Incidence of Poorly Controlled Diabetes in Surgical Population

NCT ID: NCT04070963

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

888 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-01

Study Completion Date

2019-12-31

Brief Summary

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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

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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

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

HbA1C

Intervention Type OTHER

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

Interventions

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HbA1C

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lim Wan Yen

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Facility Contacts

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Lim Wan Yen, MBBS

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 25452860 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12005338 (View on PubMed)

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.

Reference Type RESULT
PMID: 27146460 (View on PubMed)

Other Identifiers

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201812-00075 C

Identifier Type: -

Identifier Source: org_study_id

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