Greetings from Music City USA (also known as Nashville, TN), where the American Association of Clinical Endocrinologists’ 24th annual conference just began. Within the aesthetically impressive Music City Center in the heart of town, AACE 2015 Day #1 featured a series of parallel “special sessions,” three of which were related directly to diabetes and obesity. In the morning, a trio of speakers led a practice update on diabetes technology. Dr. Bruce Bode (Atlanta Diabetes Associates, GA) never fails to impress with his broad situational awareness of what’s going on in diabetes technology – we’ve been listening to him for years and thinks he gets more insightful all the time. Today, his insights surrounded Medtronic’s ongoing work to develop patch pumps for both type 1 and type 2 diabetes. The renowned Dr. Irl Hirsch (University of Washington, Seattle, WA) spoke on the practical topic of pump and CGM downloads, sharing his belief that the “timing of insulin is the most important part of dosing” (and it’s fascinating and telling that this is so hard for so many patients). A phenomenal panel discussion featuring Drs. Hirsch, Bode, and Timothy Bailey (UCSD, San Diego, CA) closed out the session, touching on highly valuable and very opinionated insights on real-world obstacles to closing the loop and the off-label use of SGLT-2 inhibitors in type 1. Get ready! Diabetes tech is just becoming more insightful and more controversial.
In the afternoon, drugs and obesity took over the spotlight. In a four-hour “2015 Diabetes Update,” Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX) led off with a big talk on glucagon, noting candidly that he is optimistic about GLP-1/PYY dual agonists and less positive about glucagon receptor antagonists due to potential safety issues. That was interesting. Dr. John Buse (UNC, Chapel Hill, NC) ended a talk on the cardiovascular safety of incretin-based therapies by noting that CVOTs must be longer and enroll lower-risk patients to best explore possible cardioprotection, which he believes is possible with GLP-1 agonists. We find it disappointing that there are over a dozen of these ongoing and it sounds like none had optimal trial design and very few have patients checks of patients that could help assess benefits.
Across the hall, AACE led a session dedicated to its new “Tool Kit” for obesity, which includes the staging system that came from its consensus conference last year on obesity. Dr. W. Timothy Garvey (University of Alabama, Birmingham, AL) discussed AACE’s future plans, which include the creation of a new evidence-based guideline (expected to be finished in late summer/early fall) and a second consensus conference on obesity early next year. We also heard Dr. Felice Caldarella (Hunterdon Medical Center, Flemington, NJ) comment on how Medicare unfortunately only reimburses obesity counseling for primary care providers, not endocrinologists. That is odd – we hadn’t realized that. Dr. Arial Sharma has done some very valuable thinking on obesity staging and we hope his views are included on the staging end. Thanks to AACE for all this ambitious and forward thinking work.
The day ended with a dinnertime Sanofi and Regeneron-supported corporate symposium on the new PCSK9 inhibitor class of drugs for LDL lowering and other indications – the lead candidates, Sanofi/Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab) are under FDA and EMA review. The session packed the house with a crowd of around 350 attendees, which for us merely reinforces the clear, very broad excitement for the class given that type 2 diabetes and dyslipidemia are so often comorbid conditions.
See below for a list of our top ten highlights from day #1 followed by a selection of full write-ups. AACE is a fairly long meeting at five days so check out our conference preview for a look at what to expect on days #2-5.
Top 10 Highlights
1. Dr. Bruce Bode’s outstanding presentation shared news that Medtronic is working on type 1 and type 2 patch pumps (this has been on-again, off-again for awhile and generally does change with each new head of Medtronic Diabetes Care – we’re glad to hear it’s on again).
2. A panel discussion with Drs. Timothy Bailey (UCSD, San Diego, CA), Bruce Bode (Atlanta Diabetes Associates, GA), and Irl Hirsch (University of Washington, Seattle, WA) shared highly valuable and very opinionated insights on real-world obstacles to closing the loop, the off-label use of SGLT-2 inhibitors in type 1, and the misconception of data downloading as time consuming.
3. Dr. Irl Hirsch (University of Washington, Seattle, WA) spent the majority of his presentation emphasizing the importance of CGM and insulin pump downloads in contemporary diabetes care and confirmed that the results of his FLAT-SUGAR pilot study will be presented at ADA 2015 (!).
4. Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX) emphasized the importance of targeting glucagon in diabetes therapy but expressed skepticism about glucagon receptor antagonists due to safety concerns, reserving his enthusiasm for PYY/GLP-1 and other combination approaches.
5. In a special session on obesity, Dr. W. Timothy Garvey (University of Alabama, Birmingham, AL) discussed AACE’s future plans, which include the creation of new evidence-based guidelines and a second consensus conference on obesity. AACE is clearly becoming quite ambitious on this front and we’re very impressed. In the same session, Dr. Felice Caldarella (Hunterdon Medical Center, Flemington, NJ) pointed out that Medicare reimbursement for obesity counseling is restricted to primary care providers, excluding endocrinologists.
6. Euglycemic ketoacidosis continues to be raised as a safety issue with using SGLT-2 inhibitors in type 1 diabetes. There are now said to be hundreds of cases and it’s also being seen in type 2 though much more rarely (exclusively surrounding surgery as we understand it).
7. There is more to GLP-1 agonists than their effects on the GLP-1 receptor.
8. In a presentation on the future of the closed loop, Dr. Timothy Bailey (UCSD, La Jolla, CA) presented a CGM snapshot from a recently published study testing a single 10-unit dose of Afrezza in combination with an artificial pancreas system.
9. Retinopathy expert Dr. Michael Tolentino (Center for Retina & Macular Disease, Lakeland, FL) endorsed Bayer/Regeneron’s Eylea (intravitreal aflibercept) over other treatments for diabetic macular edema (DME).
10. An evening symposium sponsored by Sanofi and Regeneron provided a packed room of around 350 attendees with background on the exciting new PCSK9 inhibitor class for LDL lowering.
- Executive Highlights
- Top 10 Highlights
- Detailed Discussion and Commentary
- Diabetes Technology Update for Your Practice
- Current Pump and CGM
- Case Studies: Interpreting Pump and CGM Downloads
- Panel Discussion
- Diabetes Technology Update for Your Practice
Top 10 Highlights
1. Dr. Bruce Bode’s outstanding presentation shared news that Medtronic is working on type 1 and type 2 patch pumps. This work was last discontinued around early 2014, though the project sounds like it is now moving (at what pace, of course, remains unclear – this seems to ebb and flow with who is running Medtronic Diabetes Care). The patch pump business model is fairly different from Medtronic’s traditional durable pump business, of course, particularly from a cash flow perspective, though a type-2 specific product is certainly consistent with the company’s recent business unit creation and hiring of Dr. Bob Vigersky. (As a reminder, we learned in February that the Sanofi partnership was dissolved.) Dr. Bode also revealed that Animas’ Calibra Finesse bolus-only insulin delivery device is going into clinical trials across the US – still, J&J’s 1Q15 call shared that the Finesse is still “a couple years out.” Last, Dr. Bode said that Tandem’s dual-chamber pump has encountered reservoir compatibility issues with glucagon, which is consistent with the company’s de-prioritization of this R&D program (per the 1Q15 call). See more details and Q&A below.
