HbA1c Variation Study
Research type
Research Study
Full title
HbA1c Variation Study
IRAS ID
306497
Contact name
Pamela Reid
Contact email
Sponsor organisation
Abbott Diabetes Care Ltd
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This is a study to gather data to evaluate the relationship between HbA1c and average glucose levels. HbA1c is the standard measure of glycemic levels used for the diagnosis and management of diabetes. However, there are important limitations recognised for this assay, in that it is impacted both by glucose levels and RBC turnover. The study design requires participants have blood tests every two weeks for HbA1c; this high frequency of HbA1c blood tests is required to increase the likelihood of capturing periods of significant change in average glucose. Identifying and characterising periods of rapid change in this study is vital to predicting optimal HbA1c windows and eliminating less informative HbA1c collection in the future. Participants will have fortnightly HbA1c tests and will wear two FreeStyle Libre continuous glucose monitoring sensors at a time, for the duration of their participation in the study (approximately six months). In addition to the frequent HbA1c tests, venous blood will be collected from the participants at the start and end of the study and analysed (tests including but not limited to complete blood count, biochemistry, haemoglobinopathy screen, haematology panel, liver function panel and iron panel). These results will help assess and interpret the data collected in the study. There are no effectiveness endpoints. The safety analysis will be a summary of all adverse events (AEs) from all enrolled participants.
REC name
South West - Frenchay Research Ethics Committee
REC reference
21/SW/0177
Date of REC Opinion
9 Feb 2022
REC opinion
Further Information Favourable Opinion