The Artificial Pancreas Reforming Type 1 Diabetes Treatment

1.What is it?

  • The DGLB1 system is an automated insulin delivery device (AID) launched by Diabeloop in early 2019, that automatically regulates blood glucose levels for type 1 diabetics using AI, meaning no need for strict carb counting or manually administering insulin doses (1)

2.Why is it Important

  • Type 1 diabetes mellitus (T1DM) affects around 400,000 people here in the UK, with incidence increasing around 4% each year as the ageing population predicament continues to develop. (2)
  • Current T1DM management involves a rigorous management system, consisting of:
    • Strict carbohydrate counting
    • Exercise and activity recording
    • Blood sugar readings before every dose of medication
    • An insulin dosage routine that can be either scheduled or unit doses relative to the carb and activity measurements
  • Due to this routine, lives of most sufferers revolve heavily around the limitations of their condition due to the repeated management required.
  • This is where these popularly termed ‘artificial pancreases’, have the biggest potential, as they automatically read the blood glucose release the appropriate dose of insulin.
  • They have potential to provide patients with a greater level of freedom in their day to day care and lead more normal lives
  • This can further benefit patients, as it lowers the risk of potential hypoglycaemic and hyperglycaemic attacks, which tend to be related to insulin misuse in T1 diabetics such as inappropriate or missed doses. This prevents the development of severe complications like diabetic ketoacidosis that are exacerbations of this imbalanced blood glucose.

  • The DGLB1 system is the 2nd AID device approved in the EU, after the Medtronic Minimed, which has made news recently after having many of their devices recalled over a security flaw exposed by the FDA, giving hackers the potential to access and manipulate the doses given by the device, a situation with high risk of fatality. (3)
  • But, unlike the Medtronic, the DGLB1 has a ‘hybrid closed loop system’, which prevents any connection of the system to external devices in normal setup. However, there is an optional telemedicine setup that allows for further monitoring via their servers, so it is unsure whether this setup has the same vulnerability as the Medtronic. (1)
  • The device is only approved for adults over 22 at the moment, and as 29,000 of people with T1DM in the UK are children (2), there is still a demand for this technology here. Such a device could be of most benefit in children as they themselves are unable to manage their condition alone, so this device would not only reduce restriction on the child’s day to day but give parents more freedom and peace of mind not needing to constantly regulate their child’s activities.
  • Thankfully, Diabeloop are aware of this need, and are looking into developing a device for children that can meet the appropriate approvals, with clinical trials currently underway.

3.How does it work?

  • The DGLB1 system communicates between 3 components that make up its self-regulating ability:
    • A Continuous glucose monitor (CGM) to monitor blood glucose levels (Dexcom G6 CGM)
    • A patch insulin pump to administer the insulin dose (currently the Kaleido insulin pump)
    • A handset hosting the Diabeloop algorithm and user interface, that dose the bulk of the work but has no other app or cellular capability
  • Every 5 minutes, the CGM takes a recording of blood glucose, which is picked up by the handset via Bluetooth
  • The DBLG1 AI analyses this data in real time, all the while considering the patient’s physiology, history and data entries (entries of the patient’s diet or activities to help the system predict the change in blood glucose) – these all are considered to determine the correct insulin dose to be administered.
  • This system is based on a machine learning algorithm, so with increased entries and readings, it gets better at regulating the patient’s unique response to insulin so that insulin levels can be kept as low as possible and the patients’ blood glucose is maintained on a much steadier course far closer to normal.

References

  1. https://www.diabeloop.com/
  2. https://jdrf.org.uk/information-support/about-type-1-diabetes/
  3. https://www.fda.gov/medical-devices/safety-communications/certain-medtronic-minimed-insulin-pumps-have-potential-cybersecurity-risks-fda-safety-communication

Author – Shahmeer Noori

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