Advice

Summary

Summary

The MiniMed 640G integrated sensor‑augmented pump therapy system with SmartGuard is a continuous glucose monitoring and insulin delivery system for people with type 1 diabetes. It can automatically suspend insulin delivery if blood glucose is predicted to drop below a pre‑set level within 30 minutes. The available clinical evidence on the effectiveness and safety of the system is limited to 1 abstract, which reports a small, short‑term prospective case series in which the sensor‑determined glucose level did not reach a pre‑set low limit in most predictive insulin suspensions. Two further proof‑of‑concept studies showed that the same algorithm as that used in the MiniMed 640G prevented hypoglycaemia both during night hours and during exercise. The MiniMed 640G system (insulin pump and transmitter) costs £3485 with additional consumable costs of about £400 per month.

The MiniMed 640G with SmartGuard is a new integrated sensor‑augmented pump therapy system, which became available during the development of the NICE diagnostics guidance on integrated sensor-augmented pump therapy systems.

Product summary and likely place in therapy

  • The MiniMed 640G system combines a continuous glucose monitor and insulin pump to automatically deliver insulin and maintain blood glucose levels within a pre‑set range.

  • The system would be used by people with type 1 diabetes who have episodes of disabling hypoglycaemia despite optimal management with continuous subcutaneous insulin infusion.

Effectiveness and safety

  • The available clinical evidence on the safety and effectiveness of the MiniMed 640G system when used with the SmartGuard predictive algorithm is limited.

  • One 4‑week prospective case series of 40 patients (reported as a conference abstract) with type 1 diabetes assessed the ability of the MiniMed 640G to prevent hypoglycaemia, and its acceptability to users. In 83.1% (1930/2322) of the predictive insulin suspensions, the sensor‑determined glucose level did not reach the pre‑set low limit. The results from the patient questionnaire suggested that the patients found the system easy to use and helped them achieve better glucose control.

  • Two proof‑of‑concept studies of the algorithm incorporated in the MiniMed 640G system included a total of 32 patients. One randomised, controlled, crossover trial of 10 patients with type 1 diabetes (reported as a conference abstract) concluded that the algorithm could reduce overnight hypoglycaemia. Only 2 of 10 participants reached the pre‑set blood glucose threshold when SmartGuard was on, compared with 9 of 10 participants when SmartGuard was off. One case series of 22 patients with type 1 diabetes showed that hypoglycaemia was prevented in 12 out of 15 patients during an exercise session.

Technical and patient factors

  • The MiniMed 640G system incorporates a proprietary algorithm (SmartGuard) that predicts blood glucose levels. It is designed to reduce the need for frequent daily blood glucose measurements and manual insulin injections.

  • It can automatically stop insulin delivery if blood glucose is predicted to drop below a pre‑set level within 30 minutes, and will restart delivery when glucose levels recover.

  • The MiniMed 640G became available during the development of the NICE diagnostics guidance on integrated sensor-augmented pump therapy systems. It differs from the MiniMed Paradigm Veo system mainly in having the automated stop and restart functions described above.

Cost and resource use

  • The MiniMed 640G insulin pump costs £2995 and the transmitter and charger costs £490 (all excluding VAT).

  • Consumables including glucose sensors, infusion sets and insulin reservoirs cost around £400 (excluding VAT) per month.