Type 1 College Athlete Shares His Success Story

It is refreshing to see so many people living with type one diabetes in the sports world. Billy Fredrick is another great athlete out there representing us on the baseball field. Billy received a full scholarship to UCSB (University of California, Santa Barbara), who was ranked 6th in the nation in baseball, despite living with diabetes since he was a child. Billy’s story is one of perseverance, commitment and talent and I thought it would be great to share his journey in the hopes it would inspire children to never quit on their dreams. 

Hi Billy, thank you so much for taking the time to talk to me. I think many kids who are diagnosed with type 1 think that this may stop them from living their dreams. I thought talking to you would be inspiring and show them that type 1 doesn’t have to stop them from anything they set out to do!

Allison, thank you for having me. I am very happy to talk about living and conquering diabetes. Life with diabetes is no easy task, but we can still accomplish great things.

I understand you were diagnosed at 11 years old with type 1 diabetes. How did you and your family handle the diagnosis?

It wasn’t easy at first. My life changed drastically. I had to begin checking my blood and taking shots of insulin. Moreover, I had to be aware of exercise intensity and carb amount in my diet. This sudden change took some time to get used to.

As the months passed, the new daily routine became habit and reflex. My family and I became more knowledgeable and confident in the process as time progressed.

Photo provided by Billy Fredrick

I have a 10-year-old myself, so I know at that age, some children do like their independence while others still enjoy their parent’s help. Were you hands-on with your diabetes management, or did your parents handle things until you were ready? 

I wasn’t super independent as a kid, so I was happy to hand over the responsibility to my parents. My mom did an incredible amount for me. She would come to school at lunch every day to check my blood and give me shots or work my pump. She would wake up around 2-3 am every morning to check my blood while I slept. She also had a big record book, where she documented all my glucose levels and food intake, in order to discover any important patterns that may help with my management. She was and still is a super mom!

At what age did you start managing your own diabetes and what was the driving factor behind when you decided to take control?

I started being fully dependent when in high school. My family and I felt that I would be able to handle it then. I was committed to it, so it went well. Commitment is an ongoing topic within the diabetes conversation; it is so necessary. I would also handle it at baseball practice as well. My daily schedule was consistent, so I was quickly able to find basal/bolus rates that worked well for me.

How were things socially for you growing up with type one diabetes? Were you vocal about it or did you not talk about it much?

At 11 years old, popularity or coolness is the most important factor at school. At first, I was worried that I might be looked down upon by my peers. However, I was very surprised at how accepted I was within my friend group, and elsewhere. They were kind and understanding towards it.

Here’s the bottom line: I was not a different person; I was still Billy, and my friends knew I was still Billy.

I tried to hide the fact in elementary school, but by the time I was in junior high, I was open to talking about it.

At what age did you start playing baseball? Were you nervous about managing your diabetes while playing? Were your coaches supportive?

I played baseball since I was five, and had developed a passion for it by the time I was diagnosed.

I was never nervous during games. I usually had plenty of time to check my blood in between innings. Baseball also doesn’t require a large amount of exercise, which allowed me to be so stable.

All my coaches were very supportive of me, and gave me the liberty to take breaks when I was low.

Photo provided by Billy Fredrick

Did you then, and do you now, wear a CGM or a pump? What do you find to be your most helpful tool in managing your diabetes during a baseball game?

I never played with a CGM. I didn’t want to wear another thing on my body during the games. I thought it may have been a hassle. Checking my blood a lot was the biggest tool in managing my level during the games. I brought some tablets to the field in my back pocket if I felt I was gonna go low in the outfield. I also brought a variety of food to the game (some high carb, some low carb), this allowed me to refine my blood sugar, and give me energy. Near the end of my college career, managing my diabetes was very easy because I was a seasoned veteran.

I use a Medtronic pump and CGM now. I like them. My control is getting better and better with it.

I understand you hit .333 during the College World Series, where you drove in a game-winning run with a bunt! You must have been stoked! How do the excitement and adrenaline affect your blood sugar during the game?

That is a great question. My blood sugar goes up pretty quickly when there’s a lot of excitement. There were many times during playoffs that year when adrenaline kicked in and spiked my blood sugar. Nervousness is another factor; it brings my blood sugar up also. A key is to remain attentive to your emotions during games.

Generally though, it tends to balance itself out with the exercise, so not much needs to be done on my part.

Did you ever experience burn out or have a difficult time managing your diabetes during baseball that made you want to stop playing? Can you tell us about that time?

I have never been burnt out during baseball. I was so committed to baseball and diabetes, that I was willing to push through any trial.

However, after I stopped playing, I did get burnt out a few times. I thought managing my levels would be easier when not an athlete, I was wrong. It was harder. My routine was less consistent (I only exercised a few times a week). This inconsistency caused my blood sugar to drop during times of exercise, and rise during times of rest. This made it difficult. As a solution, I am making exercise more commonplace. Exercise is incredibly important as a diabetic, and for normal people as well.

What are your favorite go-to snacks for lows?

Blue Gatorade or orange juice are my go-to beverages. Goldfish are also awesome!

Did you know any other people living with diabetes that inspired you to become a baseball player or in any other way?

I am sort of the black sheep of the family. I have no relatives who are diabetic.

It was fun to see baseball players like Jason Johnson and Sam Fuld play in the big leagues.

Your success story is amazing, what are your plans after college? Where do you see yourself in 5-10 years from now?

After getting my degree in Geography at UCSB, I decided to go to my community college to get another bachelor’s degree. (I didn’t really have many majors available to me because I was a busy student-athlete at UCSB.) I am currently working toward my bachelor’s in Mechanical Engineering, and would enjoy designing anything from bridges to car parts for my career.

