Continuous Glucose Monitoring for Gestational Diabetes: An Ancillary Study to the iGDM Trial

C
Christina M. Scifres, MD

Primary Investigator

Enrolling By Invitation
18 years - 100 years
Female
Phase N/A
20 participants needed
5 Locations

Brief description of study

What is the purpose of this study?
The purpose of this ancillary study to the iGDM randomized clinical trail is to determine whether CGM can reveal additional information about maternal glucose values above and beyond the information obtained from checking blood glucose values 4 times per day.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Participants who enroll in the iGDM study will be identified as eligible for CGM for iGDM, and these participants will be assessed for interest following enrollment in iGDM. Recruitment for the study will occur telephonically, through email, and in-person depending on method of iGDM recruitment and/or participant preference. Study coordinators will verbally provide information regarding CGM for iGDM if a potential participant expresses interest in the study.

Detailed description of study

What will happen during the study?

  • Participants will wear CGM monitor (placed between 32-36 weeks)vfor 10 days. The CGM device will be applied by research staff or if desired, by the participant, under direct supervision by research staff. The CGM sensor will be applied to the abdomen, upper buttocks, or back of the arm away from skin folds, where there is hair, near the waistband or areas of scarring, tattoos, irritation or open wounds.
  • An additional waterproof adhesive will be applied to help prevent the sensor from being dislodged and a transmitter will be attached.
  • Participants will be provided with a handout that has instructions for care.
  • After 10 days, participants will remove the sensor and dispose of it.  

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Gestational diabetes
  • Age: 18 years - 100 years
  • Gender: Female

Inclusion criteria
Must have already agreed to participate in the iGDM randomized clinical trial. 
 

Updated on 17 Dec 2024. Study ID: OBGYN-IIR-CGM-FOR-IGDM, 24158
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