06 · TRIALS

Clinical Trial Management

Multi-site trials, comparator devices, statistical validation.

Active trials
11
Subjects enrolled
2,184
+38 this week
Sites
42
Approved protocols
9

Trial registry

IDStudySitesEnrollmentStatus
CT-2231Non-invasive Glucose Validation Phase II14
482/600
Enrolling
CT-2104AF Detection vs 12-lead Holter6
220/220
Analysis
CT-1998SpO2 Accuracy vs Co-Oximeter3
90/100
Active
CT-2245Cortisol Proxy Pilot2
22/60
Enrolling

Clarke Error Grid — CT-2231 glucose validation

n = 12,480 paired
A (clinically accurate)
84.2%
B (benign)
13.1%
C (correction)
1.9%
D (error)
0.7%
E (severe)
0.1%

Statistical metrics

MARD8.2%
MAE11.4 mg/dL
RMSE14.8 mg/dL
Correlation r0.94
0.88
Versus YSI 2300 hexokinase reference, n=12,480 paired samples across 14 sites.

Comparator devices

  • Abbott Libre 3
    CGM
  • Medtronic Guardian 4
    CGM
  • Dexcom G7
    CGM
  • AccuChek Guide
    SMBG
  • Contour Next One
    SMBG
  • YSI 2300 Stat Plus
    Lab
  • Hexokinase Method
    Lab

Regulatory documentation

  • Ethics Committee — CT-2231
    Mar 12, 2026
    Approved
  • CDSCO Application Phase II
    Apr 02, 2026
    Approved
  • ICMR Registration
    Apr 18, 2026
    Approved
  • ISO 13485 QMS audit
    Jul 22, 2026
    Pending

Site enrollment velocity

Subjects enrolled / monthTarget line: 60