Executive Highlights
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In diabetes technology, we saw results from a number of small studies around CGM, telehealth, and decision support on day #4.
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First, we saw CGM diagnosing diabetes and increasing diabetes intelligence at the same time! To start, a study suggested that one ten-day wear session of Dexcom G6 could he used to diagnose diabetes with similar performance to the oral glucose tolerance test. Wow! Considering the convenience of wearing CGM compared to OGTT or even getting an A1c done, in the future, diagnostic CGM could be an area to watch – just think about the power of how useful this would be in terms of pre-venting : > diabetes, if the conclusion is negative. We wonder to what degree there is potential to pre-vent pre-diabetes (T1D or T2D, the possibilities are endless).
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Staying on CGM, cool data from Glooko showed improvement in glycemia during the early period of the COVID-19 pandemic, though slight; and
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Also on CGM, a new CONCEPTT secondary analysis found that Time in Range could be a valuable predictor for suboptimal pregnancy outcomes in women with type 1, particularly in the early part of the pregnancy.
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On telehealth, data from Joslin showed older adults were more likely to prefer phone-based visits over video-based ones, a trend that could become increasingly important if telemedicine continues to make up a significant percentage of diabetes visits. Of course, if video results work better, consideration of how to present the idea of telehealth is key! Check out on the diaTribe YouTube channel this excellent Joslin Clinic video that could be titled “how to do telehealth” from Ms. Andreina Millan-Ferro.
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In decision support, a couple of presentations from DreaMed showed that Advisor Pro was non-inferior to expert physicians in providing dose decisioning advice to type 1s and type 2s on MDI. We’re getting into really interesting waters here – while of course, we’d prefer for patients to have access to real HCPs who speak diabetes, we’d much prefer automated decision support if it is compared to nothing, a dismissive HCP, etc.
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In diabetes therapy, University of Miami’s Dr. Jay Skyler gave his annual closing talk at ATTD on type 1 immunotherapies. Since last year’s talk, the field has seen significant movement spurred by new data (for example, imatinib for use in adults recently diagnosed with type 1 diabetes has new data about to hit The Lancet that was shared broadly here and of course, there is new data on anti-CD3 teplizumab that is weeks away from an FDA decision), although a broader trial testing aggressive combination therapies has yet to be initiated even though we thought we’d see this by 2021 since it’s been discussed “in theory” for easily a decade. We also caught an informative Novo Nordisk-sponsored symposium detailing the diverse applications of oral GLP-1 Rybelsus across the type 2 diabetes spectrum (and potentially in type 1 diabetes down the line). And brand new news on that front - there is a clinical trial underway specifically looking at the effects of oral semaglutide in adolescents with type 2 diabetes, PIONEER TEENS. This is a super-obvious example of a trial we’ve never heard about that we sure hope is using CGM to measure Time in Range and other obvious endpoints of interest.
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In big picture, we tuned into what one of our team characterized an enthralling talk by our fearless leader Ms. Kelly Close on how social media and the “Diabetes Online Community” can be leveraged to improve diabetes education, engagement, and empowerment. That is so kind! Kelly feels that tremendous power has gone to those researchers and clinicians alike who have developed real power online, whether it be those whose tweets can propel research, those that can lift institutions, or those that can influence government payers, just to name a few. We’ll be back soon with our social media list to know going into ADA shortly.
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Last, but not least, we’re bringing you our coverage of this year’s virtual Exhibit Hall. See below for our take on Abbott, AMF Medical, Capillary Bio, Convatec, Diabeloop, Indigo, Insulet, Medtronic, Menarini Diagnostics, Novo Nordisk, Panda Insight, Sanofi, Terumo, and Undermyfork.
That’s a wrap! After 26 scientific sessions, 15 oral presentations, and 20 industry symposia and workshops, ATTD 2021 came to a close Saturday afternoon. See our top highlights from the final day below – we’ll be back by the end of summer with more on the 580 abstracts (we’re already at work on the ADA abstracts, you know!)
- Diabetes Technology Highlights
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- 1. Using Dexcom G6 as a Diagnostic Tool for Diabetes Performs Comparably to Oral Glucose Tolerance Test
- 2. Glooko Real-World Data Shows Improvements in Glycemia Following Shelter-in-Place Orders During COVID-19 Pandemic for Both CGM and BGM Users; TIR from 62% to 63% for CGM Users
- 3. Time in Range (70 mg/dl – 140 mg/dl), Time >140 mg/dl, and A1c at 24 Weeks Gestation are Consistently Predictive of Suboptimal Pregnancy Outcomes in Women with Type 1
- 4. Joslin Diabetes Center Data Shows Older Adults (≥65 Years) More Likely to Use Phone Visits vs. Video Visits Compared to Younger Adults (40-64 Years)
- 5. DreaMed’s Advisor Pro Decision Support Software Shown to be Non-Inferior to Expert Provider Recommendations for T1s on MDI; Agreement Rate Between Advisor Pro and Expert Providers Higher Than Agreement Between Providers
- 6. Non-Inferiority of DreaMed’s Advisor Pro Insulin Dose Decision Support Software Compared to Expert Provider Advice in the Management of T2D on MDI; 60% Agreement Rate Between Advisor Pro and Expert Advice Compared to 51% Agreement Between Providers
- 7. FreeStyle Libre Detects 3x Hyperglycemic Events and 2x Hypoglycemic Events Compared to BGM in Patients with Diabetes Hospitalized with COVID-19 Pneumonia
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- Diabetes Therapy and Big Picture Highlights
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- 1. Dr. Jay Skyler’s 2021 Update on Type 1 Immunotherapies Spotlights Continued Lack of “Aggressive Combination Therapies,” Imatinib as the Latest Candidate to Only Show a Transient Benefit
- 2. Rybelsus Data Reinforces Oral GLP-1 Efficacy across Type 2 Diabetes Continuum; Potential for Oral GLP-1s in T1D Emerges During Q&A
- 3. Ms. Kelly Close on the Power of Social Media and Peer Support
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- Exhibit Hall
Diabetes Technology Highlights
1. Using Dexcom G6 as a Diagnostic Tool for Diabetes Performs Comparably to Oral Glucose Tolerance Test
In a very interesting presentation, Dr. Spencer Frank, algorithm engineer at Dexcom, presenting feasibility results using Dexcom G6 as a tool for diagnosing diabetes. Of course, the traditional method for diagnosing diabetes is the A1c test with varying thresholds defined as normoglycemia, prediabetes, and type 2 diabetes. However, Dr. Frank noted that oral glucose tolerance tests (OGTTs) are often used to diagnose diabetes, particularly gestational diabetes, and OGTT results do not always agree with A1c. By looking at both mean glucose and glycemic variability using CGM data, Dr. Frank hypothesized that an algorithm would be able to classify patients’ profiles as normoglycemia, prediabetes, or type 2 diabetes. Aggregated Dexcom CGM data was taken from several previous studies (n=716 total sensor sessions), fed to the classification algorithm, and compared against the A1c measurement.
