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Bionic: The Data

bionic chalkboard

It was approaching 2:30, and our portion of The 2014 Bionic Pancreas Camp Study was scheduled to end at 3pm. We needed make our way to the building where all 13 girls, and their families, would be meeting with the Bionic Pancreas Team.

Along the way, I took a few moments to grab a quick video clip of Sugar describing her bionic parts before she had to remove the device…

{Sidebar: At first glance, things  might appear too bulky for real world function, but keep in mind this is the trial device. It’s slated to be used throughout the Multi-Center Study (for adults only) that began in June 2014. At the completion of that study, in May 2015, this device will reach the end of its useful life.}

After finishing our little video, she tucked everything away in her bionic belt and we walked inside to find a seat. A group of girls were huddled at one end of the room, and I encouraged her to sit with them, but she shook her head, and sat down beside me instead.

“I want to be next to you when they take it back.”

I could sense her sadness: Sad to be leaving camp. Sad to say good-bye to Ally. Sad to remove her “BioPanky”. Sad that school would be starting within days of our return home…back to life, back to reality…

The team showed us a slideshow of pictures they had taken, made a few announcements, and answered some of our questions (another post, another day – stay tuned!) While Ed Damiano was talking, the rest of the study  team began removing the remaining Bionic Pancreases from around the room.

Dr. Steven Russell had inserted Sugar’s Dexcom sensor and started her blinded CGM on the first day of camp, so it felt fitting that she would hand everything back to him at the end.

steven russell

She smiled as she removed each piece and pulled out her sites. I wasn’t sure what to expect when that moment arrived, but she handled it very gracefully. I, on the other hand, felt a heaviness inside my heart. The previous few hours had provided me with a glimpse into what life could be like with an artificial pancreas…suddenly 2017 felt very far away.

While we waited for our turn to review her data, the nursing staff did some final assessments. In addition to a few other things, she was weighed and measured (again), and they inspected her skin for any signs of breakdown. They were very thorough.

We quickly inserted a new pump site and hooked her back up to her Animas Ping. Dr. Russell met with us privately to look at active insulin on board, leftover from the Bionic Pancreas…and that was it.

One minute she was Bionic. The next it was over. There was some finality in those moments. This experience was really coming to an end, and it was time to start making the journey home.

The Data

I know this is the nitty-gritty everyone is waiting for, but I need to make a disclaimer first:

I did not see any other child’s data, therefore I cannot comment on the girls’ results as a whole. I also cannot reveal my daughter’s subject ID, nor can I share any specific numbers regarding her results until after the study is published. I don’t mean for any of this to sound vague, but I do not want to risk the integrity of the study or do anything that could otherwise delay progress. Thank you for understanding!

The study was divided into two parts: 5 days of blinded CGM monitoring on Usual Care and 5 days of monitoring on the Bionic Pancreas.

Sugar was offered the same amounts of food at the same times of the day, and remained equally physically active throughout the entire camp experience.

Sugar alerted the Bionic Pancreas to administer additional insulin when she was going to eat meals only. She did not alert it to cover snacks.

Hypoglycemia

She did not have any significant episodes of hypoglycemia during the 5 days and nights she wore the Bionic Pancreas. (Hypoglycemia is defined as less than 70.) There was one dip that fell slightly below 70, but she did not require any intervention outside of the normal Bionic Pancreas glucagon function to manage it.

There was a significant amount of hypoglycemia (including a couple days with 2-3 episodes) that required intervention with fast acting glucose during the week she was monitored on usual care. This continued to be the case, despite camp staff’s intervention to her basal rates.

Hyperglycemia

She had one finger stick reading documenting hyperglycemia above 200 while wearing the Bionic Pancreas.

She had six finger stick readings documenting hyperglycemia above 200 while on usual care.

Averages

Her overall average for the 5 days on the Bionic Pancreas fell well within an acceptable target range. Based on those 5 days, her predicted A1c was about 1.5 points lower than her current A1c. (In 9 years, we have never achieved an A1c nearly that low, let alone accomplishing it without significant hypoglycemia).

Her overall average for the 5 days on usual care was also well within an acceptable target range. However, this number included several episodes of both hypo and hyperglycemia. Based on those 5 days, her predicted A1c was consistent with her current A1c.

(A perfect example of how similar averages can result in very different A1c outcomes, eh?)

THIS POST IS PART OF A SERIES DOCUMENTING SUGAR’S EXPERIENCE IN THE 2014 BIONIC PANCREAS SUMMER CAMP STUDY.

FURTHER READING:
Category: bionic pancreas
  • Alysha Heise says:

    Just the sentence you wrote “the normal Bionic Pancreas glucagon function”……..is music to my ears!

    December 7, 2014 at 1:22 pm

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