 14-day wear and is designed to record glucose levels every 15 minutes over the two-week period (~1,340 data points). This stands in contrast to the consumer version that takes readings more frequently – on the order of once/minute – which is why the sensor must be scanned with the touchscreen reader every eight hours. We are unsure what fraction of Indian providers actually prescribe professional CGM (probably very low); however, we believe the technology could give clinicians an opportunity to become acquainted with the latest generation of technology and access to comprehensive data rarely available in India. Big picture, this sort of use makes much more sense in India, where very few people have significant resources and where there is no safety net for patients.
• As a reminder, Abbott began recruiting participants for a US pilot study of the Libre Pro earlier this year (ClinicalTrials.gov Identifier: NCT02336945), and we continue to await results.

8. We continue to see on EU social media sites that Libre is popular – see our appendix for a look at what patients have recently been saying. As we noted at 3Q14, patients have been overwhelmingly wowed by the “no fingersticks” message, the simplicity and form factor of the device, the discretion, the ease of a ~1 second reading (without really having to stop what they are doing), and the convenience of unlimited readings. The design has led these individuals to test far more often than they would have on BGM alone. Ultimately, increased adherence and enhanced self-management (via access to overnight trends, etc.) could be the greatest testament to this novel category of monitoring.

• One common critique of the FreeStyle Libre is that the product has caused some itching and rashes. This does not appear to be a significant problem, but it is notable to see repeated mentions of this on social media – of course, itches/rashes are common with any long-term sensor and it’s not surprising that the 14-day wear would be linked to such issues. We did not experience this problems in the diaTribe test drive of Libre.

9. Prepared remarks highlighted the US launch of Abbott’s newest BGM, the FreeStyle Precision Neo. The marketing message is one of accessibility: “Skip the Copay.” Neo test strips are available over-the-counter, at $14-17 for 25 strips (~$0.62 per strip). We wonder whether the over-the-counter focus is reflective of a new US strategy to more directly compete with store brands, or potentially, appeal to consumers with high deductible health plans (particularly those on Exchange Bronze plans, where the first $5,000 is out of pocket). Per its commentary on profitability today, management may believe that Neo can help drive some positive margins in the US business. Previously, we had been curious to see whether Abbott would push this launch forward or would focus its effort on bringing the Libre to the US. As it stands, the timing on the latter is unclear and probably not very near-term – as such, it is promising to see Abbott continue to invest in new products stateside despite the challenging environment.

• As a reminder, Abbott announced the US launch of the Neo last week – see our full report for details. The meter is on the very basic side in terms of features, but brings a super slim profile thinner than an iPhone 5 (0.34 in). Abbott has also packaged the Precision Neo strips individually in flat foil, further building on the portability front. For comparison, Neo test strips’ pricing (~$0.62 per strip) is more than Walmart’s Reli-On Prime ($0.18 per strip) and CVS-branded meters made by AgaMatrix (~$0.22 per strip), and roughly on par with Walgreens store brand strips made by Nipro (~$0.50-$0.70 per strip). The pricing is significantly cheaper than the cash price for Big Four strips, which are generally above $1 a strip, and even range up to $1.75 per strip (!) for LifeScan’s Verio strips. The Neo meter retails at $22-27, on par with the out-of-pocket for most basic meters these days. Abbott’s official Neo website can be found here. The meter and strips are available online at major US retailers (Walmart, CVS).

10. There were no additional pipeline updates on FreeStyle Libre or other Abbott meters. Management has alluded to expanding the Flash Glucose Monitoring category to other areas, and the Pro version is the first of these – we wonder if the reader could be incorporated into a phone that has NFC built-in. We also wonder if a continues version of FreeStyle Libre could be developed, though that would increase the cost and potential change the on-body form factor. 