What advice would you tell a child living with type 1 diabetes who wants to play a sport but is reluctant to try due to their condition?

When your blood sugar is good, you are just like a completely normal person, capable of anything. My first recommendation is to work hard toward good blood sugar levels, because that opens the door to opportunity. Secondly, don’t be afraid to try new things.

Something that comes to mind is that no one on the other team knew I was diabetic. I seemed like a regular person to them. That is exactly how diabetics should think of ourselves. When we are committed to good blood sugar, nothing will hold us back.

Billy, thank you so much for taking the time to speak to me today. I am a huge baseball fan (and a baseball mom) so I just love your success story and know it will inspire so many children out there!

Thank you, Allison! I am glad you are a big baseball fan as well, and wish the best of luck to your son in his future baseball career!

Source: diabetesdaily.com

New Research: Hybrid Closed-Loop System Outcomes (ADA 2020)

Technology is truly changing the lives of many people with diabetes across the world. Advancements continue in many areas, including the development and testing of various automated insulin delivery systems.

The MiniMed 670G insulin pump system is the first of it’s kind in providing automatic insulin delivery adjustments based on continuous glucose monitoring (CGM) data. Now, two recent research studies, the results of which were just presented this weekend at the American Diabetes Association (ADA) 80th Scientific Sessions, are highlighting the positive outcomes of the system for young and adults patients.

Outcomes in Adult Patients

Dr. Stephanie Kim, MD, MPH, from the University of San Francisco, CA, presented the results of a single-center research study in adult patients with type 1 diabetes. The researchers enrolled 52 patients (47% female, average age 46 +/-12 years, average diabetes duration of 27 +/- 15 years) utilizing the Medtronic 670G system and started “Automode” delivery of insulin between 2017 and 2019, in an effort to evaluate the impact of automatic delivery on glycemic outcomes.

The study subjects were stratified into two groups, depending on baseline blood glucose levels (defined as A1c level of higher than 7.6% or lower than or equal to 7.5%). The A1c levels were evaluated at baseline (before starting Automode) and again approximately 17 months after starting Automode.

The data revelated that while the A1c level did not change significantly in patients in the lower A1c cohort, there was improvement in the group with baseline A1c>7.6%. These patients improved their A1c, on average, from 8.3% to 7.8% using this system.

Outcomes in Youth

Dr. Goran Petrovski, MD, PhD, of Sidra Medicine in Qatar, reported on the results of an observational study of children and young adults with type 1 diabetes who used multiple daily insulin injections (MDI) and switched to the MiniMed 670G hybrid closed-loop system. A total of 42 patients (ages 7-18, mean age 12 years) were enrolled in the study.

Excitingly, the study outcomes demonstrated considerable improvements to the average A1c levels (8.4% at baseline to 6.7% at 3-months follow-up, and 6.9% at 6-months follow-up) after initiating the hybrid closed-loop system therapy. Also, the time-in-range (defined in this study as blood glucose levels between 70-180 mg/dL) improved considerably with the use of this technology. Notably, no instances of diabetic ketoacidosis (DKA) or severe hypoglycemia were reported. The authors declared no conflict of interest and concluded that “children and adolescents with T1D can successfully initiate the HCL system, achieve and maintain better glycemic control than previous MDI regimen.”

Petrovski et. al. (Presented at ADA 2020)

Conclusions

Technology that can help people with diabetes better manage their blood glucose levels continues to improve. Notably, while the glycemic improvement in youth who transitioned from MDI to the automated system were considerable, the improvements were much more modest in the study on adults using this system who switched to Automode. Altogether, the data highlight the potential of technology to improve outcomes, while also revealing that technology use (at least as it stands today) is generally not enough on its own, to achieve optimal results. Patient education regarding diet, exercise, and the numerous intricacies of dosing insulin remain central to optimizing outcomes.

Source: diabetesdaily.com

Review: “Not Just a Patch” for Your CGM Sensors

What do you want to get out of a protective patch for your continuous glucose monitor (CGM) sensor?

For me, it’s all about extending the life of the sensor for as long as possible by keeping the adhesive in place and offering extra protection from moisture. I’ve tried many different patches for various versions of my Dexcom CGM (most recently, the G6) throughout the years. One big issue I’ve always had was not being able to change the patch effectively, without having the Dexcom adhesive peel off. I felt, once that patch is on, I’m more than likely stuck with it, until I actually change my sensor.

Enter, Not Just a Patch, a product that allows one to easily change the patch without disrupting the original sensor and its adhesive.

I received samples to try out from the company at no cost. I did not receive any additional compensation for this review and all opinions are my own.

Who They Are

Not Just a Patch was founded by Pete Loman, who lives an active lifestyle with type 1 diabetes. After being disappointed with the patches he’s tried, Pete began experimenting with creating his own. Eventually, he developed a unique product that offers complete coverage of the sensor, with the option of a non-stick area in the center of the patch for easy patch changes without disturbing the sensor adhesive. Altogether, the new product affords additional protection from moisture and also minimizes the possibility of the sensor becoming knocked off. Furthermore, the sensor not actually sticking to the patch (but rather around it) helps minimize the sensor and its adhesive coming loose when changing the patch, allowing for potentially longer sensor sessions.

Pete explains on his website,

“One key design improvement is the “non-stick” section of the patch. Namely, the middle piece of the patch doesn’t stick to the actual sensor, thereby allowing you to change the patch as often as you like, to suit your activity or your fashion choices. Furthermore, this feature allows complete coverage of the device, meaning that your CGM sensor is always protected and, you can have more confidence while wearing it.”