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Overall, Dexcom CGM + the classifier algorithm performed similarly to oral glucose tolerance tests at diagnosing diabetes. Based on a single wear session (i.e., 10 days of data), the algorithm was able to diagnose diabetes with a sensitivity of 0.71 and specificity of 0.93. For reference, OGTT performs with a sensitivity and specificity of 0.77 and 0.99, respectively. The positive predictive value (i.e., the probability that someone diagnosed with diabetes actually has diabetes) was relatively low at 0.71; however, Dr. Frank believes this number can be improved by further algorithm enhancements. Importantly, the diagnostic algorithm performed well for those who clearly had or clearly did not have diabetes: sensitivity on patients with A1c ≥7% was 1 (i.e., the algorithm correctly identified all of the patients with A1c ≥7% as people with diabetes) and the specificity on patients with A1c <5.7% was 0.98 (i.e., the algorithm correctly identified 98% of patients with A1c <5.7% as normoglycemic).
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Use of Dexcom CGM as a diagnostic tool could fit nicely within Dexcom’s broader CGM initiatives. Over the past few years, Dexcom has made significant investments in penetrating the newer type 2 non-intensive market with Dexcom Hello, an expanded sales team, and significant ad spend all in the last year. In the future, it’s possible we could see broader populations (e.g., all pregnant women, people with CVD, etc.) get a CGM during their clinic visit. Presumably, this would help catch a significant number of people with undiagnosed diabetes or prediabetes earlier in the disease progression – and the value, of course, that would come from the additional education for patients and HCPs is massive, as is, of course, the energy that would come to both groups as well as the authority (also for both!)
2. Glooko Real-World Data Shows Improvements in Glycemia Following Shelter-in-Place Orders During COVID-19 Pandemic for Both CGM and BGM Users; TIR from 62% to 63% for CGM Users
On Saturday morning, Senior Data Scientist Sarine Babikian (Glooko) presented results form a large set of Glooko users in the US and Europe showing slight improvements in glycemia during the early part of the COVID-19 pandemic. The results presented by Dr. Babikian built on the data Glooko shared back in June 2020 via blog post. Dr. Babikian’s analysis included ~62,000 CGM users and ~130,000 BGM users across the US and Europe using Glooko. CGM users were much more likely to have type 1 diabetes (92% type 1s vs. 45%) and significantly younger (28 years vs. 64) compared to BGM users.
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Jan – mid-March 2020 |
mid-March – May 2020 |
US CGM users |
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Time in Range |
62% |
63% |
Mean glucose |
166 mg/dl |
165 mg/dl |
US BGM users |
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Mean glucose |
169 mg/dl |
168 mg/dl |
European CGM users |
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Time in Range |
82% |
83% |
Mean glucose |
162 mg/dl |
160 mg/dl |
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In general, Time in Range and mean glucose improved slightly following shelter-in-place orders. For CGM users in both the US and Europe, the Time in Range increase was ~1 percentage point (~15 minutes/day); for European users, Time in Range increased from a much higher baseline of 82% vs. 62%. Correspondingly, mean glucose declined by 1-2 mg/dl following shelter-in-place orders. While Time in Range was not available for BGM users, mean glucose declined by a similar 1 mg/dl, suggesting the glycemic improvements from the pandemic were similar.
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Looking at the data graphically, another trend is obvious: the weekly fluctuations in glycemia were flattened out during the early part of the pandemic. In particular, glucose control is typically best on Thursday of any given week – the chart below uses Time in Range as an example. Glucose control is typically worst on the weekends. From mid-March to May 2020, this day-to-day variability was largely flattened as traditional work-/school-week patterns were erased. Of course, the chart below also shows clearly that Time in Range was on average higher on any given day of the shelter-in-place than before.
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For US users with activity data, the average number of daily steps decreased from 2,300 to 1,300. This is a pretty drastic decline, though it matches well with data we saw from Evidation Health in early 2020.
3. Time in Range (70 mg/dl – 140 mg/dl), Time >140 mg/dl, and A1c at 24 Weeks Gestation are Consistently Predictive of Suboptimal Pregnancy Outcomes in Women with Type 1
Dr. Claire Meek (University of Cambridge) presented secondary analysis from the CONCEPTT trial that assessed the ability of various CGM metrics and biomarkers to predict neonatal outcomes in pregnant women with type 1 diabetes. As a reminder, CONCEPTT showed that using CGM in pregnant women with type 1 diabetes reduced A1c and improved both maternal and neonatal outcomes. In the study presented today, researchers used data from 157 pregnant women with type 1 from the CONCEPTT study to assess the ability of: (i) A1c, (ii) CGM metrics (i.e., mean glucose value, Time in Range (70 mg/dl-140 mg/d), time above range (>140 mg/dl), time below range (<70 mg/dl), coefficient of variation, and standard deviation), and (iii) alternative laboratory markers that measure glycemia over two weeks (i.e., glycated CD59, 1,5 anhydroglucitol, fructosamine, glycated albumin) to predict neonatal outcomes. Four pregnancy-related outcomes were assessed: preterm birth, large-for-gestational-age, neonatal hypoglycemia, and neonatal intensive care unit (NICU) admission. Overall, the study found that A1c, Time in Range (70 mg/dl – 140 mg/dl during pregnancy), and time above range (>140 mg/dl) were the “most consistently predictive” metrics and showed “good predictive ability” for many outcomes. Generally, alternative lab markers and other CGM metrics had a lower predictive value than did A1c, Time in Range, and time >140 mg/dl. However, glycated CD59 showed promising predictive power.
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Looking at the big picture (shown below), Time in Range was a better early predictor (12 and 24 weeks), while A1c was a better predictor at 34 weeks. At both 12 and 24 weeks, Time in Range, time above range, and mean glucose were the best metrics to predict preterm birth. A1c was only able to predict preterm birth with statistical significance at 24 weeks. Time in Range, time above range, standard deviation, and A1c were able to predict large-for-gestational-age as early as 12 weeks and saw even stronger associations when assessed at 24 and 34 weeks. NICU admission and neonatal hypoglycemia were best predicted at 24 weeks by mean glucose, Time in Range, time above range, glycated CD59, and A1c. At 34 weeks, A1c was a better predictor of neonatal hypoglycemia, preterm birth, and NICU admission than was Time in Range.
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It was terrific to see the always-fascinating pregnancy CGM data – without a doubt, we will see even more data on the use of CGM in pregnant women in the future. Certainly, to date, CONCEPTT pregnancy data is hard to beat. As background for recent impact, Closer Look readers watching pregnancy will remember that Health Canada temporarily authorized the use of Dexcom G6 in pregnant women with type 1, type 2, or gestational diabetes during the COVID-19 pandemic in July 2020. The European market now has several CGMs indicated for use in pregnancy (or at least, are not contraindicated against use in pregnancy): Dexcom G6, Abbott FreeStyle Libre, and Cascade Waveform, Agamatrix’s CGM that is making waves. As a reminder, this was approved for use in late 2019. For now, there are no CGMs indicated for pregnancy use in the US, but off-label usage is quite common. This is a tough one and a great example where there is data from the US but no FDA approval because the EU approval was easier to get – but, then, the people with diabetes in the US can’t get reimbursement – sigh.