Appendix – European Social Media on FreeStyle Libre

• Every day ups and downs: "What has it been like so far? In a word, amazing … One of the other things I have already noticed is that the Libre makes glucose monitoring so effortless that I am inclined to check more frequently rather than less.”
• Type I Diabetes, Coeliac Disease, Tennis: A more technical analysis of FreeStyle Libre, highlighted by thoughts on pros and cons + a comparison to Dexcom’s G4 Platinum.
• How Fast?: “Personally I think the biggest game changer is for those on MDI (multiple daily injections). On MDI if you wanted to try out a CGM you would be looking at upwards of £1000 start up costs … on Libre its £134 for a start up pack that includes 2 sensors and a reader. Sensors after that are £48.”
• DiabetesTechReview: “In my opinion CGM is the future for insulin dependent diabetics, strips just leave too many blind spots. The Abbott Freestyle Libre is not a perfect system, but its relative affordability, and ease of use make it a good step in the right direction.”
• #FreeStyle Libre on Twitter
  
  • ‏@HanSuppiah: “#FreeStyleLibre: 1 week in. Have become addicted to scanning and am blown away by the lovely #eyeopening data. #DOC”
  • ‏@rustyjellybaby: “Can #freestylelibre be considered an addiction? I'm without sensor and missing it.”
  • @alistair1975: “Time in Target … just broke 25% for the 1st time. Was 13% three weeks ago. #freestylelibre”

What Social Media Was Saying in early September 2014

• Fun, Young, and Type 1: “I must have tested 40 times on the first day, just because I could…Having that kind of detailed data in front of me is not only allowing me to take control, but it’s persuading me to do so.”
• Diabetogenic: “For me, the benefit of not having to prick my finger to check my BGL is a huge, huge bonus and I know that there are many people who find this the thing they hate most about diabetes management.”
• Ninjabetic: “I can’t feel a thing when I’m wearing it, sleeping on the side that it’s on or when I’m moving my arm (not that I madly flap my arms around anyway!)…If you can afford it then perhaps it might be worth trying it out for yourself as the initial start-up cost is much lower than CGM technology.”
• The Tangerine Diabetic – Compares the FreeStyle Libre and Enlite CGM across availability, accuracy, convenience, software, setup, size, and more.
• #FreeStyleLibre on Twitter:
  
  • @misswhiplash: “Excited and very impatient about the impending arrival of my #freestylelibre … I WISH IT WAS HERE ALREADY.”
  • @justinkb: “Wow. Just wow. Tech geeks will almost want to be diabetic! https://www.freestylelibre.co.uk/default.aspx #freestylelibre”
  • @rustyjellybaby: “First wake up and I'm in love. Not only can I see I've been low but been low since 2am #FreeStyleLibre”
  • @docsamphillips: “#FreeStyleLibre @doctorinsulin @karen_a_adamson. i have been wearing this 7th day. Close to capillary readings”

Appendix – ATTD 2015 Coverage of FreeStyle Libre

FreeStyle Libre System Accuracy Study

Timothy Bailey, MD (UCSD, San Diego, CA)

Dr. Tim Bailey shared never-before-seen data from Abbott’s 72-patient, 14-day pivotal CE Mark trial of its factory calibrated FreeStyle Libre system, which demonstrated a solid overall MARD of 11.8% vs. YSI (the study had 1,238 paired sensor-YSI points). We first saw top line results from this study at EASD 2014, where Libre demonstrated an overall MARD of 11.4% vs. FreeStyle Precision BGM (13,195 paired points). One criticism of the data shared at EASD was the use of BGM as the reference device, as most CGM studies have in-clinic days with YSI – it was good to see that the 14-day, factory calibration holds up against that standard as well. New subgroup analyses also showed that the sensor remains accurate near the hypoglycemic range, where MAD was 9.5 mg/dl vs. YSI for glucose values in the 51-80 mg/dl range – this is the first time Abbott has shared this data (see below). As a reminder, the product label recommends a confirmatory fingerstick when hypoglycemic, though commentary during Q&A suggested that patients are routinely skipping these steps, testament to its real-world accuracy. Similarly, the sensor maintained its accuracy even when glucose values were rapidly changing as Dr. Bailey shared a comparison of data excluding vs. including all points < 80 mg/dl or changing at > 2 mg/dl. Reported MARD were not statistically different for the two subgroups: 10.4% (exclusive) vs. 11.4% (inclusive).