2. A panel discussion with Drs. Timothy Bailey (UCSD, San Diego, CA), Bruce Bode (Atlanta Diabetes Associates, GA), and Irl Hirsch (University of Washington, Seattle, WA) shared highly valuable and very opinionated insights on real-world obstacles to closing the loop, the off-label use of SGLT-2 inhibitors in type 1, and the misconception of data downloading as time consuming. On the latter, all three panelists estimated that the time required to analyze a data output is actually not that much – typically in the single digits (minutes). The rate-limiting part of the process, suggested Dr. Bailer, is that data downloading is “synchronous” with appointments – patients do not download data before coming into the clinic, which means precious in-clinic time is wasted on uploading the data (the actual analysis is quick). We heard widespread agreement that developing a system (e.g., taking a patient’s CGM/pump from them while they are in the waiting room) is a key to expediting this process, though we imagine it is not easy to push forward with such structural changes. See below for full details on the panel.
- Drs. Hirsch and Bode shared that one of their biggest concerns with the artificial pancreas is the scarring and fibrosis associated with insulin infusion. Dr. Hirsch spoke to the very real and frustrating phenomenon of diminishing insulin absorption at infusion sites that results in very little usable real estate. Importantly, he attributed the lipohypertrophy to the infusion of the foreign protein itself, not the set. He emphasized that next-gen infusion sets – including BD’s recently FDA cleared design – will help with kinking and comfort, though he does not believe they will reduce the incidence of scarring and fibrosis (how disappointing this was to hear). With patients getting on pump therapy earlier and earlier, he stressed that this physiologic issue needs attention. Indeed, we would agree that while the efficacy side of closing the loop is a critical question, practical questions like this should be at the fore as well.
3. Dr. Irl Hirsch spent the majority of his presentation emphasizing the importance of CGM and insulin pump downloads in contemporary diabetes care and confirmed that the results of his FLAT-SUGAR pilot study will be presented at ADA 2015. An informal poll of the audience revealed that ~50% of the ~200 attendees routinely download CGM and pump data. Dr. Hirsch noted ruefully that this figure is significantly higher except among pediatric endocrinologists he has surveyed as generally most of them download. [Of course, the high percentage may reflect some degree of sampling bias from asking AACE-attending endocrinologists themselves – they are likely more engaged than average.] He believes that there are two reasons that providers do not download technology: (i) there is no infrastructure in the office for downloads leading to misconceptions of a lack of time; and (ii) downloading is a new idea – providers never received downloading education in their training (which is highly disappointing in our view though unsurprising – Close Concerns alums in med school now say the training encompasses acute care much more than chronic case, as it relates to diabetes). To that we would add software/cables that are hard to use – of course, this is getting better as offerings like Diasend, Glooko, and Tidepool improve/come to market. Dr. Hirsch emphasized the difficultly in rationalizing glycemic targets without referring to downloaded data – as Dr. Bruce Bode affirmed: “I can’t live without a download. I’m wasting time without one!” For more insight from his presentation, including what he sees as the biggest patient mistake in using CGM, please see below.
4. Dr. Ralph DeFronzo (University of Texas Health Science Center, San Antonio, TX) emphasized the importance of targeting glucagon in diabetes therapy but expressed skepticism about glucagon receptor antagonists due to safety concerns. After reviewing the substantial body of clinical data demonstrating the importance of glucagon in diabetes pathophysiology, he noted that glucagon receptor antagonists have attracted a great deal of interest in the field (companies with candidates in development include Isis, Lilly, and Ligand). While he agreed that this class is exciting in terms of efficacy, he cautioned that the long-term impacts are largely unknown, listing alpha cell hyperplasia, increased pancreatic weight, elevation in a range of proglucagon-related peptides, and decreases in lipid oxidation (which could lead to insulin resistance) as potential concerns. No serious safety signals have emerged in clinical trials of these agents thus far, though most of the studies to date have had relatively short durations. He also expressed skepticism about the potential of GLP-1/glucagon dual agonists, as he believes determining the correct dose ratio will be very challenging. Out of the various fusion proteins targeting metabolic dysfunction and appetite regulation, Dr. DeFronzo expressed the most enthusiasm for PYY/GLP-1 combinations – we do not know of any companies currently developing such combination products, though it would certainly be an interesting area to pursue. Dr. DeFronzo also listed PYY/oxyntomodulin, GLP-1/oxyntomodulin, and GIP/GLP-1 as other potentially promising combination approaches. However, he emphasized during Q&A that weight loss achieved by any means would take away the need for all the therapies under discussion (“we could throw away 70%-80% of the drugs we have”), adding onto the increasingly accepted idea of obesity as a gateway disease.
- Dr. DeFronzo also suggested that data on GLP-1 agonist/SGLT-2 inhibitor combinations (another one of his favorites) could be presented at EASD in September, significantly ahead of schedule. This would be truly exciting. We’ve heard a lot of anecdotal excitement about this due to the ease of the pill and the cool satiety factor of GLP-1 – this is a classic case where the weight loss with both has worked very well for some patients in particular – and better than just SGLT-2s on their own, which some doctors have privately shared, have just resulted in patients eating more and not gaining weight rather than eating the same amount and losing weight. As a reminder, Dr. DeFronzo is currently conducting a study in collaboration with Janssen investigating combination therapy with J&J’s Invokana (canagliflozin) and Novo Nordisk’s Victoza (liraglutide). He stated that the investigators are hoping to complete the study within the next six months and suggested that data could be available as early as EASD in September – this would be a significantly accelerated timeline from the original primary completion date of February 2016. Dr. DeFronzo spoke in more depth on the potential of this combination at the recent GTC Diabetes Summit, suggesting that adding a GLP-1 agonist could potentially double the efficacy of SGLT-2 inhibitors by blunting the compensatory increase in endogenous glucose production.
5. In a special session on obesity, Dr. W. Timothy Garvey (University of Alabama, Birmingham, AL) discussed AACE’s future plans, which include the creation of new evidence-based guidelines and a second consensus conference on obesity. Dr. Garvey prefaced by noting the need for comprehensive, evidence-based guidelines in obesity medicine, commenting that some of the current guidelines are not adequately comprehensive and that the multiple existing guidelines can create confusion among providers. AACE is thus planning to fill this gap with guidelines focused on a complications-centric approach; Dr. Garvey stated that the guideline is expected to be finished by late summer or early fall. Notably, Dr. Garvey also announced that this past Tuesday, the AACE board has approved a second consensus conference on obesity, which is to take place early next year. The conference will bring together various professional societies as well as patients with the goal of harmonizing existing guidelines – please see our coverage of AACE’s first consensus conference from last March for more. In addition, AACE is working on creating a white paper and toolkit that will offer practical guidelines and efficient data-gathering methods for providers to simplify the practice of obesity medicine, which will eventually be translated into a CME program – tools in the toolkit include algorithms, guidance on equipping and staffing an office for obesity management, strategies for patient communication, and more. We are excited to see AACE investing in such significant initiatives in obesity and alongside the Endocrine Society’s recent guideline for obesity pharmacotherapy, we hope that these efforts will quell the reluctance among many providers to aggressively treat overweight and obesity.
- In the same session, Dr. Felice Caldarella (Hunterdon Medical Center, Flemington, NJ) pointed out that obesity counseling under Medicare is only reimbursed for primary care providers, excluding endocrinologists – this understandably prompted dismay among attendees. Reimbursement codes for obesity screening, nutrition counseling, and intensive behavioral counseling and therapy are thus of little use to endocrinologists; additionally, Dr. Caldarella commented that the national average of reimbursement for such services is only $26. We strongly agree that this loophole in the incentive structure is quite an obstacle for obesity treatment, as primary care providers’ time with patients is overall even more limited than that of endocrinologists – see our coverage of NPR and Kaiser Health’s related article for more on this. In response to attendees’ frustration regarding this restriction during Q&A, Dr. Michael Gonzales-Campoy (Minnesota Center for Obesity, Metabolism, and Endocrinology, Egan, MN) stressed that AACE is indeed concerned about these constraints and is working with federal agencies on the issue. We would also note that these limitations remain in the context of the recent USPSTF “B” recommendation to provide behavioral interventions for overweight and obese adults with CV risk factors (in addition to the older “B” recommendation to screen all adults for obesity and provide behavioral interventions for those with a BMI of at least 30 kg/m2), making the federal government’s current policies a bit paradoxical.
6. Euglycemic ketoacidosis continues to be raised as a safety issue with using SGLT-2 inhibitors in type 1 diabetes. We heard consensus that such off-label should be limited until the field has better adverse event data on the use of the drug class in the type 1 population. Although little is known about the mechanism behind the effect, Dr. Irl Hirsch suggested that a key contributor may be the fact that SGLT-2 inhibitors allow patients to lower their insulin doses significantly. During his talk on glucagon, Dr. DeFronzo suggested that the elevated glucagon production seen with SGLT-2 inhibitors may contribute by pushing the liver into a ketogenic mode, as elevated glucagon is normally a signal of a fasting state. Dr. Hirsch also noted that most cases of euglycemic ketoacidosis in his experience have been linked to J&J’s Invokana (canagliflozin), though this may be a result of its first-in-class status in the US. Dr. Vivian Fonseca (Tulane University, New Orleans, LA) noted reports from Japan of the phenomenon happening in type 2 diabetes patients. His recommendations were for type 1 diabetes patients using SGLT-2 inhibitors off label to check urine ketones regularly, although he did not urge all patients taking the drugs off label to stop immediately.
7. There is more to GLP-1 agonists than their effects on the GLP-1 receptor. That was a key point in Dr. John Buse’s (University of North Carolina, Chapel Hill, NC) presentation on the cardiovascular safety of incretin-based therapies. He highlighted the distinction between data on GLP-1 agonists vs. native GLP-1. Native GLP-1 is metabolized into compounds that themselves appear to have beneficial downstream effects on targets such as vascular epithelial cells. However, GLP-1 agonists are designed to resist metabolism by DPP-4 and do not yield the same types of metabolites. As a result, the preclinical and early clinical cardiovascular benefits seen with native GLP-1 cannot necessarily be assumed to exist for GLP-1 agonists, although Dr. Buse did seem generally optimistic that the sum of GLP-1 agonists’ cardiovascular effects should be beneficial. On a closing note, Dr. Buse pointed out that longer outcome trials enrolling patients with less longstanding diabetes are needed to test the hypothesis of cardioprotection. Along these lines, we have been hearing more and more that CVOTs as they are currently designed can do little more than check the box for basic safety – this is so incredibly disappointing from a patient perspective that we can barely think straight about it. .
8. In a presentation on the future of the closed loop, Dr. Timothy Bailey (UCSD, La Jolla, CA) presented a CGM snapshot from a recently published study testing a single 10-unit dose of Afrezza in combination with an artificial pancreas system. In the study (Zisser et al., JDST 2015) each subject was given two meal tests, one with a 10-unit Afrezza dose taken before the meal and one without, both under control of a zone model predictive control algorithm. The premise is that the ultra-rapid-acting kick-in from Afrezza compensates for the slower onset of action of injectable insulin - this could enable a fully automated closed-loop that does not require manual meal input. Both the published results and the pair of CGM traces on Dr. Bailey’s slides looked good: there was a marked improvement in time in range (70-180 mg/dl) from 60% to 82%, with a reduction in postprandial glucose peak from a mean of 205 mg/dl to 172 mg/dl. We first saw this study presented at ATTD 2013, and it’s great to finally see it published. Quite impressive to see and an intriguing application for Sanofi’s Afrezza, which posted modest figures in its first quarter of reported sales (see our Sanofi 1Q14 Report for more.
9. Retinopathy expert Dr. Michael Tolentino (Center for Retina & Macular Disease, Lakeland, FL) endorsed Bayer/Regeneron’s Eylea (intravitreal aflibercept) over other treatments for diabetic macular edema (DME). His opinion was based on the results of an NIH-sponsored study comparing Eylea vs. Roche/Novartis’s Lucentis (intravitreal ranibizumab) vs. Genentech’s Avastin (bevacizumab) that showed significantly greater improvements in visual acuity overall with Eylea vs. either comparator. However, full results showed that the difference was driven entirely by the subgroup with a baseline visual-acuity letter score <69 (~20/50 vision); based on this, we have wondered to what extent the medical community will view the results as a clear-cut win for Eylea. For its part, Roche has suggested that the broader population of patients enrolled in the diabetic retinopathy trials for Lucentis (those with both proliferative and non-proliferative retinopathy) could give the drug an edge over Eylea. Time will tell – as Dr. Tolentino acknowledged, it is the opinions of payers that will ultimately carry the most weight.