4. Joslin Diabetes Center Data Shows Older Adults (≥65 Years) More Likely to Use Phone Visits vs. Video Visits Compared to Younger Adults (40-64 Years)
Dr. Elena Toschi (Joslin) presented results from a retrospective analysis of Joslin patients over the past couple years, in particular focusing on differences in telemedicine utilization by age. The data were all taken from adults with type 1 diabetes, broken into two groups: adults aged 40-64 years old and adults 65 years or older. At Joslin, between March 13 and mid-May 2020, all clinic visits were done via phone. Between mid-May and June 5, 2020, all clinic visits were done either via phone or video. After June 5, 2020, some in-person visits began to take place again. In total, Dr. Toschi’s analysis included clinic visit information from 3,585 patients from 2019 and 3,406 patients from 2020 – what a dataset!
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For both groups of adults, average number of visits per patient increased in 2020 compared to 2019. In 2019, essentially all of Joslin’s visits were conducted in person with both groups of adults averaging ~two visits per person. In 2020, the average number of visits per person rose to ~2.5 – while, of course, potential explanations for this could include the additional guidance and advice needed during the COVID-19 pandemic, that could easily also be ease of use of telemedicine and less downside coming from competing priorities. The 2.5 visits per person in 2020 broke down into ~1 in-person visit and ~1.5 telemedicine visits.
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On average, older adults were more likely to use phone-based visits over video-based visits. As shown in the charts below, when both options were available, ~30%-40% of older adults chose to have phone-based videos, compared to ~15% of the younger adults. Similarly, 35%-40% of older adults chose to have their visits over video, compared to 60% of younger adults. Presumably, the remainder chose to conduct their visits in-person. Not too surprisingly, we’ve heard multiple providers over the past year generally express a preference for conducting telemedicine visits over video; see here, for example, for more learning in an excellent “Beyond Telemedicine” Virta mid-pandemic webinar. Of course, multiple KOLs also point out that they want what works well for people with diabetes, some of whom don’t have good video access. That said, on the video “plus” side, in particular, the screen-sharing feature has been highlighted as being valuable for allowing patients and providers to review glucose or insulin data together. While that is possible, it goes on what we’ve begun calling our “diabetes SLUDGE list” in honor of Dr. Cass Sunstein, celebrated Harvard scholar and famous author of Pulitzer prizewinning book Nudge: Improving Decisions About Health, Wealth, and Happiness. Sludge is, according to Dr. Sunstein, “frictions – paperwork burdens or administrative obstacles – that hinder meeting the targets for the individuals …” What would you add to the SLUDGE list in diabetes? On this study, in the future, we’d love to see more analysis for the drivers of older adults’ preferences for phone-based visits – specifically, what is modifiable and what’s not. Finally, for both in-person and video-based visits, older adults had lower rates of missing appointments, with comparable levels between in-person and video-based (see graphic below).
5. DreaMed’s Advisor Pro Decision Support Software Shown to be Non-Inferior to Expert Provider Recommendations for T1s on MDI; Agreement Rate Between Advisor Pro and Expert Providers Higher Than Agreement Between Providers
Dr. Amir Tirosh (Sackler School of Medicine) presented data from a survey study of 20 international physicians indicating that the DreaMed Advisor Pro decision support system is non-inferior at giving insulin dosing advice to expert providers for patients with type 1 on MDI. As a reminder, Advisor Pro offers insulin dosing recommendations based on CGM or BGM data and requires sign-off from providers before patients are allowed to change dosing regimens to ensure providers remain involved in the insulin dosing process. A number of studies have investigated the non-inferiority of Advisor Pro’s recommendations for patients on pump therapy (most notably, the Advice4U study from ATTD 2020). Today, Dr. Tirosh presented new data on insulin dosing recommendations for case study patients on multiple daily injections. Specifically, DreaMed surveyed 20 providers with an average of over 15 years of experience treating people with type 1. DreaMed provided the physicians with anonymized data from 17 patients with type 1 on MDI who had an average age of 35, average Time in Range of 58%, and A1c of 7.4%. The vast majority of the case study patients were using CGM. Participants were asked to provide the insulin dose adjustment advice they would give to these patients. To analyze survey results, Dr. Tirosh’s group evaluated the “level of agreement/disagreement on the direction of insulin dose adjustments” and “the magnitude of change in insulin dose adjustments” both between providers and between providers and the Advisor Pro recommendations.
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Starting with direction of change, Advisor Pro agreed with providers on adjustments 67% of the time. For comparison, providers agreed with each other 62% of the time, demonstrating non-inferiority of the recommendations from Advisor Pro (p<0.001). Looking at disagreements, Advisor Pro disagreed with the direction of adjustment suggested by providers 19% of the time, equal to the 19% disagreement rate amongst providers themselves. Again, this result suggests non-inferiority of the Advisor Pro recommendations to those from expert providers (p=0.004).
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Looking at the magnitude of the suggested insulin dose adjustment, Advisor Pro was again non-inferior to expert advice, but recommended more conservative adjustments than did physicians. As Dr. Tirosh expressed, this is due to the built-in safety features of Advisor Pro that limit the size of recommended changes to roughly 20%-30% of established insulin doses. As decision support tools, including apps, closed loop systems, and smart insulin delivery devices, have become more common, some have said they would be interested to see data on how Advisor Pro may be able to mitigate clinical inertia compared to some of these other interventions. We agree, though of course coming to agreement on how one would standardize definition for inertia isn’t particularly straightforward – and that’s the first step, defining it! As well, we would like to see if any calculations have been done to identify which populations for whom provider-based decision support tools like Advisor Pro have the largest potential to improve glycemic control and outcomes. Sounds like an excellent project for our tech team, the authors of the Digital Diabetes Coaching competitive landscape to suss out before the final ATTD report comes back to you – expect a call, if you’ve got a lot of good experience here, or write to the team to let them know your thoughts! We’ll send a copy of Nudge, above, to the first and fifth of you to respond!
6. Non-Inferiority of DreaMed’s Advisor Pro Insulin Dose Decision Support Software Compared to Expert Provider Advice in the Management of T2D on MDI; 60% Agreement Rate Between Advisor Pro and Expert Advice Compared to 51% Agreement Between Providers
In the second of back-to-back DreaMed Advisor Pro presentations, Dr. Ofri Mosenzon (Hassadah Medical Center) showed data indicating non-inferiority of Advisor Pro insulin dosing recommendations to advice from expert providers for patients with type 2 diabetes on MDI. In this session, Dr. Mosenzon presented data from a survey of 16 physicians with an average of 18 years of experience treating patients with diabetes. While the majority of physicians came from endocrinology (n=13), DreaMed’s survey population also included two general medicine practitioners and one internal medicine physician. All physicians surveyed in the study were presented 15 case studies from patients with type 2 who had an average age of 63 and an average A1c of 7.5%. Additionally, patients had an average Time in Range of 65% and 83% of patients used CGM technology. Primary outcomes in this study were agreement or disagreement between expert provider and Advisor Pro generated insulin regimen adjustments assessed in terms of direction of dosing change for both basal and bolus insulin doses.
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Advisor Pro agreed with individual physician recommendations for basal dose adjustments 60% of the time. Similar to the data for type 1s, this is higher than the rate at which expert physicians agreed with each other (51%), demonstrating non-inferiority of Advisor Pro’s dosing recommendations (p<0.001). Rates of Advisor Pro vs. physician disagreement and physician vs. physician disagreement were similar at 26% and 27%, respectively. Turning to bolus insulin recommendations, Advisor Pro again saw a higher agreement rate with individual physician recommendations at 46% of the time, compared to physicians who agreed amongst themselves 43% of the time. Finally, while there was a slight increase in basal rate disagreement between Advisor Pro and expert recommendations, it was still non-inferior to provider-to-provider disagreement (, (34% vs. 33%; p<0.021). Given that this study was conducted with a population of providers well-versed in diabetes management, we are curious what the results would have looked like if DreaMed were to conduct a similar investigation among primary care providers where many individuals with type 2 receive the majority, if not all, of their diabetes-related care.
