NICE Guidance Recommends Integrated Automated Glucose Monitoring System For People With Type 1 Diabetes

The guidance recommends the system as an option for people with type 1 diabetes who experience frequent episodes of disabling low blood glucose (hypoglycaemia) despite optimal management with insulin pump therapy^.

The management of type 1 diabetes, which affects around 370,000 adults and 24,000 children in the UK, involves lifelong insulin therapy to regulate blood glucose levels. With conventional insulin regimens some people can have difficulty in achieving blood glucose control and balancing the risk of disabling hypoglycaemia, and hyperglycaemia (a high blood glucose level) - both of which can be potentially life-threatening. It is thought that around 30% of people with type 1 diabetes have problematic hypoglycaemia which can affect many aspects of daily life and result in significant anxiety.

The MiniMed Paradigm Veo system consists of a glucose sensor placed under the skin that continuously measures glucose levels, an insulin pump which delivers insulin continuously, and a transmitter which sends glucose level readings wirelessly from the sensor to the pump.

The system alerts the user if glucose levels become too high or low, if levels are rapidly changing, or if the system predicts levels will be too high or too low in the near future. An automated low glucose suspend function operates independently of user action and stops insulin delivery for 2 hours if the user fails to respond to the alert.

Commenting on the guidance, Professor Carole Longson MBE, NICE Health Technology Evaluation Centre Director, said: “The independent Diagnostics Advisory Committee heard that one of the greatest fears for people with type 1 diabetes and their carers is severe hypoglycaemia. This can have a substantial impact on quality of life by leading people to restrict their daily activities. It can also cause significant anxiety for carers, particularly parents who may have to wake several times a night to check on their child.

“The committee concluded that using the MiniMed Paradigm Veo System may help people with type 1 diabetes improve their glucose control and as a result may reduce the number of diabetes-related complications they experience and improve their quality of life. Using the system may also make it easier for people to stick to their treatment.

“The ability of the system to automatically suspend insulin delivery when it detects that a person’s glucose levels have become too low could help in reducing the incidence of hypoglycaemia that happens during sleep and the associated anxiety. The system could also offer benefits to the NHS through cost and resource savings by reducing the number of hospital admissions and consultations associated with diabetes-related complications.”

Professor Longson continued: “The committee considered that current evidence suggests that the MiniMed Paradigm Veo system may have benefit in reducing rates of severe hypoglycaemia. But the overall evidence base to support the best use of integrated sensor augmented pump therapy systems needs to be improved. The guidance therefore recommends that the company makes arrangements to collect, analyse and publish data to demonstrate that using the MiniMed Paradigm Veo System results in a sustained clinical impact on preventing or improving control of disabling hypoglycaemia.”

A further integrated automated glucose monitoring system without a low glucose suspend function – the Vibe and G4 PLATINUM CGM system – was also considered as part of this evaluation. The committee concluded that the system shows promise but there is currently not enough evidence to support its routine adoption in the NHS; more evidence is therefore needed to demonstrate its clinical effectiveness in practice.”