Tandem’s Control-IQ Cleared for Ages 6-13: Automated Insulin Delivery for Children!

This content originally appeared on diaTribe. Republished with permission.

By Divya Gopisetty, Hanna Gutow, and Albert Cai

In exciting news, Tandem announced expanded clearance for the hybrid closed loop Control-IQ. The system is now available for children ages 6-13

The FDA cleared Tandem’s automated insulin delivery (AID) system, Control-IQ, for children ages 6-13, last week in the US. This system is designed to increase time in range for users and it does – see below for the data!

To date, the only other hybrid closed loop system available for children is Medtronic’s MiniMed 670G, which is approved for children seven years and older. Control-IQ is the first system with automatic correction boluses and no fingerstick calibration (thanks to the Dexcom G6 sensor that it uses).

Control-IQ launched in January of this year for people 14 years and older. Since then, more than 40,000 t:slim X2 pump users have upgraded their pump software to Control-IQ. We saw very positive real-world data presented at ADA this year – in the first 30 days using Control-IQ, users’ time in range increased by 2.4 hours per day, and individuals were in active closed loop 96% of the time.

At the ATTD conference in February, the trial for Control-IQ in children presented strong results. Results from that trial were used to get this week’s FDA clearance. In that trial, we learned that:

  • Children using Control-IQ spent 67% time in range, compared to 55% for children using a sensor-augmented pump. This is a massive difference that equals nearly three more hours in range each day.
  • Children using Control-IQ reached 80% time in range overnight, compared to 54% in the control group – similarly, this change is even bigger, at over six hours more daily time in range.

Control-IQ still should not be used in children under the age of six, in people who require less than ten units of insulin per day, and in children who weigh less than 55 pounds.

For more information on the system, check out Kerri Sparling’s Test Drive of Control-IQ where her time in range improvement was quite impressive! You can also Katie Bacon’s piece on one family’s takeaways (her own!) from the first month of their teenage daughter using Control-IQ.

Source: diabetesdaily.com

Control-IQ: The Good, the Challenges, and Tips

This content originally appeared on diaTribe. Republished with permission.

After a month of her daughter using Control-IQ, Katie Bacon reviews the pros and cons of the algorithm and shares her family’s tips and takeaways

When the email came through in early April that our daughter, Bisi, could now download the software to run Control-IQ on her t:slim insulin pump, the timing seemed perfect. After all, our family was staying at home due to COVID-19, so we had plenty of time together to do the training and figure out the new system and how it worked for Bisi and her blood glucose levels. Plus, from everything I’d read about COVID, keeping blood sugars as stable as possible was more important than ever, and it seemed like Control-IQ could help us with that. (The Control-IQ algorithm uses data from Dexcom’s CGM to lower insulin delivery when a low is predicted and to increase insulin when a high is predicted – learn more about Control-IQ here.)

Bisi has now been on the new system for about a month, and while it hasn’t been a magic bullet and we’re still learning, Control-IQ has improved Bisi’s time in range by about 5% (and we’re hopeful that her time in range will continue to improve). Also, even more importantly, it’s improved her quality of life – and ours, as the parents who watch out for her. When I sat down with Bisi recently to ask her about the change, I got her perspective on the burden she feels diabetes has placed on her ­– and the power of Control-IQ to lighten that load. She told me that before using Control-IQ, at any given time 30-40% of her focus was on diabetes. I was taken aback by this percentage, since Mark (my husband) and I have always tried to take some of the weight for her. As she told me, “It feels demanding, like a lot of pressure, as if someone’s poking my head.” But with Control-IQ, she says, she doesn’t need to worry about much except bolusing insulin at mealtime. She has fewer highs, fewer lows, and she says she feels better physically than she did before. “For as long as I can remember, diabetes has been a main focus of my life, but it really shouldn’t be that way. So it’s been nice not to focus on it as much,” she said.

In terms of what Bisi has experienced over the past few weeks since switching to Control-IQ, I’ve divided my thoughts into the pros and cons of the system as we’ve experienced it; I’ve also included tips drawn from what we’ve learned from Bisi’s endocrinologist and DCES.