• As a reminder, the pivotal study was conducted in four centers across the US in type 1 and type 2 patients on insulin therapy. Patients wore two sensors on the back of their arm for 14 days and were asked to: (i) perform eight capillary blood glucose tests daily; (ii) scan the sensor following each test; and (iii) attend three in-clinic eight-hour YSI sessions. Notably, Dr. Bailey shared that 24% of patients had a baseline A1c > 8.5% and that 22% of patients had a baseline A1c < 7.0% - a nice mix of well-controlled and out-of-control patients.
  
  • We saw topline results from this study at EASD 2014 where Abbott’s factory calibrated FreeStyle Libre system demonstrated an overall MARD of 11.4% vs. FreeStyle Precision capillary fingersticks (87% of points were in Zone A of the Consensus Error Grid, 13% in Zone B). MARD was lowest on day one (15.7%), improved to 11.9% on day two, and hovered between 10.3% and 11.8% on days 3-14. The study had 13,195 paired FreeStyle Libre-BGM data points (range: 23-498 mg/dl).
• FreeStyle Libre demonstrated excellent accuracy in the hypoglycemic range vs. both YSI and fingersticks. MAD was just 9.5 mg/dl vs. YSI (n=53) and just 10.0 mg/dl vs. fingersticks (n=901). A bigger testament to Libre’s hypoglycemic accuracy came from Dr. Bailey’s colleague, Dr. Iain Cranston who noted, “Half my patients have not done a fingerstick in two months. They come to rely on Libre.” The data below is cut at 50 mg/dl and 80 mg/dl, so it is tough to know what the accuracy is for <70 mg/dl vs. > 70 mg/dl (i.e., did most of the 50-80 mg/dl points fall in the 70-80 mg/dl bucket?). Even still, based on our experience wearing the device, it is very accurate in hypoglycemia, so the point is more semantics than anything.

Table 1: FreeStyle Libre vs. YSI in Hypoglycemia

Table 2: FreeStyle Libre vs. BG Capillary for Low Blood Glucose

• Libre demonstrated impressive results even when glucose values were rapidly changing. Dr. Bailey shared subgroup analysis for results excluding vs. including all points < 80 mg/dl or changing at > 2 mg/dl/min. Impressively, the reported MARD were not statistically different: 10.4% (exclusive) vs. 11.4% (inclusive). We thought this was a clever and smart way to summarize the data.

Table 3: Sensor Results During Times of Rapidly Changing/Low Blood Glucose

• Mr. Bailey shared positive data from user experience studies of FreeStyle Libre in the pivotal study. There was no background on how these questions were asked – we assume Yes/No. Still, the data pointed to why patient uptake has been so strong in these early days, especially in those that have avoided current CGM due to comfort/wearability:
  
  • 100% agreed that the sensor was easy to apply.
  • 88% agreed that applying the sensor was less painful than a routine fingerstick (more to the point, we’d add that it’s only required every 14 days).
  • 86% agreed that the sensor did not get in the way of daily activities.
  • 96% agreed that Libre is comfortable to wear.
  • 96% agreed that scanning the sensor is less painful than pricking my finger (We’re not quite sure how these 4% of patients were scanning or what magical lancing device they were using – Adam and Kelly have both used it and say the scanning is completely painless.).
• Very few adverse events were reported among patients in the study. Only 26 subjects reported any sort of discomfort around the sensor insertion site and all reports were consistent with what would be expected following insertion of a sensor into the skin:
  
