Improving glucose control for patients with diabetes undergoing surgery

Improving glucose control in patients with diabetes following elective surgical intervention: the role and accuracy of novel glycaemic monitoring

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN59885540

Enrollment

Registered

2025-05-20

Start date

2025-04-01

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus (T2DM) Nutritional, Metabolic, Endocrine

Interventions

Participants will use self-monitoring of blood glucose (capillary finger prick glucose testing as per standard care) for 14 days. Participants will also have continuous glucose monitoring using Freest

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients aged =18 years at the time of signing the Informed Consent Form 2. Type 2 diabetes mellitus defined as a preadmission diagnosis 3. Scheduled for elective urology or gynaecological-oncology surgery within 6 weeks of consent process 4. Expected in-patient stay of at least 24 hours

Exclusion criteria

Exclusion criteria: 1. Unable to provide written informed consent 2. Unable to follow study instructions 3. Diet-controlled type 2 diabetes mellitus 4. Currently using a continuous glucose monitor 5. Day case procedure planned 6. Diabetes other than type 2 diabetes mellitus 7. Dementia or cognitive impairment

Design outcomes

Primary

Measure	Time frame
1. Trial procedures for recruitment and perioperative implementation of continuous glucose monitoring (CGM), via Freestyle Libre 2, to inform the design and delivery of a larger study 2. Patient acceptability and recruitment rate for the proposed study measured using the Glucose Monitoring Experiences Questionnaire (GME-Q) on day 14 latest 3. Pilot data to inform the design of a larger study	—

Secondary

Measure	Time frame
1. The accuracy of Freestyle Libre 2 glycaemic monitoring when compared with finger-prick testing in postoperative urology and gynaecology-oncology patients with type 2 diabetes measured at multiple points throughout the postoperative period 2. Time per day (00:00 to 23:59) spent in euglycaemia (3.9-10.0 mmol/l) during hospital admission measured using continuous blood glucose monitoring 3. Time per day (00:00 to 23:59) spent in hypoglycaemia (10.0 mmol/l) during hospital admission measured using continuous blood glucose monitoring 5. Patient satisfaction with continuous blood glucose monitoring measured using the Glucose Monitoring Experiences Questionnaire (GME-Q) on day 14 latest 6. The incidence of postoperative complications in the perioperative period and the incidence of severe hypoglycaemia measured using continuous blood glucose monitoring by day 30 7. The accuracy and feasibility of using Freestyle Libre monitoring intraoperatively to report blood glucose readings measured using continuous blood glucose monitoring intraoperatively	—

Measure

Time frame

1. The accuracy of Freestyle Libre 2 glycaemic monitoring when compared with finger-prick testing in postoperative urology and gynaecology-oncology patients with type 2 diabetes measured at multiple points throughout the postoperative period 2. Time per day (00:00 to 23:59) spent in euglycaemia (3.9-10.0 mmol/l) during hospital admission measured using continuous blood glucose monitoring 3. Time per day (00:00 to 23:59) spent in hypoglycaemia (10.0 mmol/l) during hospital admission measured using continuous blood glucose monitoring 5. Patient satisfaction with continuous blood glucose monitoring measured using the Glucose Monitoring Experiences Questionnaire (GME-Q) on day 14 latest 6. The incidence of postoperative complications in the perioperative period and the incidence of severe hypoglycaemia measured using continuous blood glucose monitoring by day 30 7. The accuracy and feasibility of using Freestyle Libre monitoring intraoperatively to report blood glucose readings measured using continuous blood glucose monitoring intraoperatively

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Countries

England, United Kingdom

Contacts

Public ContactSimon Howell

s.howell@leeds.ac.uk+44 (0)1132064516

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026