The Products

Currently, the company offers several types of patches that are compatible with the Dexcom G4, G5, and G6, as well as for the Freestyle Libre, Medtronic Guardian, and the MiaoMiao 1 and 2.

The patches are available for purchase in a variety of bright colors, ranging from neutral/nude to bright green, yellow, orange, blue, pink, etc.

For all available patches, the user has the discretion of removing the central portion of the adhesive backing, which would prevent the sensor from sticking to the patch (see image below).

Photo credit: Not Just a Patch

The patches can be purchased on the company website in packs of twenty and come in at just under $1 per patch in price.

My Review

Like many people with type 1 diabetes who use a CGM, I have tried various patches before. The distinguishing feature of this one was the patch not being stuck to my sensor. That feature definitely worked well, and I was able to seamlessly change the patch without affecting my Dexcom G6 or its adhesive whatsoever. Being able to have the entire device covered, as well as changing the patch easily and as frequently as I wish, also gave additional protection against moisture. Overall, it improved the life of the sensor adhesive and sensor performance.

Currently, I am well into my second 10-day run with my sensor, after using the most recent sensor restart hack, and I am happy to say that not only is the sensor performing well, but I noticed while changing the patch that the original sensor adhesive looked almost brand new, despite an already long wear time.

Overall, I would say that while the product initially appears similar to what’s already available, and is comparable to others on the market as far as material, shape, color, and overall design goes, it definitely offer its unique advantages.

Summary

I liked this product. It performed well to protect my sensor from moisture and I really enjoyed being able to easily change the patch without dealing with it sticking to and peeling off the Dexcom adhesive. If you’re someone who has an active lifestyle and is hoping to get more life out of their sensors, I’d definitely recommend giving this product a try!

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Have you tried this product? What are your thoughts? Please comment below; we love hearing from our readers.

Source: diabetesdaily.com

What’s Coming and What’s Delayed in Continuous Glucose Monitoring?

This content originally appeared on diaTribe. Republished with permission.

By Albert Cai

Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics

With several clinical trials on hold due to the COVID-19 pandemic, we’re bringing you a roundup of the latest updates on future continuous glucose monitors (CGM). Understandably, the FDA also announced a few months ago that it would focus its efforts on devices related to COVID-19. With the disclaimer that it’s impossible to know exactly when the pandemic will subside, when trials might resume, and how FDA reviews might be affected, here is the latest news we’ve heard from companies.

Click to jump to a product, which are organized alphabetically.

Abbott FreeStyle Libre 2

CGM

Image source: Abbott FreeStyle

What’s new? FreeStyle Libre 2 keeps the same “scanning” feature as the original FreeStyle Libre, but adds Bluetooth connectivity. This is important because it enables optional high and low glucose alerts. Users who enable these alerts will be able to get a notification on their reader or phone whenever their glucose reading goes above or below their specified ranges. Looking ahead, the Bluetooth feature will also allow FreeStyle Libre 2 to be part of automated insulin delivery systems (AID), like Insulet’s Omnipod Horizon.

Like the original FreeStyle Libre, FreeStyle Libre 2 has 14-day wear, is factory-calibrated (no fingerstick calibrations required), and can be scanned with either a phone or a reader device (the reader for FreeStyle Libre 2 is blue, instead of black). Importantly, FreeStyle Libre 2 will be offered at the same price as the original FreeStyle Libre.

When’s it coming? The FreeStyle Libre 2 has already launched in a few European countries (we know of Germany and Norway) and will launch in others soon. In the US, FreeStyle Libre 2 has been under FDA review for over a year. In March, Abbott said that it was working through “some finishing items” and was “very confident” the device would be cleared soon.

Dexcom G7

Dexcom

Image source: Dexcom

What’s new? Dexcom’s G7 will be fully disposable (the transmitter and sensor are combined and thrown away together) and have longer wear (we believe somewhere around 14-16 days). Remember that the Dexcom G6 sensor lasts for 10 days but has a transmitter that is re-used for 90 days. The G7 will be considerably slimmer than G6 and will have a lower cost of manufacturing in bulk, though consumer pricing is not yet determined – we imagine it will be similar. The G7 will keep the same accuracy, no fingerstick calibrations, and Bluetooth connectivity as the G6.

Dexcom has been developing G7 in partnership with Verily, the division of Alphabet formerly known as Google Life Sciences. There has been mention from Verily that an accelerometer may also be built-in to the G7 device, but we aren’t sure if that feature made it into the final version of G7. Having a built-in accelerometer could allow the G7 to also track physical activity, like a Fitbit or other fitness tracker.

When’s it coming? Dexcom planned on launching G7 in “early 2021,” but with most clinics placing new trials on hold, Dexcom is expecting a “minimum delay of approximately six months.” It’s difficult to know when clinics will be able to conduct trials (and when people will feel comfortable enrolling in trials), but assuming a six-month delay, G7 could be on the US market sometime in the second half of 2021.

Medtronic “Project Zeus” CGM

Abbott FreeStyle

Image source: Medtronic

What’s new? Medtronic’s next CGM, referred to as “Project Zeus,” will reduce the number of required fingerstick calibrations and have improved accuracy (compared to its current offering, Guardian Sensor 3). The new CGM will require day-one calibration (unclear on the number of fingersticks that will be required on day one), compared to Guardian Sensor 3, which requires at least two fingerstick calibrations every day. Medtronic expects Project Zeus to launch with a “non-adjunctive” indication, meaning users will be able to bolus insulin based on CGM reading alone, and not have to perform a confirmatory fingerstick. the new CGM will keep the same seven-day wear, size and shape, and reusable transmitter component as the Guardian Sensor 3 (pictured above).