  • Moderate to severe erythema – 4% of the time
  • Other moderate symptoms – 1% of the time
  • Mild symptoms – less than 9% of the time (Moderate vs. mild symptoms were not defined.)
• Although Libre is only approved for upper arm wear, commentary during Q&A suggested that most patients are taking liberties with sensor placement – the re-location does not appear to be affecting accuracy. Said Dr. Iain Cranston (Portsmouth Hospitals NHS Trust, Portsmouth, England) during Q&A: “Most people using Libre have purchased the devices themselves, so will put it where they damn well like. The upper quadrant of the buttocks is a popular place, and it stays on for two weeks. On the abdomen is another popular place, but more likely to fall off. It’s incredibly anecdotal reporting thus far though.” The upper arm can be a tough sell for patients (less body fat for some; more visible), so we are not surprised to see patients taking initiative, as they have with traditional CGM as well. The company has said it is exploring approval for some of these other sites for wear, though that would simply allow for different marketing and training more than greater uptake.

Questions and Answers

Q: You mentioned Libre’s great precision – why would you want to cross check with fingersticks?

Dr. Bailey: It turns out that the precision of this can replace fingersticks. There are still some caveats with rapid changes or with hypo but a replacement is here and that’s pretty exciting for patients.

Dr. Cranston: Half of my patients have not done a fingerstick in two months. Patients have come to rely on Libre.

Q: D you have to wear the sensor on your arm? Could you wear it anywhere else? What would be the differences?

Dr. Bailey: At my site, you had to wear it on your arm. In reality, you can’t even imagine all the places patients actually put the devices, but I don’t know the data.

Dr. Cranston: Most people using Libre have purchased the devices themselves, so will put where they damn will like. The upper quadrant of the buttocks is a popular place, and it stays on for two weeks. On the abdomen is another popular place, but more likely to fall off. It’s incredibly anecdotal reporting thus far though.

Q: Is there any data on interfering substances?

Dr. Cranston: I have not seen study data relating to it, though I believe it is there. It is not something I recommend people need to avoid. I think the clinical sheet that comes with it tested against 20 substances, and although they can measure differences in the value from that, they are not clinically different.

Q: Could you tell us more about the first hour of insertion after the new sensor?

Dr. Bailey: The first hour is the calibration. In our study, 100% of the sensors came online. The only sensors that did not perform had to do with problems with insertion. Once they were inserted, they all reported accurate data.

Dr. Riveline: In my experience, patients noted that accuracy was not as good in the first day.

Dr. Cranston: I tend to advise people to not act according to what they see on the sensor in the first 12 to 14 hours. In an anecdotal way, it does appear that the sensor will tend to read a little bit lower on day one. It’s totally anecdotal and someone from the company will probably shoot me for saying that but that’s what I’ve heard.

Dr. Bailey: This is the first presentation of the YSI data; there will be more data pretty soon.

Q: Any allergic reactions to adhesives? Are there any case reports on that? Maybe on social media?

Dr. Cranston: Yes, on social media there are absolutely reports of that. There were photos of that – like people can be allergic to any adhesive. What I’ve found absolutely stunning and what I’ve seen is that they leave them on! It shows how much they like Libre. Normally when you have something that itches, you take it off. Some patients have had quite a nasty reaction because they want to leave the sensor on.

Q: What about the sensor in a hairy area? Or the abdomen? Do people need to be careful about knocking it off?

Dr. Cranston: It’s only a five-millimeter sensor. So if it’s really hairy area, then you might have problems with getting the sensor inserted. On the back of the arm, I have never shaved an arm to put it on. As for knocking a sensor off, of course you can. People tend to put it on the front part of the arm and it gets knocked off. But on the back, it is better.

Q: Can you talk about Libre vs. BGM?

Dr. Cranston: This should pass as a glucose meter. It meets all the criteria.

Q: Would you recommend patients to do more or less fingerstick measurements in the first 24 hours after putting the sensor on?

Dr. Riveline: I would recommend the same number of SMBGs as usual due to the lower accuracy.