10. An evening symposium sponsored by Sanofi and Regeneron provided a packed room of around 350 attendees with background on the exciting new PCSK9 inhibitor class for LDL lowering. The two furthest-along agents in the class, Sanofi/Regeneron’s Praluent (alirocumab) and Amgen’s Repatha (evolocumab), have demonstrated ~40%-70% reductions from baseline in LDL cholesterol in a wide range of patients, including those with statin intolerance. Additionally, phase 3 post-hoc analyses appear to show roughly 50% reductions in CV events, although these are not outcomes trials and involve fairly few events (see our ACC 2015 Report for more background on this). During the dinner, diabeto-cardiologist Dr. Robert Eckel (University of Colorado, Aurora, CO) declined to predict whether the FDA will approve Repatha and Praluent for broad indications or stick with targeted subpopulations (i.e.: familial hypercholesterolemia) until outcomes data arrives in 2018. However he did note that no matter how clinically compelling PCSK9 inhibitors are, the drugs will not be used if they are not covered by payers and must therefore be at least somewhat affordable. The panel agreed that most patients should try proven therapies like statins (and possibly even ezetimibe) before going to PCSK9 inhibitors.
Honorable Mention: When it comes to the growing body of evidence comparing weekly GLP-1 agonists head-to-head vs. rapid-acting insulin in addition to basal insulin, the most important factor is not A1c. Rather, Dr. Vivian Fonseca (Tulane University, New Orleans, LA) suggested that the difference largely comes down to two numbers: 8 and 28. Patients using a weekly GLP-1 agonist plus basal insulin will take eight injections a week, whereas patients going to basal-bolus will step up to 28 injections a week. In his view, this is one of the biggest explanations for his observation that the combination of GLP-1 agonists and basal insulin is being used more in clinical practice as an alternative to MDI.
Detailed Discussion and Commentary
Diabetes Technology Update for Your Practice
Current Pump and CGM
Bruce Bode, MD (Atlanta Diabetes Associates, GA)
Dr. Bruce Bode provided a phenomenally comprehensive overview of current and future diabetes technology offerings, sharing new details on Medtronic’s, Animas’, and Tandem’s pipelines. As he did last year, Dr. Bode also shared his view on the advantages and disadvantages of various pump and CGM offerings – see our detailed coverage for his tables on the pros/cons of current pump and CGM products (Medtronic, Dexcom, Animas, Roche, Tandem, Asante, Insulet, Valeritas).
- Dr. Bode disclosed new details on Medtronic’s pipeline, revealing that the company is working to develop patch pumps for both the type 1 and type 2 spaces. This is the first update we have heard on Medtronic’s interest in a patch pump product since it was revealed at the 2014 Analyst Day that the technology was no longer in the company’s pipeline. We assumed that Medtronic had compromised with its MiniMed Flex “hybrid pump” (a durable pump that can be worn on or off the body), though judging from Dr. Bode’s slide deck, it seems like these are separate projects. Details were not shared, though it is good to hear there is at least some movement within Medtronic on this front. Timing, of course, is a big question mark.
- The interest in a type 2 patch pump is not altogether surprising, given Medtronic’s increasing move into type 2. The business model is certainly different from the company’s traditional pump business, though the new management team is clearly focused on trying new things – the slew of recent announcements have included: DreaMed artificial pancreas algorithm licensing; Diabeter clinic acquisition; Glooko investment; and a new partnership with IBM. Of course, these announcements make headlines, but the cadence of products is ultimately a test, and we look forward to hearing specific timelines and product launches. Dr. Bode revealed that Animas’ Calibra Finesse bolus-only insulin delivery device is going into clinical trials across the US. In J&J’s 1Q15 call, management shared that the Finesse is still “a couple years out,” which would put commercialization in 2017 at the earliest. Given management’s conservative commentary on the technology of late, it is good to hear that J&J continues to prioritize the device on some level. Of course, this project has moved quite slowly, given the Calibra acquisition occurred in July 2012.
- Though he did not share details, Dr. Bode also hinted that LifeScan is planning to come out with a new web-based, data-downloading platform called the “Reveal.” This is the first we have heard of this system, and we don’t know what it will look like. As a reminder, J&J is one company that has not agreed to partner with Tidepool, and the news makes us wonder how the launch of J&J’s own web-based proprietary software might play into that strategic decision.
- Tandem has reportedly faced reservoir compatibility problems with glucagon, a challenge that has stunted the development of a dual-chamber pump. In its 1Q15 call, management was pretty clear that the JDRF-partnered dual chamber pump is definitely not a near-term project, especially relative to insulin-only closed-loop systems (possible late 2017 launch). Interestingly, the BU/MGH group have not reported similar issues with the Tandem pumps they use, though their academic research studies swap out the glucagon at least daily – perhaps Tandem has been trying out three-day use, or is using the Xeris formulation instead of the reconstituted Lilly/Novo Nordisk glucagon. Given all the questions surrounding glucagon’s cost, as well as Tandem’s limited R&D funds, we do think it’s smart to prioritize insulin-only at this point.
- On Tandem’s pipeline, Dr. Bode commented that the 480-unit t:flex “will be available very quickly”; this is consistent with management’s 1Q15 commentary putting shipment in June 2015. According to Dr. Bode, the current challenge is establishing capacity to meet demand.
- Dr. Bode closed his presentation by offering stirring commentary on the utility of patch pumps in the type 2 space – “you take any of your patients failing MDI and put them on this, you’ll be shocked.” We have certainly been saying for years that there have been many many happy patients with Valeritas. He suggested that patients fail MDI because of non-adherence to insulin regimens, an obstacle that around-the-clock patch pump therapy addresses directly. We agree with Dr. Bode that this area has tremendous potential to help many patients out there, though it has suffered from not enough industry focus – Valeritas’ V-Go is the only product available in the US, and the company has only rolled it out regionally. As a reminder, Valeritas filed for an IPO earlier this year, but postponed the offering in March. Still, the interest of big players like Medtronic and BD suggest the type 2 simple patch pump landscape has upside.
Questions and Answers
Q: I have heard Animas reps claim their pumps are more accurate in terms of basal and bolus delivery. What do you think of their data?