When’s it coming? The trial for Project Zeus began in June 2019 and is expected to wrap up within the next month. Medtronic expects to submit the CGM to the FDA by the “end of the summer.”

Senseonics Eversense XL (180-day)

Eversense XL

Image source: Eversense XL

What’s new? The “XL” extended life-version of Senseonics’ Eversense in the U.S. will have the same size and features as the original Eversense, but the Eversense XL is implanted for 180 days, rather than the 90-day Eversense. As a reminder, the Eversense sensor is implanted in the users’ upper arm in a clinic and remains there for the sensor duration; a silver-dollar sized on-body transmitter is worn on the outside of the arm to deliver readings to a smartphone. Senseonics is targeting reducing calibrations from 2 per day to 1 per day with same non-adjunctive indication.

When’s it coming? Eversense XL is already available in Senseonics’ European markets. The trial for Eversense XL in the US wrapped up in late March, and Senseonics has previously aimed for FDA clearance in “late” 2020. We aren’t sure whether that timeline has been pushed back due to COVID-19, but the fact that the trial has already completed is encouraging.

Source: diabetesdaily.com

The Biggest News in Diabetes Technology from ATTD 2020 – A Deep Dive on CGM and more!

This content originally appeared on diaTribe. Republished with permission.

By Jimmy McDermott, Eliza Skoler, Divya Gopisetty, Emily Fitts, Frida Velcani, Kelly Close, and Albert Cai

The diaTribe team is on the ground in Madrid, Spain to cover the latest news in diabetes technology from ATTD. Here are our top highlights from the conference so far …!

The 13th annual Advanced Technologies and Treatments in Diabetes (ATTD) conference brought together many great minds in diabetes in Madrid, Spain. With nearly 3,800 attendees from more than 81 countries, ATTD continues to grow dramatically; while it has been since the start in Prague in 2008 one of the most impactful meetings in diabetes, it is now considered one of the top three in the world. Why? It shows the powerful momentum behind diabetes technology in so many respects, from CGM and BGM to automated insulin delivery (AID) to smart pens to new therapies to new learnings in behavioral medicine. Here are some of diaTribe’s key highlights from the conference – we’ve focused on learnings about CGM and the closed loop and will be back with even more after the conference concludes!

Click to jump to a section!

1. Dr. Rich Bergenstal shares tips for understanding CGM data 

2. Data shows use of CGM features is linked to increased time in range

3. Dexcom announces big milestone for G6 in pregnancy, the CE-Mark; available in UK “starting spring 2020”

4. Results show benefits of DIY closed-loop systems: lower A1C and more time in range using Loop

5. WISDM Trial: CGM helps older adults with type 1 diabetes reduce hypoglycemia and improve time in range 

6. Increased FreeStyle Libre scanning frequency is associated with reduced time with both high and low blood sugar

7. MiniMed 670G data shows time in range increases with Auto Mode

8. Tandem’s Control-IQ increases time in range in children

1. Dr. Rich Bergenstal shares tips for understanding CGM data

Dr. Rich Bergenstal from the International Diabetes Center gave tips for interpreting continuous glucose monitor (CGM) data. The audience responded enthusiastically when Dr. Bergenstal explained “FNIR” (Flat, Narrow, In-Range) to describe “ideal” blood sugar: high time in range and flat glucose levels with few ups and downs. To learn more about FNIR, check out our resource page on time in range. Dr. Bergenstal shared a few more catchphrases:

Time in Range

Image source: diaTribe

  • MGLR: More Green, Less Red; refers to the stacked time in range bars (pictured right).
  •  “Thinking fast and slow” – this refers to making “fast”, in-the-moment medication or behavioral changes based on real-time CGM numbers, and “slow” analyses of blood sugar data to understand and act on trends over time. It also recalls the famous prize-winning book from 2011.
  • STAR: Steady, Tight, And in-Range; this is another one we’ve heard lately, and even though it wasn’t in Dr. Bergenstal’s presentation, it’s also very aspirational, just like FNIR!
Screenshot

Image source: diaTribe

2. Data shows use of CGM features is linked to increased time in range

Time in Range

Image source: diaTribe

Dexcom presented real-world data from G6 CGM users showing that people who were most engaged with G6 features (such as alerts, the share-follow platform, and Dexcom Clarity) showed significant improvements in their blood glucose management. These highly-engaged users had the highest time in range and spent 38% less time each day in hypoglycemia (pictured right).

Here are the G6 features that Dexcom highlighted:

  • Alert Settings: Users can set their own target blood glucose range and the G6 will automatically notify them if their glucose levels cross the high or low threshold. This means that users don’t have to constantly self-monitor their blood sugar; 55% of G6 users used this feature to customized their settings.
  • Time in Range

    Image source: diaTribe

    Urgent Low Soon (ULS) alert: This predicts and notifies a user 20 minutes before they cross their low blood glucose threshold. Real-world user data shows that people using ULS spent less time in hypoglycemia (six minutes less below 55 mg/dl and ten minutes less below 70 mg/dl).

  • Dexcom Follow: People with diabetes can share CGM data with their family, friends, and care partners to help monitor glucose levels (with the iPhone app or Android app). This feature was especially helpful among children, whose time in range increased proportionally to the number of people able to view their data.
  • Dexcom Clarity: Weekly reports allow people with diabetes and healthcare professionals to see blood glucose trends and develop insights into their diabetes management (with the iPhone app or Android app). Users can receive encouraging notifications when they achieve their blood glucose goals. The data shows that more understanding of how one’s glucose levels change over time correlates with better outcomes: using weekly Clarity reports led to an increase in time in range by 9%. Additionally, in a study of 26,000 people, those who used Clarity with mobile notifications had 64% time in range, compared to 52% time in range for people who only used the CGM. Learn more about Clarity here!

3. Dexcom announces CE-Mark for G6 in pregnancy; available in UK “starting spring 2020”

Dexcom announced European approval (formally called the “CE Mark”) for its G6 CGM for use during pregnancy for women living with type 1, type 2, or gestational diabetes. This is so exciting! The official “label” is set to launch in spring of 2020. The G6 now joins Abbott’s FreeStyle Libre as approved CGM for pregnant women in Europe – as a reminder, the FreeStyle Libre 2 has alarms (better for pregnancy), and has been approved in Europe for some time. While no CGM is yet approved for pregnant women in the US (though many are using it off-label), the European announcement should help to increase awareness and education around the world. Every pregnant woman in the world with diabetes or pre-diabetes should have CGM in the opinion of many experts (virtually all the ones we know).

  • Mt. Sinai’s Dr. Carol Levy shared compelling data from the T1D Exchange around CGM in pregnancy. Comparing 2010-2013 to 2016-2018, self-reported CGM use in pregnant women increased from 35% to 65% and average A1C in pregnant women dropped from 6.9% to 6.6%. We bet if time in range data were available, we’d see a big increase.
  • Dr. Levy showed the outcomes of 50 women who used Dexcom CGM during pregnancy. 93% of these women recorded no diabetic ketoacidosis (DKA) or severe hypoglycemia. Typically, about 50% of women with gestational diabetes have a baby with a high birth weight. This percentage was 12% in the group of women using CGM in this trial.
  • As we’ve seen at previous conferences, data supporting CGM during pregnancy is overwhelmingly positive. The CONCEPTT trial examined Medtronic’s Guardian CGM in pregnant women and showed many encouraging results, including:
    • Reduced birth weight of the baby
    • 100 more minutes per day in target glucose range for the pregnant mother
    • 72 fewer minutes per day in hyperglycemia for the pregnant mother

Experts believe that even these encouraging results underestimate the impact of CGM on positive health outcomes for pregnant women and their children. Broadly speaking, pregnancy can cause multiple challenges to diabetes management that CGM can help ease. Pregnant women experience more blood glucose variability with increased insulin resistance and are at a greater risk of hypoglycemia. Learn more here about gestational diabetes.

4. Results show benefits of DIY closed-loop systems: lower A1C and more time in range using Loop

An observational study on Loop, a do-it-yourself (DIY) closed-loop system, found that Loop improved diabetes management significantly. The study followed people using an automated insulin delivery (AID) system, continuous glucose monitor (CGM) readings, and a communications bridge device, called “RileyLink.”

New users (people in the study who had never used this closed-loop system before) showed:

  • An A1C reduction from 6.8% to 6.5% after three months and to 6.4% after six months – and if you think that is not very much, think again!
  • An increase in time in range from 68% to 73%, which is more than one hour per day spent in-range! These time in range benefits occurred in the first month of closed-loop use and were constant throughout the rest of the study.
  • Benefits in A1C and time in range across all age groups.
  • Improvements in user-reported outcomes, including measures of diabetes management distress, sleep quality, and fear of hypoglycemia. Not too many details were shared on this part and we look so forward to learning more!

It is important to note that people in the study were classified as having “well-managed” diabetes at the start of the study, meaning they had relatively low A1Cs (6.8% baseline) and were close to meeting time in range goals, and came from high education levels and socioeconomic status backgrounds. This underscores the need to improve access to closed-loop systems for broader groups of people with diabetes.

Looking ahead, the study will end on March 31, 2020 and all participants will complete a six-month follow-up, so full results will not be available until later this year.

5. WISDM Trial: CGM helps older adults with type 1 diabetes reduce hypoglycemia and improve time in range

The WISDM study examined the impact of continuous glucose monitor (CGM) use in people with type 1 diabetes above the age of 60. Participants used either the Dexcom G5 CGM or standard blood glucose meters (BGM). After six months, the CGM group spent less time in hypoglycemia (with blood glucose below 70 mg/dl) and two more hours per day in-range (70-180 mg/dl), compared to the BGM group. There was also a greater A1C reduction in the CGM group (0.3% decrease compared to no change in the BGM group). Importantly, people using CGM reported significantly fewer severe hypoglycemia events (defined as requiring assistance of another person). These benefits were seen whether people were using insulin pumps or multiple daily injections (MDI).

For the next six months of the study, the individuals using standard blood glucose meters switched over to CGM. New data shows that the people who switched to CGM spent significantly less time in hypoglycemia and more time in range. The CGM-only group maintained the outcomes from the six-month mark, which was also positive to see.

The WISDM study continues to show that CGM is as important, desired, and effective for older adults as it is for younger adults. Indeed, participants who used CGM in this study reported using it 95% of the time. As CGM becomes easier to use and more affordable in the coming years, we look for this valuable technology to be adopted by more people of all ages and backgrounds. That can’t come soon enough!

6. Increased FreeStyle Libre scanning frequency is associated with reduced time with both high and low blood sugar

Dr. Ramzi Ajjan of University of Leeds presented data across many countries and regions showing that more FreeStyle Libre scans each day was associated with reduced time in both hyperglycemia (high blood sugar) and hypoglycemia (low blood sugar).

