Glucose monitoring by Freestyle Libre in patients with Type 2 diabetes mellitus from India A pooled analysis
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Abbott Healthcare Pvt.Ltd.
- Enrollment
- 1,200
- Locations
- 10
- Primary Endpoint
- Estimate the average TIR across 12-15 centres in patients with Diabetes in India with the help of cross sectional data available
Overview
Brief Summary
This study aims to evaluate the average Time in Range (TIR) in Type 2 Diabetes Mellitus (T2DM) patients using the FreeStyle Libre system across 12 centres in India. The secondary objectives include assessing the percentage of patients achieving recommended TIR targets and exploring variations in TIR based on factors such as age, gender, BMI, medication type, and comorbidities. Data from approximately 1500 patients will be analyzed, focusing on key metrics like Time in Range (TIR), Time Above Range (TAR), Time Below Range (TBR), and glucose variability. Statistical analysis will include Spearman’s coefficient and linear regression to determine relationships between various patient characteristics and glycaemic control.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 80.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Patients aged above 18 years with a diagnosis of T2D using Libre for glucose monitoring will be included in the study.
Exclusion Criteria
- •Patients below 18 years as well as patients using continuous glucose monitoring instrument other than Libre will be excluded.
- •Patients having difficulty in handling device and are non-compliant will be excluded.
Outcomes
Primary Outcomes
Estimate the average TIR across 12-15 centres in patients with Diabetes in India with the help of cross sectional data available
Time Frame: Baseline, 4 weeks
Secondary Outcomes
- •Estimate % of patients with diabetes in India achieving recommended TIR targets (in line with customized targets based on comorbidities/ type of diabetes)(•Estimate average TIR among different patient profiles with T2DM based on 1) comorbidities 2) Age groups 3) Form of pharmacotherapy (Non Insulin, Basal Insulin, MDI) 4) Duration of diabetes)
Investigators
Rohit Bhandari
Indegene Private Limited