Tenth Annual Clinical Diabetes Technology Meeting (CDTM 2014)

April 4-5, 2014; Los Angeles, CA; Full Report – Draft

Executive Highlights

The Tenth Annual Diabetes Technology Society Clinical Diabetes Technology Meeting (CDTM) was held in Los Angeles this past weekend. This was just the second year that the conference granted attendees the opportunity to receive a Certified Diabetes Technology Clinician (CDTC) credential, and (as with last year) the vast majority of attendees chose to sit for the final exam. There were around 75 registered attendees, down from the sold-out crowd of ~180 attendees last year in Atlanta, GA (higher than usual last year due to the new credentialing that many traditional attendees now have). Notably, there was a rich mix of physicians, physician assistants, registered nurses, diabetes educators, and other providers. Some attendees clearly had extensive experience with diabetes technology, while others had less familiarity and were using the meeting as an opportunity to dive into the diabetes technology field. The program featured sessions and hands on demonstrations in three specific areas: SMBG and interpreting A1c values, CGM, and insulin delivery.

We did not see (or expect to see) new data presented at CDTM; nonetheless, speakers provided a range of valuable commentary on diabetes technology. Notably, Dr. Fran Kaufman (Medtronic Diabetes, Northridge, CA) shared timing updates on Medtronic’s predictive low glucose suspend system, the MiniMed 640G – the company is working to file an IDE; US studies could begin by end of 2014, and will last ~18 months. From Dr. Anne Peters (USC, Los Angeles, CA), we saw a striking example of Invokana in type 1 diabetes and heard her thoughts on the growing number of insulin pump models. Hallway chatter was abundant at CDTM, and we heard plenty of commentary on the pros and cons of the Dexcom G4 Platinum and Medtronic Enlite. Attendees also shared a broad spectrum of thoughts regarding MannKind’s inhaled insulin, Afrezza.

In BGM, the clear highlight was Dr. David Klonoff’s wide-ranging talk. Although the FDA standards are not yet set in stone, Dr. Klonoff guessed that they will emerge from the review process largely unchanged. He suggested that working with a 100% accuracy window requirement with the point-of-care standards will also be very difficult for manufacturers, and will lead to devices that are slower, bulkier, and/or more expensive.

Much of the meeting’s other learning centered on the more pragmatic, safety-centered, day-to-day use of diabetes technology that attendees will find useful in clinical practice. However, we were glad to see presenters devote some time to present and future trends in diabetes technology, including evolving accuracy standards, post-marketing device monitoring and enforcement, future generations of glucose sensors, and more.

Our top ten highlights from the meeting are listed below, followed by more detailed coverage of several of the meeting’s most instructive presentations. As with last year, we were very impressed with Diabetes Technology Society founder Dr. David Klonoff and the CDTM conference team for organizing such an informative meeting for a broad spectrum of care providers in diabetes

 