Dr. Cranston: I would say it depends on why they have it. But what I tell patients is not to react to what’s happening actually. I tell them to try not to react too much in the first week. Once you have an idea of what your profiles look like, then in the second week, you can react.

Q: What happens to the needle used to insert the sensor?

Dr. Clifford Bailey (Moderator): It’s in and out before you can see it.

Q: Do insurance companies pay in the US, UK, and France?

Dr. Bailey: It’s not clear in the US. Reimbursement is critical for patients to have access. It would be wonderful if this were covered. It’s not covered in the US or France.

Dr. Cranston: In the UK, it has not been looked at by NICE. I’m not aware of any immediate plans to do that. There is the question of whether an individual can get it funded, but that’s a conversation between the patient and insurance companies and I’m not sure that anyone’s managed it.

Dr. Riveline: I think we have to fight to obtain reimbursement but it hasn’t happened yet.

Dr. Clifford Bailey: If you look at the costs incurred by fingersticks compared with this, then this is very competitively priced. I think that that’s going to be a very big factor in actually deciding the mass use of this new device.

Dr. Cranston: Yes, about ten tests a day is the same price.

Q: How do you think about Libre plus a pump?

Dr. Riveline: I think it’s a good thing for a lot of patients but there is no combination with a pump. It depends on the patient. There are patients who don’t want to have alarms. For some patients with a pump, that’s a good thing.

Dr. Cranston: It’s important to say what it’s not. The Libre plus a pump cannot be an artificial pancreas since data is not continuously collected but instead is episodically collected. That said, many Libre users don’t have pumps. They are treating with insulin injections as they normally would. Is it accurate? In my eyes, yes it is. Do they do it? Yes, they do. Some patients have used a wizard with this and nobody’s factored in an arrow-based wizard, but they visually adjust.

Q: In a situation of rapidly changing glucose, there is a lag time. How does this work out for Libre?

Dr. Bailey: The overall lag time is 4.5 minutes. We don’t have data on rapid change. This is when you want to confirm with fingersticks. Particularly when it’s trending down, check with fingersticks.

Dr. Cranston: When they see a vertical arrow, it is easy to flash again in five minutes. I say, don’t work on a single value. The first flash tells you that you need another again. It’s not that hard to get a second look.

Q: How is it possible to have this MARD without calibration?

Dr. Bailey: Everyone is working on this technology. This is the first released product. Every product out there has its advantages. That’s the one thing about this product.

Dr. Cranston: Let’s make it clear that it’s not that this isn’t calibrated. It is. It’s just not calibrated against fingersticks. It’s calibrated in the lot.

Dr. Bailey: It also has to do with drift. Other sensors would drift and you would have to recalibrate. This one doesn’t drift. Standard meters aren’t that accurate too. So factory calibration is great because it gets rid of using inaccurate meters in calibration.

Q: Can I walk across the street to the nearest pharmacy and buy one?

Dr. Riveline: In France, it was possible to have the device directly bought from the company. But it’s no longer available because a lot of type 1 patients asked for the device. So we have to wait for more devices to be built. The cost is 120 euros for the device and 60 euros for each sensor.

Q: Could you comment on the clinical relevance of using Libre?

Dr. Cranston: I don’t think that there is anybody who has come to me with a profile or that I have put a sensor on where we haven’t gotten clinical value from the profile. There is always something we can clinically get out of the profile.

Q: Is there enough data yet to make diabetes diagnoses in previously undiagnosed patients?

Dr. Cranston: I think it’s a really good question. We’re trying to collect some data about that. Traditionally, diagnosis is based on complications. So we’d have to do it indirectly. I have to say, when you see a normal glucose profile on one of these devices, there’s nothing else that looks like a normal glucose profile. Low variability and a completely flat profile is what normal looks like. We’re looking at Libre in post-transplant profiles to see how it changes.

-- by Varun Iyengar, Adam Brown, and Kelly Close