A new concept in insulin delivery
Technology facilitates the use of insulin pumps, which can both deliver drug therapy and aid patient self-management.
Patients using such technology expect accurate and safe drug delivery and immediate identification of problems. However, most continuous subcutaneous insulin infusion (CSII) systems ‘lock in’ information such as HbAc1 readings, meaning that when this is accessed by a health care professional (HCP) it is not contemporaneous.
This product focus outlines the features of the Cellnovo System, a mobile-connected diabetes management system (DMS), comprising real-time data capture and a range of safety features which allow both clinician and patient to manage their diabetes more effectively.
Diabetes management
Patients with type 1 diabetes mellitus (T1DM) require insulin therapy to achieve an optimal glycated haemoglobin (HbA1c) level. This can be delivered via syringe, pen, nasal spray, jet, and continuous subcutaneous insulin infusion (CSII). However, a number of factors such as low adherence to diet, medication/testing regimens and appointment keeping [1], diabetes-related stress [1], and disruption to normal life because of medication regimens [2], can affect the effectiveness of insulin regimens and/or concordance.
Using a continuous subcutaneous insulin infusion system can ameliorates or eliminate these factors; they allow the patient to take control of their diabetes, which may help improve concordance. However, a 2012 audit supported by the Juvenile Diabetes Research Foundation (JDRF), Diabetes UK (DUK) and the Association of British Clinical Diabetologists (ABCD) [3], reported that only 6% of adults with T1DM use a CSII system, despite 15-20% of this population being eligible under NICE [4] guidance. This compares poorly with many European countries where more than 15% of type 1 patients are treated with CSII, and the United States of America, where estimates suggest a 40% use [5].
Why use continuous subcutaneous insulin infusion?
Continuous subcutaneous insulin infusion (CSII) therapy eliminates the need for daily injections and facilitates easier delivery of bolus insulin, which can potentially improve HbA1c and reduce low blood glucose episodes [6]. In addition, CSII allows flexibility in diet and meal times (users can exercise without having to eat large amounts of carbohydrate) and eliminates the unpredictable effects of intermediate and long-acting insulins [6].
The first pump delivery system was developed in the 1960s [7], although the first commercial pump was not marketed until 1978. Today, a CSII system comprises an external pump that delivers insulin continuously from a refillable storage reservoir via an infusion tube attached to a subcutaneously placed cannula. The pump can be programmed to deliver a basal rate of insulin; higher infusion rates are delivered when required [4]. Most systems have a programmable memory, safety lockout features and remote control functions [8]. However, CSII systems, particularly durable pumps, are not without problems; infusion errors can occur due to pump failure, infusion tube blockage, infusion site problems (e.g. infection), insulin stability issues, user error, or a combination of these [9].
Several varieties of insulin pump are commercially available, the two main products being durable pumps and patch pumps. Durable pumps include an infusion set which connects the subcutaneous cannula to the pump device via an infusion line. Examples include the Animas Vibe® Ping®, the Roche Accu-Chek® Combo, the Medtronic MiniMed Paradigm®VeoÔ and the Advanced Therapeutics DANA Diabecare R®. In patch pumps, the cannula and delivery system is inbuilt into the device. They are worn directly on the body and controlled by a wireless device making them more discrete than durable pumps. The lack of long tubing increases flexibility, with a smaller, lightweight device capable of being manipulated discretely [10]. Examples include the Insulet OmniPodÒ and the Cellnovo system.
This Cellnovo mobile diabetes management system has numerous safety features and comprises three core parts;
1. Handset
The handset contains an integrated Blood Glucose Meter (BGM) and an extensive library of applications (apps). It is used to programme insulin delivery, and automatically captures all information about the patient’s insulin therapy. Screen lock prevents accidental programming and/or changes
2. Pump
The small pump connects wirelessly to the handset. Insulin regimens are entered into the handset and the pump controls and monitors insulin delivery. The Intelligent Delivery System allows a 24-hour basal profile (programmable in hourly increments), maximum basal and bolus rate setting and cannula priming. The SmartCalc bolus calculator provides bolus delivery based on patient-programmed inputs such as carbohydrate intake, insulin to carbohydrate ratio, BG correction ratio, time to target and desired BG target range.
