Gestational DiabetesNCT05648721
The Effects of a Digital Application for GDM Management in Improving Patients' Compliance
A study testing Datos mobile health application and Regular follow-up in people with Gestational Diabetes and Pregnancy in Diabetic, run by The Baruch Padeh Medical Center, Poriya at 5 sites in Israel.
Trial summary
Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gestational Diabetes, Pregnancy in Diabetic
- What is being tested?
- Datos mobile health application and Regular follow-up
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 5 sitesIsrael
- Study dates
- 18 May 2023to Apr 2026
- 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
- Pregnant women diagnosed with GDM from 13.0 gestational week
- Recruitment until 34.0 gestational week
- 18 years old and older
- Singleton pregnancy
Who cannot join
- Women with pre-gestational diabetes mellitus
- Multiple pregnancy
- Women without a Smartphone that can support the GDM application
- Refusal to participate
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Israel5 sites, 5 recruiting
- Recruiting
Emek medical center
Afula
Zohar Nachum
- Recruiting
Rambam medical center
Haifa
Dana Vitner
- Not yet recruiting
Wolfson medical center
Holon
Lilia Tamayev
- Not yet recruiting
Galilee medical center
Nahariya
Maya Wolf
- Recruiting
Baruch Padeh Medical center, Poriya
Tiberias, North, 15208
Enav Yefet, MD/PhD
About this study
Official title: The Effects of a Digital Application for Gestational Diabetes Management in Improving Patients' Compliance and Satisfaction, Glycemic Control and Pregnancy Outcomes: A Multicenter Randomized Controlled Trial
Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy.
Recently, mobile health (mHealth) applications have been introduced as a resource to improve self-management and follow-up among pregnant women. The proposed study will examine the efficacy of the GDM management mHealth application in improving patients' compliance and satisfaction, glycemic control, and pregnancy outcomes.
A multicenter randomized controlled trial of women with GDM treated in the GDM clinics. Women will be randomly allocated to a research group that will use the GDM application and a control group that will receive regular follow-up without the GDM application. The primary outcome is patient compliance, defined as the actual blood glucose measurements/instructed measurements ×100. Secondary outcomes include glycemic control parameters, and maternal and neonatal complications.
- Conditions
- Gestational Diabetes, Pregnancy in Diabetic
- Being tested
- Datos mobile health application, Regular follow-up
- Keywords
- Gestational diabetes, Pregnancy, Mobile-health application, Compliance, Complications
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Datos mobile health applicationOther
The mobile Health application will send women reminders to perform glucose tests and test results will be sent to the clinic personnel for evaluation. The clinic personnel will receive an alert if a woman does not send glucose charts or when there is an abnormality in the test results. In addition, women will be able to communicate with the clinic's personnel via chat, messages, phone calls, and video.
Regular follow-upOther
Regular follow-up according to the local clinic protocol
| Study group | Role | What they receive |
|---|---|---|
| Mobile health application | Experimental | Use of GDM application for GDM management Receives: Other: Datos mobile health application |
| Control | Other | Regular follow-up without the GDM application Receives: Other: Regular follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance
Defined as the actual blood glucose measurements/instructed measurements ×100
Measured: During the follow up in the clinic (around 4 months)
Secondary outcomes (19)
Mean blood glucose of the daily glucose charts
Measured: During the follow up in the clinic (around 4 months)
Percentage of off-target glucose measurements
Measured: During the follow up in the clinic (around 4 months)
Need for pharmacotherapy for glycemic control
Measured: During the follow up in the clinic (around 4 months)
polyhydramnios
At least once
Measured: During the follow up in the clinic (around 4 months)
Preeclampsia/gestational hypertension
Measured: During the follow up in the clinic (around 4 months)
Induction of labor
Measured: At birth
Instrumental or cesarean delivery
Measured: At birth
shoulder dystocia
Measured: At birth
Third- or fourth-degree perineal tears
Measured: At birth
Neonatal birth weight
Measured: At birth
Neonatal intensive care unit admission
Measured: A week after delivery
Hypoglycemia of the newborn
Measured: During hospitalization after delivery (around one week)
Respiratory morbidity of the newborn
Measured: During hospitalization after delivery (around one week)
Number of neonates who needed phototherapy
Measured: During hospitalization after delivery (around the first week)
Neonatal death
Measured: During hospitalization after delivery (around the first week)
Neonatal hypocalcemia
Measured: During hospitalization after delivery (around the first week)
Neonatal hypomagnesemia
Measured: During hospitalization after delivery (around the first week)
Apgar score
Measured: One and Five minutes after birth
Patients' satisfaction from the monitoring protocol
According to numeric rating scale (1-least satisfied, 10-most satisfied)
Measured: Will be evaluated up to 2 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2022
- Study start18 May 2023
- Primary completionDec 2025 (estimated)
- Study completionApr 2026 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Collaborators
- Bar-Ilan University, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05648721
- Sponsor's protocol ID
- 56-22-POR
- Status last verified
- Nov 2023
- First submitted
- 22 Nov 2022
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Digital Application for Gestational Diabetes Management in Improving Patients' Compliance and Satisfaction, Glycemic Control and Pregnancy Outcomes: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05648721
- Acronym / sponsor ID
- 56-22-POR
- Conditions
- Gestational Diabetes, Pregnancy in Diabetic
- Keywords
- Gestational diabetes, Pregnancy, Mobile-health application, Compliance, Complications
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Collaborators
- Bar-Ilan University, Israel
- Study start
- 18 May 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 13 Dec 2022 (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.
