Time-In-Range Based Risk Stratification of Type 2 Diabetes Microvascular Complications
TRACK2
Time-in-Range (TIR), a Novel Continuous Glucose Monitoring (CGM) Based Measure, to Improve Risk Stratification of Microvascular Complications in Type 2 Diabetes
1 other identifier
observational
500
1 country
1
Brief Summary
The goal of this observational study is to learn about the role of Time-in-Range to stratify the risk of micro vascular complications in adults with type 2 diabetes. The main questions it aims to answer are:
- 1.Is a lower Time-in-Range associated with a higher risk of diabetes microvascular complications, independent of HbA1c?
- 2.Is Time-in-Range lower among sulfonylurea and premixed insulin therapy users compared to non-sulfonylurea and non-premixed insulin therapy users, respectively.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 14, 2021
CompletedFirst Submitted
Initial submission to the registry
February 16, 2023
CompletedFirst Posted
Study publicly available on registry
March 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 7, 2023
April 1, 2023
2.6 years
February 16, 2023
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Presence of Diabetes Retinopathy
Based on Fundal Photography grading
10 years
Presence of Diabetes Neuropathy
Based on 10g monofilament foot examination
10 years
Presence of Diabetes Nephropathy
Urine microalbumin-creatinine ratio in mg/g
10 years
Secondary Outcomes (4)
Continuous glucose monitoring derived glycemic variables
14 days
Severity of Retinal degenerative changes
10 years
Severity of corneal neuropathy
10 years
Severity of diabetes peripheral neuropathy
10 years
Interventions
Continuous glucose monitoring using Freestyle Libre Pro, Foot examination with monofilament and neurothesiometer, HbA1c and Urine Microalbumin Creatinine Ratio, Corneal confocal microscopy, Fundal photography, Optical coherence tomography, Optical cohere
Eligibility Criteria
Study population will be recruited from people with type 2 diabetes attending Singapore General Hospital outpatient clinics.
You may qualify if:
- Type 2 diabetes,
- Age \>= 21 years,
- Ability to provide informed consent,
- HbA1c done within 6 months of recruitment between 6-12%
You may not qualify if:
- Undergoing active chemotherapy or immunotherapy for cancer
- Currently taking oral or injectable steroids
- Chronic kidney disease on dialysis
- Women who are pregnant or breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Singapore General Hospitallead
- Singapore Eye Research Institutecollaborator
Study Sites (1)
Singapore General Hospital
Singapore, 169856, Singapore
Biospecimen
Tear Samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suresh Rama Chandran, MD, MRCP(UK)
Singapore General Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2023
First Posted
March 28, 2023
Study Start
October 14, 2021
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
April 7, 2023
Record last verified: 2023-04