Unlike traditional CGM, FreeStyle Libre does not continuously send real-time glucose data to the reader; instead, the sensor patch must be “scanned” with the reader to get the real-time glucose value, trend arrow, and trend graph. By scanning more frequently, people are viewing their blood sugar data in real-time more often. This allows them to make adjustments to avoid highs and lows, whether by introducing a new habit or working to change a longstanding behavior.

The data shows that as the number of scans per day increased, time spent in hyperglycemia and hypoglycemia decreased. For example, in the UK, the lowest number of scans (about five per day) resulted in 44% time in hyperglycemia, which fell to 24% time in hyperglycemia with the higher number of scans (about 45 per day – obviously on the high end, but you get the idea!). Find more data here.

7. MiniMed 670G data shows time in range increases with Auto Mode

Screenshot

Image source: diaTribe

Medtronic presented data from 7,847 people with diabetes across Europe who used the Auto Mode function of Medtronic’s MiniMed 670G AID system. Among 3,139 670G users, average time in range increased from 62% to 71% before and after using Auto Mode – that’s 2.3 hours more time in-range each day!

The increase in time in range corresponded with a drop in time spent in hypoglycemia and hyperglycemia. These users spent just 1.8% of their time with blood glucose levels under 70 mg/dl, and 0.6% of their time with blood glucose levels under 54 mg/dl. On the hyperglycemia side, users spent 21% of their time with blood glucose levels over 180 mg/dl, and 6% of their time with blood glucose levels over 250 mg/dl. Time in range improvements were seen one month after enabling Auto Mode.

Screenshot

Image source: diaTribe

8. Control-IQ increases time in range in children ages 6-13

Dr. R. Paul Wadwa of the Barbara Davis Center for Diabetes presented highly anticipated results from the DCLP-5 trial of Control-IQ in children ages 6-13 years old. Over 16 weeks, time in range increased from:

  • 53% to 67% in the group using Control-IQ
  • 51% to 55% in the group using a pump and CGM, without Control-IQ.

This means that the children using Control-IQ spent about two and a half more hours each day in their target blood sugar range, compared to the kids using a standard pump and CGM.

Like the adult trial of Control-IQ, most of the increase in time in range occurred at night. At night, the Control-IQ group reached an astounding 80% time in range compared to 54% in the standard pump and CGM group. Overall, time spent above 180 mg/dl was 31% for the Control-IQ group, compared to 43% in the standard pump and CGM group. Time below 70 mg/dl was not changed in either group. There were no cases of diabetic ketoacidosis (DKA) or severe hypoglycemia in the trial.

Dr. Boris Kovatchev from the University of Virginia gave a more detailed comparison of the adult and child Control-IQ trials in the slide below:

Screenshot

Image source: diaTribe

Control-IQ was cleared in December for people ages 14 years and older. Control-IQ is expected to be submitted for approval in children in early 2020.

Thank you so much to the conference organizers Professors Moshe Philip and Tadej Battelino – what an outstanding gathering, and much appreciation for making so many people with diabetes and advocates feel so welcome. You can see so much more on the ATTD Facebook homepage, including the compelling opening ceremony with keynote speaker Dr. Jay Skyler giving a moving talk about technology past and present, as well as a video of talented Spanish musicians and dancers to close out the first night! The live stream was also much appreciated. Thank you so much to technology watcher Albert Cai and his team for their brilliant help in identifying key themes at this memorable conference. We’ll be back with more learnings on therapies, behavior, insulin and more …

Source: diabetesdaily.com

Cracking the Code: CEO Eran Atlas Talks Dreamed’s Revolutionary Tech

This content originally appeared on Beyond Type 1. Republished with permission.

By Jordan Dakin

Beyond Type 1: Can you talk about the founding of DreaMed?

Eran: DreaMed started as part of one of the biggest institutes for people with type 1 diabetes in Israel. The director of this institute is Professor Moshe Philip (co-chairman of ATTD). His vision was to bring in technological people to try to develop solutions to help the needs of people with diabetes. One of our first projects was to create an algorithm for automated insulin delive­ry… We were the first in the world to do automated insulin delivery clinical trials outside of a hospital and we published these results in the New England Journal of Medicine. This was the first manuscript about people looping and then we were the first to send people home with automated insulin delivery in 2012.

We created a relationship with Medtronic Diabetes, which allowed us to communicate with their insulin pump and a continuous glucose monitor. After we finished a lot of sessions of clinical trials, we decided we wanted to regulate our technology software as a standalone medical device. That’s why we established DreaMed in 2014. Since then, we’ve made a licensing deal with Medtronic. They were the first investor in the company and our technology will be part of their next-generation advanced hybrid closed loop system: the 780G. But working on the closed loop project, we always knew that not all the people with diabetes would have access to closed loop, but we very much believe that the majority will have access to continuous glucose monitoring (CGM) technology.

The thing that we were focused on is how we can use our expertise to create something that will be able to help the providers and the patient better dose insulin based on data that comes from CGM and from insulin delivery devices. For that purpose, we started to develop a technology that we call today the DreaMed Advisor. DreaMed Advisor is a decision support system that captures all data and recommends very precise, personalized insulin delivery for that specific patient. Not in a real-time manner, but in the manner of a treatment plan.

BT1: Can people on MDI utilize DreaMed advisor?

E: It’s not regulated for MDI patients at the moment. Our MDI version is on clinical trials, and I really hope that during this calendar year, we’ll be able to share the status of these programs and how fast we think it will be available on the market.

Do you think part of the reason people are sometimes slow to adopt technology is because there are some who question using it for matters like medical decisions?

