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Our mission is to provide healthcare professionals with unbiased clinical research information, easily.
Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03935191
Recruitment Status Not yet recruiting
First Posted May 2, 2019
Last update posted May 2, 2019
The purpose of this prospective observational study is to establish the performance and safety of the Dexcom G6 CGM System utilized for up to a 10-day wear period in pregnant women with diabetes mellitus.
Primary Study Objective: To determine the accuracy of Dexcom G6 CGM System glucose readings in reference to arterialized venous sample YSI glucose measurements in pregnant women with diabetes mellitus. Secondary Study Objective: To assess the safety of the Dexcom G6 CGM System, through characterization of device-related Adverse Events (AEs), in pregnant women with diabetes mellitus.
Device: Dexcom CGM System
Device: Dexcom CGM System
Dexcom CGM System
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, , Learn About Clinical Studies.-->
1. Age ≥ 18 years;
2. Currently in the 2nd or 3rd trimester of pregnancy;
3. Diagnosis of GDM, T1DM, or T2DM;
4. Willing to avoid insulin injections or wear an insulin pump insertion set within 3
inches from the sensor site;
5. Able to follow study procedures;
6. Able to speak, read, and write in English or Spanish.
1. Extensive skin changes/diseases that preclude wearing the required number of devices
on normal skin (e.g., extensive psoriasis, recent burns or severe sunburn, extensive
eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis) at the
proposed wear sites;
2. Known allergy to medical-grade adhesives;
3. Hematocrit of < 30%; 4. Prescribed tocolytic drugs for treatment of pre-term labor or experiencing high-risk pregnancy complications, including, but not limited to, pre-eclampsia or HELLP syndrome (hemolysis, elevated liver enzymes, and a low platelet count) during current pregnancy; 5. Currently receiving dialysis treatment or planning to receive dialysis during the sensor wear period; 6. Require a Magnetic Resonance Imaging (MRI) scan, Computed Tomography (CT) scan, or diathermy during the sensor wear period; 7. Current participation in another investigational study protocol (if a subject has recently completed participation in another drug study, the subject must have completed that study at least 30 days prior to being enrolled in this study.); 8. Working for a competitive medical device company or having an immediate family member or person living within the same household who works for such a company (e.g., Medtronic, GlySens Inc., Abbott Laboratories, Roche, Senseonics, Waveform, and Ascencia/POCTech); 9. Any condition that, in the opinion of the Investigator, would interfere with their participation in the trial (e.g., marked visual impairment) or pose excessive risk to study staff handling venous blood samples (e.g., known history of HIV or Hepatitis B or C).
Contact: Cynthia Makady 858-200-0272 firstname.lastname@example.org
Study Director: Stayce Beck DexCom, Inc.