The system automatically records all insulin delivery, so patient diaries are not required. Alarms are triggered in:
- In cases of unintended delivery, under-delivery, no delivery in both basal or bolus doses, or occlusion
- After 72-hours of cartridge usage (insulin effectiveness cannot be guaranteed beyond this)
Each insulin cartridge has a identification microchip which prevents re-use of a faulty or non-Cellnovo cartridge
The unit can be worn for 1 hour in water up to a depth of 1.1m. It is the only pump that includes a 3-axis accelerometer to measure movement, which when accessed through the Activity application, can both monitor and motivate activity.
3. Data management
Data is stored in a secure web-based management system which can be accessed at any time by the patient via the Members’ Portal. Here the patient can access analytical tools which allow them to review their medical data. It also provides an extensive suite of support tools such as the Cellnovo Academy, Knowledge-Based Articles (KBA), FAQs, iChat and User Guides.
The Clinician Portal allows healthcare professionals to view the data for their patients, and to access a similar set of analytical tools, facilitating more effective support to those patients who need it.
As data are achieved in real time and immediately delivered to the user over an encrypted mobile web connection, any potential problems that might otherwise go unnoticed can be dealt with immediately by the healthcare team. Conversely, patients who are managing well need no longer attend a clinic just to check their diabetes management. Visits can be focused on interpreting and responding to information instead of spent piecing it together from memory and written journals. With access to all the data, patients and clinicians will be able to make swift assessments and decisions with the confidence of accurate and comprehensive knowledge.
In partnership with patients, professionals are able to diagnose product queries and complaints, and often solve any use issues with reduced inconvenience to the user. Additionally, the full traceability of the product from manufacture to disposal can ensure that batch issues are quickly identified and allows for automatic re-ordering of supplies.
Quality of life is improved using a CSII system [11] and outcomes such as clinical and quality of life indicators also suggest that such systems are preferable to multiple daily injection regimens [11].
Cost effectiveness of the system is also demonstrable. The safety features ensure that resources are not spent dealing with accidental under/over dosing, and the remote monitoring facility means that the patient does not always have to attend a clinic, thereby freeing up health care professionals’ time.
Box 1 contains an abridged interview with Professor Stephen Bain, Assistant Medical Director for Research & Development for ABM University Health Board and Clinical Lead for the Diabetes Research Network in Wales [12], outlining his thoughts on the product.
Conclusion
This novel system facilitates self-management of diabetes. The safety features plus the programmable handset facilitates safe and effective insulin delivery and can ameliorate issues of concordance; patients are likely to use their pump effectively if they are confident in its performance (thereby allowing normal activities of living) and that they can contact a professional when necessary.
Box 1. Abridged interview [11] (reproduced with kind permission from Touch Endocrinology.com)
What makes the Cellnovo system different to other insulin delivery devices?
It is different because it is the first mobile diabetes management system, providing intuitive operation, internet connectivity and real-time tracking. The system was created to reduce adverse incidents through its safety features and its ability to capture real-time data for rapid analysis and intervention by the patient and/or clinician where necessary.
Which patients are likely to benefit most from this technology?
The system plays to the particular requirements of younger T1DM patients, as they are generally more ‘tech-savvy’ and active, but this is not to exclude other age groups; quality of life is improved using a CSII system. Outcomes in clinical indicators and quality of life indicators also suggest that such systems are preferable to multiple daily injection regimens.
Does the system have any drawbacks?
Interestingly, anecdotal feedback from users indicates that the safety alarms, one of the main tenets of the system, can be embarrassing if they sound in public. The fact that the insulin cartridge automatically disconnects after 72 hours can be inconvenient if it occurs during the night, or if the patient is not at home, or they do not have a new cartridge to hand. Further development of the system, for example, by widening appropriate alarm parameters, should balance safe and accurate delivery of insulin and facilitate a ‘normal’ life for the patient.
Some users initially felt they had to be more ‘tech-savvy’ to understand how to use the handset and online interface, but over time they have become more competent. Others have expressed concern that their data are transmitted to an online portal, but have since conveyed satisfaction in regards to the security and completeness of the information, as well as the ability to share their data with their clinical team.