pcnr
All Issues

All

Issue 14Issue 13Issue 12Issue 11Issue 10Issue 9Issue 8Issue 7Issue 6Issue 5Issue 4Issue 3Issue 2Issue 1

Diabetes management made simple; the Cellnovo diabetes management system

Product Focus

Cellnovo Diabetes Management System

According to Diabetes UK [1], approximately 345,000 people in the UK are living with Type 1 diabetes. Management regimens can be rather a ‘moveable feast’ as diet, exercise, lifestyle, concomitant illness or disease and insulin delivery mechanism can affect the body’s use of insulin. Poorly controlled blood glucose and deranged blood glucose variability level can cause hypo/hyperglycaemic episodes, which may in the long term, contribute to microvascular disease [2]. Often when regimens are not effective, patients’ quality of life and concordance can be affected, and vice –versa. This may be due to:

  • Faulure or low adherence to diet, medication, testing regimens and appointment keeping [3]
  • A lack of a team approach to care [3]
  • The impact diabetes has on the relationship with family/friends [4], for example, having to adjust insulin regimen to accommodate diet/activity [5]
  • Medication regimens interfering with normal life [4] but conversely, risk taking behaviours such as alcohol and/ ordrugs [5]
  • Fear of hypoglycaemic attack [5]
  • Self monitoring of glucose levels then adjusting dosage can be complicated – recorded/actual control can vary [5]

Continuous subcutaneous insulin infusion (CSII)

Insulin pumps provide a convenient way of delivering a continuous subcutaneous insulin infusion (CSII). Pumps facilitate a personalised regimen such as 24h basal infusions and on-demand bolus delivery for acute periods of elevated blood glucose. This mimicking of the natural physiology of the pancreas aims to maintain a constantly normal blood glucose level and avoiding the high blood glucose levels that are associated with meals or the low levels that come from too much insulin.

The advantage of a pump over other delivery systems include:

  • Fewer injections [6]
  • Flexibility [6]
  • The ability to fine-tune regimens to personal lifestyle / needs [6]
  • Improved glycaemic control (lower HbA(1c) [7,8]
  • Reduced frequency of hypoglycaemic episodes (better glucose variability control) [8,9]
  • Enhanced quality of life versus specific MDI regimens in type 1 diabetes mellitus [7]

Despite these obvious advantages, a 2012 audit supported by the Juvenile Diabetes Research Foundation (JDRF), Diabetes UK (DUK) and the Association of British Clinical Diabetologists (ABCD) [10], suggests that only 6% of adults with T1DM use CSII, despite 15-20% of this population being eligible under NICE guidance [11]. This compares poorly with some European countries, where more than 15% of T1DM patients are treated with CSII, and the USA, where estimates suggest a 40% use [12]. In children (under 18 years of age), of the estimated 26,500 with T1DM, only 19% were using CSII.

Clearly, more needs to be done to increase these figures; given that technology and gadgets are mainly the domain of younger people (who hasn’t asked a person several decades younger then themselves to deal with a technical problem?), a system which incorporates technical excellence with ease of use may be of benefit.

Types of pumps

Tethered pumps such as the Animas Vibe®, the Roche Accu-Chek® Combo (Roche Insight), the Medtronic MiniMed Paradigm®VeoÔ and the Medtronic 640G are the most commonly used. An infusion set (length ~30-100cm) connects the subcutaneous cannula to the pump device which can be programmed to deliver a basal rate of insulin; higher infusion rates are delivered by the push of a button when required [11]. Most also have programmable memory, safety lockout features and remote control functions [13].

Patch pumps have been introduced more recently. They are worn directly on the body and controlled by a wireless device, making them more discrete than tethered pumps. The can improve concordance because they facilitate increased flexibility, easier technical operation and a smaller, lightweight device which is capable of being manipulated discreetly. Examples include the Insulet OmniPodÒ and the Cellnovo system.

Cellnovo system

This mobile-connected diabetes management system is fully programmable and captures data in real time. It comprises a handset and a pump, and a unique wireless connection to a web portal.

