Individualised Preoperative Optimisation of Glycaemic Control in Patients with Diabetes Mellitus

Completed

• Conditions: diabetes; diabetes mellitus; 10018424

• Registration Number: NL-OMON48583
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 256

Inclusion Criteria

- Diabetes mellitus type 2 (diagnosis at least 3 months prior to pre-operative screening)
- Age 18 - 85 years
- Elective non-cardiac surgery
- Scheduled for surgery at least 7 days from date of screening
- Informed consent

Exclusion Criteria

- Bariatric surgery
- Palliative surgery
- Outpatient or day case surgery
- (Potentially) pregnant or breast-feeding
- Unable to communicate in Dutch or English, psychiatric disorder, known therapy incompliance or deemed unfit by the researchers for another reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint of the study will be the preoperative fasting glucose<br /><br>concentration. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary outcomes are postoperative blood glucose concentrations, incidence of<br /><br>hyperglycaemia and hypoglycaemia (glucose >10 mmol l-1 or <4 mmol l-1,<br /><br>respectively) and change from baseline HbA1c, fructosamine, and<br /><br>1,5-anhydroglucitol. Finally, number of days at home up to 30 days after<br /><br>surgery will be assessed, which is a single, pragmatic, patient-centred<br /><br>outcome.</p><br>