FFL 2019 (Friends for Life)

July 17-19; Orlando, FL; Highlights – Draft

Executive Highlights

  • In his annual update at Children with Diabetes’ renowned 20th annual Friends for Life meeting, Dr. Ed Damiano shared updated timing on Beta Bionics’ iLet Bionic Pancreas. The insulin-only pivotal trial protocol was just submitted to the FDA – it aims to begin in 1Q20 (adult and pediatric), finish before the end of 2020, and enable an FDA PMA submission in late 2020/early 2021. Also in 2020, Beta Bionics will submit for an ACE pump indication and a CE Mark. The bihormonal pivotal trial (with Zealand’s dasiglucagon) is now delayed to a ~2H20 pivotal trial start. The goal is for an insulin-only launch in ~early/mid-2021, followed by a bihormonal launch in ~2022-2023. We got to play with the Gen 4 iLet dual-chamber pump – the touchscreen, no-button, no-charging-port design is terrific, and the user experience is poised to be the simplest of any closed-loop system in near-term development. While the timelines have been extended since last year, the pump hardware has come along very nicely, and financing is no longer an obstacle ($126 million raised in ten months!). Notably, several Wall Street med tech analysts flew down to FFL just to see Dr. Damiano present – we’re not surprised at all to see this and hope they paid a premium to the nonprofit Children with Diabetes.

  • Tidepool CEO Howard Look highlighted strong progress on interoperable automated insulin delivery (AID) partners Insulet, Dexcom, and Medtronic and set cautiously optimistic expectations on FDA submission of the iOS app: “We never want to be the company that contributes to mis-set expectations (like ‘a cure in five years’), so we want to keep expectations low. We hope it's measured in months, not years. We let the FDA know that we set an aggressive target of trying to have a submission prepared before the end of the (calendar) year, but there's a lot that’s out of our control, so that's just an estimate. We promise to keep the community up to speed as things proceed.”

  • See below for more highlights from Gary Scheiner on maximizing CGM, Dr. Bill Polonsky on diabetes burnout, our favorite FFL story on CGM use at diagnosis (boy has it changed expectations), and how to watch diaTribe’s two sessions (panel discussion with Dr. Bruce Buckingham, advocate Cherise Shockley, and dQ&A leader Ms. Alice Morgan), a talk by Adam about some of Adam’s favorite lessons learned).

Hello from Orlando, Florida, where we were excited to attend Children with Diabetes’ 20th (!) annual Friends for Life Conference! This annual gathering brings thousands of attendees to Disney’s Coronado Springs resort, eager to hear the latest and greatest in diabetes technology, therapy, and practical tips surrounding diabetes management. Read our top six highlights below!

Top Six Highlights

1. Beta Bionics iLet Update: 2020 Pivotals for Insulin-Only, Bihormonal; Compelling iLet Gen 4 Hardware; ACE Pump submission to FDA in mid-2020

In his 13th consecutive Friends for Life presentation, Dr. Ed Damiano provided an update on Beta Bionics’ iLet Bionic Pancreas, including: (i) a detailed timeline update on the path to commercialization (2020 milestones include starting and completing the insulin-only pivotal trial, an ACE Pump submission to FDA, beginning the bihormonal pivotal trial, a potential FDA PMA submission of the insulin-only system, and starting the CE Mark process); (ii) a review of the continually-improving Gen 4 iLet dual-chamber pump hardware (smart design choices to enable “diabetes without numbers” and a touchscreen, no-button, no-charging-port design for durability – this has received rave reviews from patients); (iii) a new development agreement to use Unomedical infusion sets in both iLet pivotal trials; and (iv) more detailed CGM data from the recent seven-day crossover home study comparing insulin-only to bihormonal use. We were highly impressed with the Gen 4 iLet device itself, which has the simplest user experience of any closed-loop system in near-term development – bodyweight-only initialization, optional qualitative meal entry, and no pump settings (no basal rates, no correction factors, no insulin sensitivity). Always cool, Dr. Damiano was carrying a fully functioning Gen 4 iLet around, which was capable of pumping insulin and Zealand’s dasiglucagon (prefilled cartridge) and also receiving data from a Dexcom G6 CGM. With $126 million raised in ten months and the insulin-only pivotal study protocol just submitted to FDA (1Q20 start), Beta Bionics has many critical building blocks in place. The goal is now for an insulin-only iLet launch in ~early/mid-2021 (~18-24 months from now), followed by a bihormonal launch (with Zealand’s pumpable dasiglucagon) in ~2022-2023 (30-48 months from now). While the timelines do keep getting pushed back, organizational funding and pump hardware are no longer obstacles. Notably, several Wall Street med tech analysts flew down to FFL to see Dr. Damiano present – unsurprisingly, attendees (and of course analysts) were all excited about the iLet’s user experience advantages, the robust clinical experience to date, and Dr. Damiano’s relentless drive. See more below on the timeline, iLet design, and data.

