- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04070963
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
Study Overview
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Singapore, Singapore, 669598
- Recruiting
- Lim Wan Yen
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Contact:
- Lim Wan Yen, MBBS
- Phone Number: 84884019
- Email: Lim.Wan.yen@singhealth.com.sg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age >21 years old
- able to give informed consent
- Scheduled to have preoperative blood taken during clinic visit
Exclusion Criteria:
- Age < 21 years old
- unable to given informed consent
- Not required to have routine preoperative blood tests taken
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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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.
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To take additional blood test of HbA1C once patient consented to the study
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diabetes incidence
Time Frame: 12 months
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To determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore
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12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Association of HbA1C levels with post operative complications
Time Frame: 12 months
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To identify and characterize any association between preoperative HbA1c level and postoperative complications, including morbidity and mortality.
|
12 months
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Collaborators and Investigators
Sponsor
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)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201812-00075 C
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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