Detecting Hyperglycaemia in Cancer Patients Treated with Oral Dexamethasone
Research type
Research Study
Full title
Detecting Hyperglycaemia in Cancer Patients Treated with Oral Dexamethasone and Pre-existing Diabetes or at Risk of Type 2 diabetes
IRAS ID
172954
Contact name
Henrietta Mulnier
Contact email
Duration of Study in the UK
1 years, 0 months, 3 days
Research summary
The aim of the feasibility study is to better understand & detect the blood glucose (BG) excursions that can occur in chemotherapy patients treated with oral dexamethasone (a steroid). The study will observe six participants receiving chemotherapy & high dose dexamethasone for a duration of three days. They will have pre-existing diabetes treated with metformin or diet alone. They will be recruited from the Bristol Haematology & Oncology Centre clinic. If subject numbers are inadequate, people with a high risk of Type 2 diabetes will be identified to ensure six participants are recruited. They will be observed for potential hyperglycaemia (high BG levels) using three methods: self monitoring of blood glucose (SMBG) (finger prick capillary BG monitoring often performed routinely by people with diabetes), urine dipstick testing for glucose (an old fashioned, easy method of detecting abnormal BG level) and continuous glucose monitoring (CGM) (a glucose sensor that is also used routinely in clinical care is inserted into the subcutaneous tissue and secured on the surface of the skin, records measurements of glucose every five minutes for up to seven days). These measurements will be taken for two days before chemotherapy and dexamethasone administration to act as baseline readings then continue during dexamethasone treatment and for two days after a total of 7 days. The participants will be asked to record results from SMBG & urine dipstick testing in a journal with any record of physical activity, a food diary, notable symptoms, & when they urinate. These data will be compared & analysed for correlation to periods of hyperglycaemia to identify appropriate tests and timings to detect hyperglycaemia. The participant’s views on the study will also be sought. The results will inform the design & methods for a diagnostic accuracy study to detect hyperglycaemia in cancer patients receiving dexamethasone.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
15/SW/0238
Date of REC Opinion
8 Sep 2015
REC opinion
Further Information Favourable Opinion