Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus. (TEGEDIM)

Hasselt University

Status: Enrolling

Conditions: Gestational Diabetes; Telemonitoring

Treatments: Device: iHealth Gluco-Smart application

Study type: Interventional

Funder types: Other

Identifiers

NCT06251466

Z-2022147

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Telemonitoring group

Experimental group

Description:

Participants randomized in the telemonitoring group receive a glucose meter to monitor their blood glucose levels at home. They need to perform the same measurements as the control group. The only difference lies in how they transmit their blood glucose measurement to the hospital. After each measurement, they need to register these levels once a week in the iHealth Gluco-Smart application. This data is send, via Bluetooth and Wi-Fi, to an online dashboard, called Dharma, for review by the researchers of the Mobile Health Unit of Hospital Oost-Limburg (ZOL) in Genk. Participants measuring abnormal blood glucose levels at one of the four time points are requested to measure their blood glucose levels again on the following day. The researcher contacts the endocrinology department if any abnormal blood glucose values are detected. Interventions including, starting insulin treatment, will be performed by the endocrinologist when necessary.

Treatment:

Device: iHealth Gluco-Smart application

Control group

No Intervention group

Description:

Pregnant women randomized in the control group receive a glucose meter to monitor their blood glucose levels at home. They need to measure their blood glucose levels four times a week, including: before breakfast, two hours after breakfast, two hours after lunch, two hours after dinner. These values are then called by the pregnant women to the endocrinology department. Interventions including, starting insulin treatment, will be performed by the endocrinologist when necessary.