Timing

  • Beta Bionics just submitted the insulin-only pivotal trial’s clinical protocol to the FDA, which aims to begin in 1Q20 (adult and pediatric), finish before the end of 2020, and enable an FDA PMA submission in late 2020/early 2021 if all goes as planned (it’s wise to estimate submission over this slightly broader time period). Relative to FFL 2018 expectations for a 2H19 pivotal start, the insulin-only trial is about ~3-6 months delayed. The team plans for an FDA IDE submission of the iLet Gen 4 device itself in early 2020, to be quickly followed by an ACE Pump 510(k) submission in ~mid-2020 – the first we’re hearing of plans for an ACE pump designation, and a good  strategic move as it aims to be interoperable with multiple CGMs (Dexcom G6, Senseonics Eversense). The CE Mark process also aims to begin in 2020. Dr. Damiano’s goal for FFL 2020 is to be well into the insulin-only pivotal trial, an RCT that will take place at 16 sites around the US and enroll hundreds of participants. We expect high demand for this trial.

    • Dr. Damiano aims for FDA approval of the insulin-only iLet in ~18-24 months, implying a launch could happen around early/mid-2021 – this would put the iLet’s launch after Insulet’s Horizon (expected in 2H20), and ~12-18 months behind planned launches of Tandem’s Control-IQ (expected in 4Q19) and Medtronic’s MiniMed 780G (expected by April 2020). Bigfoot is now prioritizing its smart pen platform first (2020 launch), with the pump system to follow after; we’d guess Beta Bionics is ahead of Bigfoot on this front.

  • The bihormonal pivotal trial is now expected to start in ~2H20 (back from the previous “1H20”) goal, proceeding in an adult phase until late 2021 and a teen/pediatric pivotal until the end of 2022. FDA PMA reviews of the bihormonal system – including a chronic indication for Zealand’s dasiglucagon – are expected in 1H22 (adults) and 2H22 (teens). Relative to FFL 2018 expectations for a late 2019/early 2020 start, the bihormonal pivotal is ~6-12 months delayed.

    • Dr. Damiano aims for FDA approval of the bihormonal iLet in ~30-48 months, implying a launch around ~2022-2023. Obviously, the closed loop landscape could look quite different at that point, and the need to obtain chronic drug approval for dasiglucagon extends the timeline quite a bit. That said, Beta Bionics is the only player positioned to have a dual-hormone system. E like the flexibility – some patients may be willing to pay a premium; from our experienced with closed loop systems to date, we believe it may well enable significantly higher “time in range” for some patients.

  • Over the past 12 years, every IDE submitted for the Bionic Pancreas has been approved by FDA in 30 days – “I’d like to emphasize that the FDA is a collaborator in this – they are not an obstacle and they never have been.”