7. FreeStyle Libre Detects 3x Hyperglycemic Events and 2x Hypoglycemic Events Compared to BGM in Patients with Diabetes Hospitalized with COVID-19 Pneumonia
On Saturday morning, Italy’s Dr. David Brancato (Hospital of Partinico) presented the results of an observational, retrospective study that assessed the clinical utility of FreeStyle Libre for inpatients with COVID-19 pneumonia and diabetes (n=31; baseline A1c of 7.9%), prediabetes (n=11; baseline A1c of 6.1%), or incidental hyperglycemia (fasting glycemia > 125 mg/dl; n=9). All participants were treated with the steroid dexamethasone and underwent parallel glucose assessment via BGM (specifically MyStar Extra or Glucomen Areo 2K) and via FreeStyle Libre CGM. The study found that FreeStyle Libre detected three times more episodes of hyperglycemia and twice as many hypoglycemic events than did routine BGM assessments in patients with diabetes (14 vs. 4 episodes/day, p<0.0001; 3.4 vs. 1.7 episodes/day, p<0.0001, respectively). FreeStyle Libre also revealed many hyperglycemic and hypoglycemic events in patients with prediabetes and with incidental hyperglycemia (7.9 episodes/day and 3.7 episodes/day, respectively), suggesting that these patients should receive similar routine management to those with diabetes and that it is important to assess for incidental hyperglycemia in patients with COVID-19 pneumonia. With CGM, episodes of hyperglycemia were defined as >15 minutes >180 mg/dl and episodes of hypoglycemia were defined as >15 minutes <70 mg/dl.
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Patients with diabetes and COVID-19 pneumonia had a Time in Range of 58% and spent 22% of time >180 mg/dl and 3.2% of time <70 mg/dl. Notably, participants with diabetes spent 15% of time >250 mg/dl, which is significantly higher than the consensus goal for <5% of time >250 mg/dl. It’s worth noting that this is a group of patients who had reasonably low A1c values at baseline (mean 7.9%), and yet they were still spending a significant amount of time in severe hyperglycemia while hospitalized with COVID-19 pneumonia. Patients with prediabetes or incidental hyperglycemia had an average Time in Range of 79% and spent only 14% of time >180 mg/dl and 1.5% of time <70 mg/dl.
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The study found that there were high levels of variability in the mean glucose value throughout a 24-hour period among both patients with diabetes and patients with prediabetes/incidental hyperglycemia. Among patients with diabetes, mean glucose values were significantly above target throughout the day during five intervals (hours 03-08, 08-12, 12-18, 18-22, and 22-02) with a majority of participants with diabetes having a mean glucose above the goal between 8 am and 10 pm. Per Dr. Brancato, this study “is the first study to show such a pattern in COVID-19 disease.”
Diabetes Therapy and Big Picture Highlights
1. Dr. Jay Skyler’s 2021 Update on Type 1 Immunotherapies Spotlights Continued Lack of “Aggressive Combination Therapies,” Imatinib as the Latest Candidate to Only Show a Transient Benefit
In typical ATTD fashion, this year’s final plenary session was dedicated to type 1 diabetes cures, or as ATTD co-chair Dr. Tadej Batellino aptly put it, “what we really dream about” in the diabetes community. As at last year’s ATTD, Dr. Jay Skyler (University of Miami) gave the closing talk of the symposium, presenting on the latest in immunotherapies. While much of Dr. Skyler’s review echoed similar themes from last year, we picked up on two key advancements:
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First, growing support for teplizumab as the first drug shown to delay the onset of type 1 diabetes. As a reminder, original data presented at ADA 2019 showed a median two-year delay to time of diagnosis, and follow-up data presented at ADA 2020 showed an extended delay of up to three years. Dr. Skyler emphasized efficacy differences between teplizumab subgroups (greater likelihood of response from individuals who are ZnT8 negative, absent of HLA-DR3, or present of HLA-DR4), which he believes may be useful for stratifying patients in the future. While not mentioned in Saturday’s talk, we note that teplizumab is currently under FDA review after a positive AdComm vote in May 2021.
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Second, Dr. Skyler highlighted new (currently in press at Lancet Diabetes & Endocrinology) follow-up data on imatinib (tyrosine kinase receptor inhibitor) in adults recently diagnosed with type 1 diabetes – a compound that has flown relatively under the radar since its original data readout at ADA 2017. New follow-up data shows that although imatinib conferred benefits on C-peptide and beta cell glucose sensitivity during the six months of treatment, these differences were eliminated by two years’ time.
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Imatinib is the latest example that supports Dr. Skyler’s theory that short-term treatments may not be able to deliver the long-term benefits sought after in type 1 diabetes (low-dose ATG, anti-TNF, and anti-IL-21 and liraglutide being a few other examples). In the case of anti-TNF alpha, Dr. Skyler pointed out that patients with rheumatoid arthritis use the drug for “years and years,” and people with type 1 diabetes may need to do the same. As such, Dr. Skyler continues to support an “aggressive combination therapy” delivered over a longer period of time; Dr. Skyler himself has long been working to initiate the Diabetes Islet Preservation Immune Treatment Trial (DIPIT), designed to apply long-term anti-TNF, deliver immunomodulation via ATG or anti-CD3, and preserve beta cell health with a GLP-1. Unfortunately, companies have not been willing to supply anti-TNF or the IL-2 drugs – airing concerns that other drugs will be used alongside their drugs (“My drug is going to get blamed if something goes wrong”). Back at EASD 2018, Dr. Skyler stated that it has been “very difficult” to navigate this, and we commend his longstanding commitment to this important trial. According to ClinicalTrials.gov, the trial is now set to initiate in December 2021 (pushed from December 2018), with a primary completion date of June 2024 (pushed from January 2020).
2. Rybelsus Data Reinforces Oral GLP-1 Efficacy across Type 2 Diabetes Continuum; Potential for Oral GLP-1s in T1D Emerges During Q&A
A star-studded Novo Nordisk symposium explored the reasons why oral formulations of GLP-1, like first-to-market Rybelsus (oral semaglutide), may benefit a diverse population of people with type 2 diabetes. To start, symposium moderator Dr. Richard Pratley explained the medical rationale for oral semaglutide and reviewed glycemic (-1.0 to 1.4% at the 14 mg dose) and weight loss data (-3.4 to 4.4 kg at the 14 mg dose) from the phase 3 PIONEER program. While the benefits of oral semaglutide do not differ substantially from injectable formulations, Dr. Pratley emphasized that its oral formulation may lead to initiation of GLP-1 treatment earlier in the continuum of the disease and may improve acceptance and adherence for some patients, who would prefer to avoid injectables. Notably, Dr. Pratley also emphasized that oral semaglutide is an “easy medication for primary care providers to prescribe” – a theme that came up throughout today’s session.