A: When you get into accuracy, they are probably slightly more accurate. They have a publication that just came out. It looks at 0.1 increments of insulin doses and how often they are above that. Does that mean much? In the big picture of things, if most people are off by a half unit of insulin, it doesn’t matter. If you are at five units a day, it matters. But if you are at 30-40 units a day, it doesn’t matter. Some people are talking about 0.01 units increments that do not make a difference except in unique individuals. There are so many issues with tubing and length of tubing – so many variables involved – that it’s not so clinically relevant.
Q: Can you talk about active insulin? Is there a lot of value in pre-bolusing?
A: I set active insulin at the true duration of insulin, which is 4 hours. Pediatric providers say that when you give smaller dose it doesn’t last for four hours. But in a clamp study, it does. Pediatric patients do sometimes take a partial dose up front. So to do that, providers might put the active insulin at two hours. We’ll have good data at ADA that if you use faster-acting insulin, there is a significant decrease in postprandial spikes with a significant decrease in hypoglycemia. That’s also been shown with inhaled insulin very clearly.
Q: Can you talk about the possibility of DKA with SGLT-2 inhibitors? What is the mechanism of action?
A: SGLT-2 inhibitors activate the ketogenic pathway. You spill glucose into the urine and that masks the ketoacidosis. Even at 150-200 mg/dl, we are seeing patients going down a ketogenic pathway.
[Comment]: I just wanted to clarify. I’m on a t:slim pump. It’s nice and easy to use. They do have a new algorithm. You used to have to fill the cartridge after you put it into the device, but now you can put the cartridge in after you fill it. And off-label, you can go about five refills without changing it.
Q: How do you look at data in office? What is your process?
A: Once you get comfortable with one software, you tend to stick with that. And once you use that system, you get good at it. If you have five systems, you want to pull your hair out. Ultimately, you need smart software. Tidepool will hopefully work for everybody. They have to be good though. They are working for everybody. Right now, manufacturers have different systems. Overall, I can’t live without a download. I’m wasting time without one.
Q: How do you get patient to change dosage in between visits?
A: With pediatric patients, I try to teach the parents how to make changes on their own. And they do it. But how does a patient do it? If they are comfortable, I have them do it themselves. Otherwise, I have them upload the and then we go into the web-based server and educate them. I provide that for free. As a note, I’m starting to charge for looking at real-time CGM remotely. If you don’t charge for it, you’re not going to get paid.
Case Studies: Interpreting Pump and CGM Downloads
Irl Hirsch, MD (University of Washington, Seattle, WA)
Dr. Irl Hirsch (University of Washington, Seattle, WA) spent most of his presentation discussing CGM and insulin pump downloads, and again expressed his belief that within five years, CGM penetration will outstrip that of insulin pumps. An informal poll of the audience revealed that ~50% of the ~200 attendees routinely download CGM and pump data. Dr. Hirsch noted ruefully that this figure is significantly higher than that seen among pediatric endocrinologists he has surveyed. [Of course, the high percentage may reflect some degree of sampling bias from asking AACE-attending endocrinologists themselves. After all, his informal survey of educators at AADE 2014 revealed that only 5% of the ~400 attendees worked with providers who routinely download CGM and pump data.] Ultimately, Dr. Hirsch believes that there are two reasons that providers do not download technology: (i) there is no infrastructure in the office for downloads leading to misconceptions of a lack of time; and (ii) downloading is a new idea – providers never received downloading education in their training. [To that we would add software/cables that are hard to use – of course, this is getting better as offerings like Diasend, Glooko, and Tidepool improve/come to market.] However, Dr. Hirsch emphasized the difficultly in rationalizing glycemic targets without referring to downloaded data – as Dr. Bruce Bode affirmed: “I can’t live without a download. I’m wasting time without one!” Dr. Hirsch concluded that patient education on data downloads is even more preferable, as it enhances self-management and allows patients to begin to own their diabetes.
- Dr. Hirsch was very optimistic on the future of CGM – he again expressed his belief that within five years, CGM penetration will outstrip that of insulin pumps. In this lecture, Dr. Hirsch focused on what he sees as the most common patient mistakes in using CGM: (i) over- and under-calibration of the sensor; (ii) ignoring the sensor readout and only responding to alarms; (iii) overreaction to alarms and not taking into account lag times (e.g., insulin stacking); and (iv) not using enough SMBG to confirm a final dosing decision.
- One of the first components Dr. Hirsch looks at in patients’ downloads is standard deviation (SD). Though it is not perfect, the metric provides an indicator of glucose variability and a quick assessment of a patient’s “diabetes fingerprint.” That said, he emphasized the importance of thinking about SD in the context of the mean (i.e., coefficient of variation, the variable of choice in his FLAT-SUGAR pilot study, which he confirmed will be presented at ADA 2015). Several quick and dirty calculations that Dr. Hirsch uses to get a sense of patients’ management include:
- For SMBG: SD x 3 < mean glucose. This first-line metric allows clinicians to see if patients are giving their insulin at the correct time and regularly matching their food with insulin. That said, Dr. Hirsch noted that patients who can get to this point are often still making some endogenous insulin. SD x 2 < mean glucose is the minimum amount of variability without having excessive hypo or hyperglycemia, independent of HbA1c. This rule only works for means between 120-180 mg/dl.
- For CGM: SD x 3 < mean. Dr. Hirsch was forward-looking, noting that current CGM downloads often have 3,000 data points, and we need better metrics. In his opinion, coefficient of variation (CV), TIR (time in range), TBR (time below range), and TAR (time above range) all need to be correlated with outcomes, as they are important pertaining to markers of inflammation, oxidative stress, and severe hypoglycemia. His FLAT-SUGAR study is looking at all of these parameters, though coefficient of variation is the metric of choice.
- “This is much more complicated than A1c itself!” Dr. Hirsch presented his wish list for downloads. For pumps this included basic insulin statistics, TDD, % basal, % use of bolus calculators, time-specific bolus calculator over-rides and under-rides, and a daily summary to better understand ICR, ISF, basal rates. For CGMs, Dr. Hirsch requested basic blood glucose statistics, overall patterns, and daily decision making to best understand how patients think through challenges.
- Dr. Hirsch shared that the “timing of insulin is the most important part of dosing.” He said that in the context of the many variables that influence the size of a dose – carb counting, insulin on board, sensitivity factor, etc. – and the current speed of insulin, it is not the dose that usually matters as much as when it is given – “If you give insulin 10-20 minutes after you eat, you’re toast!”