iLet Gen 4 Device
  • The iLet Gen 4 device is a touchscreen-operated, slim (15 mm thick), dual-chamber pump with no buttons or charging ports. It will use an inductive recharging pad like an Apple Watch – a huge win for reliability (charging ports break) and waterproofing. A small indentation on the top of the device (third picture below) wakes the screen up, eliminating the need for a traditional push button to wake up the device (which can also break). The iLet Gen 4 will work with Dexcom’s G6 and Senseonics’ Eversense CGM, three different insulins (Humalog, Novolog, Fiasp), and Zealand’s dasiglucagon. (We aren’t sure how the entry of the Dexcom G7 will affect demand.) Prefilled cartridges will offer a simplicity advantage over other systems, and the mostly icon-driven display is very intuitive – it definitely passed our no-instruction-manual test. The dosing algorithms are built into the device, though users can opt to pair the pump with a smartphone (via Bluetooth) for secondary data display. The insulin-only and bihormonal configurations use the same hardware and software – when the insulin-only system launches, it will have a plug on the glucagon chamber, but all the bihormonal software will be built into the device. (“As soon as we have approval for glucagon, it will come to life – no software or hardware upgrade needed.”) Dr. Damiano estimates the prefilled Zealand dasiglucagon cartridge will last a week.

  • “This device has commercial legs – it is very scalable, and we can build it in large numbers at fairly low cost. It is intended to be a commercial device, and it is easier to manufacture than anything we’ve built before. It is also much more serviceable.” – Dr. Damiano

  • The team has really improved the pump hardware over time, and the Gen 3 iLet used in bridging studies (silver device below) will be retired “in a few weeks.” A few years ago, we questioned whether it was the right move for Beta Bionics to build its own pump, but that was clearly a move that looks to be working well for the company – the improvement in size and user experience has been rapid and impressive. Beta Bionics' decision to build a development team with relevant diabetes device background is funneling into a robust, de novo design with fewer potential failure points.

Gen 4 iLet (left), Gen 3 iLet (middle-left), Gen 2 iLet (middle right), iPhone X (right)

  • Right before FFL, Beta Bionics and Convatec announced a non-exclusive collaboration and development agreement to make “portions” of Unomedical’s infusion set portfolio available for use with the iLet. These will be used in the pivotal trials next year. The announcement does not specify which sets will be offered (and it’s not a commercial agreement), though Dr. Damiano did show us that cross-channeling the insulin and glucagon sets will be impossible – they will have different connectors (see image below). (The prefilled cartridges also cannot be mixed up, as they are different sizes and won’t fit into the wrong pump chamber.) We wonder if the bihormonal set will have a single-adhesive, side-by-side cannula design, as we saw in Unomedical’s ATTD booth. We also wonder what is happening with the US launch of Unomedical’s excellent all-in-one, single-button, hidden-needle Mio Advance inserter – it has been FDA cleared for well over a year, and we assume Medtronic has some exclusivity on it. Will Beta Bionics have access to this set at launch?

  • In line with FFL 2018, Dr. Damiano highlighted the system’s utter simplicity – to initialize (especially in MDI users) and to use. “It will be more like a smartphone experience than a medical device.” A later slide noted, “The bionic pancreas is the quintessential example of personalized digital medicine.” He highlighted the bodyweight-only initialization, the prefilled cartridges, the optional qualitative meal announcement, and the adaptation over time as key differentiators from other AID systems.

Insulin-only vs. Bihormonal Data
  • Following the topline announcement in June, Dr. Damiano shared slightly more detailed CGM outcomes from first home-use study of the dual-hormone iLet using Zealand’s liquid-stable dasiglucagon in a pre-filled cartridge. Two seven-day experiment arms tested insulin-only and bihormonal use in n=10 adults with type 1 diabetes. The one new data point is on the last line in the slide below – the percentage of participants meeting ADA goal (i.e., estimated A1c <7%, meaning a mean glucose of less than 154 mg/dl). This number was 50% with insulin-only vs. an impressive 90% with bihormonal. Time-in-range was a robust 79% with bihormonal vs. 71% with insulin alone, with about one-third less hypoglycemia when glucagon was added (2.4% vs. 3.6%). Mean glucose was 10 mg/dl lower with the addition of glucagon (139 vs. 149 mg/dl).

    • It will be interesting to see where the time-in-range ceiling is for insulin-only vs. bihormonal systems – the pivotal studies of 670G and Control-IQ have come in at ~70%-72% time-in-range. Can an insulin-only system deliver >80% time-in-range in an overall study population, as Medtronic hopes with its MiniMed 780G? We’d love to see a breakdown of time-in-range by carbohydrate intake, since that is among the most critical variables that influences time-in-range, independent of algorithm and level of automation.

