New NICE guidance recommends that people with Type 1 diabetes who have disabling hypoglycaemia (hypos) despite being on an insulin pump should be given access to a sensor-augmented pump to help them better manage their blood glucose levels. Existing NICE guidance around who is given a regular insulin pump has not changed. This new guidance is focused on who should get a sensor augmented pump.
Diabetes UK supports the use of an integrated sensor-augmented pump therapy system, which combines continuous glucose monitoring (CGM) with continuous subcutaneous insulin infusion (CSII), for patients who have disabling hypos. However the charity is concerned that the new NICE guidance does not encompass all available technology that could potentially help patients who have disabling hypos to manage their condition.
Severe symptoms tend to lead to disabling hypos
Hypos can be mild, in which case they are generally corrected by eating or drinking something sugary, or severe, which is defined as the individual needing help from another person for recovery. The main symptoms of mild hypos are blurred vision, dizziness, fatigue, hunger and sweating. More severe symptoms include confusion, convulsions and unconsciousness. Severe symptoms tend to lead to disabling hypos, and these can happen often and without warning for some people with Type 1 diabetes.
In children, especially those younger than five years old, there is research to suggest that severe hypos can cause long term cognitive impairment. Hypos can also occur during sleep (nocturnal hypoglycaemia) and this is particularly serious because the person cannot detect its symptoms while sleeping and may not wake up during an episode. This can lead to the hypo becoming more severe. Repeated hypos can also lead to an impaired awareness of hypos, and this can lead to people with Type 1 diabetes being less able to notice when their blood sugars have dropped too low. Fear of recurrent hypos not only decreases quality of life in the short term but can also hinder treatment adherence and good glycaemic control.
Technology can make a huge difference
An integrated sensor-augmented pump therapy is designed to measure glucose levels every few minutes and allow real-time adjustment of insulin therapy. This technology also alerts the user if their glucose levels become too high or low and some systems can automatically suspend insulin delivery when blood sugar levels drop too low. It can make a huge difference to people who, despite their best efforts, are struggling to control their blood sugar levels.
But Diabetes UK also recognises that due to the pace of advancing technology, these just published NICE guidelines are already out-of-date.Simon O’Neill, Director of Health Intelligence at Diabetes UK, said: “Clinicians should be aware of these guidelines but also bear in mind the other systems that exist but have not been recommended in these guidelines to ensure they consider the best option for each patient. Systems that have not been recommended in the guidelines include the Vibe and G4 Platinum CGM system and the MiniMed 640G system. These are not yet included in the guidance as NICE wants to see robust evidence of clinical effectiveness of the devices in clinical practice in the first instance.”
The new diagnostics guidance currently only supports the use of the MiniMed Paradigm Veo system. During the development of the guidance and adoption resource, NICE became aware of a new integrated sensor-augmented pump therapy system, the MiniMed 640G system (Medtronic), becoming available. NICE has responded to this by producing a Medtech Innovation Briefing (MIB) on the MiniMed 640G system. An MIB isn’t a recommendation, but provides objective information on device and diagnostic technologies to aid local decision-making by clinicians, managers and procurement professionals.