- Dr. Hirsch believes that the biggest limitation of insulin bolus calculators is that they always assume glucose is unchanging at the time of advice – indeed, he believes that “trends trump insulin on board.” Dr. Hirsch finds that patients who over- and under-ride their bolus calculators ~20-25% of the time tend to be in the best control; those who never over- or under-ride are often not adjusting for glucose trends – of course, this requires patients are on CGM, which is still not usually the case at this stage of penetration. From a clinical perspective, he emphasized that a patient with a blood glucose of 200 mg/dl with “two arrows down” is very different from one with “flat arrows” or “two arrows up.” We would certainly agree, and this was a major point of our November 13 presentation at the FDA’s Workshop on Bolus Calculators and Interoperability.
- Dr. Hirsch – along with his co-presenters – cited concerns over reimbursement as the most formidable barrier to wider adoption of data downloading. There was no consensus on a solution, but it seemed like nothing short of structural reimbursement reform will provide a long-term solution. We agree, though the mechanics of making this happen continue to allude us. Below, we have included some of the some notable quotes from Dr. Hirsch’s presentation and the resulting Q&A:
- “The issue is that diabetes is a very time-intensive disease. I’m not convinced that the way we do it is the most efficient way. I don’t think we use the web enough. We should have web classes. We should have Skype and Facetime classes. However, where I live in particular, we can’t get reimbursed for that kind of therapy. We need to though. We have that kind of technology available.” – Dr. Hirsch
- “We have to mobilize the online patient community. We talk about legislative approaches and ways to get reimbursed. This is something we can’t ignore. If we sit on our butts, then legislators and governments will determine our payments.” – Dr. George Grunberger
- “I can’t live without a download. I’m wasting time without one!” – Dr. Bruce Bode
Questions and Answers
Q: I’ve got a lot of patients who are pumpers. I also have patients who refuse to buy into that. I don’t know what to tell those people. Do you think patients should sign a contract? How do you deal with that? I’d say that’s 30% of my insulin-treated patients.
A: I do the best I can. We’ve had people die from hypoglycemia. We are learning more about the mechanisms of this. All I can do is be a partner. Yelling at them and scolding them does not work. I sleep at night knowing that some patients aren’t going to play the program.
Q: With respect to exercise physiology, how do you deal with the fact that 45-60 minutes of aerobic exercise is different from 30 minutes of anaerobic exercise?
A: The good news on exercise is that most patients tend to repeat exercise patterns day after day, or week after week. So we can individualize our treatment. If someone is on MDI or pump and is going to bolus within 3-5 hours of exercise, I have them cut down on their bolus dose. Patients on pumps, I’ll have them cut their basal dose. And with patients on MDI, that’s why I like to use glargine or detemir two times a day, because then you can cut one of them down even if they are not on a pump.
Q: How do you set your basal rates on a pump with patients? Do these vary?
A: With pump patients, one of the problems is that absorption on day 1 is different from that on day 3. It’s difficult.
[Comment]: I had a similar population with at least 30% of patients that didn’t want to be on pumps and would even fake their blood sugars. I think there is a gene that all of us diabetics inherit for lying and non-compliance. The point is that education is a big factor here. We’ve been doing team education in our office for 15 years. It is basic to what these patients do. You cannot yell at them. If you teach them why you’re doing certain things, that helps. If they understand why, it can help. Unfortunately, governments and insurance companies do not pay for education anymore. That’s so unfortunate because that’s the basis of therapy. We have data that shows that patients who get education do better. We also know that lower socio-economic groups tend to do worse, and we have cultures that tend to do worse. We need studies that look at those cultural issues and get governments to appreciate those challenges.
A: The issue is that diabetes is a very time-intensive disease. I’m not convinced that the way we do it is the most efficient way. Having said that, I don’t think we use the web enough. We should have web classes. We should have Skype and Facetime classes. However, where I live in particular, we can’t get reimbursed for that kind of therapy. We need to though. We have that kind of technology available. I agree with everything you said. Yelling and screaming makes no sense at all.
Timothy Bailey, MD (UCSD, San Diego, CA), Bruce Bode, MD (Atlanta Diabetes Associates, GA), and Irl Hirsch, MD (University of Washington, Seattle, WA)
A panel discussion with Drs. Timothy Bailey, Bruce Bode, and Irl Hirsch shared highly valuable and very opinionated insights on real-world obstacles to closing the loop, the off-label use of SGLT-2 inhibitors in type 1, the misconception of data downloading as time consuming, and more.
- Euglycemic ketoacidosis was again raised as a safety issue with use of SGLT-2 inhibitors in type 1 diabetes. We heard consensus that such off-label use should be limited until the field has better adverse event data on the use of the drug class in the type 1 population. Dr. Bode was adamant in advising providers to “hold of using [SGLT-2s] in type 1s.” Indeed, while education and regular ketone checks may mitigate the problem, Dr. Hirsch suggested that this is still an area of serious concern that is developing; he was relatively reserved in his commentary as he noted that he is involved in a publication on the topic that should be coming out shortly (presumably for communication to the FDA and/or via publication to the clinical community).
- Although little is known about the mechanism behind the effect, Dr. Hirsch suggested that a key contributor may be the fact that SGLT-2 inhibitors allow patients to lower their insulin doses significantly. Dr. Hirsch did acknowledge that most cases of euglycemic ketoacidosis in his experience have been linked to Invokana (canagliflozin), though this is most likely a result of its first-in-class status. We expect this to be a very closely-watched issue by HCPs (especially the KOLs who are now well-attuned to it) for SGLT-2 inhibitors in type 1, especially given that multiple influential thought leaders appear to be seeing similar things (e.g., Dr. Anne Peters at ENDO 2015). Certainly, the ongoing phase 3 studies testing SGLT-2s in type 1 should bring out clearer data. It is early to say if this issue will keep the entire drug class away from type 1 diabetes patients; on the plus side, Dr. Bailey shared that the class has yielded some strikingly positive improvements in A1c and glycemic variability in his type 1s.
- In response to a question from the highly regarded Dr. Robert Vigersky, all three panelists emphasized that the notion of data downloading as time consuming is partially a misconception. Said Dr. Hirsch, “The time isn’t that big an issue because we all know what we want to look at.” All three panelists estimated that the time required to analyze a data output is typically in the single digits except in extreme cases when a “pattern” is not immediately evident (usually because of a lack of data). Instead, Dr. Bailey suggested that the rate-limiting part of the process is that data downloading is “synchronous” with appointments – patients do not download data before coming into the clinic, which means precious in-clinic time is wasted on uploading the data while the actual analysis is quick. We heard widespread agreement that developing a system (e.g., taking a patients CGM/pump from them while they are in the waiting room) is a key to expediting this process, though we imagine it is not easy to push forward with such structural changes in all healthcare settings.
