Incidence of Poorly Controlled Diabetes in Surgical Population

• Conditions: Diabetes Mellitus
• Interventions: Other: HbA1C

• Registration Number: NCT04070963
• Lead Sponsor: Singapore General Hospital

Brief Summary

Our study aims to determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore using preoperative HbA1c as a screening tool.

Detailed Description

The study aims to determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore using preoperative HbA1c as a screening tool.

The investigators aim to follow up on the incidence of perioperative complications in this cohort. In the longer term, the investigators hope to evaluate the role of a preoperative diabetic screening and intervention program as an opportunistic "teachable moment" for surgical patients. This may help to achieve greater control of the disease burden in Singapore.

Specific aims:

Specific Aim 1: To establish the incidence of undiagnosed diabetes/prediabetes among surgical patients in Singapore, based on HbA1c level ≥ 6.1% prior to surgery Specific Aim 2: To establish the incidence of poorly-controlled diabetes among surgical patients in Singapore, based on HbA1c level ≥ 8% prior to surgery Specific Aim 3: To identify and characterize any association between preoperative HbA1c level and postoperative outcomes

Study Timeline

• Study Start: 2019-05-01
• Study First Submitted: 2019-07-28
• Status Verified: 2019-08
• Study First Submitted QC: 2019-08-26
• Last Update Submitted: 2019-08-26
• Study First Posted: 2019-08-28
• Last Update Posted: 2019-08-28
• Primary Completion: 2019-09-01
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 888

Inclusion Criteria

1. Age >21 years old
2. able to give informed consent
3. Scheduled to have preoperative blood taken during clinic visit

Exclusion Criteria

1. Age < 21 years old
2. unable to given informed consent
3. Not required to have routine preoperative blood tests taken

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cohort	HbA1C	We propose a prospective, observational single-centre pilot study in the PAC (SGH), on participants aged 21 years and above. A HbA1c test will be added to their routine preoperative blood tests. The incidence of newly-diagnosed DM/pre-diabetes (HbA1c ≥6.1%) and poorly controlled DM (HbA1c ≥ 8%), demographic details and presence of significant comorbidities will be analysed.

Primary Outcome Measures

Name	Time	Method
Diabetes incidence	12 months	To determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore

Secondary Outcome Measures

Name	Time	Method
Association of HbA1C levels with post operative complications	12 months	To identify and characterize any association between preoperative HbA1c level and postoperative complications, including morbidity and mortality.

Trial Locations

Locations (1)

Lim Wan Yen; 🇸🇬 Singapore, Singapore