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Dr. Alice Cheng (University of Toronto) took to the virtual stage to discuss early initiation of an oral GLP-1. To do so, Dr. Cheng used the case example of “James,” a 42-year-old male recently diagnosed with type 2 diabetes; James is currently treated with metformin, but his A1c continues to be above target. Using the ADA’s 2021 guidelines for glucose-lowering medications in type 2 diabetes, Dr. Cheng shared that there indeed would be support for James to initiate an oral GLP-1. For patients without established ASCVD, CKD, HF, or risk factors (who would strongly be recommended to initiate a GLP-1 or SGLT-2 inhibitor), the ADA recommends using individualized goals to reach the patient’s target A1c. GLP-1s are recommended both for patients who (i) need to minimize hypoglycemia; or (ii) need to minimize weight gain/promote weight loss. Compared to other potential options like SGLT-2 inhibitors and DPP-4 inhibitors, data from PIONEER 2 showed that oral semaglutide had a greater benefit on A1c vs. empagliflozin (comparable weight loss), and data from PIONEER 3 showed that oral semaglutide had stronger A1c declines and weight loss vs. sitagliptin. As such, Dr. Cheng would strongly consider an oral GLP-1 for James due to its variety of metabolic benefits at his stage in the disease continuum.
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Next, Dr. Esteban Jódar Gimeno (Universitary Hospital Quironsalud Madrid) presented applications of oral GLP-1 at the other end of the diabetes progression spectrum, using the case study of “Alice,” a 65-year-old woman who has had type 2 diabetes for 18 years; Alice is currently treated with metformin and insulin, has experienced two hypoglycemic episodes in the last month, and her A1c has gradually increased over the past year to 9.5%. In order to determine whether oral semaglutide would be a viable next step for Alice, Dr. Gimeno presented data from PIONEER 8, which examined the drug as an add-on to insulin. At both 26 and 52 weeks of treatment, oral semaglutide conferred statistically significant improvements to A1c and body weight vs. placebo. Importantly, these benefits were seen without an increase in hypoglycemia, a key concern for this patient population. Furthermore, across all PIONEER program trials, no interaction was seen between A1c benefits and either duration of diabetes or baseline age. Therefore, Dr. Gimeno believes oral semaglutide would be a “good option” for Alice due to its aforementioned metabolic benefits, CV safety as proven by PIONEER 6, and low risk of hypoglycemia.
Select Q&A
Dr. Pratley: From the audience, Dr. Cheng, what are your thoughts on using oral semaglutide in adolescents?
Dr. Cheng: It’s an interesting prospect because we know the benefits of GLP-1 RAs from a weight perspective as well, not just the metabolic effects on A1c. There is a clinical trial underway specifically looking at the effects of oral semaglutide in adolescents with type 2 diabetes [PIONEER TEEN], so I look forward to the results from an efficacy and safety perspective as well in that group. In that group, I think oral medications may be more acceptable than a once-weekly injection, but again, I think patient preference is something that needs to be discussed.
Dr. Pratley: We have seen efficacy of GLP-1 RAs in adolescents with type 2 diabetes, for example with liraglutide. I expect the efficacy with oral semaglutide would be very similar to what we see in adults, but of course, we need to wait for the trial and updated label for use in this population.
Dr. Pratley: Also from the audience, are there any studies of oral semaglutide in patients with type 1 diabetes? There is no study in patients with type 1 diabetes. A related question, however, is “could this be used in patients with adult-onset autoimmune diabetes?” That’s maybe not the same more aggressive type of diabetes we see in kids, but one where we’re more likely to see preservation of C-peptide. This is total speculation, but Dr. Gimeno, what are your thoughts?
Dr. Gimeno: In fact, we have some evidence of when the GLP-1 RAs could be used in this population, and they are safe and efficacious. This is very exciting to think about the potential benefit in maintaining and even increasing the beta cell mass, but, in fact, we need trials. We are talking about something similar to people with type 1 diabetes, and we know the GLP-1 RAs have some benefits in that population, with very minor decreases in hemoglobin but important weight benefits and some kind of stabilization of blood glucose metrics. I think this should be highlighted because, due to intensive therapy, we have ~1/3 of the type 1 population with obesity. Probably, this benefit on body weight would be interesting.
Dr. Pratley: Your latter point is very important. In the US, 60% of adults with type 1 diabetes are either overweight or have obesity. They struggle with it as much as my patients with type 2 diabetes. We did a literature review that showed there is no trial or evidence of weight loss medications, or even diets, to help people with type 1 diabetes manage their weight, so I think it’s really an interesting idea about the use of that medication in patients with auto-immune diabetes, but of course, we need more trials.
Dr. Pratley: To summarize, in the type 2 population, which patient segment do you think is ideal for oral semaglutide? And are there any segments in which you wouldn’t use oral semaglutide?
Dr. Cheng: I see a role for it throughout the journey of someone living with type 2 – from the beginning right through to the end, perhaps for different reasons, but I do see the value. In terms of who not to use it in, if I have patients who have frailty, who are struggling to maintain weight or eat properly, or their appetite is already suppressed for other reasons, that is a group where I might shy away from a GLP-1 RA.
3. Ms. Kelly Close on the Power of Social Media and Peer Support
In her talk on the utility of social media and the diabetes online community (DOC), Ms. Kelly Close (The diaTribe Foundation) encouraged members of the audience who are researchers or clinicians to become more involved in social media to either learn more about research or spread the word about their own or to help support others – giving “social media” prescriptions is definitely gaining in popularity and we like the idea of this, especially as it might encourage those could themselves benefit who are HCPs or researchers to try it! Click here for a link to download Kelly's slides.
Specifically, as we understand it, the DOC can simultaneously educate, engage, and empower people with diabetes to actively participate in their healthcare. HCPs are also integral to the DOC, both in publishing reputable information and resources for patients and directing patients to safe communities and platforms. For HCPs who do not want to post, consistently browsing diabetes channels on social media sites like Twitter and Facebook can provide necessary insight to patients’ thoughts and actions to improve care delivery – it can also teach them a lot about diabetes if they are following colleagues like Dr. Dan Drucker or Dr. Diana Isaacs or Ms. Hope Warshaw or Ms. Natalie Belleni or Ms. Cherise Shockley or Mr. Mike Warshaw and the list goes on and on and on! There was lots of encouragement for the audience to cover organizations like Diabetes UK and ADA and Beyond Type 1 and others. And, notably, this has been studied and there is good support for it! We’d love to see this in Standards of Care and will be asking what sort of study would have to happen for this! In fact, an impressive 2019 study by Litchman et al. found that for every one-point increase on a five-point DOC engagement scale, there was a 34% reduced chance of having A1c above 7%. DOC platforms are relatively widely used – data from diabetes market research organization dQ&A also showed that 38% of people with T1D and T2D were active online. However, Close also emphasized when utilizing social media, it is important to retain patient privacy and act ethically when posting or interacting with DOC members. Still, the majority of people with diabetes look to HCPs as their primary sources of information according to data from dQ&A. According to Ms. Close, social media is a complement to face-to-face HCP-patient interaction, with patients spending more time online than in clinic, and an opportunity to lead with curated sources of factual information and support from different people’s personal stories.
