NCT04070963

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
888

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

4 months

First QC Date

July 28, 2019

Last Update Submit

August 26, 2019

Conditions

Keywords

Incidence of Diabetes MellitusHbA1C

Outcome Measures

Primary Outcomes (1)

  • Diabetes incidence

    To determine the incidence of undiagnosed and poorly controlled diabetes among surgical patients in Singapore

    12 months

Secondary Outcomes (1)

  • Association of HbA1C levels with post operative complications

    12 months

Study Arms (1)

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

Interventions

HbA1COTHER

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

Cohort

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Age \>21 years old
  • able to give informed consent
  • Scheduled to have preoperative blood taken during clinic visit

You may not qualify if:

  • Age \< 21 years old
  • unable to given informed consent
  • Not required to have routine preoperative blood tests taken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lim Wan Yen

Singapore, 669598, Singapore

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25452860BACKGROUND
  • Wee HL, Ho HK, Li SC. Public awareness of diabetes mellitus in Singapore. Singapore Med J. 2002 Mar;43(3):128-34.

    PMID: 12005338BACKGROUND
  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2019

First Posted

August 28, 2019

Study Start

May 1, 2019

Primary Completion

September 1, 2019

Study Completion

December 31, 2019

Last Updated

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations