Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus.

NCT06251466 | Recruiting

• 1 other identifier: Z-2022147
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Gestational Diabetes; Telemonitoring

Keywords

Gestational outcomes; User-experience

Outcome Measures

Primary Outcomes (5)

• 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.

  Cesarean birth is a maternal risk associated with macrosomia, which is more prevalent in pregnancies complicated with gestational diabetes mellitus. The expected result includes a reduction in cesarean births when incorporating telemonitoring into the standard care of gestational diabetes mellitus compared to the standard care alone.

  After gestation

• 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.

  Pregnant women with gestational diabetes mellitus are at increased risk of preterm delivery compared to an uncomplicated pregnancy. Proper management of gestational diabetes mellitus could reduce the risk of preterm birth in pregnancies complicated with gestational diabetes mellitus. Therefore, it is expected to have fewer preterm births in the telemonitoring group compared to the control group.

  After gestation

• 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.

  The Apgar-score serves as an assessment tool for the postnatal health status of newborns. It encompasses five parameters, including: breathing effort, heart rate, muscle tone, grimace response (reflex irritability in response to stimulation), and color. These parameters will be assigned a score on a scale of 0 to 2, where 0 represents a low score and 2 corresponds to the highest score. These scores are then added together to give a total score (maximum 10) that is recorded at 1 minute, and 5 minutes following birth. It is assumed to see higher Apgar-scores in the telemonitoring group compared to the control group, attributable to the enhanced follow-up method.

  After gestation

• 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.

  Macrosomia, defined as a birth weight \> 4000 grams, is associated with serious maternal and neonatal adverse outcomes, including cesarean birth and birth fractures, respectively. Therefore, it is important to evaluate the birth weight of neonates. The expected result includes a reduction in birth weight of neonates (\< 4000 grams) when incorporating telemonitoring into the standard care of GDM compared to the standard care alone.

  After gestation

• 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.

  Development of gestational diabetes mellitus is associated with neonatal adverse outcomes, including admission tot the neonatal intensive care. The addition of telemonitoring into the standard care process of gestational diabetes mellitus can improve the prenatal follow-up process, potentially impacting neonatal outcomes. It is expected to see fewer admissions to the neonatal intensive care in the telemonitoring group compared to the control group.

  After gestation

Secondary Outcomes (3)

• 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

• 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

Other Outcomes (1)

• Satisfaction and usability of the modified care process through the administration of patient and staff questionnaires compared to the conventional follow-up approach.

  From diagnosis of gestational diabetes mellitus until birth

Study Arms (2)

Telemonitoring group

EXPERIMENTAL

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.

Device: iHealth Gluco-Smart application

Control group

NO INTERVENTION

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.

Interventions

iHealth Gluco-Smart application 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.

Telemonitoring group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of gestational diabetes mellitus
• Minimum 20 weeks of pregnancy
• Is proficient in Dutch
• Signing the Informed Consent

You may not qualify if:

• \<20 weeks of pregnancy
• Diagnosis of type 1 diabetes
• Congenital anomalies identified in the fetus
• Participant does not own a smartphone

Sponsors & Collaborators

• Hasselt University: lead
• Ziekenhuis Oost-Limburg: collaborator

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ine Lowyck

  Ziekenhuis Oost-Limburg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dorien Lanssens

CONTACT

+32494919476; dorien.lanssens@uhasselt.be

Ine Lowyck

CONTACT

ine.lowyck@zol.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor - navorser

Model Details: 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.

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 9, 2024
• Study Start: December 18, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: February 9, 2024

Record last verified: 2024-02

Locations

BE (1)