Exhibit Hall
Diabetes Technology
Abbott
Abbott’s booth at ATTD proudly proclaims “Welcome to the Futur3” in gold, highlighting the company’s new FreeStyle Libre 3 real-time CGM launched in Europe in a few countries at the end of 1Q21. That system is smaller and thinner than the first two FreeStyle Libre systems and, in a first for Abbott, sends glucose data in real-time via Bluetooth to a phone/reader without the need for scanning. Outside of the products, we were very excited to see an excellent brochure on how to use Time in Range and CGM-derived metrics. In particular, the brochure states, “HbA1c is the key tool for assessing risk for diabetes complications” and “TIR, derived from continuous glucose monitoring (CGM) data, complements HbA1c and provides more actionable information than HbA1c alone.” The brochure also provides a valuable graphic of the consensus targets for CGM metrics and notes that every 5% increase in TIR is clinically significant and that a 10% increase in TIR roughly corresponds to a 0.8% decrease in A1c.
AMF Medical
AMF Medical’s booth places its Sigi patch pump (currently in development) front and center. A cool 60-second video (available here). Sigi’s patch pump consists of three pieces: (i) a disposable adhesive pad and flexible cannula that patients can wear for three days “or longer”; (ii) a rechargeable pump that will last for “years” and snaps into the on-skin pad; and (iii) a disposable “easy-lock” cap to seal in compatible prefilled insulin cartridges. To our knowledge, Sigi is smaller and thinner than Insulet’s Omnipod, EOFlow’s EOPatch, and Roche’s Accu-Chek Solo “micropump,” the three patch pumps available in Europe; Sigi will also be compatible with pre-filled insulin cartridges, making the re-fill process easier. AMF’s booth included a poster with results from a small, human factors study on the Sigi pump performed at Lausanne University Hospital in Switzerland (n=15 type 1s). In general, Sigi was preferred by users: all users preferred Sigi over Roche’s Accu-Check Solo and most preferred the design and ergonomics of Sigi over Insulet’s Omnipod. Three-quarters of the participants also favored Sigi over tubed pumps. Finally, 69% of participants shared “high willingness” to adopt the Sigi pump. We last heard that FDA and CE submissions are currently slated for late 2023/early 2024 with ramped commercial rollouts in 2024 and 2025.
Biocorp
Biocorp’s colorful booth welcomed attendees in with a an uplifting 30-second video with the tag-line “ready to live” advertising the company’s Mallya smart cap for disposable insulin pens. Biocorp’s booth also included a 90-second video challenging people with diabetes to “upgrade your life” highlighting the data sharing capabilities of the Mallya smart cap that allow providers and loved ones to stay up to date with a patient’s insulin dosing patterns and behaviors. This was great to see. Directly ahead of ATTD 2021, we caught an hour-long Biocorp webinar on Mallya that launched late last year in Romania and that Roche is working to bring to the French market. In the webinar, Biocorp CEO Eric Dessertenne discussed the development of Mallya and the rationale behind targeting the disposable insulin pen market, which according to Mr. Dessertenne makes up 90% of the total insulin pen market today – no doubt this was discussed to quell or dissuade negative opinions about the harmful environmental impact of diabetes garbage, which is (or at least seems) endless. Biocorp’s Mallya webinar also emphasized a number of the company’s partnerships to advance smart insulin delivery technology including integration with Diabeloop to bring an adapted AID algorithm to the Mallya smart cap. We are curious if this project will also include a Dexcom partnership for Mallya as G6 is integrated with Diabeloop’s current AID algorithms. Additionally, Amalgam is working to integrate its iSage insulin dosing support app with the Mallya smart cap, which when also used with an iSage connected BGM can give patients a closed data loop with a single app-based interface with all of their diabetes treatment information.
Brighter
Brighter’s virtual booth focused on the company’s “Actiste” product – “a combined product and service that includes a lancet, blood glucose meter, and insulin pen in a single device.” According to Brighter’s materials, Actiste is CE-marked, and tracks the time and volume of insulin doses. Actiste also connects to a companion app that is CE-marked, stores all insulin dosing and BGM data, and allows users to tag meals, workouts and other events likely to impact glycemic control. Though not currently available, Brighter is working to add a function supporting downloadable reports that users can share with their providers. Additionally, via Actiste, patients get their lancets and test strips automatically resupplied and Actiste’s integrated design combining lancets, BGM, and insulin delivery, can reduce the number of diabetes devices patients need to carry. Actistse certainly has an interesting design, and is the first device in some time to try to combine glucose monitoring and insulin delivery intro a single handheld system (we’re going to check our file – we believe that one of the majors still in the field tried this back in the day).
CamDiab
CamDiab certainly got a lot of attention at this year’s ATTD with a number of data read-outs and presentations, but its virtual booth was on the slightly smaller side. Links in the booth brought attendees to the CamDiab website highlighting user reviews of the CamAPS FX system which is available in a limited number of clinics in the UK. CamDiab also included a short animated video introducing attendees to the CamAPS FX system including its unique boost and ease off functions allowing for higher and lower insulin dosing respectively to meet patients’ activity and behavioral needs. CamDiab’s booth also featured a 10-minute training video for providers interested in using the CamAPS FX system in their practices that also walked through CamDiab’s online traning portal that has been used by providers and patients throughout the pandemic.
Capillary Bio
Capillary Biomedical’s booth provides links directing users to check out the company’s SteadiFlow technology, scientific presentations, and its flagship product, the SteadiSet infusion set with SteadiFlow technology. Capillary Bio’s website calls infusion sets “the weakest link” in pump therapy and estimates that as many as 25% of current infusion sets fail prior to the end of their third day. With its SteadiSet infusion set, CapBio is targeting seven-day wear with reduced kinking. In October, the company received $1.5 million in funding from HCT to help support three trials to confirm SteadiSet’s reliability and consistency out to 7-14 days.
Convatec
Convatec had a highly interactive booth that featured several videos and descriptions of Convatec products in a round virtual space. The booth offers a short video of the production facility for Convatec’s infusion sets, a two-minute video celebrating the 100-year anniversary of the discovery of insulin, a short video of Jack, a professional sailor with diabetes, on his experience with problem-shooting insulin pump and infusion set issues. The booth also features descriptions of the company’s inset 30 infusion set that has an integrated insertion device and its Mio Advance all-in-one infusion set that has an integrated one-touch inserter and automatic retracting needle that is sold exclusively under Medtronic’s name and trademark and launched in the US last July. As a reminder, the inset 30 infusion set is marketed by Medtronic as Mio 30 and by Tandem as AutoSoft 30. The booth also includes a description of i-port Advance injection port for MDI, which is trademarked by Medtronic.
Diabeloop
Diabeloop’s booth offered a plethora of information on the company’s AID algorithms and included an instructive 13-minute video on the DBLG1 system and how the system can be personalized to each patient’s needs. As a reminder, Diabeloop’s DBLG1 algorithm launched in March as part of an AID system with Roche’s Accu-Chek Insight insulin pump and Dexcom G6. The Diabeloop/Roche/Dexcom system is currently available in Germany, Spain, Italy, Switzerland and the Netherlands. The Diabeloop/Kaleido pump/Dexcom G6 AID system is still in “pre-launch” in France. Diabeloop’s ATTD booth focused on the DBGL1 and DBL-hu systems’ personalization to users’ needs and preferences. The booth also takes you to a website on the DBLG1 AID algorithm, as well as the system’s key features. As a reminder, the DBLG1 is a smartphone-based algorithm that: (i) requires only four parameters at set up (weight, total daily dose, meal ratios, and safety basal rate profile); (ii) allows for adjust of target, aggressiveness, hypoglycemia and hyperglycemia thresholds; (iii) offers “intuitive” food and exercise logging, physical activity settings (light, moderate, intense), and “Zen Mode” allows users to temporarily increase their target glucose value to reduce the aggressiveness of the algorithm; and (iv) connects to web platform for data sharing with caregivers and providers. The DBL-hu system is targeted to those with highly unstable diabetes and requires a closer relationship between the user, their provider, and Diabeloop.
