Telemonitoring for managing gestational diabetes during pregnancy
A Monocenter, Randomized Controlled, Pilot Study of Telemonitoring for Gestational Diabetes Mellitus.
This study is testing whether using a smartphone app to monitor blood sugar levels can help pregnant women with gestational diabetes manage their condition better and improve outcomes for both them and their babies.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hasselt University Academic / other |
| Locations | 1 site (Genk, Limburg) |
| Trial ID | NCT06251466 on ClinicalTrials.gov |
What this trial studies
This interventional study explores the use of telemonitoring (TM) in prenatal care for women diagnosed with gestational diabetes mellitus (GDM). By integrating TM into standard care, the study aims to enhance the monitoring of blood glucose levels, allowing for quicker responses to any abnormalities. Participants will use the iHealth Gluco-Smart application to track their glucose levels at specified times, which will be communicated to healthcare providers for timely treatment adjustments. The goal is to improve both maternal and newborn outcomes through optimized monitoring strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women diagnosed with gestational diabetes mellitus who are at least 20 weeks along and proficient in Dutch.
Not a fit: Patients who are less than 20 weeks pregnant, have type 1 diabetes, or have identified congenital anomalies in the fetus may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of gestational diabetes, reducing complications for both mothers and their babies.
How similar studies have performed: Other studies have shown promising results with telemonitoring approaches in managing chronic conditions, suggesting potential success for this novel application in gestational diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of gestational diabetes mellitus * Minimum 20 weeks of pregnancy * Is proficient in Dutch * Signing the Informed Consent Exclusion Criteria: * \<20 weeks of pregnancy * Diagnosis of type 1 diabetes * Congenital anomalies identified in the fetus * Participant does not own a smartphone
Where this trial is running
Genk, Limburg
- Ziekenhuis Oost-Limburg — Genk, Limburg, Belgium (Recruiting)
Study contacts
- Principal investigator: Ine Lowyck — Ziekenhuis Oost-Limburg
- Study coordinator: Dorien Lanssens
- Email: dorien.lanssens@uhasselt.be
- Phone: +32494919476
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.