Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
The Seven Continuous Glucose Monitoring System · 1 trial · 1 indication
For each patient's CGM data, we calculated the total area under the curve (AUC) for values above the predefined cutoffs of 110, 120, 130, 140, and 180 mg/dL. Patients wore the CGM for different amounts of time; therefore, the total AUC for the entire duration of CGM use was divided by the number of 24-hour periods of data collection. We called these normalized values "AUC-110," "AUC-120," "AUC-130," "AUC-140," and "AUC-180," and they reflect both the magnitude and duration of hyperglycemic excursions above the predetermined thresholds in an average 24-hour period. Birth weight percentile was determined using birth weight data derived from 1999 and 2000 United States Natality datasets. The correlation coefficient (r) was calculated between birth weight percentiles and each of the following: AUC-110, AUC-120, AUC-130, AUC-140, AUC-180, and 1-hour GCT result.
| Arm | Type | Description |
|---|---|---|
| Continuous Glucose Monitor in pregnancy | OTHER | The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS. |
| Name | Type | Description |
|---|---|---|
| The Seven Continuous Glucose Monitoring System | DEVICE | Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS. |
Inclusion Criteria: * Pregnant patients * Age 18-50 * Gestational age less than 28 weeks Exclusion Criteria: * Minors less than 18 years of age * Multiple gestation * Known fetal anomalies
The Seven Continuous Glucose Monitoring System is a device being studied for use in gestational diabetes. It is designed to monitor glucose levels continuously, and a clinical trial evaluated its correlation with glucose tolerance testing and pregnancy outcomes in women with gestational diabetes.
The Seven Continuous Glucose Monitoring System is developed by DexCom, Inc., a company publicly traded under the ticker symbol DXCM. DexCom is the sponsor of the clinical trial investigating this continuous glucose monitoring system for gestational diabetes.
The Seven Continuous Glucose Monitoring System is in Phase 1 clinical development. It is an investigational device, not yet approved, and is being studied for gestational diabetes. One Phase 1 trial has been completed, involving 57 participants.
The Seven Continuous Glucose Monitoring System has one completed clinical trial, NCT00850135, titled "Correlation of Continuous Glucose Monitoring and Glucose Tolerance Testing With Pregnancy Outcomes." This Phase 1 study enrolled 57 women with gestational diabetes in the United States.
The Seven Continuous Glucose Monitoring System is not FDA approved. It is an investigational device currently in Phase 1 clinical development for gestational diabetes. The completed trial, NCT00850135, was an uncontrolled study that did not use randomization or blinding.