NICE Recommends Medtronic’s Glucose Monitoring System

The UK’s healthcare costs regulator is recommending Medtronic’s integrated automated glucose monitoring system for managing blood glucose levels in some people with Type 1 diabetes.

In final guidance, the National Institute for Health and Care Excellence says the MiniMed Paradigm Veo system is an option for people with Type 1 diabetes who experience frequent episodes of low blood glucose despite management with insulin pump therapy.

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

Carole Longson, NICE’s Health Technology Evaluation Centre director, says the independent diagnostics advisory committee considered evidence suggesting 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 recommends that Medtronic makes arrangements to collect, analyze and publish data to demonstrate that using the system results in a sustained clinical impact on preventing or improving control of disabling hypoglycaemia.

The guidance also requires that the MiniMed Paradigm Veo system should be used under the supervision of a trained multidisciplinary team that is experienced in continuous subcutaneous insulin infusion and continuous glucose monitoring if the person or the caregiver:

• Agrees to use the sensors for at least 70 percent of the time;
• Understands how to use it and is physically able to use the system; and
• Agrees to use the system while having a structured education program on diet and lifestyle, in addition to counseling.

The committee also evaluated a further integrated automated glucose monitoring system without a low glucose suspend function – the Vibe and G4 Platinum CGM system. The committee concluded the system shows promise, but there currently is insufficient evidence to support its routine adoption in the NHS, Longson says.

Read the guidance here: www.fdanews.com/02-16-NICEMiniMed.pdf. — Jonathon Shacat