I think what we’re experiencing right now are more logistical issues – how the data flows from the devices to the platform, the fact that clinics are using multiple platforms to download the data from the patient devices, and the fact that most of what we see today is not digitalized. Clinics are still printing reports – about 20 to 30 pages every visit. They don’t have the manpower because they are so overloaded with work: all the documentation, mailing the claims, dealing with that download of the data when the patient arrives at the clinic, etc.

But what I see when I visit clinics and when I talk to people and I hear lectures is that 2020 might be a moment where some of the barriers can be solved. Not all of them, but some of them can be overcome to allow us to implement such a program.

One of the things that is very interesting to me is the role of the people with diabetes in this. Everybody knows that people with diabetes pay a lot of money for healthcare costs, right? The majority of that is from the insulin costs, but even to see a doctor, there is a certain co-pay and co-insurance that patients are paying each visit. The question is how much patients will be open to removing the barriers, and saying, “I prefer to pay out of pocket for a service that will allow me to get the titration of my data with technology, together with a healthcare provider that is considered a top doc because they have clinical studies behind them. For that, I’d be willing to pay out of pocket and eventually, I will save costs because I will pay less, and I will get better outcomes, and I will spare my other costs of going to the ER in hypoglycemia and DKA because of that.” I think that patients are playing an important role in this equation.

I’m sure a big goal for DreaMed is to lessen the burden on physicians in terms of needing to see patients so frequently.

In no way are we trying to make providers obsolete. We think that they are an essential part of patient care because at the end of the day, caring for a patient with type 1 diabetes or any type of diabetes is not just about numbers, it’s not just about the type of insulin. There are a lot of things behind it and we need our providers in the game.

Dr. Greg Forlenza from the Barbara Davis Center very nicely told me, “With your technology, I’ll finally be able to go back and practice the art of medicine and not be a technician.” I think that this is the service that we would like to bring to providers because if we’re able to let them go back to dealing and practicing the medicine, and we can take away some of the barriers, all the technicality and calculations, and we’re going to provide better, more frequent care for their patients. I think that everybody will be happy about that. One of the goals that we have for this year is to try to build the right model in order to make that happen.

We’ve heard that certain endos are starting to charge a co-pay for visits where they review CGM technology, which hasn’t previously been the case. So costs in terms of things like that seem to only be going up for these patients.

I understand what you’re saying, I think that we need to look at that. We have two sides to this. Number one: there’s the side of the provider that spends a lot of hours caring for their patients and the majority of these hours are non-billable time. In the end, we want to find a way for the providers to collect some of this money because we don’t want our doctors to lose money. We want them to sustain their business so they will be able to provide us better care.

But the magic here is creating that without significantly increasing the costs on the patient side. Because if it will increase the cost from the patient’s side, the patient will say, “I don’t want to download my data, don’t charge me for that” and that means we lose because then they’re not going to get that same tight control. These are some of the questions that we are trying to find answers to. How can we be innovative not just on the technology side but also on the commercial side to find a model that will be good for providers but also good for patients?

If someone is interested in utilizing DreaMed’s technology, where do they go from there? Do they just contact their physician and ask if they can use DreaMed?

Right now, that’s the right process. They need to go to the doctor and tell them, “I’ve heard about this cool technology, here’s the information,” and put some polite pressure on the doctor to explore the technology and see if they can implement it. If the clinic is using Glooko, we are integrated, so they can continue to use their Glooko account and we will be able to get into agreement with the clinic and open Advisor on top of Glooko.

If the clinic is using Tidepool, or if the patient has an account, we are also integrating data from Tidepool, so we will be able to just provide a clinic our standalone platform and then connect the clinic’s Tidepool account. From there, every time that a patient downloads his data through Tidepool, we would be able to pull that data and analyze it, then provide recommendations for the provider.

What do you envision as the next step? What’s ahead for DreaMed?

I think that next step from our end is to develop more technologies so we will be able to expand our intended users. We’re working to reach patients on multiple daily injections – that’s our first goal. Then we’ll go to those on insulin with Type 2, either multiple daily injections or basal only. That’s from the development side. For 2020, our main goal is to try to find the right commercial model and how we can have as many patients as possible enjoy this technology as fast as possible.

Can you talk a bit more about the importance of patients having access to any and all options?

I think that patients should have the right to get access to the top tier docs anywhere, anytime that they want to. But that doesn’t mean that they will be able to make all of their treatment decisions alone. I think that there is a great deal of importance in having healthcare providers as part of patient care. But I do think that it’s wrong for patients to have to wait for six months to see a doctor in order to change something in their treatment.

We need to find ways to make top tier treatment accessible to everyone… This is what we believe in. It’s in our mission to provide the best solutions for people with diabetes with our technology.

Do you have a personal connection to type 1 diabetes?

Nope. I don’t have a personal connection. I’ve been working in this business for 14 years. Seven years of my career was spent in the hospital. I was the technical guy in the clinic sitting in the corridors, talking to patients. We did closed loop studies and in those closed loop studies, we did 24-hour studies, stayed overnight, and took care of patients. So I have a very strong connection to people with diabetes.

The fact that we have the ability to provide something to improve their care is a privilege. It’s not something that everybody gets the chance to do in their lifetime. That’s why I’ve been a part of this for so long, this same type of work, because I don’t have a personal connection, but I have an emotional connection to people with diabetes.

Source: diabetesdaily.com

Automated Insulin Delivery: Six Universal Observations and Understandings

This content originally appeared on diaTribe. Republished with permission.

By Laurel Messer

Six universal facts about automated insulin delivery systems, and the things you should keep in mind about this revolutionary technology

Automated insulin delivery (AID) systems are moving towards the forefront of diabetes management. AID systems combine continuous glucose monitors (CGM) with smart algorithms to automatically adjust insulin delivery.

