📣 Presentation of the primary outcome results from the CREATE Trial, which assessed open source automated insulin delivery (AID) compared to sensor-augmented pump therapy (SAPT) in adults & kids with T1D, at #ADA2022!

@DrMartindeBock1 presenting on behalf of CREATE team.

Shout out to the amazing CREATE study team.

(PS - there’s another publication from our team about HCPs learning experience on open source AID for this study, too! doi.org/10.1111/dme.14…)

2/ #ADA2022
The CREATE trial aimed to study the efficacy and safety of an open source automated insulin delivery system, with a large scale, long term randomized controlled trial.

3/ #ADA2022
If you're interested, the full study protocol paper for the CREATE trial is open access and available at rdcu.be/b4wUR

4/ #ADA2022
Quick overview - there was a 4-week run-in period to adjust to CGM (which most participants didn't have experience with), before being randomized to AID (intervention) or SAPT (control).

Note: continuation phase data to be presented at EASD!

5/ #ADA2022
Primary outcome was % time in sensor glucose range during the final 2 weeks of the 6 month trial.

Secondary outcome included A1c, safety data, psychosocial impact, etc.

Study enrolled both adults & kids with T1D.

6/ #ADA2022
The AID system studied included a version of open source AID, AndroidAPS (2.8), which uses #OpenAPS algorithm (v0.7.0).

Learning objectives slightly modified compared to real world. All other settings/features including SMB, autosens, etc available to participants.

7/ #ADA2022

14% improvement TIR (p<0.001) as mean adjusted treatment affect.

AID improved TIR: 61.2 ± 12.3% to 71.2 ± 12.1%

(Control arm TIR: 57.7 ± 14.3% to 54.5 ± 16.0%)

No treatment effect by age interaction was detected (p=0.56)

8/ #ADA2022
AID improved TIR for both kids and adults overall, but was most effective at night for both groups.

This graph shows the DIFFERENCE in percentage of TIR, so you can see the bigger difference at night vs day and overall.

9/ #ADA2022
Of note, the TIR improvements occurred at the start of the intervention and were sustained throughout the study period (6 months).

10/ #ADA2022
Overall, we mentioned there was 14% TIR improvement treatment affect in AID from 70-180 mg/dL.

But take a look at the 70-140 mg/dL range - there is also 16% overall treatment affect, with no increase in hypoglycemia.

Mean sensor glucose reduced 22 mg/dL

11/ #ADA2022
Safety wise? No severe hypoglycemia or DKA in the trial.

Any adverse device events (ADE) were rare; similar between control and intervention groups; and were typically pump-associated events like site occlusions. No algorithm-associated ADE were observed.

12/ #ADA2022
We used a proxy method to assess time spent in automation, and in the AID arm automation was active 94% of the time during the study duration.

13/ #ADA2022
Conclusion from the CREATE trial:

Open-source AID, using the OpenAPS algorithm within a modified version of AndroidAPS, is efficacious and safe in children and adults with type 1 diabetes compared to sensor augmented pump therapy.

14/ #ADA2022
Here is a visual summary of the CREATE trial primary outcome results presented at #ADA2022:

You can also read a blog post summary I wrote of the CREATE trial and results here: bit.ly/3zkAFsL


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More from @danamlewis

Jun 5
I just realized it's been 3 (!) years since I published my book on automated insulin delivery, with the goal of helping increased conversation and understanding of AID technology for people with diabetes, their loved ones, and healthcare providers!

I'm still very proud that it is available to read for free online, free to download a PDF (both of which have been done thousands of times each: ArtificialPancreasBook.com), or as an e-book, paperback, and now hardback copy. Proceeds from the purchased copies go to Life For A Child.
And, more recently, it has also been translated into French by the wonderful Dr. Mihaela Muresan and Olivier Legendre!

The French translation is available in Kindle, paperback, hardback, or free PDF download formats as well.

