Randomised controlled trial of pharmacist-led patient counselling in controlling hypoglycaemic attacks in older adults with type 2 diabetes mellitus (ROSE-ADAM): A study protocol of the SUGAR intervention

INTRODUCTION: Hypoglycaemia is one of the most serious adverse effects of diabetes treatment. Older adults are at the highest risk to develop hypoglycaemia. Several studies have established the important positive role of educational interventions on achieving glycaemic control and other clinical outcomes, however, there is still a lack in studies that evaluate the impact of such type of interventions on hypoglycaemia risk in elderly patients with type 2 diabetes. The purpose of this research is to evaluate the effectiveness of pharmacist-led patient counselling on reducing hypoglycaemic attacks in older adults with type 2 diabetes mellitus. METHODS: and analysis: This study is an open-label, parallel controlled randomised trial, which will be conducted in the outpatient clinics at the largest referral hospital in the north of Jordan. Participants who are elderly (age ≥ 65 years), diagnosed with type 2 diabetes mellitus, and taking insulin, sulfonylurea, or any three anti-diabetic medications will be randomly assigned to intervention (SUGAR Handshake) and control (usual care) groups. The SUGAR Handshake participants will have an interactive, individualised, medications-focused counselling session reinforced with a pictogram and a phone call at week six of enrolment. The primary outcome measure is the frequency of total hypoglycaemic events within 12 weeks of follow up. Secondary outcomes include the frequency of asymptomatic, symptomatic, and severe hypoglycaemic events, hypoglycaemia incidence, and time to the first hypoglycaemic attack. We will also conduct a nested qualitative study for process evaluation. ETHICS AND DISSEMINATION: The Human Research Ethics Committee of the University of Lincoln and the Institutional Review Board of King Abdullah University Hospital approved this protocol. The findings of this study will be presented in international conferences and published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: The study protocol has been registered with ClinicalTrials.gov, NCT04081766.