Gestational diabetes mellitus (GDM) is the most prevalent complication in pregnancy. Patients' follow-up and treatment is performed in specialized GDM clinics that teach and support women in implementing lifestyle changes, blood glucose self-monitoring, and nutritional and pharmacologic therapy.
Recently, mobile health (mHealth) applications have been introduced as a resource to improve self-management and follow-up among pregnant women. The proposed study will examine the efficacy of the GDM management mHealth application in improving patients' compliance and satisfaction, glycemic control, and pregnancy outcomes.
A multicenter randomized controlled trial of women with GDM treated in the GDM clinics. Women will be randomly allocated to a research group that will use the GDM application and a control group that will receive regular follow-up without the GDM application. The primary outcome is patient compliance, defined as the actual blood glucose measurements/instructed measurements ×100. Secondary outcomes include glycemic control parameters, and maternal and neonatal complications.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile health application | Experimental | Other: Datos mobile health applicationUse of GDM application for GDM management |
| Control | Other | Other: Regular follow-upRegular follow-up without the GDM application |
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)
- Pregnant women diagnosed with GDM from 13.0 gestational week
- Recruitment until 34.0 gestational week
- 18 years old and older
- Singleton pregnancy
Key exclusion criteria (4 listed)
- Women with pre-gestational diabetes mellitus
- Multiple pregnancy
- Women without a Smartphone that can support the GDM application
- Refusal to participate
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 |
|---|---|---|
| Datos mobile health applicationThe mobile Health application will send women reminders to perform glucose tests and test results will be sent to the clinic personnel for evaluation. The clinic personnel will receive an alert if a woman does not send glucose charts or when there is an abnormality in the test results. In addition, women will be able to communicate with the clinic's personnel via chat, messages, phone calls, and video. | Other | Mobile health application |
| Regular follow-upRegular follow-up according to the local clinic protocol | Other | Control |
Primary outcome
Patient compliance
Time frame: During the follow up in the clinic (around 4 months)
Defined as the actual blood glucose measurements/instructed measurements ×100
19 secondary outcomes
Mean blood glucose of the daily glucose charts
Time frame: During the follow up in the clinic (around 4 months)
Percentage of off-target glucose measurements
Time frame: During the follow up in the clinic (around 4 months)
Need for pharmacotherapy for glycemic control
Time frame: During the follow up in the clinic (around 4 months)
polyhydramnios
Time frame: During the follow up in the clinic (around 4 months)
Preeclampsia/gestational hypertension
Time frame: During the follow up in the clinic (around 4 months)
Induction of labor
Time frame: At birth
Instrumental or cesarean delivery
Time frame: At birth
shoulder dystocia
Time frame: At birth
Third- or fourth-degree perineal tears
Time frame: At birth
Neonatal birth weight
Time frame: At birth
Neonatal intensive care unit admission
Time frame: A week after delivery
Hypoglycemia of the newborn
Time frame: During hospitalization after delivery (around one week)
Respiratory morbidity of the newborn
Time frame: During hospitalization after delivery (around one week)
Number of neonates who needed phototherapy
Time frame: During hospitalization after delivery (around the first week)
Neonatal death
Time frame: During hospitalization after delivery (around the first week)
Neonatal hypocalcemia
Time frame: During hospitalization after delivery (around the first week)
Neonatal hypomagnesemia
Time frame: During hospitalization after delivery (around the first week)
Apgar score
Time frame: One and Five minutes after birth
Patients' satisfaction from the monitoring protocol
Time frame: Will be evaluated up to 2 months after birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Datos mobile health application and Regular follow-up in people with Gestational Diabetes and Pregnancy in Diabetic, run by The Baruch Padeh Medical Center, Poriya at 5 sites in Israel.
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 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel. 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 Enav Yefet, MD/PhD (972-46652306, enyefet@pmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance (time frame: During the follow up in the clinic (around 4 months)). 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 5 Jul 2024.