Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06251466
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2024-01-09
Brief Title:
Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus
Sponsor:
Hasselt University
Organization:
Hasselt University
Study Overview
Official Title:
A Monocenter Randomized Controlled Pilot Study of Telemonitoring for Gestational Diabetes Mellitus
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TEGEDIM
Brief Summary:
This interventional study examines the addition of telemonitoring TM in prenatal care for gestational diabetes mellitus GDM By incorporating TM into the prenatal care for GDM it is expected to achieve faster and improved follow-up resulting in faster reaction time in the detection of aberrant blood glucose levels Therefore the overarching aim is to improve maternal and newborn pregnancy outcomes through optimized monitoring strategies TM
Detailed Description:
Gestational diabetes mellitus GDM is characterized by the onset of spontaneous hyperglycemia typically diagnosed in the second or third trimester of gestation GDM can have short-term complications for both the mother and the unborn child including neonates with macrosomia which can complicate delivery necessitating a cesarean section While GDM usually resolves following delivery it can also have long-term consequences including neonatal hypoglycemia increased risk of developing maternal hypertension and type 2 diabetes Therefore a proper follow-up including monitoring of blood glucose values plays a crucial role in preventing both the pregnant woman and the unborn child from potential complications
The principal measures for blood glucose level regulation in GDM involve lifestyle modifications comprising dietary adjustments and exercise supplemented as necessary by intermittent insulin therapy Together with these lifestyle modifications andor insulin therapy these pregnant women also need to measure their blood glucose values once a week at home at four different time points including before breakfast two hours after breakfast two hours after lunch and two hours after dinner These measurements are performed with a glucose meter and are called to the nurse of the endocrinology department This medical information allows the endocrinologist to make treatment adjustments low sugar diet or insulin therapy when necessary potentially preventing the need for hospitalization due to GDM-associated complications
However a limitation of this standard care lies in the potential oversight by pregnant women in monitoring and reporting their blood glucose values to the endocrinology department Unfortunately this may result in the delayed detection of alarming values Additionally it imposes an increased workload on nurses as they are required to contact these patients on each occasion Altogether there is less effective follow-up leading to an increased risk of developing GDM-complications for both the mother and neonate This less effective follow-up may contribute to increased healthcare costs particularly in situations where hospitalization is required due to GDM-related complications
Adding telemonitoring TM to the standard care of pregnant women with GDM offers a viable solution to mitigate the limitation described above TM can be defined as the use of telecommunication technologies to assist the transmission of medical information between the patient and the caregiver Regarding the care of GDM the pregnant women are expected to self-monitor their blood glucose levels at home Subsequently they will input these values directly into a smartphone application called iHealth Gluco-Smart This application is coupled to a hospital-based platform where these values can be evaluated by the researcher and the endocrinology department
The principal measures for blood glucose level regulation in GDM involve lifestyle modifications comprising dietary adjustments and exercise supplemented as necessary by intermittent insulin therapy Together with these lifestyle modifications andor insulin therapy these pregnant women also need to measure their blood glucose values once a week at home at four different time points including before breakfast two hours after breakfast two hours after lunch and two hours after dinner These measurements are performed with a glucose meter and are called to the nurse of the endocrinology department This medical information allows the endocrinologist to make treatment adjustments low sugar diet or insulin therapy when necessary potentially preventing the need for hospitalization due to GDM-associated complications
However a limitation of this standard care lies in the potential oversight by pregnant women in monitoring and reporting their blood glucose values to the endocrinology department Unfortunately this may result in the delayed detection of alarming values Additionally it imposes an increased workload on nurses as they are required to contact these patients on each occasion Altogether there is less effective follow-up leading to an increased risk of developing GDM-complications for both the mother and neonate This less effective follow-up may contribute to increased healthcare costs particularly in situations where hospitalization is required due to GDM-related complications
Adding telemonitoring TM to the standard care of pregnant women with GDM offers a viable solution to mitigate the limitation described above TM can be defined as the use of telecommunication technologies to assist the transmission of medical information between the patient and the caregiver Regarding the care of GDM the pregnant women are expected to self-monitor their blood glucose levels at home Subsequently they will input these values directly into a smartphone application called iHealth Gluco-Smart This application is coupled to a hospital-based platform where these values can be evaluated by the researcher and the endocrinology department
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None