NICE Okays Medtronic Veo System for Certain Type 1 Diabetic Patients

Miriam E Tucker

February 12, 2016

The United Kingdom's National Institute for Health and Care Excellence (NICE) has recommended Medtronic's sensor-augmented insulin-pump–therapy system for use in people with type 1 diabetes who experience "disabling" hypoglycemia.

The recommended device, the MiniMed Paradigm Veo System, was launched by Medtronic in the United Kingdom in 2009. It consists of a continuous glucose sensor, an insulin pump, and a transmitter that sends glucose level readings wirelessly from the sensor to the pump and alerts the user if levels change rapidly and/or are trending out of target range. The system includes a "low-glucose-suspend" feature that automatically stops insulin delivery for 2 hours if the blood glucose drops below a preset threshold and the user doesn't respond to the alarm.

But since its launch, the system has generally been available only through self-funding to individuals who can afford it or rarely through "individual funding requests" to the NHS.

Now this new decision, which follows draft guidelines issued last summer, will enable those with type 1 diabetes who experience "disabling hypoglycemia" to access the system. This is defined as repeated and unpredictable hypoglycemic episodes that result in persistent anxiety about recurrence and that are associated with a significant adverse impact on quality of life.

Michael Connellan, senior media manager for the Juvenile Diabetes Research Foundation (JDRF) in the United Kingdom, told Medscape Medical News last year that, if confirmed, the new guidance would mean "that the device will be put in the hands of more of those who need it. The guidance — which has emerged from [NICE] after consultation with JDRF and others — will tell UK healthcare professionals to consider prescribing the Veo, free at source via the NHS, for people who meet the criteria."

Veo Must Be Used Properly, Data Collected and Published

The Veo system must be used under the supervision of a trained multidisciplinary team experienced in the use of sensor-augmented insulin-delivery devices in type 1 diabetes patients.

In addition, the patient or caregiver must agree to use the sensors for at least 70% of the time, understand how to use it, be physically able to use it, and agree to receive a structured education program on diet and lifestyle as well as counseling.

And Medtronic must arrange the collection, analysis, and publication of data on the use of the MiniMed Paradigm Veo system.

NICE did not recommend another integrated glucose management system, the Vibe (Animas) and G4 Platinum CGM (Dexcom), because it does not include the low-glucose-suspend feature.

This system "shows promise, but there is currently insufficient evidence to support its routine adoption in the NHS for managing blood glucose levels in people with type 1 diabetes," NICE states, adding that "robust evidence is needed to show the clinical effectiveness of using the technology in practice."

Nevertheless, NICE also notes that "people with type 1 diabetes who are currently provided with the MiniMed Paradigm Veo system or the Vibe and G4 PLATINUM CGM system by the NHS for clinical indications who are not recommended in this NICE guidance should be able to continue using them until they and their NHS clinician consider it appropriate to stop."

Also at this time, NICE has not recommended the Veo's successor, the MiniMed 640G, which includes a low blood glucose prediction feature and was launched in 2015.

NICE states: "The available clinical evidence on the effectiveness and safety of the [MiniMed 640G] system is limited to one abstract…and two further proof-of-concept studies," and it notes the cost of the system (insulin pump and transmitter) is £3485 ($5230) with additional consumable costs of about £400 ($600) per month.

However, Medtronic says it will collect, analyze, and publish data on the 640G and successive-generation systems to contribute to future NICE guidance.

System Could Save NHS Millions of Pounds

According to Medtronic, nearly 60,000 hospital admissions in the United Kingdom last year resulted from severe hypoglycemia in people with type 1 diabetes, costing the NHS approximately £55 million.

And NICE has calculated that the use of the Veo system could result in annual savings of £1700 per person from reduced ongoing costs compared with using a stand-alone continuous glucose monitor with an insulin pump, the company notes. This comprises £300 to £1600 for each avoided hospital admission for diabetes with hypoglycemia, £80 to £240 for each avoided accident and emergency visit, and £180 to £230 per ambulance call per patient.

"Avoiding episodes of severe or disabling hypoglycemia can be one of the biggest challenges associated with managing type 1 diabetes. Preventing hypoglycemic attacks, which put the lives of patients at risk and lead to costly [accident and emergency] A&E admissions and hospitalization, is a priority area for the NHS," commented Peter Hammond, an endocrinologist at Harrogate District Hospital, United Kingdom, in a Medtronic statement.

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