The guidance recommends the system as an option for people with type 1 diabetes who experience frequent episodes of disabling low blood glucose (hypoglycaemia)i despite optimal management with insulin pump therapyii.
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 regimensiii 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 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. 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 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 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.”
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Notes to Editors
- 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.
- 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.
- 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 guidance
- The diagnostics guidance on integrated sensor-augmented pump therapy systems for managing blood glucose levels is available on the NICE website.
- The guidance states that:
1.1 The MiniMed Paradigm Veo system is recommended as an option for managing blood glucose levels in people with type 1 diabetes only if:
- they have episodes of disabling hypoglycaemia despite optimal management with continuous subcutaneous insulin infusion and
- the company arranges to collect, analyse and publish data on the use of the MiniMed Paradigm Veo system (see section 7.1).
1.2 The MiniMed Paradigm Veo system should be used under the supervision of a trained multidisciplinary team who are experienced in continuous subcutaneous insulin infusion and continuous glucose monitoring for managing type 1 diabetes only if the person or their carer:
- agrees to use the sensors for at least 70% 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 programme on diet and lifestyle, and counselling.
1.3 People who start to use the MiniMed Paradigm Veo system should only continue to use it if they have a decrease in the number of hypoglycaemic episodes that is sustained. Appropriate targets for such improvements should be set.
1.4 The Vibe and G4 PLATINUM CGM 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. Robust evidence is needed to show the clinical effectiveness of using the technology in practice.
1.5 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 that 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.
About type 1 diabetes
Type 1 diabetes affects 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. Insulin moves the blood glucose into cells where it is used to produce energy. With diabetes, the body is unable to use the glucose in this way, so it builds up in the blood.
- 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.
- In the UK, more than 1 in 16 people are thought to have either diagnosed or undiagnosed diabetes. About 90% of those affected have type 2 diabetes, in which insufficient insulin is produced or the insulin is unable to respond in the usual way. The remaining 10% have type 1 diabetes, also referred to as insulin-dependent diabetes or early-onset diabetes, an auto-immune condition in which the pancreas does not produce any insulin
About the NICE Diagnostics Assessment Programme
- For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance
- 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
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