Frequency of SU-hypoglycaemia in older frail patients with diabetes
Research type
Research Study
Full title
A 16 week PILOT Study to determine the Frequency of Suphonylurea-Associated Hypoglycaemia in older moderately frail patients with type 2 diabetes mellitus poorly controlled on metformin: an open label study ( DIAFRAIL Study)
IRAS ID
171290
Contact name
Alan Sinclair
Contact email
Eudract number
2015-003032-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
A high percentage of older people have type 2 diabetes taking a commonly prescribed treatment called metformin have poor glucose (sugar) control which can increase the risk of diabetes complications. It is usual to consider adding in another medicine at this stage to improve glucose control and medicines called sulphonylureas are often advised in widely accepted clinical guidelines. Sulphonylureas can also increase the risk of a patient having a 'hypo' (low blood sugar) but this is a risk often accepted in routine clinical practice. In our PILOT study, however, we aim to assess by close monitoring how often older people with type 2 diabetes who have some features of frailty (which can sometimes increase the risk of a ‘hypo’) are aware of having a low blood sugar state. We thus wish to assess the risk of sulphonylureas in older people. Twenty patients aged 70 years and over will be asked either to carry on with metformin only for 16 weeks (control group, n = 10)) or to receive in addition, a sulphonylurea called glimepiride for 16 weeks (intervention group, n =10)).There will be 4 visits to their GP surgery: after an examination, a blood test will be taken to measure their glucose control and they will be asked to carry out routine self-glucose monitoring throughout the period. Five in each group will be asked to take part in continuous subcutaneous blood glucose monitoring (CSBG) using a patient-friendly device called Dexcom G4 Platinum which can be worn on the back of the upper arm for up to 72h and records glucose levels automatically. This takes place in the patient’s own home and is done at weeks 1, 8, and 16. Patients will be given full instruction and support and have a direct telephone number (24h/day) to call for advice throughout the study.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
15/SC/0447
Date of REC Opinion
14 Sep 2015
REC opinion
Further Information Favourable Opinion