Pros of Control-IQ:

  • Graph

    Image source: diaTribe

    We’ve found that Control-IQ works particularly well at night, when Bisi isn’t eating anything or bolusing. While our nights had already improved with Basal-IQ (which did a good job minimizing Bisi’s lows), Control-IQ brings down any highs as well (see the graph on the right). I’d say that when Bisi’s pump only dealt with the lows, we still had to wake up maybe six to eight nights a month, on average – and sometimes multiple times in one night. But in the month since Bisi started on Control-IQ, we’ve only had to wake up three times. This is a big change in our quality of sleep (and quality of life).

  • Control-IQ helps keep blood sugars down during the day. As before, Bisi’s blood sugars are less stable during the day, when her activity is variable and when she’s eating meals and snacks. But now, Control-IQ raises her basal rate when she’s headed high and gives modified boluses (60% of what’s called for) if the highs are sustained. We’ve found that her blood sugar does not rise as steeply, according to her CGM, and also that it often tops out at a lower number than it used to.

Cons of Control-IQ:

  • There were a few instances where Bisi had sustained lows that were more difficult than usual to counteract with carbohydrates. These instances have all been when she’s started exercising with a lot of active insulin on board, due to Control-IQ turning up her basal rate in response to a high. Before using Control-IQ, if Bisi’s blood sugar was high, she (maybe with a reminder from me) would have to make a decision to either turn up her basal or give a correction. If she knew that she was going to get exercise in the near future, she wouldn’t do either of those things. But now they happen automatically, so she’s sometimes stuck with too much active insulin on board. It requires a different kind of thinking and a different kind of planning than before.
  • Both Bisi and I wish there were a little more flexibility in Control-IQ so she could set her own target. Bisi used to set her target at 100 day and night, and would often run at 80 or 90 while she was sleeping. With Control-IQ’s built in Sleep Mode target of 110, Bisi runs a little higher than she is used to, especially at night.

Thoughts and Tips for using Control-IQ:

  • We have found that being consistent about pre-meal bolusing is even more important with Control-IQ than it was before. If Bisi waits too long to bolus, her blood sugar goes too high, she gets more basal and an extra 60% bolus from Control-IQ, and then her blood sugar goes too low later on.
  • While it might seem like Control-IQ could enable people to be a little freer in what they eat, so far it has emphasized the benefits of eating low carb as the best way to avoid food-related spikes and insulin-related dips. No matter how good an algorithm is, it’s always going to be reactive rather than proactive, and we’ve found that the smaller the inputs in terms of number of carbs eaten, the more smoothly Control-IQ works. (I think this is partly why it tends to work better for Bisi at night, when she’s not eating anything, than during the day.)
  • Bisi’s endocrinologist validated our sense that exercise-related lows can be steeper with Control-IQ, since you tend to have more active insulin on board. Because you can’t do a temporary basal rate with Control-IQ, she suggested that we set up an alternate program with basal rates cut by 50%. If Bisi knows she’s going to exercise, she can turn on this alternate program 90 minutes to 2 hours before. Or, if she’s eating beforehand, she can put in fewer carbs/give less insulin. Either way, the trick is remembering.
  • During Bisi’s most recent appointment, her endocrinologist pointed us to a feature of Bisi’s Tandem reports that’s helpful to look at as a way to adjust settings. She told us to focus on the difference in the Logbook section between the Basal Total Delivered and the Basal Profile Setting, as a way to tell whether her basal rate at any given time should be raised or lowered; the closer the settings are to the amount of insulin that’s being delivered, the more smoothly the Control-IQ algorithm will work. She also suggested that we “Marie Kondo” (streamline and declutter) Bisi’s basal rates, which had proliferated over time, to help us see more easily where adjustments need to be made.
  • We realized that if Bisi has a random high blood sugar, particularly at night, we should assume that something has gone wrong with her pump site. Before Control-IQ, pump site failure was only one of several reasons – including the dawn phenomenon and the meal she’d eaten the night before – that her blood sugar might have gone high. This realization has helped us reduce that middle of the night detective work, when your brain is at its foggiest. If Bisi has a persistent high, the problem is most likely the pump site, not the algorithm.
  • One adjustment that Bisi has struggled with is remembering to turn off her insulin when she takes off her pump to shower or play sports. (The Control-IQ algorithm is thrown off when the system doesn’t have an accurate sense of how much insulin you have on board.) This is a work in progress for us.