- Dr. Irl Hirsch shared that his biggest concern with the artificial pancreas is the scarring and fibrosis associated with insulin infusion. Dr. Hirsch spoke to the very real and frustrating phenomenon of diminishing insulin absorption at infusion sites, resulting over time in little usable real estate. Importantly, he attributed the lipohypertrophy and scarring to the infusion of the foreign protein itself, not the set. He emphasized that next-gen infusion sets – including BD’s recently FDA cleared design – will help with kinking and comfort though he does not believe they will reduce the incidence of lipohypertrophy. With patients getting on pump therapy earlier and earlier, he stressed that this physiologic issue needs attention – “Every patient that uses a pump, you have to look at skin every visit. It’s more important than looking at their feet every visit.”
- While we would point out that the efficacy side of closing the loop is a critical question, clearly practical questions on the human physiology side should be at the fore as well. They deserve attention in the near future (especially considering how quickly the loop is closing) and we are glad to hear Dr. Hirsch raising the level of conversation.
- Panelists concurred that a significant upshot of the artificial pancreas on clinical practice will be the enabling of telemedicine. Dr. Bailey suggested that closed-loop systems will change the therapeutic model from one in which providers “tune the patient” to one in which they tune algorithms. With the availability of data (e.g., insulin usage, glucagon usage, 24/7 blood glucose), we heard consensus that closed-loop systems should facilitate remote monitoring and wide-scale population tracking. This is a benefit of closed-loop not often discussed, but certainly one with interesting potential to scale an increasingly limited number of providers. We remain somewhat skeptical, however, that providers have the bandwidth to deal with remote data/algorithm management, particularly in a US reimbursement environment that doesn’t support it.
Q: I use a lot of SGLT-2s off-label in type 1s that are overweight. Have you noticed a reduction in insulin in pump patients on SGLT-2s. I have noticed about a 30% reduction.
Dr. Tim Bailey (UCSD, La Jolla, CA): I try not to prescribe SGLT-2s to type 1s at this point because of concerns with diabetic ketoacidosis out there. I have seen two cases and Dr. Anne Peters [USC, Los Angeles, CA] had three cases. But patients love these drugs. There’s a weight benefit; it helps postprandials; weight comes down. But now we know personally or know of patients with DKA. It’s nothing new in patients, but it’s new for patients on this drug. It’s an education effort that we’re going to have to tell them a few times.
Dr. Irl Hirsch (University of Washington, Seattle, WA): I have to choose my words carefully because our report will hopefully be coming online soon. The patients I am concerned about are those in surgery. What we are realizing is that measuring glucose may not reflect what is happening in the liver. It’s tough because where I live with a lot of Asian patients, they are insulin deficient and you see reduction in insulin usage, but you don’t know if they’re getting enough insulin in the liver to reduce ketogenesis. There’s got to be labeling for these drugs in type 1s. What happens is that we tend to give someone a lower dose, they get the flu, and then they drop their insulin further – that results in DKA. I think the bottom line is that all patients should be doing ketone testing. Anyone on SGLT-2 inhibitors has to have the ability to check their ketones at home.
Dr. Bruce Bode (Atlanta Diabetes Associates, Atlanta, GA): I think the rule of thumb is that you should hold of on using SGLT-2 inhibitors in type 1s. Only phase 2 trials have been finished. Phase 3 trials are starting. This is an issue of prescribing a drug when we don’t have safety data on it. Phase 3 will give us safety data. If you are going to use it, never stop your insulin even if you have someone with a GI virus. You have to be very careful.
Q: Do you notice any dosage or brand differences?
Dr. Hirsch: What I can tell you is that we see the most euglycemic DKA with the compound that has been on the market the longest. But the mechanism is the same for all of these.
Dr. Bode: I would just note that there have been cases of DKA in type 2s with normal glucose. These are patients who aren’t eating anything. If you aren’t eating, bad things are going to happen.
Q: There is a concern about overuse of glucagon and physiological use of glucagon. What safety data do we have?
Dr. Bode: There is very little data out there on the continuous use of glucagon. It’s a question to be answered. I asked Irl if he’ll wear an artificial pancreas. He says he’s out of real estate.
Dr. Hirsch: This is an important generic comment. What do we see with long-term physiological glucagon use in glucagonoma. You get rashes and diarrhea. This is the problem. We have patients that have been on pumps for 20-30 years, and they have literally run out of real estate for the pumps. Am I the only one seeing this? [50% of the audience raises their hands]. We try to use the hip and other sites. I don’t believe it’s the catheter. I think it’s the fact that we’re infusing this foreign protein, and I don’t know if part of the problem is the fact that when they started they were using animal insulin. I had a patient earlier this week – I’ve been trying to get him to take a pump holiday, and I finally got him onto MDI. He came back and told me that “this is the first time in five years that I’ve really got my insulin like I thought I was.” I’ve got to tell you; this is a giant experiment. I’ll give you another example. I saw a lady who started on a pump in 1982 and in she is in her 70s, who suffered from DKA because of the scarring and fibrosis. Every patient that uses a pump, you have to look at skin every visit. It’s more important than looking at their feet every visit.
Dr. Bode: Some patients don’t have issues. Some patients have tremendous issues. We do have new sets coming out, and we’re going to see newer infusion sites that will be more comfortable for patients. But lipohypertrophy is a real issue.
Dr. Bailey: There are combination infusion sets too in Europe. But anything to reduce lipohypertrophy is important. Checking site is very important.
Dr. George Grunberger (Grunberger Diabetes Institute, Bloomfield Hills, MI): We talked about importance of downloads, but on downloads you don’t see the frequency of site changes. That’s another variable.
Dr. Hirsch: You’re right. Changing the infusion site also influences the amount getting absorbed. But on CareLink, you can see it. The bottom line is that with the scar tissue and fibrosis, we need to do skin biopsies to really understand the mechanism of what is going on. I don’t think the new infusion sets are going to have as big of an impact. You’ll see less kinking but it’s the foreign protein– the insulin – that causes the problems we see.
Dr. Robert Vigersky (Medtronic Diabetes, Los Angeles, CA): How much time does it take you to review downloads?
Dr. Hirsch: We have a system. We have now been on Epic for roughly a year. From my point of view, it has been an epic disaster. It has not been good. There have been some good things though. Whether it is a CliniPro download or Diasend, it’s put into a PDF format and it’s put into Epic immediately. So the download can occur at the end of the hall 100 feet away, and I have their data immediately on my computer. On the issue of the time I have with patients and how long it takes to download: Diasend and Animas are extremely slow. The quality is a different issue. The time isn’t that big an issue because we all know what we want to look at. There are certain things I will look at and the main thing is that I look at the last five days of the individual detailed data. Individually, I go through that time period with patients and can spend less than ten minutes just doing that and can figure out quickly if we need to make changes. Because we have system that we have running, it is quick. Now if I was the only endocrinologist in a bigger clinic, it could not go that quickly.
