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RECRUITING
NCT07889388
NA

RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study

Sponsor: Bionime Corporation

View on ClinicalTrials.gov

Summary

This study will evaluate the accuracy and safety of the RIGHTEST iFree 2 Continuous Glucose Monitoring (CGM) System in pregnant women with type 1 diabetes, type 2 diabetes, or gestational diabetes. The system uses a small sensor placed under the skin to measure glucose levels in the fluid between cells. Approximately 104 women will participate at study sites in Germany and Taiwan. Each participant will wear two sensors, one on each upper arm, for up to 15 days. During one clinic visit lasting up to six hours, blood samples will be collected every 15 minutes. Sensor readings will be compared with laboratory blood glucose measurements to assess accuracy. Participants will also be assessed for side effects, including skin reactions at the sensor sites, and will receive a safety follow-up after sensor removal. No procedures will be used to deliberately raise or lower blood glucose levels.

Official title: Evaluation of the Effectiveness and Safety of the RIGHTEST™ iFree 2 Continuous Glucose Monitoring System in Pregnant Women With Diabetes Mellitus

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

104

Start Date

2026-06-09

Completion Date

2027-03

Last Updated

2026-11-02

Healthy Volunteers

No

Interventions

DEVICE

RIGHTEST iFree 2 Continuous Glucose Monitoring System

The RIGHTEST iFree 2 Continuous Glucose Monitoring System (Bionime Corporation) measures interstitial glucose continuously for up to 15 days.

Locations (1)

Institut für Diabetes-Technologie Forschungs- und Entwicklungsgesellschaft mbH an der Universität Ulm

Ulm, Baden-Wurttemberg, Germany