Read 6 tweets
Sep 24, 2020
1/THREAD - my presentation is kicking off at #EASD2020 about open source automated insulin delivery.

(You can see a full version of my presentation here: bit.ly/DanaMLewisEASD…, or read the summary below!)
Note we should differentiate between open source (where the source of something is open), and DIY (do-it-yourself) implementations of open source code. Open source means it can be reviewed and used by individuals (thus, DIY or #DIYAPS) or by companies.

/2 #EASD2020
Open source automated insulin delivery (AID) has evolved since the first open source system, #OpenAPS, was made available in Feb 2015!

There are now three open source AID systems (OpenAPS, Loop, AndroidAPS) commonly used by the #DIYAPS community.

/3 #EASD2020
Read 25 tweets
Jun 13, 2020

Poster 988-P at #ADA2020 by Jennifer Zabinsky, Haley Howell, Alireza Ghezavati, @DanaMLewis Andrew Nguyen, and Jenise Wong: “Do-It-Yourself Artificial Pancreas Systems Reduce Hyperglycemia Without Increasing Hypoglycemia”

(PDF available at bit.ly/DanaMLewisADA2…)
This was a retrospective double cohort study that evaluated data from the @OpenAPS Data Commons (data ranged from 2017-2019) and compared it to conventional sensor-augmented pump (SAP) therapy from the @Tidepool_org Big Data Donation Project. #ADA2020
One month of CGM data (with more than 70% of the month spent using CGM), as long as they were >1 year of living with T1D, was used from the @OpenAPS Data Commons. People could be using any type of DIYAPS (OpenAPS, Loop, or AndroidAPS) and there were no age restrictions. #ADA2020
Read 12 tweets
Jun 13, 2020

Poster 99-LB at #ADA2020 by @danamlewis, @azure_dominique, and Lance Kriegsfeld, “Multi-Timescale Interactions of Glucose and Insulin in Type 1 Diabetes Reveal Benefits of Hybrid Closed Loop Systems“

(full content also available at bit.ly/DanaMLewisADA2…) Image
Background - Blood glucose and insulin exhibit coupled biological rhythms at multiple timescales, including hours (ultradian, UR) and the day (circadian, CR) in individuals without diabetes. But, biological rhythms in longitudinal data have not been mapped in T1D. #ADA2020
It is not known exactly how glucose and insulin rhythms compare between T1D and non-T1D, and whether rhythms are affected by type of therapy (Sensor Augmented Pump (SAP) or Hybrid Closed Loop (HCL)). #ADA2020
Read 26 tweets
Jun 12, 2020
At #DData2020 today, I got to present (virtually!) a study called “AID-IRL”, which was an opportunity to learn from several people using commercial automated insulin delivery systems in the real world.

Here’s more information about the study, and what I learned!

1/ I did semi-structured phone interviews with 7 users of commercial AID systems in the last few months. The study was funded by @DiabetesMine. Study participants received $50 for their participation. #DData2020 Image
2/ I sought a mix of longer-time and newer AID users, using a mix of systems. Control-IQ (4) and 670G (2) users were interviewed; as well as (1) a CamAPS FX user since it was approved in the UK during the time of the study. #DData2020 Image
Read 28 tweets
Jun 8, 2020
I've been appreciating the list of books shared - for adults and kids alike - around #BlackLivesMatter. But we need more - we can always use more.

I want to extend an offer - my DMs are open - if anyone is thinking about writing a book and wants to talk about self-publishing.
This an open offer for the future, too - so if you think "ooh, maybe", feel free to take one of these tweets and stick it on your calendar for 3mo from now, or a year, or whenever you think you might have time/energy/desire and want the reminder.
I'm by no means an expert (&I don't have experience w/ traditional publishing), but I've self-published both kids fiction books & a non-fiction book, so I'd love to encourage or support anyone who wants to help bring these important stories & conversations to longer-written form.
Read 5 tweets

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