RHAM - Phase 2
Research type
Research Study
Full title
Remote HbA1c monitoring (RHAM) using dried blood spot sample collection – Phase 2
IRAS ID
197375
Contact name
Sandra MacRury
Contact email
Sponsor organisation
University of the Highlands and Islands
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
Five per cent of the Scottish population is registered as having diabetes. Good blood glucose control is essential for effective management of diabetes with high blood glucose increasing the risk and associated costs of complications. Glycaemic control in diabetes is monitored by regular testing of HbA1c. In NHS Highland patients requiring HbA1c tests attend their GP practice for venepuncture, with blood samples sent to Raigmore Hospital for analysis. This project aims to provide a more convenient and acceptable method of blood sample collection especially for rural dwellers: dried blood spots prepared by the patient at home using capillary blood. The project builds on a pilot study which demonstrated a favourable (strong) correlation between venous and capillary dried blood spot HbA1c levels. The study is being conducted in two phases: PHASE 1 (completed)involved semi-structured interviews to the point of saturation with a cohort of patients attending urban (Inverness) and peripheral (Skye) diabetes clinics to ascertain views on the dried blood spot and HbA1c self-testing approach in diabetes management. This has both informed questionnaire and protocol content and augmented opinions of service users on the wider question of compliance with long-term monitoring of diabetes. The final protocol for Phase 2 (the current study) reflects these views. PHASE 2 - Participants attending routine clinics in Inverness will be recruited and asked to prepare dried blood spots in clinic and also at home and return these by post to Raigmore Hospital in Inverness for analysis. Results will be compared with HbA1c levels in venous samples taken at the routine clinics. A questionnaire will assess participants’ views on ease of use and acceptability after completion and return of dried blood samples.
This research ethics application deals with PHASE 2 of the study.REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0214
Date of REC Opinion
22 Mar 2016
REC opinion
Further Information Favourable Opinion