Incidence of Poorly Controlled Diabetes in Surgical Population

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: HbA1C

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 Type: Observational
• Enrollment (Anticipated): 888

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 669598
    • Recruiting
    • Lim Wan Yen
    • Contact: Lim Wan Yen, MBBS; Phone Number: 84884019; Email: Lim.Wan.yen@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients who comes through the pre operative anesthesia clinic due to scheduled elective operation, who fits the inclusion criteria of the study.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort; 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.	Other: HbA1C; To take additional blood test of HbA1C once patient consented to the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diabetes incidence	To determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Singapore General Hospital

Publications and helpful links

General Publications

• 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.
• Wee HL, Ho HK, Li SC. Public awareness of diabetes mellitus in Singapore. Singapore Med J. 2002 Mar;43(3):128-34.
• 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 Singap. 2016 Mar;45(3):83-90.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 28, 2019
• First Submitted That Met QC Criteria: August 26, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 26, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: HbA1C; Incidence of Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 201812-00075 C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No