  • “An insulin ‘regimen’ is a failed proposition – the idea that you would take the same amount day to day.” In a two-week study, the average person on the Bionic Pancreas has a 50% difference between the most/least insulin-requiring day. “Sometimes, we see a 100% difference!” This is not yet well understood – how many factors play into insulin dosing (see Adam’s 42 Factors) and how it’s simply not possible to prescribe the right doses.

Investors and Benefit Corp Structure
  • “We are in a really good position to get this finished.” From the end of August 2018 to this month, Beta Bionics has raised an impressive $126 million – including from partners Lilly, Novo Nordisk, Zealand, and Dexcom. “We have a lot of money to get this done. We wondered (as a public benefit corporation) – can we attract the right investors and capital to get this done? The answer is, resoundingly, yes.” The Beta Bionics team is over 30 people now – fast growth, but still very lean considering how far the product and team has come.

  • Beta Bionics recently obtained ISO13485 certification, an important step on the path to manufacturing the iLet medical device.

  • “Beta Bionics is a Massachusetts public benefit corporation – we can prioritize the type 1 diabetes community above shareholders, and we are protected under law to do that. That is a mainstay in our corporate philosophy.” Beta Bionics’ mission is as follows:

    • To provide and protect our turnkey solutions for safe and effective autonomous glycemic control;

    • To bring our technology to as many people living with diabetes or other conditions of glycemic dysregulation as possible in an expeditious and responsible manner;

    • To continue to innovate and to offer the latest advances as expeditiously and responsibly as possible; and

    • To act in the best possible interest of the community of people living with diabetes or other conditions of glycemic dysregulation in connection with fulfilling our corporate functions.

  • Beta Bionics meets the standards of both a Massachusetts public benefit corporation, as well as a Certified B Corporation. These standards include higher levels of transparency, accountability, sustainability, and performance. Read more on the About page here.

2. Tidepool Loop: Howard Look On the Path to Interoperable AID – Shares History of #WeAreNotWaiting, positive progress with partners (Insulet, Dexcom, Medtronic)

Howard Look shared the inspiring Tidepool story and provided an update on Tidepool Loop following the eventful ADA. Download his slides here, and see the key Tidepool Loop slides below. As they usually do, Tidepool kept expectations realistic about their hopes for the timing of the Tidepool Loop FDA submission. When asked, Mr. Look said, “We never want to be the company that contributes to mis-set expectations (like ‘a cure in five years’), so we want to keep expectations low. We hope it's measured in months, not years. We let the FDA know that we set an aggressive target of trying to have a submission prepared before the end of the (calendar) year, but there’s a lot that's out of our control, so that's just an estimate. We promise to keep the community up to speed as things proceed.” This reflects fast progress since the October 2018 announcement to build a regulated version of the DIY iOS app, of Insulet joining in November, the Jaeb observational study kicking off in January, and partners Dexcom and Medtronic joining in June. Tidepool meets with the FDA frequently and is currently working on the submission path – will it receive an iController designation?

3. Gary Scheiner’s Top CGM Tips on Alerts, Data Analysis, Calibration, Time-in-Range, SD, and More

Educator extraordinaire Mr. Gary Scheiner provided his always-popular session on CGM, sharing valuable tips for using CGM, finding patterns in the data, device settings, and more. His ingredients for success fit on one slide: go in with the right expectations; use CGM at least 90% of the time; look at the display 10-20 times per day; do not over-react to the data (take insulin-on-board into account); adjust your therapy based on trends/patterns; calibrate properly (accurate BGM, wash hands); minimize nuisance alarms. See key slides and commentary below!

  • Can CGM data be trusted? Yes, with only a few exceptions listed below. Mr. Scheiner called out Dexcom’s G6 as quite accurate on day one, and noted that FreeStyle Libre still has “issues” with accuracy in hypoglycemia. (We expect this to be significantly improved with FreeStyle Libre 2.) For parents in the room, he highlighted CGM inaccuracy when recovering from hypoglycemia – CGM can take a while to show that glucose has recovered, which can drive overtreatment of lows with food. To confirm a low has been adequately corrected, Mr. Scheiner recommends taking a fingerstick.

