V1 STRATUS Study
Research type
Research Study
Full title
Freestyle Libre and hospital admissions, mortality and quality of life in high risk type 2 diabetes patients (the STRATUS study.)
IRAS ID
273948
Contact name
Ramzi Ajjan
Contact email
Sponsor organisation
The University of Leeds
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 4 days
Research summary
Type 2 diabetes is a condition characterised by elevated levels of sugar (glucose) in the blood.
lots of medications to treat diabetes are available however some of these medications, particularly insulin injections but also certain tablets, can lead to 'overtreatment' leaving the patients blood sugar too low. This is called hypoglycaemia.
We know from previous studies that hypoglycaemia requiring an ambulance call to assist is dangerous, with patients frequently suffering significant health problems, including death, in the months after the ambulance attended. What is currently less clear is whether anything can be done by the patient or medical professionals to reduce this risk and the aim of this study is to see if the use of a special glucose measuring device and additional input from a diabetes nurse can reduce these adverse events.
We propose to conduct the following study:
- Recruit patients who have type two diabetes after an ambulance has been called to treat hypoglycaemia.
- Randomise into two groups.
- One group will be returned to standard care after a baseline visit and to wear a 'blinded' sensor for two weeks at month 6.
- The second group will receive regular input from a diabetes nurse over six months and also use a special glucose sensing device which allows for a large number of glucose measurements to be taken.
- Both groups will have blood tests taken at 0 and 6 months as well as being asked to complete a set of questionnaires.
- After 12 months groups will be analysed to assess how many participants in each group had significant health problems/died during the study and whether there was any difference in blood tests and quality of life measures (questionnaires) between the two.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
21/YH/0115
Date of REC Opinion
23 Jul 2021
REC opinion
Further Information Favourable Opinion