Gestational DiabetesTEGEDIMNCT06251466
Telemonitoring of Pregnancies Complicated With Gestational Diabetes Mellitus.
A study testing iHealth Gluco-Smart application in people with Gestational Diabetes and Telemonitoring, run by Hasselt University at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Telemonitoring
- What is being tested?
- iHealth Gluco-Smart application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- 18 Dec 2023to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of gestational diabetes mellitus
- Minimum 20 weeks of pregnancy
- Is proficient in Dutch
- Signing the Informed Consent
Who cannot join
- <20 weeks of pregnancy
- Diagnosis of type 1 diabetes
- Congenital anomalies identified in the fetus
- Participant does not own a smartphone
Trial locations and contacts
1 site in 1 country.
Ine Lowyck contact
Belgium1 site, 1 recruiting
- Recruiting
Ziekenhuis Oost-Limburg
Genk, Limburg, 3600
Ine Lowyck, 089325050, ine.lowyck@zol.be
About this study
Official title: A Monocenter, Randomized Controlled, Pilot Study of Telemonitoring for Gestational Diabetes Mellitus.
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).
Read the 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
- Being tested
- iHealth Gluco-Smart application
- Keywords
- Gestational outcomes, User-experience
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iHealth Gluco-Smart applicationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Pregnant women with gestational diabetes mellitus are more intensively follow-up compared to an uncomplicated pregnancy. This allows for more efficient monitoring of glycemic values. This in turn enables rapid intervention strategies, such as adjusting diet or increasing insulin units, in response to deviations from desired blood glucose levels. Subsequently, additional prenatal consultations can be reduced in the telemonitoring group compared to the control group.
Measured: 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.
Pregnant women with gestational diabetes mellitus will be hospitalized more often in comparison to an uncomplicated pregnancy. Early detection of gestational diabetes mellitus can make treatment more efficient and reduce the number of hospitalizations. It is expected to see less hospitalizations when adding telemonitoring to the standard care of gestational diabetes mellitus compared to the standard care alone. This reduction can be due to faster response to abnormal blood glucose values and thus less complications.
Measured: 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.
The duration between the identification of abnormal glucose values and the implementation of interventions is frequently prolonged due to delayed or absent communication of glucose data. This study will assess whether the addition of telemonitoring in treatment regimens results in a shorter duration for these interventions. Such interventions may encompass dietary adjustments or adjustments to insulin dosages.
Measured: From diagnosis of gestational diabetes mellitus until birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start18 Dec 2023
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Responsible party
- Principal investigator, Dr. Dorien Lanssens, Hasselt University
- Investigators
- Ine Lowyck, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251466
- Sponsor's protocol ID
- Z-2022147
- Acronym
- TEGEDIM
- Status last verified
- Feb 2024
- First submitted
- 9 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocenter, Randomized Controlled, Pilot Study of Telemonitoring for Gestational Diabetes Mellitus.
- ClinicalTrials.gov ID
- NCT06251466
- Acronym / sponsor ID
- TEGEDIM / Z-2022147
- Conditions
- Gestational Diabetes, Telemonitoring
- Keywords
- Gestational outcomes, User-experience
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Collaborators
- Ziekenhuis Oost-Limburg
- Study start
- 18 Dec 2023 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 9 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Telemonitoring group | Experimental | Device: iHealth Gluco-Smart applicationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of gestational diabetes mellitus
- Minimum 20 weeks of pregnancy
- Is proficient in Dutch
- Signing the Informed Consent
Key exclusion criteria (4 listed)
- <20 weeks of pregnancy
- Diagnosis of type 1 diabetes
- Congenital anomalies identified in the fetus
- Participant does not own a smartphone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iHealth Gluco-Smart applicationiHealth 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. | Device | Telemonitoring group |
Primary outcome
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.
Time frame: After gestation
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.
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.
Time frame: After gestation
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.
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.
Time frame: After gestation
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.
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.
Time frame: After gestation
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.
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.
Time frame: After gestation
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.
3 secondary outcomes
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.
Time frame: 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.
Time frame: 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.
Time frame: From diagnosis of gestational diabetes mellitus until birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ine Lowyck contact
Ine Lowyck principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iHealth Gluco-Smart application in people with Gestational Diabetes and Telemonitoring, run by Hasselt University at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dorien Lanssens (+32494919476, dorien.lanssens@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: After gestation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.