Top Ten Highlights

  1. At the meeting’s only full company-sponsored session, Dr. Francine Kaufman (Medtronic Diabetes, Northridge, CA) shared that Medtronic is working to file an FDA IDE for its next-generation predictive low glucose suspend system, the MiniMed 640G. She suggested that a decision could come in a few months, and if positive, studies could begin by the end of the year. Submission could ideally happen ~18 months later (suggesting mid-2016, although we got the feeling that this was a very rough estimate). This is the first US timing we’ve heard on this exciting automated insulin delivery device – per Medtronic’s F3Q14 call, launch of the MiniMed 640G was expected to occur by October 31, 2014 (a three-month delay from the JP Morgan timeline). Dr. Kaufman also shared that Medtronic is starting studies with its third-generation Enlite sensor, although she did not comment specifically on the new generation’s features. Medtronic announced the launch of the second-generation Enlite CGM (“Enhanced Enlite”) during ATTD 2014. At the time, it was available in six countries in Europe, and a rollout to additional Western European countries was expected within a few months. To date, we have not heard detailed plans for the second generation Enlite in the US, though our understanding is that it will be part of the MiniMed 640G. Dr. Kaufman also flashed a picture of Medtronic's combined sensor and infusion set, teasing that it could be available any time between now and a couple years from now. While certainly positive from a patient experience point of view, there are clear R&D and commercialization challenges to overcome with a three-day sensor wear time.
  2. Dr. Anne Peters (University of Southern California, Los Angeles, CA) ended her presentation on insulin delivery with a remarkable twist: She shared a set of CGM traces from a type 1 diabetes patient she had seen recently, who was consistently hyperglycemic (>200 mg/dl) until a specific moment, at which point the glucose levels fell dramatically and stayed squarely within the target range for the rest of the day. Dr. Peters shared that the change was due to the patient’s first dose of J&J’s SGLT-2 inhibitor Invokana (canagliflozin). She strongly emphasized that this usage of the drug was off-label, though the chart said it all. It was certainly an impressive note to end on, and the results underscore the exciting potential for SGLT-2 inhibitors in type 1 diabetes due to their insulin-independent mechanism of action.
  3. Dr. Peters also provided thoughts on currently available insulin pumps and pens. She characterized the Medtronic MiniMed 530G as “the first step towards closing the loop,” suggested that the company’s sensors are “only going to get better,” and characterized threshold suspend as a great feature for some (but perhaps not all) patients. She was positive on the Tandem t:slim’s vivid screen, although she noted that some patients dislike having to press multiple buttons to unlock the device. Insulet’s OmniPod, in her view, trades off the convenience of no tubing for a device that is “kind of a lump.” She characterized the Asante Snap as a remarkably different approach, emphasizing the importance of being able to download pump data easily and effectively (the company has partnerships with Diasend [launched], Glooko [in development], and Tidepool [in development]). On the pen side, Dr. Peters likes Novo Nordisk’s relatively new NovoPen Echo, which shows the size and timing of the patient’s previous dose on a tiny screen at the dial end of the pen. The pen has been available in the EU, Canada, and Israel for some time, and was made available in the US earlier this year. It is targeted towards children (and comes with customizable skins), but Dr. Peters emphasized that the Echo can be a good device for adults as well.
  4. Diabetes Technology Society (DTS) founder Dr. David Klonoff (Mills Peninsula Health Services, San Mateo, CA) shared his views on the new FDA BGM accuracy standards. Although the FDA standards are not yet set in stone, Dr. Klonoff guessed that they will emerge from the review process largely unchanged – this was disappointing to hear, since we have heard so much backlash against them, particularly regarding the incredibly stringent point-of-care requirements. On that note, Dr. Klonoff suggested that working with a 100% accuracy window requirement with the point-of-care standards will be very difficult for manufacturers, and will lead to devices that are slower, bulkier, and/or more expensive. He also hypothesized that the FDA will not back down from these stringent requirements. Alarmingly, Dr. Klonoff said that CMS is considering a move to stop covering point-of-care meters that do not meet these standards, which could lead to the vast majority of existing meters being removed from hospitals - he emphasized the need for CMS, the FDA, doctors, and patients to come to a better solution together. We couldn’t agree more. Dr. Klonoff did not provide any updates on the efforts to develop a formal post-market meter surveillance program for BGM devices (see our coverage of the September 9 meeting), but (later in the day) did state that we will hearing more about the problem of inaccurate low-cost meters in the coming year. He also emphatically stated that it is wrong for payers to be forcing patients onto poorly performing products (a statement which earned him an enthusiastic round of applause from the audience).
  5. We heard comparisons between the Dexcom G4 Platinum and Medtronic Enlite CGM sensors from both presenters and attendees. The very energetic Ms. Christine Kessler (Walter Reed National Military Center, Bethesda, MD) suggested that the Dexcom G4 Platinum is a great device for many patients, but there is a real risk of more absentminded patients losing or breaking the receiver. She was a fan of Medtronic’s CareLink data management tool, a sentiment shared by a few CDEs and physician assistants we spoke with. There was broad recognition (especially during the hands-on CGM workshop) that Dexcom’s screen and user interface is preferable to Medtronic’s, and a few attendees expressed hope that Medtronic would be able to make progress in this regard. However, we also heard clear opinions that Medtronic’s pump-CGM integration is a powerful positive factor for patients – indeed, some patients opt for the MiniMed 530G/Enlite on this attribute, despite a preference for the Dexcom interface. Ms. Kessler noted that patients on the Dexcom sensor are generally very loyal to the product, and she is curious to see if the Enlite will inspire a similar level of loyalty. For more patient views on the Dexcom G4 Platinum and Medtronic Enlite, contact Richard.wood@d-qa.com.
  6. We also enjoyed hearing participants’ thoughts on a broad set of recent and future diabetes therapies, including MannKind’s inhaled insulin Afrezza (which recently received a very positive FDA AdComm vote). There was a fairly even mix of optimism and skepticism regarding Afrezza, and it was clear that the baggage from Pfizer’s discontinued inhaled insulin Exubera (both in terms of its safety and the user experience) are fresh in the minds of many. One physician assistant wondered aloud who will actually end up prescribing Afrezza – she noted that primary care physicians may not be sufficiently comfortable or knowledgeable regarding the product’s specific dosing considerations. On the bright side, a CDE who had participated in MannKind’s phase 3 clinical trial program shared that her type 1 diabetes patients loved Afrezza as a “break” from injectable insulin.
  7. Cloud based technology was mentioned throughout the meeting, from Dr. Tim Bailey’s opening plenary on glucose pattern recognition to Dr. Joyce Lee’s ending discussion of mobile technology. Both speakers noted Tidepool as a big-time company to watch as it integrates real-time data from multiple devices, even from different sectors ranging from patients to providers to companies, on an open-source, open access cloud database. It is wonderful to see this organization receiving increasing recognition at conferences, since its goals are so ambitious and patient focused. As we have previously covered Glooko and Telcare, we are also on the cloud-based data wagon – future innovations in this space have real potential to change healthcare delivery and tighten the feedback loop between patients and HCPs. On the app side, Dr. Lee highlighted mySugr’s great user interface and WellDoc’s ability to garner reimbursement for BlueStar.
  8. Mr. Ron Nagar, President and CEO of Insuline Medical, shared with us that the company is developing the next generation of the InsuPad, a wearable warming device currently being rolled out in Europe that significantly reduces the onset of action of injectable insulin (and reduces the required dose). For background, see our EASD 2013 Diabetes Technology Report, where Dr. Andreas Pfützner (IKFE, Mainz, Germany) presented results from the Barmer Reimbursement study. Although Mr. Nagar did not provide many specifics, he led us to believe that the next generation of the InsuPad will utilize disposable clips that can be placed on insulin pens (and thrown away) that will log insulin administration data for subsequent download and analysis. We speculate that data will be transmitted from the clip to the heating device wirelessly, and that the data will be stored on the device itself. We also spoke with Mr. Nagar (who has experience with non-invasive glucose monitoring) about Google[x]’s contact lens glucose meter project – he did not seem hugely optimistic, noting that tightening accuracy standards and the time lag between blood and tear glucose levels will make the lens project very challenging. He stated that he sees a contact lens device as more useful for tracking broad trends than for dosing insulin.
  9. Dr. Joyce Lee made a convincing case for clinicians to engage with mobile health and social media, not just to share knowledge, but also to learn from creative patient innovations. Several patient “hacks” that Dr. Lee shared reinforced the point that patients are often experts in troubleshooting and creatively thinking about their diabetes management. One brilliant example came from a patient who had trouble hearing her CGM alarm at night. By placing her CGM in a glass on her nightstand and utilizing the iSeismometer iPhone app to detect the CGM vibrations, the patient ensured she was aware when her CGM alerted her of glucose thresholds.
  10. During the insulin delivery workshop, we learned that many diabetes specialists worry about patient hospitalizations, as hospitalists and critical care staff are often uneducated on the proper use of diabetes technology. Several attendees shared stories of diabetes patients having hypoglycemic events as a result of hospital staff adjusting their pumps. One attendee noted that his clinic had started giving patients notes urging hospital staff to not adjust or even touch patient pumps and CGMs, a suggestion that was enthusiastically received by both workshop leaders and the general audience. An alternative solution to these hospital releases might be wider education on diabetes technology beyond just CDEs and endocrinologists.

 

Detailed Discussion and Commentary

Opening Plenary Session

Blood Glucose Pattern Recognition

Timothy S. Bailey, MD (AMCR Institute, Escondido, CA)

Dr. Timothy Bailey began by asking the question, “How many of your patients check their blood glucose every day and do nothing?” Widespread laughter and raised hands confirmed the answer. His presentation emphasized the importance of frequent blood glucose testing, but more importantly taking action from the pattern data gleaned from SMBG – of course, this is MUCH easier said than done, especially for busy clinicians trying to make sense of scattered logbook data in a matter of minutes. Dr. Bailey emphasized that pattern recognition applies to patients with both type 1 and type 2 diabetes, and also expressed enthusiasm regarding the potential of cloud data to change the BGM arena.

  • “Allowing patients to evaluate patterns in their BGM data is unequivocally beneficial to type 1 patients, but it’s helpful for type 2 patients as well.” Dr. Bailey emphasized several type 2 diabetes studies like the Structured Testing Program (STeP) for non-insulin using type 2s; the Treat to Target study in type 2 patients on insulin; and the recent PRISMA trial in non-insulin using type 2s. Dr. Bailey commented that the Treat to Target study was “the most convincing study that BGM works, even for type 2 patients,” showing that patients who are actively engaged in their blood glucose data are more proactive in their insulin dosing.
  • In terms of specific meters and solutions, Dr. Bailey characterized LifeScan’s Verio IQ meter as a “beautiful device,” especially because of it’s pattern recognition feature. (See the diaTribe test drive of the Verio IQ here, and of the more recent VerioSync here.) He also mentioned Diasend’s utility in collecting data from multiple platforms.
  • Dr. Bailey suggested that the regulatory climate for new diabetes tech innovation may be warming up, but that payer coverage is still a major question. He pointed to futuristic technology solutions such as fridge inventory applications that automatically compile shopping lists – they could be improved, but it is highly doubtful that Medicare would pay for it.
  • In the current spectrum of BGM software and mobile apps, Dr. Bailey seemed most excited about cloud data’s potential to change the BGM arena. Dr. Bailey commented that “when things get to the cloud, things are going to get a lot better for everyone.” He specifically highlighted Tidepool, suggesting that its capability to sync BGM data automatically to HCPs’ servers eliminates the hassle of patients having to download or bring their meters to the clinic, and allows doctors real-time access to patients’ results (of course, having the bandwidth to look at the results, along with liability concerns, are other questions).  

Questions and Answers

Dr. Bailey: It’s amazing what engineers are capable of creating. This is maybe why Ed Damiano is so far ahead in the artificial pancreas world because he’s an engineer and has a son with diabetes.

Q: Shouldn’t medical schools be embarrassed about the lack of training in diabetes?

A: I’ve never seen a medical school be embarrassed, but absolutely yes.

Q: What is the best time after a meal to measure blood glucose? Is it dependent on the insulin?

A: We don’t have any insulins available that are perfect. We generally know when food peaks, but knowing when the insulin peaks requires a lot of monitoring. CGM makes this much easier. When my patients go home with CGM, they learn things that I couldn’t tell them with three months of education, since they can see the data themselves.

 

Session 1: Blood Glucose Monitoring and Interpreting A1c Values

Clinical Need & Technology

David Klonoff, MD (Mills Peninsula Health Services, San Mateo, CA)

Diabetes technology pioneer and CDTM co-organizer Dr. David Klonoff opened the meeting’s first session, on SMBG. He highlighted that a number of recent opportunities and challenges (including changing accuracy standards, safety considerations for patients and non-patients, and controversial applications to non-insulin-treated type 2 diabetes patients) mean that SMBG faces a great deal of uncertainty. As expected, the new ISO and FDA draft standards for meter accuracy featured prominently in his presentation (and again in the final exam). Although the FDA standards are not yet set in stone, Dr. Klonoff guesses that they will emerge from the review process largely unchanged. Regarding the FDA draft point-of-care standards, which are even tighter, Dr. Klonoff suggested that working with a 100% accuracy window requirement will be very difficult for manufacturers, and will lead to devices that are slower, bulkier, and/or more expensive. He guided that DTS’ new error grid will likely be published this summer (in addition to a dedicated session at ADA), and expressed optimism that the FDA will endorse it. He did not provide updates on the post-marketing surveillance program initiative, but emphasized how serious the lack of such a program currently is.

  • The evolving draft accuracy standards for meters was (as expected) a major focus area of Dr. Klonoff’s presentation. He reviewed the new ISO and FDA draft standards; although the FDA standards are not yet set in stone, Dr. Klonoff guesses that they will emerge from the review process largely unchanged. He compared the reporting of accuracy within a series of very narrow (±5, 7, 10, and 15 mg/dl) intervals (part of the new FDA over-the-counter draft standards) to asking car companies to report if their cars could achieve speeds of 100, 500, and 1,000 mph (in other words, next to impossible). As promised, these standards came up on the final exam.
    • Regarding the FDA draft point-of-care standards, which are even tighter, Dr. Klonoff suggested that working with a 100% accuracy window requirement will be very difficult for manufacturers, and will lead to devices that are slower, bulkier, and/or more expensive. He also forecast that the FDA will not back down from these stringent requirements. Alarmingly, CMS is considering a move to stop covering point-of-care meters that do not meet these standards, which could lead to the vast majority of existing meters being removed from hospitals. Dr. Klonoff emphasized the need for CMS, the FDA, doctors, and patients to come to a better solution together.
  • Dr. Klonoff also briefly touched upon DTS’ cooperative effort to design a error surveillance grid. He expressed optimism that the FDA will endorse the grid, as the agency needs a surveillance error grid in order to effectively assess and enforce meter accuracy. The document will likely be published in summer, and it will be discussed at a dedicated session at ADA. See our coverage of it from DTM 2013. The grid uses an intensive methodology, with each blood glucose value from 0 mg/dl to 600 mg/dl assigned a unique risk score based on a survey of 206 HCPs. The final product is a tie-dye grid that is intended to help with post-market surveillance.  
  • Dr. Klonoff compared BGM usage to ordering a pizza, discussing the range of factors that can interfere before, during, and after a reading to cause error. Pre-analytical factors include improper hand washing, improper site selection, and expired or otherwise compromised test strips. Analytical factors (which the FDA is especially interested in investigating) include temperature, altitude, interfering physiologic factors (uric acid, galactose), and medications. Post-analytical factors include failure to record data, misleading messages, monitors shutting off if glucose readings are very high, and confusion over glucose units (some of these factors have led to product recalls).
  • Dr. Klonoff emphasized the importance of considering glycemic variability in addition to A1c. He endorsed the approach of targeting a glucose standard deviation that is less than half of a patient’s mean blood glucose.
  • Dr. Klonoff believes that SMBG is appropriate for non-insulin-treated type 2 diabetes patients, as long as they are following a structured testing program. In his mind, it is critical that the results of testing are translated into medication decisions. He suggested that non-insulin-treated type 2 diabetes patients who are on structured testing programs not simply test at the beginning of the day every day. Instead, he proposed that these patients test at a different time each day, or check every point (fasting, paired tests, bedtime) during just one day of the week. Either strategy provides a broader range of data throughout the day than every-day testing at a fixed time.
  • The presentation slide set contained a table detailing the challenges and opportunities ahead for blood glucose monitoring:

Barriers

Opportunities

  • Accuracy of generic monitors?
  • Accuracy of generic strips?
  • Counterfeit strips
  • Cutbacks in coverage
  • Fixed pricing and stifled innovation
  • Advances in accuracy
  • Advances in human factors
  • Advances in data presentation
  • Decision support software & mobile applications
  • FGS for better hypoglycemia detection
  • The safety section of Dr. Klonoff’s presentation mostly focused on the transmission of viral pathogens during assisted monitoring of blood glucose (AMBG, a term Dr. Klonoff helped coin to describe glucose monitoring in the care setting). A number of hepatitis B outbreaks have been linked to shared lancets at hospitals, nursing homes, and assisted living facilities. He encouraged strict adherence to established safety standards (single use lancets, use of approved sharps containers, one meter per patient when possible, disinfecting meters between use if single-patient meters are not feasible).
  • There is relatively little literature on improving the safety and comfort of lancing. Alternate site testing (AST) has been shown to reduce pain, but introduces lag. Laser lancing has been poorly received; Dr. Klonoff noted that a laser lancing demo was removed from the exhibit hall at ADA following negative attendee reactions (“painful,” “smoky”). Dr. Klonoff was a fan of the Pelikan Sun electronic lancing device, although the product had little commercial success and is no longer on the market.  

Questions and Answers

Q: The ADA has a wide range for A1cs corresponding to a given mean blood glucose. Where do those data come from?

A: It is just expert opinion; we don’t have much data supporting these as the best guidelines. Wei et al. recently re-analyzed data and published it in Diabetes Care, and it is one of the ten most important papers I have seen in my life [link to article]. They took data from a range of patients, put them in different A1c bins, and found the mean fasting, pre-meal, post-meal, and bedtime glucose readings for each bin. Now, we have a good link between blood glucose data and A1c data. For example, in the group with a low A1c of 5.5-6.5%, the mean fasting glucose was 122 mg/dl, and the delta between pre-meal and post-meal for each group was only around 30 mg/dl. That gives us reason to say that post-meal glucose levels are very important.

 

Clinical Case Studies

Jane Seley, DNP (New York Presbyterian/Weill Cornell Medical Center, New York, NY)

Dr. Jane Seley began the BGM clinical case studies by asking, “How many of you are taking the exam tomorrow?” Almost every hand went up. We were impressed with the audience’s wealth of knowledge as they called out solutions to the case studies without hesitation. The examples prompted attendees to consider individualized patient goals, A1c and blood glucose history, current medication, lifestyle, and hypoglycemia risk. Each case presented a unique set of patient circumstances that affected his/her diabetes regimen whether it was age, job, stigma, medical history, etc. We thought the presentation provided a great reminder of the heterogeneity in interpreting BGM data and finding individualized solutions.

  • The first case study pushed attendees to think creatively about glucose monitoring when a patient’s insurance only covers one strip a day. The audience was quick to suggest that seven strips a week would be enough for three pair checks (before and after meals) and an extra fasting test – enough to gather useful BGM trend data. While the better solution would of course be greater strip coverage, we found this solution resourceful, cost-effective, and grounded in the literature.
  • In her detailed discussion of interpreting BGM reports, Ms. Seley highlighted the ease of picking out trends and unusual patterns from downloadable patient data. A notable example was “the McDonald’s factor” where she saw a significant jump in blood glucose every Sunday morning. After discussing the trend with the patient, he admitted that his Sunday morning ritual included a meal at McDonald’s.
  • She also highlighted one of Dr. Bailey points, that BGM is useless unless patients are motivated to make actionable plans from this data. Recommendations for motivating patients included setting realistic targets over chunks of time, brainstorming ways to improve patient comfort (e.g. site selection, site preparation, changing device), optimizing reimbursement/lowering co-pays, and discussing BG results at every visit (especially in primary care visits).

Questions and Answers

Q: Another factor that can cloud the relationship between A1c and finger sticks is that some people are high or low glycators. Patients may have a disparity between their A1c and glucose levels that is not a fluke – those patients will just be higher or lower than expected, as a function of biology.

A: If you know someone who is a high glycator, they may have unique patterns of pre- and post-meal readings. We can take Nathan et al.’s data, and maybe from that we can establish different targets for rapid or slow glycators.  

Q: We all know that these meters must provide accurate information, but now the new suggested FDA guidelines are even more stringent. The most accurate meters currently have been denied by insurance for patients. There are no standards for patient accuracy after clearance. How can we address this? Now that type 1 patients with diabetes reach Medicare, they should also have CGM approved by insurance.

A: David and I were both at panel with the FDA and believe that this is an incredibly important topic. What should patients do with a meter that’s not accurate though approved? These monitors tend to be cheap because if you don’t build in quality it costs less. CMS has essentially been going only by cost, thus forcing patients to use low-cost meters that have been FDA cleared but aren’t performing up to standard.

Dr. David Klonoff: DTM had some panels last year and we concluded that there needs to be a surveillance program to see if meters are functioning properly. This will essentially be looking at “counterfeit monitors” that have the brand name but aren’t performing up to snuff. I’d like to see FDA be more involved. If a surveillance program were created, they would work with the program to change rules to allocate greater powers to get inaccurate products off the market. Right now they’re limited but sympathetic. In the next year we’ll hear more on this program. Patients shouldn’t have to use these counterfeit products and it’s wrong for CMS to force patients to use these meters. [Applause]

 

Session 2: Continuous Glucose Monitoring

Clinical Need and Technology

Robert Vigersky, MD (Walter Reed National Military medical Center, Bethesda, MD)

Dr. Robert Vigersky provided attendees with a thorough overview of the history of CGM, its clinical need, mechanical background, current technology, and troubleshooting errors. A number of studies have shown that CGM use can improve glycemic control, reduce hypoglycemic events and time spent in hypoglycemia, decrease glycemic variability, and empower and educate both patients and clinicians in diabetes management. He sees the two major CGM options currently available (the Dexcom G4 Platinum and Medtronic Enlite) as comparable in terms of functionality and accuracy. We were surprised to hear his view that they are similar on accuracy, as most KOLs and patients believe that the Dexcom system is more accurate. As for continuous glucose monitoring in fully closed-loop (artificial pancreas) systems, Dr. Vigersky ended by saying, “soon coming to stores near you!”

  • Dr. Vigersky compared the Medtronic Enlite and Dexcom G4 Platinum. He offered no strong opinions either way, and said the two were generally comparable in terms of functionality and accuracy. We note from our discussions with registered nurses and diabetes educators at the meeting that patients who preferred the Medtronic MiniMed 530G system valued its integrated pump and CGM. Additionally clinicians seemed to value the data from Medtronic reports over Dexcom’s. There was a broad consensus though that the Dexcom G4 had a sleeker interface, better perceived accuracy from patients, and fierce brand loyalty.
  • Dr. Vigersky briefly covered results from the ASPIRE in-home study of the MiniMed 530G (Bergenstal et al., NEJM 2013). For the full details, see page 90 of our ADA 2013 report here. The trial showed a 32% reduction in nocturnal hypoglycemic events and a 38% reduction in mean area under the curve (magnitude plus duration) of nocturnal hypoglycemia events. Notably, these benefits occurred without an increase in A1c levels.
  • In his discussion of CGM components and troubleshooting, Dr. Vigersky noted that insertion site issues are often causes of CGM inaccuracy. Patients must avoid selecting sites of recent insertion and hypertrophy, not to mention ensuring pump infusion sites and CGM sensors are the recommended minimum distance apart. Keeping with the focus on device consolidation and streamlining, Dr. Vigersky suggested that infusion sets and sensors included in the same device should arrive in the not-too-distant future. Medtronic and Insulet are the only companies working on this (to our knowledge), though several academic groups in Europe are also testing this through the AP@home project.
  • An issue that was highlighted throughout the meeting (and on the final exam) was acetaminophen’s interference of CGM accuracy. Because acetaminophen is frequently used in both home and hospital settings, clinicians should always be aware to troubleshoot this. In particular, Dr. Vigersky even recommended against CGM use in the ICU setting if the patients is on intravenous acetaminophen.
  • Dr. Vigersky noted that many patients use their CGMs to calculate insulin dosing, something he strongly advised against. He said that CGMs are built to measure glucose in the interstitial fluid (ISF), and there lag time between the ISF and blood glucose. CGM’s strength, he said, lies in its ability to provide trend information, directional cues (increasing or decreasing), and alerts/alarms. We’d note that the most recent data on ISF-blood time lag (Basu et al., Diabetes 2013) suggests the lag is only 5-6 minutes. Though CGMs are not technically approved for dosing insulin, we consistently hear anecdotal reports of patients using them in this way (particularly the Dexcom G4 Platinum).
  • In terms of CGM accuracy he stated that the YSI 2300 StatPlus was the gold standard reference. However, there was some strong audience pushback about why and whether or not this was the standard. Dr. Vigersky’s conclusion (which drew some audience laughter) was that “the YSI may not be the most accurate… but it is still the gold standard.”

Questions and Answers:

Q: Why is there such a low rate of compliance in studies where cost isn’t an issue?

A: These devices are finicky – patients have a love/hate relationship with them. They alarm when they aren’t supposed to, and people get alarm fatigue. They may be uncomfortable to wear, and some people just don’t see value in them. There are many reasons, particularly in younger individuals. Some people just don’t want to see what is going on. The device is telling them that they shouldn’t have had that extra slice of pizza. It’s not uncommon for patients to give up on them after a while, and nobody has figured out how to continue to engage them. I think part of the problem is that, just like what was said for SMBG, it takes time for the clinician to download the information, digest it, understand it, and communicate advice back to the patient. It’s a very time-consuming process on the provider’s part, which is a disincentive since providers are not getting paid for any of that time.

Q: I think variability of standard deviation in CGM allows patients to individually fine tune. How do they understand what they’re eating/timing? How can CGM affect this timing/variability?

A: I view CGM as a behavior modification. It gives a lot of insight for patients with diabetes, especially those who use prandial insulin. Its ability to give you a visual is valuable.

 

Clinical Case Studies

Christine Kessler, MN (Walter Reed National Military Center, Bethesda, MD)

Ms. Christine Kessler followed Dr. Vigersky on the podium to (very energetically) present a series of practical recommendations on CGM usage. In terms of the choice between devices, she emphasized that the decision should be individualized on a patient-by-patient basis. She stated that the Dexcom G4 Platinum is great for many, but not for patients who might be prone to losing or breaking the receiver. Ms. Kessler shared that she likes Medtronic’s CareLink data management tool (a sentiment we heard from a few attendees we talked to in the hands-on CGM workshop). Her mnemonic for retrospective CGM data evaluation is to “SLAP ‘em”: Share the CGM data side-by-side with the patient, Let them make their own observations (areas of concerns, highs and lows), Ask them what they think they can realistically improve on, and Point out the positives. Ms. Kessler emphasized that when examining a CGM trace, it is important to look for hypoglycemia before anything else, followed by nocturnal control, then post- and pre-prandial. She also suggested that providers should focus on basal control before looking at boluses; in her view, optimizing boluses can improve control, but basal control is more of a basic safety issue.

 

Session 3: Insulin Delivery

Clinical Need & Technology

Anne Peters, MD (University of Southern California, Los Angeles, CA)

Dr. Anne Peters gave one of the top presentations of the meeting, discussing topics ranging from the newest insulin pens to insulin pump comparisons to payer policies on CGM, and even the use of Invokana in type 1 diabetes (off-label, but still highly illuminating). On the latter point, she showed a CGM trace from a single poorly controlled type 1 patient that began taking Invokana, and the results were very striking – the patient went from being completely out-of-zone to completely within-zone (albeit from n=1). Regarding the ADA/EASD Diabetes Technology Commission (which we first learned about at the recent EASD Diabetes Technology Conference), Dr. Peters called for more patient representation on the commission – it currently includes six members: Drs. Richard Bergenstal, Alexander Fleming, and Anne Peters from the US, and Drs. Lutz Heinemann, Reinhard Holl, and John Petrie from Europe). Dr. Peters also provided an efficient comparison of the different insulin pumps on the market; strengths mentioned included the Tandem t:slim’s screen, the Insulet OmniPod’s lack of tubing, Asante Snap’s disposability factor and data downloads, and the Medtronic MiniMed 530G’s threshold suspend system. She expressed disappointment at the quality and availability of insulin pump safety data (see her EASD Diabetes Technology talk for more details on that front). On the pen side, she was enthusiastic about the new NovoFine Echo (which displays the time and size of patients’ last bolus), as well as other devices that help time-stamp boluses.

  • Dr. Peters showed a case study of J&J’s Invokana (canagliflozin) in type 1 diabetes (although she did emphasize multiple times that the drug is not approved for use in type 1 diabetes). She shared a CGM trace from a patient she had seen recently who had very poorly controlled glucose levels, almost always above range. This particular patient was also worried about weight gain. The following slide showed a CGM tracing from the same patient on a subsequent day. At a point in the middle of the day (marked by an arrow), the patient’s glucose levels went from the >200 mg/dl range to squarely within target range, and stayed there for the rest of the day, with no hypoglycemia. In a dramatic reveal, Dr. Peters shared that the arrow marked the patient’s first dose of J&J’s SGLT-2 inhibitor Invokana (canagliflozin). Given that the drug uses an insulin-independent mechanism of action, it has clear potential in type 1 diabetes, and we are excited to see this application of the SGLT-2 inhibitor class explored in full clinical trials. The decrease in blood glucose levels we saw in Dr. Peters’ CGM traces was so rapid that it will be important for providers to down-titrate patients’ insulin doses accordingly, to prevent increases in hypoglycemia. 
  • Dr. Peters provided an overview of currently available insulin pumps. She did not explicitly list any single pump as her overall favorite, although we thought her characterization of the Medtronic MiniMed 530G was slightly more positive.
    • Tandem t:slim – The screen on Tandem’s pump is a major strength, as it is easier to see than the gray-scale display on older pumps. However, some patients dislike having to press multiple buttons to unlock the device (a safety mechanism to prevent accidental bolusing).
    • Asante Snap – A “different approach” to insulin pumps, with a high disposability factor. Dr. Peters mentioned the importance of being able to download useful data from pumps. See our coverage of Asante’s recent data downloading partnership with Tidepool.
    • Insulet OmniPod – Good for people that don’t want to deal with tubing, although the thing itself is “kind of a lump”; ultimately not a clear winner, but definitely a great option for some patients.
    • Medtronic MiniMed 530G – Dr. Peter’s slide stated that the 530G is the “first step towards closing the loop,” and that the company’s sensors are only going to get better. Later in the presentation, she said that threshold suspend is a great feature, although it is not equally important for all patients.
  • Dr. Peters shared thoughts on some of her favorite insulin pens and pen features. She highlighted that the US insulin pen market has seen an explosion of growth from 2009 through 2012, from ~$1.7 billion to ~$3.9 billion, driven both by the Solostar pen for Sanofi’s Lantus, as well as the smaller (but faster-growing) rapid-acting insulin pens. Despite this growth, the US is still far behind other parts of the world in terms of pen usage, with many payers only covering pens if patients have impairments that make syringe injections difficult.
    • In Dr. Peters’ view, the accuracy differences between pens are not clinically meaningful – the best differentiating factors are features that help patients keep track of their insulin doses. She stated that she really likes the NovoFine Echo, which was recently made available in the US, because it shows the patient their last dose and when they took it (it also comes with a customizable skin, for pediatric patients). Other ways to make pens smarter include pen cap add-ons such as Timesulin (which shows the time of the last dose) and GoCap (still in development, but will communicate dosing history to a smartphone). 
  • Although the choice between MDI or CSII should be up to the individual (patients can do well, or poorly, on either), Dr. Peters believes that CSII therapy use guidelines should be more inclusive. After reviewing existing guidelines, she shared her own ideal list of guidelines, which would include all type 1 and type 2 diabetes patients who are interested in the technology and who are willing to comply with protocols and work closely with their healthcare provider team. 
  • As a side note, Dr. Peters stated that she is fed up of Medicare not paying for CGMs – she hopes to make a move with all her patients aged 65 and older who will be losing their CGMs. This plan drew a round of applause from attendees.
  • We appreciated a reminder of the ADA/EASD Diabetes Technology Commission (AEDTC), which is currently working to develop safety guidelines for insulin pumps. The commission is working to “support” (underlined in the slide) patients, healthcare professionals, device manufacturers, regulators, and policymakers to address diabetes technology. While the commission’s first project is to evaluate the performance and safety of insulin pumps, Dr. Peters shared that the group will eventually move on to other topics, including SMBG, CGM, and even the artificial pancreas. Dr. Peters spoke self-deprecatingly and pragmatically about the initiative, joking that the project appeared a bit “pie in the sky.” We were especially glad to hear her emphasize the need for patient representation on the commission, in some form. At the recent EASD Diabetes Technology Conference, where we first heard about the AEDTC, we learned that the commission plans to hold a press conference at the ADA scientific sessions, and to publish a statement in Diabetes Care in Summer.
  • The presentation discussed the general topic of insulin pump safety (many of which were covered in Dr. Peters’ talk at the EASD Technology Conference). Dr. Peters lamented that there is incredibly little safety data on pumps that is publicly available, and that the FDA’s safety reporting system is inadequate. A disproportionate number of reported cases have come from patients on Animas devices, even though Medtronic holds the lion’s share of the market – the reason for this imbalance is unclear and does not necessarily reflect safety issues with the pumps (lack of patient education might be a cause).

 

Clinical case studies

Donna Tomky, MSN, CDE (ABQ Health Partners, Albuquerque, NM)

Attendees gained a wealth of knowledge from Ms. Donna Tomky’s presentation of clinical case studies on insulin pumps and pens. She synthesized the most appealing features of six pumps, and ran through case studies of insulin delivery errors.

  • What is the best pump for your patient? The case studies emphasized that pump choice depends on patient lifestyle and preference. The case study patient ended up choosing the OmniPod because the tubeless design complemented her busy schedule and allowed her to take care of her energetic children. For reference, Ms. Tomsky outlined one unique feature of each pump (table below).

Medtronic MiniMed 530G

Links to the Enlite CGM sensor thus combining both the pump and CGM in one device

Insulet OmniPod

Patch pump that eliminates the hassle of tubing

Tandem t:slim

Color touch screen - considered the “iPump” because of its sleek design

Animas OneTouch Ping

One touch meter remote control

Asante Snap

300-unit prefilled cartridge

Accu-Chek Spirit

Accu-Chek meter remote control

  • One emphasized insulin delivery error was patients not pushing down the pen’s dosing button and instead dialing down the pen (effectively administering no drug). After many attendees chimed in with their own stories of this exact error happening with their own patients (even some who had been using pens for several years!), it was evident of the importance for clinicians to review proper injection technique regardless of patient experience.

 

Technical case studies

Donna Tomky, MSN, CDE (ABQ Health Partners, Albuquerque, New Mexico); Jen Block, MSN, CDE (Stanford University Medical Center, Palo Alto, CA); Donna Jornsay, CDE (Long Island Jewish Medical Center, New Hyde Park, NY)

We were excited to try out the insulin pens and pumps during the technical case studies and hands-on experiences, and this workshop did not disappoint. We practiced adjusting the pump settings, calculating doses, and troubleshooting the Medtronic MiniMed 530G, the Tandem t:slim, and the Insulet OmniPod. An important issue that came up was the lack of education that hospitalists had in diabetes technology training. One attendee shared that his practice was giving patients notes before they went in the inpatient setting, urging the hospital staff to not adjust or even touch their insulin pumps.

  • “The intense fear of diabetes complications sometimes pushes people to be trigger happy with their insulin dosing.” This insightful comment came from the first case study of a patient constantly overriding his pump’s recommended bolus doses. Fear of highs all too often result in patients reaching dangerous lows, and clinicians should be checking pump downloads to assess when patients are adding too much insulin in response to hyperglycemia.
  • In the second case study led by the fantastic Ms. Jen Block, attendees had to confront a lack of blood glucose data from a pre-teen type 1 patient. Often, adolescent patients do not feel the need to test frequently, so when hyperglycemia, hypoglycemia, or even DKA arises, clinicians are left with scarce resources to identify the root cause. As a preventative measure, clinicians should encourage patients to check their blood glucose often, have a plan for pump failure, and check blood ketones whenever possible.
  • Poorly trained pump wearers can face difficulty and even clinical danger in the inpatient setting. In the third technical case study, a type 1 patient experienced hypoglycemia after restarting her pump after discharge from an inpatient procedure (during which the hospital nurse changed the patient’s pump settings, and the patient had no idea how to reset them). The obvious solution was to recalculate and reprogram the pump and ensure thorough education on proper pump use. There was room-wide alarm at the hospital staff’s poor understanding of type 1 diabetes and insulin pump use – several attendees shared similar stories of their patients’ diabetes management being inadvertently sabotaged by inpatient staff.
  • Notably, an attendee commented that at his hospital, physicians had to sign waivers stating that they would not manipulate or even touch a patient’s pump, as it would be akin to malpractice. The rest of the audience as well as the workshop’s leaders were extremely enthusiastic about adopting this practice and even asked for the attendee to share the documents. This issue, in our view, evinces the need for diabetes technology training in hospitals and other non-diabetes healthcare facilities. Part of the Diabetes Technology Society’s possible vision for the future of CDTM is to reach wider audiences for clinical diabetes technology training, which we feel would reduce cases such as the one presented here.

 

Saturday Plenary Session

Mobile Technology and Social Media for Diabetes

Joyce Lee, MD, MPH (University of Michigan, Ann Arbor, MI)

Dr. Joyce Lee (who we may have never heard from if Dr. Klonoff hadn’t run into her in a circumstance cab ride) offered convincing motivation for clinicians to use mobile technology and social media for patients with diabetes. She ran through several examples of apps and mobile-enabled devices, highlighting Glooko, mySugr, Databetes, Telcare, and WellDoc. Dr. Lee was particularly positive about mySugr (“in terms of apps, I think this has the best user interface and screen design”) and Glooko. That said, she was honest in stating that there is not much data on mobile health in diabetes – for mobile health interventions to really take off, clinically important outcomes must be robust. WellDoc has done the most impressive job of collecting clinical data and obtaining reimbursement, and we look forward to seeing what happens as BlueStar is rolled out.

  • The market for improving diabetes care via apps is huge – 86% of the time people spend on their smartphones is on apps. According to FDA definitions, a mobile medical app is 1) an app to be used as an accessory to a regulated medical device or 2) an app to transform a mobile platform into a regulated medical device. The intended use of a mobile app (disease diagnosis, cure, mitigation, treatment, disease prevention, or affecting structure/function of the body) is crucial to whether or not it is defined as a device.
    • In the last ten years, the FDA has only approved about 100 mobile medical apps and 40 of these have been in the last two years. Dr. Lee mentioned Glooko and AliveCor as two examples of FDA approved devices. Glooko is a smartphone/cloud-based system that has FDA approval to download BGM data via a universal cable (read our reports on Glooko’s web-based population tracker and its partnership with Joslin). AliveCor is a phone case that can take an EKG; it requires almost no patient engagement other than holding a smartphone.
    • Mobile apps that are at the discretion of the FDA include those that help patients self-manage their disease like mySugr. Dr. Lee was very positive about mySugr stating, “in terms of apps, I think this has the best user interface and screen design.” The FDA also will be regulating apps that provide easy access to information related to health conditions, automate simple tasks for HCPs, or enable patients to interact with personal health records (PHR) or electronic health record (EHR) systems.
  • “As of now, the promise of mobile health has yet to be recognized… this is where social media can help. There is a diabetes technology revolution happening right under our screens!” Dr. Lee encouraged clinicians to get involved on social media to learn from patients who are connecting and innovating on spaces like Twitter, Facebook, and blogs. Clinicians should be following the mobile health and tech scene so that they cannot only learn how diabetes works in the real world, but also to direct patients to helpful resources.
  • Patients often have a wealth of knowledge on troubleshooting diabetes technology and provide pearls of wisdom when it comes to device reviews and design issues. Dr. Lee said it best: “This is about information, conversation, interaction, and patients learning from other patients.” The social media space for diabetes innovation is truly about patients living and learning from their diabetes management.
    • Dr. Lee offered examples of some clever patient “hacks” for diabetes, and common errors. For example, one patient who had difficulty hearing her CGM alarm placed it in a glass cup on her nightstand and used the iSeismometer iPhone app (which was much louder) to wake her up. Another brilliant example came from Kerri Sparling from Six Until Me who combined her glucose sensor with a Flovent to prevent frequent rashes.
  • Doug Kantor from Databetes will be coming out with a mobile app soon to record carbohydrates and blood sugar with photos. His mission to visualize his diabetes started in 2012, using numerous devices and media in combination with his diabetes devices (CGM, pump, SMBG) including his FitBit, Nike Fuel Band, Map My Run, Flickr, and even Foursquare. His end result was a beautiful and personalized visualization that helped him understand his own data – Dr. Lee noted that such personalized understanding was crucial to helping build the next big data visualization app.
  • Dr. Lee also noted that app search algorithms are not transparent, making it difficult for design researchers or clinicians to assess why and how apps are popular on the iOS and Android systems. Searching “diabetes” on the Android gives 480 results, of which only 50% are actually relevant to diabetes patients and clinicians. On the iPhone, the same “diabetes” search returns 600 results, of which 85% are relevant.
  • WellDoc’s BlueStar, an FDA-approved mobile prescription therapy for type 2 diabetes, has secured reimbursement (insurers pay $100 a month). Of course, it will be interesting to see which apps insurers recognize as medical devices, and how this affects patient adoption. As a reminder, WellDoc announced a $20 million Series A round of financing in January, led by Merck’s Global Health Innovation Fund. The investment will fund a dedicated sales force to regionally rollout BlueStar.
  • Dr. Lee also noted that Telcare is the first cellular-enabled real-time glucose meter. The cellular-powered glucose meter has an embedded  chip that transmits each test result (upon removal of the strip) to a secure cloud server that provides instant feedback and coaching to patients. She did mention though that Glooko is currently a more sensible option, as it allows patients to attach to a device they already use and have strips for. Additional the Glooko cable is Android and iPhone compatible and much cheaper at $39.95 than the Telcare device ($149.95, though insurance may cover some of the cost).

 

Overcoming Fear of Technology

Marilyn Ritzholz, PhD (Joslin Diabetes Center, Boston, MA)

In her presentation, Dr. Marilyn Ritzholz distinguished between fear of technology and resistance to technology. She explained that many patients are reluctant to switch to new devices, not necessarily due to a “phobia” but rather the reluctance to either interrupt their normal pattern of care, learn a new self-care regimen, or even acknowledge body image concerns. Dr. Ritzholz noted that physicians can be resistant to using technology as well. Importantly, new diabetes devices aren’t always the best option for some patients, especially for those who have limited cognition (e.g., memory loss) or dexterity issues. Clinicians must also consider patients’ expectations about diabetes technology and acknowledge that these devices are not a “magic bullet”; they require active engagement.

Questions and Answers

Q: Diabetes is an emotionally distressing illness especially for type 1 teen patients. The alarm is horrifying and singles them out amongst their peers. How do we deal with these issues?

A: Firstly, I would note that the rate of depression is similar between type 1 and type 2 diabetes. However we do need to address the issue of shame and this cultural stigma that promotes the idea that you have to be ashamed of an illness. We try to run support groups, which adolescents are terrible at, so we have to instill this idea in the families. We have to get away from moral condemnation and phrases like “good sugar, bad sugar, good patients, and bad patients.”

Q: Another category of patients that could be focused on are those who don’t respect hypoglycemia and are actually scared of hyperglycemia.

A: I wondered about cognition for these patients; sometimes they even appear psychotic about avoiding hyperglycemia. Their ability to decide is impaired. They are fixated on having blood glucose under 100 and remain stuck in this mindset, which creates a very difficult situation. Again, it’s bringing in the family and the family must understand how to help them. Additionally, medication may be necessary.

 

Corporate Symposium (Sponsored by Medtronic)

Advances in Diabetes Technology

Francine Kaufman, MD (Medtronic Diabetes, Northridge, CA)

In an enthusiastic and self-deprecating presentation, Dr. Francine Kaufman provided a forward-looking overview of Medtronic’s current and future diabetes devices. Notably, we learned that Medtronic has been working to submit an Investigational Device Exemption (IDE) for its next-generation predictive low glucose suspend system, the MiniMed 640G. Dr. Kaufman suggested that a decision is possible in coming months, which would allow studies to start at the end of the year. This would kick off a roughly 18-month cycle to submission (roughly mid-2016). She shared that Medtronic is starting studies with the third-generation Enlite sensor, although she did not comment specifically on the new generation’s features. The second-generation “Enlite Enhanced” sensor was made available in Europe earlier this year at ATTD, and we have not yet heard plans for the second generation in the US. Regarding the company's combined CGM sensor and infusion set, Dr. Kaufman joked that it could be available any time between now and a couple years from now. She labeled the Medtronic MiniMed 530G with Enlite as the first artificial pancreas device, given that it performs some of the functions of a human pancreas and fits the definition stipulated in the FDA Artificial Pancreas Device System (APDS) guidance. However, she did acknowledge that some people might not appreciate her using the term “artificial pancreas” for the device.

  • Dr. Kaufman discussed Medtronic’s intensive post-marketing monitoring program for the MiniMed 530G/Enlite, which was designed in collaboration with the FDA – as Dr. Kaufman noted, this has been a fairly intensive plan. The company is apparently getting a good response and feedback from its calls to patients (Dr. Kaufman suggested that patients provide plenty of comments when called, but that the issues were generally not significant enough for the patients to have contacted the company themselves), and that to date, the program has generally provided assurance of the device’s safety.

 

Hypoglycemia: The Major Barrier to Effective Diabetes Control

Steven Wittlin, MD (University of Rochester Medical Center, Rochester, NY)

Immediately following Dr. Kaufman’s dinner presentation, Dr. Wittlin presented the background and relevant literature on hypoglycemia control that supports greater CGM use, and in particular the MiniMed 530G. In Dr. Wittlin’s words, “hypoglycemia is the rate limiting step in the treatment of type 1 diabetes” and the MiniMed 530G was suggested as the first step in addressing improved control of hypoglycemia.

  • The audience was overwhelmingly supportive of Dr. Wittlin’s “wish list” for real-time sensors. His list included better alarms, alerts for alternate patient caregivers, improved accuracy and precision, improved hardware reliability, decreased lag time, sensor signal processing, smaller sizes, rapid-acting insulins, continuous closed-loop feedback vs. algorithm-based model, reduced costs, and in all caps and highlighted, “UNIVERSAL RECOGNITION BY INSURERS!!!” To this, the audience broke into applause and cheers.
  • Hypoglycemia begets more hypoglycemia, as well as increased hypoglycemia unawareness (a key finding from the ASPIRE in-clinic trial). Dr. Wittlin emphasized that recurrent instances of hypoglycemia reset the body’s threshold for detecting hypoglycemia, meaning that hypoglycemia could occur before the body actually recognizes it is in a hypoglycemic state, and before the patient can recognize and remedy the situation.
  • Hypoglycemia is markedly less frequent in patients on CGM. Presenting results from the JDRF CGM Trial, the STAR 3 study, and the 2012 SWITCH study, Dr. Wittlin impressed that CGMs can improve glycemic control while minimizing hypoglycemic events. Connecting the literature on CGM and insulin pumps to Medtronic’s key value proposition, Dr. Wittlin stated, “CGMs can help patients get the most out of their pumps; pumps can help patients get the most out of their CGMs.”

Questions and Answers

Q: When we look at studies on pediatric patients, the numbers of patients enrolled seem to be small despite the fact that pediatric diabetes is the future of diabetes. Is this a problem? The numbers are around 200 patients, but when we look at past monumental studies in adults, the n-number is much larger.

A: The studies that have that many people do so because they need that size to show statistical significance. There is a calculation of how many patients are needed to show significance. You see a zillion patients in cardiovascular studies because it takes that many to show significance. If you can show statistical significance in 200 patients, it still counts, and is much less costly.

Dr. Francine Kaufman: As a pediatric endocrinologist perspective, we love to do studies. But if we could do it in adults we’ll go down to age 14-16 so that we can talk to pediatricians as well. Yet it’s a lot to expect from anyone. Below age seven, children can’t consent and it’s difficult to get a seven year old to agree to anything. The big issue in in-home pediatric studies is gathering data. It’s a little harder when you need to draw blood, not to mention the multiple sensors and needles needed to draw that blood.

 

--by Manu Venkat, Jenny Tan, Adam Brown, and Kelly Close