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Accuracy of LINX Continuous Glucose Monitor

A Prospective Open-Label Trial Comparing the Accuracy and Reliability of LINX Continuous Glucose Monitor (CGM) - OPEN-LINX

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/10/096037
Enrollment
150
Registered
2025-10-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Linx continuous glucose monitor device: Single transcutaneous sensor applied to the left upper arm. Continuous interstitial glucose monitoring paired with companion app or reader as per

Sponsors

Khaled Salah
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Willing and able to wear all three CGM sensors (Linx, Abbott, and i-Can) simultaneously for 14-15 days. 2. Willing to perform structured capillary blood glucose testing as per protocol. 3. Capable of understanding the study requirements and providing written informed consent. 4. No participation in any other clinical study within the past 30 days.

Exclusion criteria

Exclusion criteria: 1. Diagnosed with type 1 diabetes or a recent episode of diabetic ketoacidosis (within the past 3 months). 2. Pregnant or lactating individuals. 3. Presence of chronic skin conditions or dermatological issues that may interfere with sensor placement. 4. Severe comorbidities or conditions that may impair study compliance (e.g. Cognitive impairment, psychiatric illness). 5. End-stage renal disease or significant renal impairment (e-GFR less than 30 ml/min/1.73 meter square). 6. Use of medications or medical devices that may interfere with CGM function or study outcomes, including substances affecting CGM performance (e.g. Hydroxyurea, acetaminophen, high dose Vitamin C), anticoagulants (except acetylsalicylic acid less than or equal to 100 mg), cardiac pacemakers or similar medical devices. 7. Planned medical procedures during the study that may impact CGM performance (e.g. MRI, CT scan, radio frequency ablation, high frequency electrical heat or high intensity focused ultrasound).

Design outcomes

Primary

MeasureTime frame
Accuracy-Mean absolute relative difference (MARD), error grid analysis, correlation metrics, glycemic range metrics.Timepoint: baseline and after 2 weeks—

Secondary

MeasureTime frame
User experience & satisfaction, sensor usability, sensor data reliability, adherence to SMBG protocol, safety & tolerability.Timepoint: Baseline & after 2 weeks—

Countries

India

Contacts

Public ContactAnnie R

Ragus Healthcare Pvt Ltd

annie.mattilda@sugarfit.com9742744560

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026