  • Notably, Mr. Scheiner recommended calibrating with Ascensia’s Contour Next BGM, if possible – “For my money, it’s got the best accuracy on the market.” In the views of some patients, overall accuracy is less of a big deal with CGM due to the trend hours.

  • “Calibrating the G6 can be double-edged sword.” In response to parent questions on optional calibrations for Dexcom’s G6, he mostly recommended letting the system run on its own; calibrating G6 too much is like “helicopter parenting” (the system never has a chance to run). However, he does recommend a G6 calibration if a fingerstick is more than 20% off from the G6 value.

  • If you wait two hours after the meal and the trend graph has not started to “break” (i.e., CGM coming down), fix it – e.g., by adding additional insulin. We loved this tip as a simple approach to understand when additional post-meal insulin might be needed. Hopefully this can be incorporated into CGM-based decision support systems that talk to smart pens – it could really help improve time-in-range.

  • Mr. Scheiner also does a day-of-week analysis, which can help unpack CGM patterns that may not show up on an AGP (ambulatory glucose profile). This rarely gets air time in discussions of CGM data; we love the idea! He encouraged looking at a minimum of 30 days of data to do this.

  • When you look at downloaded data, don’t go in with an open mind. Go in with an objective-based analysis.” Here’s the framework Mr. Scheiner uses:

  • Are bolus amounts appropriate? Meal doses, correction doses. Mr. Scheiner likes using the spaghetti chart for unpacking meals, as food times always vary – “you cannot use an AGP or an hourly report to do this.” He marks the high points with a black marker, showing the greatest spikes. This is a brilliant insight around AGP vs. day-by-day traces that we had not appreciated. The spaghetti chart can be, of course, quite overwhelming, so breaking it down into something understandable will be key for the field. This does seem like something that can be incorporated into automated pattern analysis – e.g., a greatest spikes analysis.

  • How long do boluses work? In the debate about insulin action time, Mr. Scheiner quipped that healthcare providers often make up a number – “It varies from person to person, and you have to use CGM to figure it out.” When glucose is high, take a correction bolus (without food) and watch the CGM until it levels off. “These are important numbers to get right. If you underestimate it, you’ll have frequent lows. If you overestimate it, you’ll have highs.” The number can change over different ages; Mr. Scheiner said most adults gravitate to 4-4.5 hours, while most kids gravitate to 3-3.5 hours.

  • Responding to Adam’s question about bolus amount vis-à-vis insulin action time, Mr. Scheiner said dose size “does make some difference, but not a huge one.” The impact relates to surface area vs. volume – a larger dose at one time will absorb a little slower than a very small dose. But the doses must have a large difference to see varying insulin action time – i.e., 6u vs. 4u boluses will have similar insulin action times, while 1 unit vs. 10 units might have a big difference. When patients do the insulin action test, he recommended doing it with an average dose insulin.

  • Is basal insulin holding blood glucose steady? The example below showed an overnight basal that was too high, though the person could easily have drawn the opposite conclusion – I have high blood sugars at breakfast, so I need more overnight insulin. The solution was to reduce overnight basal rates to prevent the rebound hyperglycemia. 

  • Are asymptomatic lows occurring? Are there rebounds from lows? Are lows being under/over-treated?

  • How does exercise affect blood glucose? Immediate / delayed effects.

  • Are there day-of-the-week patterns?

  • How do various lifestyle events affect blood glucose? High-fat meals, unusual meals, stress, illness, work/school, sex, alcohol.

  • Mr. Scheiner also provided his CGM alert settings tips, balancing benefit vs. nuisance. He recommended the following setup to start, with titration of the high alarm over time to an “allowable postprandial peak.” Of note, he is “not a big fan of predictive alerts with CGM, because things change constantly” – we agree (though recognize that some find them helpful just as alerts, even if awareness doesn’t make them preventable) and wonder about the real-world feasibility of multi-hour predictive alerts such as the IQCast hypoglycemia alert in Medtronic’s Sugar.IQ app.

