Who can use it?
All patients with Type I Diabetes, including children and the elderly.
What can I expect from it?
During fasting periods OmniCore RADD will keep the blood glucose concentration in the target range. In case of sudden surges in the body's own glucose production (due to stress, illness, growth spurts and alike) you might briefly see blood glucose value rise above target levels and then drop back to range.
During and after meals, blood glucose values will initially rise, then drop to a level above target and fluctuate around it whilst glucose is being metabolized. Blood glucose level will return to target range once the glucose absorption slows down.
The results as to how long and by how much blood glucose levels will stay above target depends on many individual factors, however the progression will be similar for most. Please note that this applies to insulin-only therapy. When used with glucagon, the progression will differ significantly; especially during mealtimes.
How do I start?
To start off, you need to provide some basic profile information: Height, weight, gender and age.
The initial analysis requires minimum 6 days of CGM and insulin infusion data prior. In case of missing data or data that is flagged as noisy, inaccurate or inconsistent by the analysis, that number will go up.
Once all data is there and the initial analysis is complete, OmniCore RADD will start running.
How does it work?
OmniCore RADD analyzes blood glucose values and insulin injections/infusions in the recent past. It utilizes machine learning algorithms to create simulations that can disect the information into the biological components responsible for the regulation and metabolism of glucose.
OmniCore RADD is not a black box artificial intelligence system, the behavior of which cannot be explained or predicted. It is a set of complex mathematical functions, which execute millions of times to create an accurate representation of the underlying biological mechanisms, to fit and evolve functions and parameters. Every single feature in OmniCore RADD is backed with an idea on how to achieve a more precise calculation and cross-validated with complementary functions that accentuate or penalize the findings.
It is based on decades of medical research carried out by scientists of many fields. It is biological and mathematical theories developed into a working computational system by its author.
The implementation has been in the making since 2019 and a stable version is running 24/7 since early 2021, with the addition of many incremental improvements to deal with the variety of challenges we encounter while living with Type I Diabetes.
The successful synthesis of theory and practice in OmniCore RADD was made possible with a strong motivation for improving the quality of life for all affected and a complete disregard for the many taboos surrounding therapy options of Diabetes Mellitus originating from our century old understanding of the disease and the industry led research that favors work on how to maintain the status-quo.
How does basal insulin scheduling work?
The primary purpose of the scheduled basal is to have a backup solution in case OmniCore is unable to communicate with the pump. As OmniCore RADD regulates basal insulin automatically, it will suspend and resume the pre-programmed schedule and perform boluses as necessary. The schedule you choose to program has no effect on the final amount of insulin delivered by OmniCore.
How does mealtime insulin work?
As with basal insulin, OmniCore RADD will detect glucose fluctuations and adjust insulin infusion to eventually reach the target blood glucose value.
How does targeting work?
You need to set at least two values:
The desired target value and the acceptable low value. Usually this will be around 5.5 mmol/L (100 mg/dL) for the target and between 4.4 mmol/L to 5.0 mmol/L (80 and 90 mg/dL) for the low value.
Rising or falling blood glucose levels rarely follow a linear pattern. The low value setting allows the algorithm to factor in a natural progression to achieve stability.
That way RADD can both get to the target faster and minimize fluctuations afterwards.
Can I set temporary targets?
Yes, but you really shouldn't. In OmniCore RADD the target is not just a number, there are strategical elements of decision making that are constructed based on the target and the actual context.
If you are concerned with sudden increases or decreases of insulin activity (due to exercise or lack of it, absorption issues etc.), you can change the targeting mode that will adjust parameters in the decision model that will allow for different amounts of glucose reserves.
Currently three targeting modes are available: Reserved, Balanced and Active.
Targeting mode can be scheduled, similar to temporary targets.
Does it work on my phone?
Not directly. The OmniCore mobile app works on Android (and soon iPhone) and allows remote control of the pumps.
The analysis, simulation, evaluation and decision algorithms run on a distributed platform of high performance computers in the cloud.
Can it run directly off the phone?
No, not at the moment. The current version requires a lot of CPU power and runs on a several multi-core servers. Development will continue towards optimizing for GPU and FPGA based architectures, still the mobile phones of today won't be able to handle the processing power required for RADD, especially given the battery constraints and the other artificial restrictions on mobile apps imposed by operating system vendors, phone manufacturers and network providers.
What does it learn about me?
OmniCore RADD uses combinations of various machine learning algorithms to figure out how to react to blood glucose changes with respect to available data at hand. It is also self-correcting and self-improving constantly. Hence a reactive and adaptive algorithm.
In terms of artificial intelligence and pattern recognition, it does look for various biological patterns to separate the sources of glucose fluctuations. It also looks for patterns in infusion site deterioration with respect to time and infusion volume.
It does not look for time of day / day of week related patterns as to how basal requirements change or what times are likely to be mealtimes or exercises. Experience has shown that algorithms that rely on daily patterns or user entered input (carbs, basal schedules, insulin ratios, action times etc.) perform poorly if these values fail to hold. OmniCore RADD eliminates this problem entirely by relying only on measurable data and therefore does not make assumptions about life style, biological cycles or other environmental attributes.
It also does not learn about your browsing habits, contact list, home address, favorite songs, app usage, chat and location history. It doesn't sell your data to advertisers, nor does it announce your glucose uptake on social media.
What insulin types are supported?
All rapid acting insulin analogues are supported (e.g. Novorapid / Novolog, Fiasp, Humalog, Apidra). OmniCore RADD doesn't ask you to specify the type of insulin you are using, since their effects vary significantly per individual. However it expects you to be using the same insulin type or mixture consistently. That means if you want to experiment with a different type of insulin, you will have to reset and have OmniCore RADD perform the initial analysis from the start of the experiment.
What are specially crafted boluses?
During a normal bolus the Pod delivers 0.05mL of liquid every 2 seconds. With special boluses the interval between 0.05mL deliveries will vary and there will be gaps of more than 2 seconds between each 'tick'. Using this bolus scheme minimizes insulin leaking from infusion sites and allows for better absorption in the long run.
How do I use glucagon?
Glucagon allows the decision making strategy to behave more aggressively. It will allow mealtime blood glucose to quickly fall to and remain at normal levels even with continued glucose absorption in the post-prandial period.
After inserting a Pod with glucagon, a calibration will take place that is initiated regularly by the system at convenient times. The decision making algorithm will incorporate the findings of the calibration and adjust insulin infusion towards an increasingly aggressive setting. At the same time it will regulate the glucagon infusion and monitor reservoir status in order to timely fall back to normal operation.
Glucagon infusion is completely optional and is at the moment experimental.
How often does the 'loop' run?
The decision process is technically not a loop, instead it's an intermediate action, that is run whenever necessary. It is triggered by CGM updates, external insulin infusions and new findings of the optimizer service, as well as at regular intervals to cover when CGM data is missing.
The actual 'loop' is the optimizer service, which is also responsible for the initial analysis. It runs continuously even when no new data is present, re-evaluates past findings, creates and adapts strategies trying to find better simulation, prediction and decision functions. This happens in a never ending loop.