InterTread study
Research type
Research Study
Full title
Individualised therapy to reduce glycaemic variability and assessment of care costs using Tresiba in Frail Older Adults with Diabetes
IRAS ID
296949
Contact name
William Strain
Contact email
Sponsor organisation
University of Exeter
Clinicaltrials.gov Identifier
U1111-1194-3347, Universal trial number
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This study aims to look at two different insulin regimens in older adults who are at least moderately frail and who have type 2 diabetes that requires insulin treatment for which they need assistance to administer.
There are several treatment options for type 2 diabetes, however, currently available treatment strategies and formularies come from from findings in young adults that do not commonly present with the issues associated with frailty and age. Treatments prescribed as standard care for young adults may not be optimal in the treatment of frail older adults due to the increased demand on health care staff to monitor the patient and administer drugs.
This study has two purposes, 1) to look at the impact of moving to the new NICE recommended targets on blood sugar variability and asymptomatic hypoglycaemia, and 2) to evaluate the cost of using a once daily treatment strategy with a more expensive ultra-long acting insulin compared to standard care (twice daily low cost insulin) when carer cost is included.
Participants will give informed consent and then will have 2 weeks of continuous glucose monitoring. Participants will then be randomised to one of two groups: 1) high cost insulin/low support, 2) low cost insulin/high support. Over 6 months participants will have their insulin adjusted to meet the new NICE targets under the care of their district nurses. After 6 months participants will again have 2 weeks of continuous glucose monitoring and that will conclude their participation in the study.
We will then compare blood sugar variability and frequency of asymptomatic hypoglycaemia as well as the total cost of treatment options including cost of drug and use of health services in both groups.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
21/WM/0074
Date of REC Opinion
6 Apr 2021
REC opinion
Further Information Favourable Opinion