  • “Time-in-range is more of a gold standard.” As expected, Mr. Scheiner encouraged the audience to look at % of time above, below, and within target range. Like Dr. Irl Hirsch and in line with the consensus recommendations, he looks for a standard deviation (SD) that is less than one-third of the average glucose (i.e., a CV of <33%).

  •  “Stress can cause blood glucose to rise faster and higher than anything you eat.” In his experience, stress alone can send blood glucose up hundreds of points quickly.

4. Dr. Bill Polonsky on Diabetes Burnout: Challenge Your Beliefs with Facts

Dr. Bill Polonsky (Behavioral Diabetes Institute) discussed causes of and solutions to diabetes burnout, providing parents in the audience with a healthy dose of relief. “Diabetes is a job you didn’t ask for – with no vacations and no breaks. Who wouldn’t get burned out?”

  • A series of three slides – “What don’t you like about T1D?” – encapsulated diabetes burnout in a single person. The third slide provided a mix of raucous audience laughter and nods.

  • While HCPs often complain about “unmotivated” patients, Dr. Polonsky believes this is highly misplaced – almost everyone is motivated to live a long and healthy life.

  • The real challenge is that diabetes is tough: “It’s a lot of work, it’s mostly invisible, most benefits are in the distant future (rather than short-term, positive incentives), and there are many common obstacles”:

    • Unreasonable expectations about what you should be doing and achieving. “My BGs should always be 80-120 mg/dl.” “I’ve got to find a way to stop eating carbs altogether.”

    • Harmful beliefs about diabetes: “Diabetes is a death sentence.” “I must let diabetes control my life.” Dr. Polonsky showed two hand-drawn pictures from people with diabetes, symbolizing their feelings about the disease: One drew a giant stop sign, while another drew a “diabetic wall” between her family and her.

    • Poor social support: “Isolation makes diabetes much harder.” There can also be way too much social support – aka “diabetes police.” “These people love you so much that they become self-appointed deputies to help you manage your diabetes; 99% of the time they are coming from a place of love/caring and trying to be helpful – but then you start to feel policed and nagged (“Should you be eating that?”). BDI has diabetes etiquette cards to help on this front.

    • Hypoglycemia – it’s aggravating, embarrassing, frustrating. Hypoglycemia fears are especially common amongst partners and parents. “Spouse insomnia is a big deal,” said Dr. Polonsky, especially in those wearing CGM. “If you have a CGM and the alarm goes off in the middle of the night, who wakes up? It’s almost universally the partner/spouse first.”

    • Frustrating, discouraging results: “I finally get my A1c down and now I’m having all these problems with lows.” “Now I’m taking insulin like I’m supposed to, and I’ve gained 10 lbs. This sucks!” “I did everything I was supposed to, and my blood sugars are all over the place.”

  • Overcoming Burnout – #1: Challenge your beliefs with facts. “Some of the most interesting and unconscious beliefs are not quite right. For instance, “Diabetes is the leading cause of adult blindness, amputations, and kidney failure. True or false? Almost everyone would agree this is true. But it is NOT true. To a large extent, it is poorly controlled diabetes that is the leading cause of adult blindness, amputation, and kidney failure. (Fact check: this doesn’t mean that good care will guarantee that you will not develop complications. It does mean, however, that with care, odds are good you can live with a long, healthy life with diabetes.)”

    • Drawing gasps from the audience, Dr. Polonsky showed rates of diabetes complications comparing 1978 data from the world-class Steno Diabetes Center to the DCCT/EDIC intensive group (2009) – both groups with 30+ years of T1D. For the DCCT group, he noted that A1c was 7% during the trial, but floated up to 8% in the years after the trial. “We’re very good at giving people the scary messages; we don’t talk enough about evidence-based hope. As William Osler said, “To live a long and healthy life, develop a chronic disease and take care of it.”

  • The DCCT/EDIC mortality data even suggested that the intensive group was living longer than what would be expected in people without diabetes. Dr. Polonsky pointed to 51 deaths in the DCCT intensive group, when 58 deaths would have been expected.