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Within the 13-minute video, Diabeloop shared real-world data on its DBLG1 algorithm. Compared to baseline, 25 type 1s saw a 0.8% A1c reduction to 7.1% (p<0.001) and increased their Time in Range by +4 hours/day to 69.7% six months after initiation. The full study was published in Diabetes Care in March 2021 and can be found here. The video also showcases data from the randomized crossover trial (n=7) that supported DBL-hu’s CE-Mark in December, which showed that compared to a predictive-low-glucose-suspend system, DBL-hu increased Time in Range by a massive +7.2 hours/day to 73% at sixteen weeks.
Dexcom
Dexcom’s green virtual booth once again featured the company’s Super Bowl ad with Nick Jonas highlighting the technological advances we’ve seen over the last few decades including with CGM technologies. Dexcom’s booth also included a 90-second video introducing attendees to Hello Dexcom, the company’s free sample program that helps providers offer their patients a one-time trial of Dexcom G6 at no-cost. Dexcom also dedicated space in their booth to their numerous partnerships including Diabeloop’s DBLG1 algorithm and automated insulin delivery system and Ypsomed’s myLife Loop Program which aims to integrate the company’s YpsoPump with Dexcom CGMs and an AID algorithm to create a “mylife Loop.” Our understanding is that Ypsomed is continuing to work on its pump and AID offerings and plans to bring an AID system to market with Dexcom CGM in “mid-2023.” During Ypsomed’s FY21 update, we also learned that the company is working with Dexcom on a new study to take place in the UK starting in the “late fall” of 2021, assessing a different AID system combining Dexcom G6, YpsoPump, anad a TypeZero algorithm in an attempt to bring automated insulin delivery to YpsoPump users ahead of the mylife Loop system.
Indigo
Belgium-based “invisible CGM” company Indigo Diabetes made its appearance on the second floor of ATTD’s virtual Exhibit Hall. The centerpiece of the booth is a short video highlighting the challenges of and stigmas associated with fingersticks. As a solution, Indigo’s CGM is a two-year implantable that measures ketones in addition to glucose. The device is truly invisible, as the device does not require any on-body component. (This is in contrast to Senseonics’ implantable Eversense CGM which still requires an on-body transmitter.) Most recently, we heard that Indigo initiated its first clinical study in March. Regulatory approval is targeted for sometime in 2023.
Insulet
Insulet’s orange and white booth prominently displayed the Omnipod and Omnipod DASH technology and focused on the two patch pumps’ features. The highlight of the booth was a two-minute video on Omnipod DASH that spotlighted the patch pump’s simple, discreet, tubeless, and waterproof design with a cannula that is not visible and “barely” felt. Insulet argues that with Omnipod DASH, users don’t have to make “wardrobe compromises” or deal with tubing and daily injections and can run, swim, play, and “enjoy life” while wearing the pump. The rest of the interactive elements send you to this site, which offers healthcare providers additional information on the Omnipod and Omnipod DASH systems. Earlier this week at ATTD, we saw impressive real-world data from 2,416 adult and 1,020 pediatric Omnipod DASH users, showing a 0.9% improvement in adult participants’ A1c and a 0.8% A1c improvement among pediatric patients in the first 90 days of use.
Medtronic
Medtronic’s expansive booth covers the company’s wide portfolio of products, which now includes a smart pen solution in InPen. Notably, InPen received CE-Marking just last week and is slated for launch in Europe in the fall. MiniMed 780G is the first product highlighted at the booth. It was a busy conference for MiniMed 780G, particularly on day 1 when we saw very strong real-world data from the first ~4,000 users of MiniMed 780G. With the recently CE-Marked no fingersticks Guardian 4 CGM and the recently launched seven-day Extended-Wear Infusion Set, Medtronic made sure visitors knew that a “no fingersticks & one infusion set change per week” would become available this “late summer.” A short video on MiniMed 780G advertises the system as helping users “focus on life, not glucose levels.” Another video on Medtronic’s “Smart MDI System,” highlights the combination of the connected InPen, Guardian 4 CGM, and the InPen app.
Menarini Diagnostics
Menarini Diagnostics’ booth focused entirely on its CGM: GlucoMen Day CGM, which is powered by WaveForm (described in this video). From what we understand, GlucoMen Day CGM is A. Menarini’s name for WaveForm’s Cascade CGM, which was CE-Marked in November 2019. The CGM is approved for abdomen wear for ages 6+, for pregnant women, and for those in dialysis. It sends minute-by-minute data directly to a mobile app (iOS, Android) via Bluetooth, can be worn for 14 days, offers customizable alerts (low/high threshold, rapidly changing glucose, 15-minute low/high predictor), and has a needle-free insertion design. One of the central drawbacks of the product is that it requires 1 calibration/day after day 1 (2 calibrations are required at startup, as well as a 55-minute warmup period), although the system is approved for nonadjunctive use. The video emphasized GlucoMen Day CGM’s environmental friendliness; all parts are reusable other than the sensor itself, and the transmitter and insertion device can both be used for up to five years. The booth also includes a brochure explaining GlucoMen Day CGM. Based on the brochure, GlucoMen Day’s performance “similar” to those on the market with a MARD of 9.9% ranging from 8.9% on Day 4 to 10.6%-10.7% on Days 10-14. There is also information on the GlucoMen areo 2K BGM, which has high sensitivity to hypoglycemia and transmits data via NFC to the associated app while also displaying data on the BGM’s screen. The sensor can also be used to assess for ketonemia and hematocrit compensation.
Panda Insight
The booth of Panda Insight, a Germany-based platform company, featured its diabetes app PanDia. PanDia allows people with diabetes to see how stress – as well as activity, nutrition and sleep – affects their Time in Range and supports people with diabetes in reducing their stress in order to improve their Time in Range via personalized feedback and action steps. The app integrates data from wearable devices and psychological surveys, but apparently can work without data from external devices. On the app, users can see their glycemic and cardiovascular data, as well as their “Stress Score” (a measure of how well they are coping with stress), their “Recovery Score” (a measure of how relaxed they are in the moment), and a “Resilience Score” (a measure of how well their body copes with strain in general). Per CEO Tatjana Weiss, at Panda Insight, “we believe that stress is the missing link for more Time in Range.” We appreciate the idea of accounting for the impact of stress on Time in Range and look forward to see in more detail what might enable this; certainly, we’d love to see data on whether the app is effective and useful for patients soon.
