Affecting around 370,000 adults and 24,000 children and young people in the UK, type 1diabetes is a lifelong condition caused by the destruction of the cells in the pancreas that produce the hormone insulin. Insulin is responsible for regulating the amount of glucose in the blood. This lack of insulin leads to loss of control of blood glucose levels. If the amount of glucose in the blood is too high, it can, over time, seriously damage a person’s eyes, kidneys or nerves and can also cause heart disease, stroke or circulation problems in the legs or feet.

Management of type 1 diabetes involves lifelong insulin therapy to regulate blood glucose levels. With conventional insulin regimensⁱⁱⁱ some people can have difficulty in achieving blood glucose control and balancing the risk of disabling hypoglycaemia, and hyperglycaemia (too high a level of blood glucose) - both of which can be potentially life-threatening. It is thought that around 30% of people with type 1diabetes 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. The automated low glucose suspend function of the system operates independently of user action and stops insulin delivery for 2 hours if the user fails to respond to the alert.

Commenting on the draft guidance, Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “The independent Diagnostics Advisory Committee heard that one of the greatest fears for people with type 1diabetes 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 consequently may reduce the number of diabetes-related complications and improve their quality of life. Using the system may also make it easier for people to adhere to treatment.

“The ability of the MiniMed Paradigm Veo system to automatically suspend insulin delivery when it predicts the person’s glucose levels will become too low could help in reducing the incidence of hypoglycaemia that happens during sleep and its 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 draft 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 automatic glucose monitoring system that doesn’t have the low glucose suspect function – the Vibe and G4 PLATINUM CGM system – was also considered as part of this evaluation. However, the draft guidance does not recommend it because there was not enough evidence to demonstrate the clinical effectiveness of using the system in practice.

Ends

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Notes to Editors

References

1.               i.        Hypoglycaemia means that treatment for diabetes can also cause blood glucose levels to become too low, causing the person to become anxious, dizzy or disoriented, have convulsions or become unconscious. ‘Disabling hypoglycaemia’ is when hypoglycaemic episodes occur frequently or without warning so that the person is constantly anxious about another episode occurring, which has a negative impact on their quality of life.
2.              ii.        Insulin pump therapy or continuous subcutaneous insulin infusion, consists of a small device worn outside the body, which continuously delivers insulin into the body through a thin tube or needle under the skin. The insulin can be given at a set rate throughout the day, which can be increased when it’s needed, for example at meal times.
3.             iii.        The care pathway for insulin therapy for adults and children is outlined in NICE clinical guideline 15 and for pregnant women in NICE guideline 3. The use of continuous subcutaneous insulin infusion is covered in NICE technology appraisal 151.

About the draft guidance

1. The draft diagnostics guidance on integrated sensor-augmented pump therapy systems for managing blood glucose levels is available on the NICE website.

About the NICE Diagnostics Assessment Programme

1. For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance  
2. Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance