A Monocenter, Randomized Controlled, Pilot Study of Telemonitoring for Gestational Diabetes Mellitus.

Brief Summary

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 and/or 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.

Primary Outcomes

Secondary Outcomes

• Number of hospitalizations in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.(From diagnosis of gestational diabetes mellitus until birth)
• Reaction time from measuring abnormal glucose values to performing an intervention in pregnancies in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care alone.(From diagnosis of gestational diabetes mellitus until birth)
• Number of prenatal consultations in pregnancies with gestational diabetes mellitus in which telemonitoring was added to the standard care of gestational diabetes mellitus compared to the standard care without telemonitoring.(From diagnosis of gestational diabetes mellitus until birth)