Dr. Grunberger: This is a critical question. Because the more experienced, the faster we get at it. However, most professionals are paid by the hour. So the more experienced we get, the less we get paid. We have to figure out how to sell our brains.
Dr. Bailey: We would love for Tidepool or some other system to get in here. Getting data to the cloud is the rate-limiting step. Medtronic does have remote downloading capability. The cloud is important. The thing is that downloading needs to be synchronous. It takes fifteen minutes to download pump and sensor data. We want to make it more asynchronous – patient uploading (preferably automatic) to cloud so that the data is already there when they come for a clinic visit. In my practice, I take three steps to a download. First, I generate a hypothesis. Then, I query the patient, getting more data and filling in the missing data. Finally, I fill in the blanks and give advice for the next step. The really hard step is figuring out the advice. The longer a patient has been with me, the shorter it takes. Newer patients can take an exorbitant amount of time.
Dr. Bode: It takes me 3-10 minutes to go through a download. If you don’t see a pattern, it’s going to take longer. If it’s all over the place, then you need lot more time. If you see a pattern, it’s going to be easy. Then you have to ask them to go home and do stuff. Our educators typically spend about ten minutes going over the reports. Then, it takes three minutes to go over their data. I analyze it separately. We bill for it. If you don’t bill for it, you won’t get paid.
Dr. Grunberger: To go back for a moment, this asynchronous element is important. We have 500 patients in our practice and only one a year actually downloads the data before they come in. That takes time to do in clinic. How do you get covered for this time? We need to figure out how to reimburse the time and our brains. Those are the resources.
Dr. Bode: You have to develop a system. We download from a lot of devices a day, and we have a system. We download 100 meters a day and 50 pumps a day. Ultimately, I think the end goal is getting smart software. After all, how many people read an EKG today?
Dr. Vigersky: Can you take about integrating this software with an EMR? Many systems are impenetrable from the outside.
Dr. Hirsch: I’m not an IT guy, but our IT guy figured out how to put the data in a PDF format to get it into Epic. Now, I can pull this stuff up instantaneously with Epic. You have to be able to do this integration.
[Comment]: We have a sign in the waiting room that says if you have a pump, CGM, or BGM, then you have to hand it over to an assistant before they begin to fill out forms. While the patient is in the waiting room doing their paperwork, they get downloaded. The actual interpretation takes under five minutes, especially if there is a pattern. Once a system is established, it’s pretty easy. Once you get the system down, it’s just a matter of getting everybody coordinated.
Q: Going back to cannula issue, do you notice differences in kinking in patients with different body fat compositions?
Dr. Bode: I think I would recommend metallic if you are thin. They will crimp more easily if hits muscle.
Dr. Hirsch: The metal cannulas do better in terms of crimping. I think over the years we’ve seen more DKA than we’re willing to acknowledge because of the crimping. People that have serious scarring and fibrosis, they don’t do well with anything we try.
Q: How do you cover a high fat meal? Like a bacon cheeseburger?
Dr. Hirsch: There’s no way to do it well. Dr. Howard Wolpert [Joslin Diabetes Center, Boston, MA] has the data on this. I’ve got to tell you something though; we’re just throwing darts. We don’t want to hit the bull-eyes; we just want to hit the dartboard. This is hard. There is no good quantitative way to get the protein and fat to get the carbs for that. The biggest concern is when you are doing this at night. If you are too aggressive, it is dangerous. That is why the CGM is so helpful. It is just really difficult to do.
Dr. Grunberger: In general, how do you deal with high fat and high protein meals?
Dr. Bode: High fat causes insulin resistance, so you’ll need more insulin. So I tell my patients to deliver 30% more insulin, but I tell them to do it over two hours. However, CGM helps you a lot. You can look back and perfect it. We have few proactive studies looking at this though.
Dr. Bailey: Bolus calculators are very simplistic. It’s really a tool to get patients to enter their carbs. It’s not really that helpful. I think the only thing that is going to solve this is the artificial pancreas. Basal-bolus therapy can’t do it. The artificial pancreas is all bolus. It’s very frequent and small doses that are being constantly adjusted.
Q: How do you deal with patients that are undercounting carbs or not telling the truth about how many carbs they are eating?
Dr. Bode: I think you’ve got to ask those patients what they are truly doing. Some of them might say, “If I put my full carbs in, I will go low.” You have to assure them that if that’s the case, then you’ll change it. People will rig the system. They’ve really got to put in the data accurately.
Q: How might the artificial pancreas modify clinical practice?
Dr. Bailey: It’s going to change the model because instead of tuning the patient, we’re going to be tuning the model. It’s going to be a very different visit. We’ll have all their insulin data and glucose data. We can guess what they are eating. It will enable more telemedicine – think what pacemakers did for the cardiology world. I’m hoping we’ll get some coverage for it, because right now, when we use telemedicine, we don’t get paid for it. The biggest change is it will enable telemedicine.
Dr. Grunberger: I think it will transform how we have these visits. It will define our practice. We don’t want people who are not in our shoes to define how we get paid.
Dr. Bode: It is going to change what you do. You’re now going to help with site selection. You’re now going to have to examine their skin and suggest other areas, especially in long-term pump users. You’re now going to have to decide – if we get better and faster insulin coming out – how to manage that. Day-to-day management of glucose won’t be there. What you do, you’ll be able to do remotely.
Dr. Hirsch: We presented the CGM JDRF study in October 2008. Only 8 weeks ago did my patients get coverage from the two major diabetes carriers in Washington. My biggest concern about the artificial pancreas and any new technology in diabetes is that even if it gets covered for patient, I don’t think we’re doing enough to cover the technology assistance patients deserve. We have failed miserably with CGM.
Dr. Grunberger: We have to mobile the online patient community. We talk about legislative approaches and ways to get reimbursed. The way is that we mobile the patient community and mobilize the consumers of our expertise. This is something we can’t ignore. If we sit on our butts, then legislators and governments will determine our payments.
Dr. Hirsch: One last thing. Someone earlier made a comment about patients not being compliant. That comment really hurt me. These patients have never been taught how to use the technology. It doesn’t mean they are not compliant. That really hurt me.
--by Melissa An, Varun Iyengar, Emily Regier, Manu Venkat, and Kelly Close
Note from the editors: A change was made from the "Diabetes Technology Update for Your Practice" session at the request of Dr. Bruce Bode on May 14, 2015.