HypoCOMPASS v1.0

• Research type

  Research Study

• Full title

  Prevention of Recurrent Severe Hypoglycaemia: a Definitive RCT Comparing Optimised MDI and CSII with or without Adjunctive Real-time Continuous Glucose Monitoring.

• IRAS ID

  17867

• Contact name

  James Shaw

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundation Trust

• Eudract number

  2009-015396-27

• ISRCTN Number

  52164803

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  People with insulin-dependent Type 1 diabetes often lose early warning of falling blood glucose. This is a major concern as it can lead to severe hypoglycaemia which can be defined as a collapse without warning or the need for help from another person because of low blood glucose. This problem can be reversed by stringently avoiding low glucose levels though this has been done in the past at the expense of having damaging high glucose levels. We have shown in a small study that further severe hypoglycaemia can be prevented in most people while improving overall glucose control using modern insulin injections or an insulin pump. We plan to further test these treatments together with a new glucose sensor which can detect low glucose levels in a definitive trial of 100 individuals currently experiencing the worst episodes of hypoglycaemia. This will show us the best way of managing and supporting all patients with hypoglycaemia in the future.

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  09/H0904/63

• Date of REC Opinion

  18 Dec 2009

• REC opinion

  Favourable Opinion