Objective
The proposal describes the further development of a novel, affordable insulin pump (InsuFlo) for T1DM patients via the following objectives:
1. Build upon the iteratively developed, advanced prototyped device to move towards a robust, compact design with a particular focus on improved usability, including possibility of using high concentrations insulin (U-200).
2. Envisioned work will further support integration with open-source artificial pancreas (openAPS) algorithm and third-party continuous glucose monitoring systems (CGMs) with the InsuFlo pump.
3. User-centric accessory development for tubing management, pump handling with a focus on cultural, age and gender nuances
4. Initial batch manufacturing and in-vitro evaluation demonstrating compliance to relevant standards
InsuFlo can help complete the triad for a user centric artificial pancreas system – insulin pump, algorithm and CGM.
Background Rationale
All T1DM patients require insulin to sustain life. Syringes and pens are presently the most popular insulin delivery devices in India and other low- and middle-income countries. Though available for more than two decades, insulin pumps are now finding relevance because of their unique ability to continuously infuse insulin, closely mimicking that of physiological secretion from a normal pancreas. Unlike insulin shots with syringes, pump infusion sites need to be changed less frequently. Documented evidence also points to the benefit of pumps in improving quality of life, clinical health metrics such as HbA1C, number of hypoglycaemic incidents among others. Despite such overwhelming evidence in support, the adoption of CSII (continuous subcutaneous insulin infusion) is sparse, particularly in resource constrained settings. Institutional factors aside, fixed, and recurring costs of such a device are often found to be a withholding factor to widespread adoption.
This is the exact problem we have attempted to address: making an affordable insulin pump that is accessible to patients at the base of the economic pyramid.
The other problem that we’ve attempted to address is the design of a pump particularly catering to patients in LMICs. This is critical to widespread adoption. A simple example of this would be the remote we’ve developed for the pump. There is quite a lot of stigmata associated with T1DM. Consequently, patients, particularly women, tend to hide the pump under clothing to prevent discovery and make use of a washroom every time they need to administer a bolus dosage or monitor delivery. The pump remote can address this problem. In contrast, most commercially available pumps do not provide for one.
Description of Project
There are approximately 230k patients suffering from T1DM in India, of these, a meagre 1-2% are estimated to be on insulin pump therapy (Kesavadev et al., 2010). This can be attributed to prohibitive costs associated with an insulin pump and a lack of commercial pump options for the patient. There is only one major player in the Indian market. Other commercial players have not found it attractive to enter/continue in price-sensitive markets like India. A baseline pump is priced at roughly 6-8-times the median monthly salary in India (Phelps and Crabtree, 2013). The situation is even direr in other LMICs with adoption rates at 0.2% for insulin pumps (Klatman and Ogle, 2020). An affordable pump design will thus enable access to insulin pump therapy for T1DM patients in extremely price sensitive geographies and can potentially impact the cost of care in other geographies as well.
InsuFlo is a novel, affordable insulin pump design under development following the user-in-loop approach to engineering design at the Indian Institute of Science, Bangalore. The proposal builds upon a robust, patent-pending design to reach the inflection point wherein the said design can be taken up for human clinical investigation and regulatory approvals via the start-up route. Targeting T1DM patients in India and other LMIC counties as first beneficiaries – the approach holds strong potential to improve affordability of quality diabetes technology and care across the globe.
This proposal will also explore the usage of higher concentration insulin (U-200) for insulin pump therapy. While the higher concentration of insulin allows for a smaller and hence more user-friendly design, it also can also lead to a reduction in the running cost of durable pumps. As part of the proposed work, the research team will explore candidate strategies to manage increased risk associated with higher concentration insulin by high accuracy mechanism and design interventions.
Pump accessories are an often-overlooked component of the T1DM management ecosystem. When designed well, they can reduce stigma, improve patient satisfaction and adoption rates. A simple example of this is the remote developed for our prototype. There are often a lot of stigmata associated with T1DM in India. Consequently, patients, particularly women, tend to hide the pump under clothing to prevent discovery and make use of a washroom every time they need to administer a bolus dosage or monitor delivery. The pump remote can address this problem. In contrast, most commercially available pumps do not provide for one by default.
As part of the proposed work, accessory development for InsuFlo will be undertaken on multiple fronts.
With adequate considerations to patient safety, the top-level device designs of our pump and communication APIs will be made available in the open-source domain, allowing multiple players the freedom to operate and test the device independently. Such an open approach may potentially enable improvement and contributions from tech-savvy patients/innovators. The communities around the open-source artificial pancreas system (OpenAPS) are active and well established. However, they are limited to software algorithms. InsuFlo could contribute to the hardware aspect of this community and complete a vital link in the triad for user centric artificial pancreas systems - insulin pump, algorithm, CGM.
Anticipated Outcome
The current proposal describes the further development of a novel, affordable insulin pump (InsuFlo) for T1DM patients, comparable to commercially available pumps in delivery accuracy, while bringing down the fixed cost by more than 70%. The project will build upon the already developed proof-of-concept InsuFlo prototype device to move towards a robust, compact design with a particular focus on usability, including possibility of using high concentrations insulin (U-200). Comprehensive in-vitro testing will validate the developed device. Envisioned work will further support integration of the InsuFlo pump with open-source artificial pancreas (openAPS) algorithm and third-party continuous glucose monitoring systems (CGMs). As an outcome, InsuFlo will transition to the next inflection point in the journey towards commercialization: a device ready for human clinical evaluation.
Relevance to T1D
Currently, T1DM is not preventable, and a long-term condition wherein the patient’s body fails to produce any insulin needed for control of blood sugar levels. Insulin pump therapy, also known as Continuous Subcutaneous Insulin Infusion (CSII), involves wearing a device (insulin pump) which provides a steady stream of insulin into the body. The insulin delivery from insulin pumps can more closely mimic what the body does naturally, thereby improving blood sugar control (Battelino, 2006). Consequently, patients can have a more flexible lifestyle. The pumps, however, still require significant input from the patients both in terms financial resources and mind-space needed to manage the technically complex device.
Though available for more than two decades, insulin pumps are only now finding relevance in India and other low and middle-income countries because of increased awareness, rising number of patients and some increase in their income levels. InsuFlo is a novel, patent-pending insulin pump design which will improve affordability of quality diabetes technology across the globe. Designed for users with limited financial resources from low- and medium-income countries as primary target, InsuFlo should benefit T1DM patients globally by providing an alternative option to pump users.
Technologies explored, such as use of high concentration Insulin, could not only enable lower running cost on one hand, but also enable compact pump design on the other. Though InsuFlo team is driven by making insulin pump technology more affordable, this is not achieved by compromising quality and safety of pump technology in any manner. The team is committed to achieving highest quality standards by surpassing the requirements derived from medical device standards and systematic risk management exercises. Affordability is achieved by novel design changes rather than cutting corners in manufacturing.
InsuFlo also builds upon the ethos of the #wearenotwaiting movement and a larger open-source community with a conscious effort to integrate InsuFlo firmware with the openAPS control algorithm. This will complete the triad of a user-centric, open Artificial Pancreas system – insulin pump, algorithm and CGM sensors. With appropriate safeguards we will also provide open-APIs to communicate with InsuFlo pump to enable further development of community based artificial pancreas systems.