The Tandem Control-IQ system was recently cleared by the FDA, and the Insulet Horizon and Medtronic Advanced Hybrid Closed Loop systems are beginning pivotal trials. These are encouraging developments. As more systems move through the pipeline and eventually into the commercial market, important patterns are emerging in user expectations and user experience. As a diabetes nurse, certified diabetes educator and research investigator, I, along with my team at the Barbara Davis Center, have worked with nearly every AID system in the pipeline, and other systems that will never make it to market. Here are six insights we have gleaned, which seem to be universal (thus far) to all AID systems:

1. You can always beat an AID system with compulsive diabetes management

Many people with diabetes compulsively attend to diabetes care in order to achieve ultra-tight glucose ranges – and are the first to ask about automated systems. What ends up happening is that these “super-users” are invariably frustrated that the system is not yielding the same results that they were able to achieve with their own calculations and management. An important point is that many automated systems are excellent at reducing mental burden for taking care of diabetes, excellent at reducing hypoglycemia, and adequate at improving glucose levels. Humans can beat automated systems if they attend to diabetes care near-constantly. The individuals who will likely be satisfied with AID are those who are comfortable with an A1C in the 7s or above, but they want to reduce the mental load of adjusting settings and micromanaging high glucose levels. The most important question to ask is, “Why do I want to start using an automated system?” If it is to achieve near-perfect glucose levels, the system will likely disappoint. If it is to reduce the burden of “thinking like a pancreas” all the time, it may be a good option. AID will excel at the marathon of diabetes care but may disappoint in the hour-to-hour sprint.

2. Systems work best when you let them work

Using both research and commercial systems, we have seen all the ways to “trick” AID systems—entering phantom carbohydrates, changing set points, performing manual corrections, overriding recommended doses. More often than not, these behaviors lead to glucose instability – reactionary highs and lows from the system destabilizing. All systems will perform best if they are used according to user instructions. This is difficult for the individual who would prefer to micro-adjust settings or desire control over all insulin delivery. Most systems work best when users learn to trust them.

3. Give the system a chance – 2-4 weeks before deciding long term potential

It may benefit us to think about AID like a new significant relationship – it can take some time to “settle.” I mean this both on an interaction level (learning how to respond to alerts, when to intervene, when to let it ride) and on an algorithm level (allowing the system to adjust internal algorithm parameters based on usage). In addition, programmable user settings may need some adjustment in the first few weeks of use, so working with diabetes educators can be helpful for initial set-up and early follow-up.

4. Bolusing is still king

If I could go back in time, I would caution device manufacturers against any whisper of not needing to bolus with AID systems. Bolusing is the singular most important action a person with diabetes can do to optimize insulin delivery on current and near-future automated systems. This will be true until insulin action time gets exponentially faster or artificial intelligence gets better at predicting human behavior, neither of which is on the immediate horizon. In order for people with diabetes to see the best performance on any system (automated or manual), they need to bolus before carbohydrates are consumed. Specific to AID, the timing of the bolus (prior to carb intake) is especially important, as the system will automatically increase insulin delivery after an initial rise of glucose levels, so a late bolus (e.g., after the meal) could lead to insulin stacking and hypoglycemia.

5. Rethinking low treatments

Low glucose levels (hypoglycemia) still happen when using automated systems. What is different with AID is that the system has been trying to prevent the low by reducing/suspending insulin, possibly hours before the low occurs. This means that an individual may need to consume significantly fewer carbs to bring glucose levels back into range – perhaps 5-10 grams of carb at first, reassessing 15-20 minutes later. This can be difficult when wanting to eat everything in sight; however, it can reduce the chance of rebounding into the 200s after over-treating.

6. Infusion sets are still infusion sets

While AID algorithms are revolutionary, the infusion set is not. It is the same plastic or steel cannula that occludes, kinks, or inflames. This hardware limits automated systems and can very quickly lead to hyperglycemia or diabetic ketoacidosis (DKA). It is important for people using AID to recognize signs of infusion set failure – persistent hyperglycemia, boluses that do not bring glucose levels down, ketones, vomiting, etc. Knowing how to treat ketones (via syringe injection of insulin and set change) can prevent a hospital admission or worse.

I love that the diabetes community learns from its members and experiences. Check out our Barbara Davis Center PANTHER (Practical Advanced THERapies for diabetes) website for our team’s latest insights on automated insulin delivery, and tools for people with diabetes, clinicians, and engineers.

Are you considering AID? Feel free to share this article with your healthcare team. For more information about AID systems that are currently available or in the pipeline, click here.

About Laurel

Laurel H. Messer is a nurse scientist and certified diabetes educator at the Barbara Davis Center for Diabetes, University of Colorado School of Medicine, Aurora, CO. She has spent the last 15 years studying how to best utilize new diabetes technologies, and remembers fondly teaching families to wrap up their corded CGM system in a plastic shower bag for bathing. Ok, not that fondly, but look how far we have come! Dr. Messer works with the Barbara Davis Center PANTHER team (Practical Advanced Therapies for diabetes), conducting clinical research trials on promising technologies to make life better for children, adolescents, and adults living with type 1 diabetes. Get in touch at Laurel.Messer@cuanschutz.edu

Source: diabetesdaily.com

Diabetes Tech Updates: Spring 2019

This content originally appeared on Type 1 Writes. Republished with permission.A couple of Saturdays ago, I was lucky enough to attend the Type 1 Tech Summit in Perth, where I had the opportunity to catch up with some of the reps from the diabetes device companies to find out what’s new. Mylife Diabetescare Last May, […]
Source: diabetesdaily.com

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