Feasibility of metabolic monitoring in SMI
Research type
Research Study
Full title
Feasibility and acceptability of 4-week continuous glucose monitoring and accelerometer recording to monitor glucose levels, mobility changes and hunger levels in patients newly initiated on antipsychotic drugs
IRAS ID
319761
Contact name
Hari Subramaniam
Contact email
Sponsor organisation
Leicestershire Partnership Trust R&D
Clinicaltrials.gov Identifier
nil, nil
Duration of Study in the UK
1 years, 6 months, 0 days
Research summary
This is a single centre pilot feasibility and acceptability study of the CGM (continuous glucose monitor) and the wearing of an accelerometer for 4 weeks and collecting weekly hunger records, serum glucose levels (in a minimally invasive way) and accelerometer records and weekly weight records during the first four weeks of treatment with antipsychotic medications. We have sourced 20 glucose monitoring meters and 20 accelerometers from charitable funds through a collaboration with the Leicester Diabetes Centre to trial the pilot feasibility trial. 20 antipsychotic drug naive patients (possibly 10 men and 10 women including those with history of previous antipsychotic drug use but who are restarted on antipsychotic drugs with at least a two-year antipsychotic drug free period) will be trialled for participation at the Leicestershire Partnership Trust. Participants will be recruited from 2 Mental Health Inpatient wards (Welford/Aston and Kirby) for ease of clinical recruitments as the CI (HS) has responsibility for inpatients at these wards. Patients will be approached about taking part by their attending clinician. It will be made clear that this will not impact their clinical care. Information will be provided to potential participants about the study, including any benefits or risks, and they will be given time to consider taking part. Patients agreeing to take part will complete informed consent with the Principal Investigator.
The participants will have a baseline assessment of mood, dietary intake, blood glucose levels and weight, in the ward where treatment is being initiated as a part of their routine clinical care. The daily records of CGM and accelerometer records for the first 4 weeks will be collected as well as subjective hunger questionnaires, their sociodemographic variables, their clinical diagnosis, and details of their drug treatment. One to one interviews will be held with their attending clinician to assess barriers and facilitators to use of CGM and accelerometers. The feasibility in a multicultural setting and the acceptability will be assessed through quantitative methods.REC name
East of Scotland Research Ethics Service REC 1
REC reference
22/ES/0052
Date of REC Opinion
22 Dec 2022
REC opinion
Unfavourable Opinion