DTN statement regarding the use of Medtrum HCL systems

The DTN committee are aware that questions have arisen since the inclusion of the Medtrum HCL system in the framework, provided by NHS Supply Chain, for the procurement of HCL systems to support the implementation of NICE TA 943. The committee has 4 key concerns regarding provision of the Medtrum hybrid closed loop system to people with type 1 diabetes in the UK:

1. We have requested published evidence of the safety and efficacy of the Medtrum HCL system from the company, who are currently unable to provide this. The safety of people with type 1 diabetes is clearly of paramount concern.
2. There were a small number of users of the Medtrum system included in the NHS England Pilot of these systems. Some of these users experienced adverse events, including an increased risk of hypoglycaemia. The safety concerns raised led to DTN recommending that Medtrum users be switched to an alternative system. While we understand that there have been updates to the Medtrum system since this pilot took place, we have not seen any evidence to date to demonstrate that these issues have been resolved.
3. We have received communication from international colleagues that current users of the Medtrum Hybrid Closed Loop system are experiencing similar issues to those observed during the NHS England Pilot.
4. There are alternative, cost-effective systems included on the framework where published evidence of efficacy and safety is available.

In light of the above, the DTN committee recommends that this system should not be provided to people with type 1 diabetes in the UK as a Hybrid Closed Loop until published evidence of safety and efficacy is provided by the company.

We note that organisations representing Paediatric Diabetes Professionals (BSPED and ACDC) have also contacted paediatric diabetes centres stating that they do not recommend the use of the Medtrum HCL system in children. These recommendations are made on clinical grounds. While we agree that the NHS must always seek out cost effective systems through which optimal treatment can be provided, we feel that it is important that there is published evidence of clinical benefit for systems that are procured. We will be happy to review this position should the required evidence be provided.

The DTN committee