Incidence of Poorly Controlled Diabetes in Surgical Population

Diabetes Mellitus Clinical Trial

Official title:

Incidence of Undiagnosed and Poorly Controlled Diabetes Mellitus Among Surgical Patients and Its Association With Perioperative Outcomes: a Single-centre Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04070963
• Other study ID #: 201812-00075 C
• Status: Recruiting
• Start date: May 1, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: Singapore General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 888
• Est. completion date: December 31, 2019
• Est. primary completion date: September 1, 2019
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• HbA1C
To take additional blood test of HbA1C once patient consented to the study

Locations

Country	Name	City	State
Singapore	Lim Wan Yen	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (3)

Pang PY, Lim YP, Ong KK, Chua YL, Sin YK. 2015 Young Surgeon's Award Winner: Long-term Prognosis in Patients with Diabetes Mellitus after Coronary Artery Bypass Grafting: A Propensity-Matched Study. Ann Acad Med Singapore. 2016 Mar;45(3):83-90. — View Citation

Phan TP, Alkema L, Tai ES, Tan KH, Yang Q, Lim WY, Teo YY, Cheng CY, Wang X, Wong TY, Chia KS, Cook AR. Forecasting the burden of type 2 diabetes in Singapore using a demographic epidemiological model of Singapore. BMJ Open Diabetes Res Care. 2014 Jun 11;2(1):e000012. doi: 10.1136/bmjdrc-2013-000012. eCollection 2014. — View Citation

Wee HL, Ho HK, Li SC. Public awareness of diabetes mellitus in Singapore. Singapore Med J. 2002 Mar;43(3):128-34. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes incidence	To determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore	12 months
Secondary	Association of HbA1C levels with post operative complications	To identify and characterize any association between preoperative HbA1c level and postoperative complications, including morbidity and mortality.	12 months