Handset

The handset wirelessly controls the pump. It has an integral blood glucose monitor, a series of sensors which control insulin delivery (including basal/bolus doses) and a mobile data connection to the Cellnovo web portal. The result of every blood glucose test is automatically logged by the software and is immediately available to the patient and clinician via the portal.

Other apps on the handset allow both patient and clinicians to track diet, insulin delivery, blood glucose and exercise - physical activity is recorded automatically by a sensor.

This automated data collection eliminates the need for patients to keep a diabetes journal and ensures that comprehensive and accurate clinical information are constantly available to all who need it.

Pump

The pump is the heart of the system; it has no buttons or physical connection to the control unit (handset) as all information is passed wirelessly. This contributes to it small, compact size, allowing its user to choose where and how to wear it (Figure 1).

The pump is waterproof and easy to detach; while it can be left on while showering or swimming (rated to survive at a depth of one metre for a whole hour), longer periods of immersion require it to be removed. Because of its small size, it can be attached directly to the skin. The unique hook and loop velcro patches make it easy to remove the pump and there is also a cap on the infusion site.

A disposable insulin cartridge fits into the pump and is connected to the infusion set. Once dosages gave been calculated and programmed into the handset, its mechanism enables accuracy of insulin delivery and monitoring. The insulin cartridge has been designed to last a maximum of 3 days in line with the maximum wearable time of the infusion set.

Within the pump is an ‘Intelligent Delivery System’ (IDS), which is unique to Cellnovo. This IDS allows:

  • A 24-hour basal profile, programmable in hourly increments
  • A maximum basal and bolus rate setting to limit the maximum programmable rates
  • Cannula prime to ensure the infusion set cannula is filled with insulin once the infusion pump and set are attached to the body

The SmartCalc bolus calculator technology provides bolus delivery recommendations based on patient-programmed inputs such as carbohydrates, insulin to carbohydrate ratio, blood glucose correction ratio, time to target and desired blood glucose target range.

A Delivery Sensor measures physical insulin delivery and the automatic release mechanism ejects the insulin cartridge if over-delivery occurs or if the insulin delivery does not match the programmed rate. In addition, a series of alarms are available:

  • Insulin delivery alarm - for unintended delivery, under-delivery or no delivery in both basal delivery or bolus doses
  • Occlusion alarm - if there is a blockage in infusion set; set at below 1 unit of missed insulin
  • Temperature risk alarm - if the ambient temperature exceeds 37°C (i.e. the threshold where insulin is known to start to break down and become less effective)
  • Cartridge Expiry alarm– triggers at 72-hours cartridge usage to signify that the insulin effectiveness cannot be guaranteed beyond 72 hours

Cellnovo online

Clinicians need to know about blood sugar levels, diet, exercise and insulin doses. However, even where such data are meticulously collected and recorded by the patient, their value is limited by the inevitable delay between visits to the clinic or periodic manual uploads – it is ‘old news’ by the time it is read. This means that problems may go unaddressed for days or even weeks.

Cellnovo’s unique data capture and monitoring system and web portal allows patients and clinicians to access contemporaneous clinical information online using a simple visual analysis. Charts and figures allow one to:

  • Track trends and patterns in blood sugar (current blood sugar, average blood sugar, insulin dosing, hypo frequency and blood testing habits)
  • See how normal routine affects blood glucose control
  • Observe insulin dosing habits to see where control may be improved
  • See exercise habits mapped out in pie charts
  • See exactly how and when the insulin was delivered

Because the clinician can also access this data in real time, they can contact the patient whenever needed with guidance and advice, thus restoring effective control when it's needed, instead of weeks later during a routine visit. In addition, using the portal, clinics can completely reorganise the way in which patients are managed; clinic visits are focused completely on current and accurate information.

Conclusion

This mobile data system has many features that facilitate safe delivery of programmed insulin regimens, yet allows changes to bolus doses where necessary.

All data is captured in real time and is available to both patients and clinicians immediately, thereby allowing any potential or real issue to be dealt with in a timely manner. It also obviates the need for a journal or complex calculations of doses against activity and or intake.

It is small and discreet and easy to programme and use, even for ‘older’ patients.

Information