Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus.

NCT ID: NCT06251466

Last Updated: 2024-02-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2024-06-30

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.

Conditions

Gestational Diabetes; Telemonitoring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Telemonitoring group

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.

Group Type: EXPERIMENTAL

iHealth Gluco-Smart application

Intervention Type: DEVICE

iHealth Gluco-Smart is an application where blood glucose measurements can be registered. This application can be coupled to a platform in the hospital, called Dharma, that enables the researchers to evaluate these blood glucose levels.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

iHealth Gluco-Smart application

iHealth Gluco-Smart is an application where blood glucose measurements can be registered. This application can be coupled to a platform in the hospital, called Dharma, that enables the researchers to evaluate these blood glucose levels.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ziekenhuis Oost-Limburg

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dorien Lanssens

Doctor - navorser

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ine Lowyck

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Dorien Lanssens

Role: CONTACT

dorien.lanssens@uhasselt.be

+32494919476

Ine Lowyck

Role: CONTACT

ine.lowyck@zol.be

Facility Contacts

Ine Lowyck

Role: primary

ine.lowyck@zol.be

089325050

Other Identifiers

Z-2022147

Identifier Type: -

Identifier Source: org_study_id