Roche
Integration and digital health continue to take center stage at the Roche booth with a short 2 and a half minute long video on Roche’s strategy of integrated Personalised Diabetes Management (iPDM) with the tag-line “united we manage diabetes better.” The video highlighted four new additions to Roche’s integrated/digital offerings including the launch of the RocheDiabetes RemoteCare solution “enabling healthcare professionals to monitor patients outside of conventional care settings,” the successful integration of Novo Nordisk’s recently launched NovoPen 6 and NovoPen Echo Plus smart insulin pens into the mySugr Logbook. Additionally, Roche highlighted two exciting updates for its insulin delivery offerings with smartphone control for its Accu-Chek Insight insulin pump from the mySugr app. Notably, Roche is the first company to offer smartphone based control for its insulin pump which both Tandem and Insulet have been working toward on the US front. Finally, Roche provided 3 colorful information sheets on its recently launched AID system in partnership with Dexcom and Diabeloop. For this system, users combine Roche’s Accu-Chek Insight insulin pump with a Dexcom G6 CGM and the Diabeloop DBLG1 hybrid closed loop algorithm on a locked down controller. With these most recent updates, Accu-Chek Insight users now have three ways to use their insulin pumps in either “loop mode,” “app-power,” or “classic mode” as Roche is calling them. While Roche’s share of the insulin pump market has continued to decline in recent quarters, being the first to offer smart phone control as well as an AID system may help boost the company’s declining market share and help get these strong products to more patients.
Tandem
Tandem’s booth was on the smaller side at ATTD this year, but it still packed a punch of information! Most notably, Tandem’s booth included a 1-minute video full of patient testimonies on the “life changing” effects of Control-IQ. We really loved how Tandem’s video focused on the online diabetes community where we know so many people have turned for support, advice, and friendship. For those less familiar with Control-IQ, Tandem’s booth included a 4-minute video on how the system works highlighting automatic correction boluses plus step-by-step tutorials for using both Sleep Mode and Exercise Mode. As a reminder, Sleep Mode allows users to tighten their glycemic control overnight while Exercise Mode allows users to target a range of 140-160 mg/dl. For the providers in attendance at this year’s ATTD, Tandem also included a link to a step-by-step infographic on downloading and reading a Diasend report which has only become more important with transitions to remote monitoring during the COVID-19 pandemic.
Terumo
Terumo’s booth proudly announces the company’s 100th anniversary year, a year that coincides with the 100th anniversary of the discovery of insulin. Terumo’s presence in the diabetes world is almost exclusively in Japan, where the company is based; however, Terumo does have a fairly broad portfolio of products in diabetes. The Terumo booth highlights Terumo’s pen needles, BGM, and new MediSafe With patch pump. Additionally, Terumo is Dexcom’s exclusive CGM distributor in Japan. An interesting brochure is targeted towards digital health companies looking for a connected BGM partner. Terumo’s BGM looks quite lightweight and compact with a design that “does not look like a medical device.”
Undermyfork
“Diabetes food diary” Undermyfork used its booth to feature its new Undermyfork Care provider platform, which was announced at DTM 2020 in November and launched in February. At the booth, a six-minute video describes the Undermyfork app (iOS; Android) and the Undermyfork Care provider platform. As a reminder, the Undermyfork app pairs CGM data with automated food-logging data to help users identify meals that help keep them in range and foods that tend to drive them out of range. The app can semi-automatically tag foods by suggesting tags to users based on image recognition (e.g., brown rice, yogurt, toast, etc.). Retrospectively, patients’ meals are automatically color-coded based on the two-hour post-prandial Time in Range: green for 75% - 100%, amber for 40% - 75%, and red for 0% - 40%. The Android version of the app launched in February. The last update we received was in February, and we’re trying to reach Undermyfork directly to learn what the current app userbase is.
As was described in the booth’s video, Undermyfork Care is the company’s provider-facing web-based platform that launched in February and allows providers to view their patients’ meal, insulin, and CGM data all in one place. As with the app, providers can filter a patient’s data by time period, by post-prandial Time in Range (green, amber, and red), and by meal tags. Providers can also view patient’s data as a daily or monthly report that shows their CGM data, as well any added meals or insulin doses. In one particularly cool feature, the “Monthly View” screen highlights days with hypoglycemic events with an H symbol, allowing patients and providers to quickly hone in on days and meals with downward glycemic excursions. Providers get access to a patient’s data once a patient shares their link, and the data automatically syncs between the patient’s Undermyfork app and the Undermyfork Care platform in real-time. Undermyfork is an A+ app from our view – Kelly’s been using it for some time and we first heard about it from Close Concerns alum Adam Brown back in 2019.
Diabetes Therapy
Novo Nordisk
A two-minute animated video on Novo Nordisk’s neatly organized virtual booth revealed that the company is in the midst of developing the “first ever regulated app that simplifies insulin initiation and helps people with diabetes remember and adjust, or titrate, their insulin dose.” The video focused on a person newly diagnosed with type 2 diabetes and his struggles starting a “new and unwelcome routine.” According to the video, as many of such patients are started on an initial insulin dose but not always (or even often) properly up-titrated, Novo Nordisk’s upcoming app will help solve this issue and prevent the “long-term health complications” associated with inadequate dosing. Novo Nordisk’s app, which the video refers to as “software on prescription,” will give patients daily guidance to stay at the same dose or increase/decrease by two units until a fasting blood glucose target is reached. We’ll be curious to see if the upcoming app is related to “DoseCheck,” Novo Nordisk’s previous basal insulin titration app launched in Brazil in June 2019. While timeline details were not shared, the video noted that the app would be “coming soon.” Other banners at the booth highlighted Novo Nordisk’s connected pens NovoPen 6 and Echo Plus, recently launched in Sweden and Denmark, and the pens’ compatibility with digital solutions from Abbott, Dexcom, Glooko, Medtronic, and Roche. Conference goers were also given the option to speak to Novo Nordisk personnel using a “Contact Us” feature.
Sanofi
Sanofi brought its A game to ATTD this year, offering an expansive virtual exhibit hall. At “Hear from Experts,” conference attendees could listen to various KOLs speak on topics ranging from integrated care with Dr. David Kerr (Sansum Diabetes Institute) to the value of Time in Range with Dr. Richard Bergenstal (University of Minnesota) to real-world safety and effectiveness of Toujeo with Dr. Niaz Khan (Imperial College London). This was incredibly valuable! Another area of the Medical Area was dedicated to a celebration of the past 100 years of insulin; there, Dr. Kerr discussed the next decade of innovations in the insulin field, highlighting the “curation of a connected ecosystem” that links wearable devices and delivery systems as the most meaningful upcoming advancement. A third section entitled “Explore Our Commitment to Diabetes” showcased a variety of recent advertisements from Sanofi. In one, the UK’s “first boxer with type 1 diabetes” Muhammad Ali spoke about how technology has significantly improved his diabetes management. Another video, directed toward Taiwanese HCPs, showcased Sanofi, Health2Sync, and Biocorp’s “Connected Ecosystem,” only available in Taiwan; in the latter, a woman used Biocorp’s Mallya smart pen attachment to dose her insulin, Health2Sync’s food diary to track her meal, and discussed the automatically uploaded data with her HCP. We particularly appreciated Sanofi’s multiple options for audience goers to interact with Sanofi medical staff and each other, via interactive talks and medical team Q&A. Most of the exhibit hall was dedicated to technology on some front, signalling an overall focus (albeit, somewhat expected at a tech-oriented conference) on drug delivery, rather than on Lantus, Toujeo, or Soliqua.
--by Hanna Gutow, Katie Mahoney, Ursula Biba, Rhea Teng, Albert Cai, and Kelly Close