Even though we still feel like we have more work to do in terms of getting the best out of the new algorithm, Control-IQ has improved Bisi’s life in important ways. As Bisi’s endocrinologist told us, “It’s not perfect, and you need to think more about active insulin than you did before. But the goal with this is to have diabetes interrupt your life less than it did before.” For Bisi, the important aim of staying in range now requires less mental effort. As she said recently when looking at her CGM graph after 24 hours of Control-IQ: “This is pure gold.”

This article is part of a series on time in range made possible by support from the Time in Range Coalition. The diaTribe Foundation retains strict editorial independence for all content.

About Katie

Katie Bacon is a writer and editor based in Boston. Her daughter, Bisi, was diagnosed with type 1 diabetes in August, 2012, when she was six. Katie’s writing about diabetes has appeared on TheAtlantic.com and ASweetLife. Katie has also written for The New York Times, The Boston Globe, and other publications. 

Source: diabetesdaily.com

A D-Mom’s Changed Perspective Using Basal IQ

Technology continues to make managing our diabetes easier. Continuous glucose monitors, apps for carb counting and insulin pumps have all alleviated some of the stress of managing our condition. Tandem Diabetes created Basal IQ technology, which allows us to spend less time worrying about going low and let our devices do the work. For a person living with diabetes, this means less stress and more sleep.

Basal IQ technology helps reduce the frequency and duration of lows by predicting glucose levels and suspending insulin if the blood sugar level is thought to go below 80 mg/dL or the Dexcom reading goes below 70 mg/dL. Insulin delivery will start automatically once the blood glucose starts to rise again.

Basal IQ is different than the newly released Control IQ, in that Control IQ can adjust insulin delivery, including the delivery of automatic correction boluses as needed, therefore helping patients avoid episodes of hyperglycemia. Using either one of these systems also means fewer fingerpricks, as you will no longer have to get manually take your blood glucose reading.

Basal IQ technology has given many people living with diabetes, and those who love them, a little more rest and some peace of mind. A pivotal study showed the use of Basal-IQ Technology on the t:slim X2 Insulin Pump demonstrated a 31% relative reduction in time spent below 70 mg/dL when compared with a CGM-enabled pump without Basal-IQ Technology. Important to note, the less amount of time spent at lower glucose levels did not mean more time spent at higher glucose levels. Maintaining your target range has become a lot easier thanks to Basal IQ technology.

Photo credit: Allison Hoffman

One woman, Allison Hoffman, who helps manage her 10-year-old daughter, Becca’s diabetes, raved about the changes to her overall well-being since switching over to Basal IQ technology after relying on Omnipod for the past few years.

Here is her story:

For 7 years my mornings were absolute hell. While I would see others sleeping in, meditating, going to the gym, etc, I was a slave to Becca’s whackadoodle blood sugar swings, which would often start around 5:00 AM. My body learned to wake up at this time, and that I doubt I’ll ever be able to change.

My mornings would include me running up and down the stairs entering the bedroom, praying I wouldn’t wake her and deny her the right to sleep in, suspending insulin (audible beep I couldn’t silence), sticking glucose tabs in her mouth, often with the pay-off of a horrible blood sugar spike. I would start 95% of my days this way.

And the frustration! No adjustments to her settings were right. If I reduced her insulin she’d go high; .35 too low, .4 too high. I would wake up at 3:00 am to set a temp basal to get the amount she needed that Omnipod didn’t have as a preset-still wouldn’t work. Nothing I did was right.

Since starting on t:slim pump with basal IQ, I finally have my mornings back. It allows more fine-tuned insulin delivery and suspends when it predicts her to go low. As long as her sensor is good, and her insulin settings aren’t way off (I will always need to determine her insulin needs, it isn’t automatic), I can have a pretty peaceful morning now.

I can watch the news, or another show, or read, and my coffee doesn’t go cold. I can sit with my dog on my lap and not have to jump up every ten minutes to go deal with diabetes. I can breathe. And Becca can sleep peacefully.

I’ve made four seesaw activities for my students this morning and she’s still sleeping.

7 years of hell. I finally have my mornings back.

If you are living with type 1 diabetes and are considering a pump, you may want to look into t:slim X2 pump along with the Dexcom G6 so you can make use of the new Basal IQ or Control IQ technology. Their slogan is “live more and worry less” and I am so glad this seems to be the case for so many.

Have you tried out this technology? How has your experience been?

Source: diabetesdaily.com