  • Overcoming Burnout – #2: Move from Black-and-White thinking to checkered thinking. It’s common to approach aspects of diabetes with a black-and-white (i.e., all-or-nothing) mindset: “I either take perfect care of my diabetes or I’m a failure.” Dr. Polonsky encouraged mixing black and white – checkered thinking – to help with burnout and take incremental steps.

  • Overcoming Burnout – #3: Managing hypoglycemia: Dr. Polonsky cited “blood glucose awareness training” as one approach to improve symptom recognition of low blood sugar cues – see here and here. He also recommended having a plan with loved ones – what should a family member of partner do during hypoglycemia? For example, “If you think I’m low, don’t say anything. But if you think I’m really low, put some juice in front of me and don’t talk. I promise to drink it.”

  • Overcoming Burnout – #4: Don’t Do Diabetes Alone. “We all need an HCP or a loved one who is rooting for us.” Dr. Polonsky shared a story of a physician that called to check up on how a patient was doing – a small act that showed he cared. That can change everything!

  • Overcoming Burnout – #5: A (Safe) Diabetes Vacation? This came up in Q&A: “The universe has given you a job to do – a 24-hour per day, 7-day per week job. Any job like that should burn you out. Like any job, what everybody needs is time off. When you have a vacation, if done well, it is restorative. There is often this expectation that no time off is allowed – no diabetes vacations. That’s not fair or reasonable. Of course, there are ways of taking time off from diabetes that are crazy dangerous. How do we help our kids, loved ones, or selves have safe ways to take a little time off from our diabetes? Like any vacation, planning ahead and making it time limited can help give you the break that you need. You might have someone else watch your kids. I remember a lady who wanted time off from the decisions. She wore CGM and trusted her husband enough that once a month, she took a day off – her husband was in charge of her diabetes. They had a relationship where he was competent enough and that worked great. For her to have a day off was a blessing. Please tell me how you do that – have a little time off. It can be a great way to prevent and cope with burnout. Or as someone earlier said, ‘I’m going to spend time with my daughter and NOT talk about diabetes.’

  • Well-known diabetes advocate Moira McCarthy in Q&A on navigating parental challenges with young adults: “Everything that Dr. Polonsky said – it’s going to be ok complication- wise – it’s good for kids to know that. Sometimes, they think they’ve already screwed things up, so why bother trying? They need us to be their safety net at that time in their life. As a parent, you need to know what’s going on at least once a day. Two things my daughter said to me recently: (i) she feels like burnout is like addiction; when she feels herself beginning to fall into it, she has to go back to step one. (ii) I try not to give diabetes any more power than it deserves. I was terrified when she was diagnosed, and I was often a mess. I now have a hugely successful young adult on Capitol Hill. You will get to the other side and it will be ok. But you will have gray hair. [Laughter]” 

5. CGM At Diagnosis – Expectations Have Certainly Changed!

Our favorite story of FFL came from Stanford’s Dr. Bruce Buckingham, who reminded us of how much expectations have changed in the CGM era. The Stanford team has been doing a study of prescribing Dexcom CGM at diagnosis. One recent night, the on-call fellow received a call at ~1:00 am from a very stressed parent: “Our Dexcom CGM is not working right now; what should we do?!” The fellow replied as expected: “Take a fingerstick.” The parent’s response? “A fingerstick? That’s barbaric!!” It was a powerful reminder of how much the field has changed, and how different the newly diagnosed experience must be with factory calibrated CGM! We’ll be fascinated to hear more experiences from this trial, as well as experiences with automated insulin delivery at diagnosis.

6. diaTribe Panel Discussion and Adam’s Favorite Lessons Learned

Links are enclosed below to watch diaTribe’s two FFL 2019 sessions: (i) a panel discussion with Dr. Bruce Buckingham, diabetes advocate Cherise Shockley, dQ&A’s Alice Morgan (VP Qualitative), and Adam Brown; and (ii) some of Adam’s favorite lessons learned over nearly ten years working at diaTribe.

 

-- by Adam Brown and Kelly Close