Clinical trial NCT06251466: Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus.
Official title: A Monocenter, Randomized Controlled, Pilot Study of Telemonitoring for Gestational Diabetes Mellitus.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes
Telemonitoring
Keywords: Gestational outcomes
User-experience
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Ziekenhuis Oost-Limburg
First posted: 2024-02-09
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomized in either the control group or the telemonitoring group. The control group receives the standard care of gestational diabetes mellitus, meaning that the participants need to call their blood glucose levels weekly to the endocrinology department. The telemonitoring group receives telemonitoring, meaning that the participants need to register their blood glucose levels weekly in a smartphone application which is coupled to a platform in the hospital.
Primary purpose: HEALTH_SERVICES_RESEARCH

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 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.

Eligibility 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

Primary outcomes:
measure: Type of delivery (natural or cesarean delivery) 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.
timeFrame: After gestation
measure: Number of preterm deliveries 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.
timeFrame: After gestation
measure: Apgar-score of neonate 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.
timeFrame: After gestation
measure: Birth weight of neonate 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.
timeFrame: After gestation
measure: Admission to the neonatal intensive care (NIC) 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.
timeFrame: After gestation
Secondary outcomes:
measure: 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.
timeFrame: From diagnosis of gestational diabetes mellitus until birth
measure: 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.
timeFrame: From diagnosis of gestational diabetes mellitus until birth
measure: 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.
timeFrame: From diagnosis of gestational diabetes mellitus until birth
Other outcomes:
measure: Satisfaction and usability of the modified care process through the administration of patient and staff questionnaires compared to the conventional follow-up approach.
timeFrame: From diagnosis of gestational diabetes mellitus until birth
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
state: Limburg
Study officials:
affiliation: Ziekenhuis Oost-Limburg
name: Ine Lowyck
role: PRINCIPAL_INVESTIGATOR
References: