Trial · NCT07889388
RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
NCT07889388, Not applicable, Recruiting, Bionime Corporation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study. Trials, record NCT07889388. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07889388
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- RIGHTEST iFree 2 CGM in Pregnant Women With Diabetes Study
- NCT number
- NCT07889388
- Status
- Recruiting
- Phases
- Not applicable
- Enrollment
- 104 participants, estimated
- Lead sponsor
- Bionime Corporation
- Conditions
- Diabetes Mellitus, Type 1 Diabetes, Diabetes Mellitus, Type 2, Diabetes, Gestational
- Interventions
- RIGHTEST iFree 2 Continuous Glucose Monitoring System
- First posted
- 2026-10-22
- Last updated
- 2026-11-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of CGM Readings Within ±20% of Reference Blood Glucose Measurements | During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear. | Percentage of raw CGM readings from the designated primary sensor within ±20% of paired venous blood glucose measurements obtained using the YSI 2300 analyzer, across the device measuring range. CGM and reference measurements are paired within a maximum time difference of 5 minutes. |
| Secondary | CGM Accuracy | During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear. | Accuracy of primary-sensor CGM readings against paired YSI 2300 blood glucose measurements, including agreement within ±20% after user calibration; 15/15%, 20/20%, and 40/40% agreement overall and by glucose range; glucose-range concurrence; mean absolute relative difference (MARD) by glucose range; reference values corresponding to LOW/HIGH readings; Clarke and Consensus Error Grid zone distributions; and glucose rate-of-change concurrence. Glucose ranges include \<54, 54-69, 70-180, 181-250, and \>250 mg/dL. Raw and user-calibrated readings are analyzed separately. |
| Secondary | Between-Sensor Precision | Throughout the sensor wear period, up to 15 days. | Precision assessed using mean paired absolute relative difference (PARD) and coefficient of variation (CV) between two sensors worn simultaneously by each participant. Readings are paired within ±30 seconds. Raw and user-calibrated readings are analyzed separately. |
| Secondary | Performance Across the Sensor Wear Period | Throughout sensor wear, up to 15 days; reference sampling on one assigned day: Day 1, Day 5 ±1, Day 10 ±1, or Day 15. | Primary-sensor accuracy assessed by 15/15%, 20/20%, and 40/40% agreement and MARD at Day 1, Day 5 ±1, Day 10 ±1, and Day 15, with each participant contributing one assigned sampling visit. Raw and user-calibrated readings are analyzed separately. Sensor survival and reading provision rates are assessed throughout wear using both primary and secondary sensors. |
| Secondary | Hypoglycemia and Hyperglycemia Alert Performance | During one sampling session of up to 6 hours on Day 1, Day 5 ±1, Day 10 ±1, or Day 15 of sensor wear. | True alert, false alert, correct detection, and missed detection rates for primary-sensor hypoglycemia and hyperglycemia alerts. Alerts are compared with reference blood glucose measurements using a ±15-minute matching window around device alerts or reference glucose events. |
| Secondary | Safety of the CGM System | From sensor insertion through the safety follow-up, within 7 days after sensor removal. | Number and percentage of participants experiencing adverse events, serious adverse events, adverse device effects, serious adverse device effects, or unanticipated problems, characterized by severity and relationship to the device or study procedures. Assessments include reactions at sensor insertion sites. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07889388
GET https://conductscience.org/api/trials/v1/NCT07889388/registered