e-DMED
Research type
Research Study
Full title
A feasibility study to determine continuous glucose monitor-derived glucose variations when preventing therapeutic inertia in potentially over-treated older people with diabetes
IRAS ID
316085
Contact name
Khamlesh Khunti
Contact email
Sponsor organisation
University of Leicester
ISRCTN Number
ISRCTN69024008
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
In diabetes care, the priority is often to manage high blood sugar levels and prescribe blood sugar-lowering therapies to prevent progressive, long-term complications associated with diabetes. However, some people with diabetes can be over-treated and for older people who are frail, this puts them at high risk of low blood sugar levels which could lead to more falls, fractures, hospitalisations and deaths.
One population particularly at risk are care home residents; high levels of cognitive impairment within this group makes self-management of their condition especially onerous. Guidelines are now in place detailing when to stop, change or reduce some diabetes medication in frail, older people but the precise blood sugar levels that are associated with low and high blood glucose events in older people is unknown.
Additionally, recent NICE guidelines have recommended extending the use of Continuous Glucose Monitoring (CGM) to type 2 diabetics with “a condition or disability (including a learning disability or cognitive impairment) that means they cannot self-monitor their blood glucose by capillary blood glucose monitoring”.Therefore, our study aims to use CGM to objectively measure blood glucose in older people with diabetes living in care homes to help clinicians safely stop, change or reduce medications in those who are potentially over-treated. The study is funded by the NIHR Applied Research Collaboration East Midlands.
The primary objective is to assess the effectiveness of using CGM aided by a scripted de-prescribing algorithm and health care professional education to assess the percentage of patients achieving a composite of more than 50% time in range and less than 1% time below range within the 12-week study period, in older people with type 2 diabetes who are potentially over-treated.GP database searches will identify care home residents with type 2 diabetes and aged 65 years and over. Participants will be recruited and asked to wear a CGM for 12 weeks and complete a diary indicating low and high blood sugar events. Healthcare professionals will use these data to review participants medication every 4 weeks and adjust their medication accordingly. Data at the start and the end of the study will be compared.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
23/LO/0659
Date of REC Opinion
15 Jul 2024
REC opinion
Further Information Favourable Opinion