Using iGlucose Device to Improve Blood Sugar Management in Pregnant Women with Diabetes
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial
This study is testing if using the iGlucose device can help pregnant women with diabetes better manage their blood sugar levels compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT04206748 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of the iGlucose Remote Patient Monitoring Device in enhancing glycemic management for women with gestational diabetes or type 2 diabetes during pregnancy. By automating glucose monitoring data, the study aims to increase the number of recommended self-monitoring blood glucose (SMBG) checks and improve clinical outcomes. Participants will be women aged 18 and older who are diagnosed with gestational or type 2 diabetes before 30.6 weeks of pregnancy. The study employs a randomized controlled trial (RCT) design to assess the intervention's impact compared to routine care.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with gestational diabetes or type 2 diabetes diagnosed before 30.6 weeks of pregnancy.
Not a fit: Patients with type 1 diabetes or those with major fetal congenital abnormalities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better blood sugar control and improved health outcomes for pregnant women with diabetes.
How similar studies have performed: Other studies have shown promise in using remote monitoring devices for diabetes management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * All patients \>/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks. * Non-anomalous singletons * Ability to provide informed consent Exclusion Criteria * Patients with Type 1 diabetes * Patients with fetal major congenital abnormalities * Patients identified/referred after 30.6 weeks
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Joycelyn Corthwaite, RD
- Email: joycelyn.a.cornthwaite@uth.tmc.edu
- Phone: 832-325-7205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.