Gestational Diabetes Mellitus (GDM)NCT05179798
The Study of Recommendation System DiaCompanion for Women With Gestational Diabetes Mellitus
A study testing mobile app in people with Gestational Diabetes Mellitus (GDM), run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
This is a randomized controlled trial of a recommendation system implementation in the treatment of women with gestational diabetes mellitus (GDM). The trial assesses the aspects of system effects on maternal glucose control, the fetus and pregnancy outcomes. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus (GDM)
- What is being tested?
- mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteRussia
- Study dates
- 12 Jan 2022to Aug 2025
- 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women diagnosed with GDM according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. fasting plasma glucose between 5.1 mmol/L and 6.9 mmol/L after the 6th week of gestation and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 10.0 mmol/L and/or 2-hour plasma glucose value between 8.5 mmol/L and 11.0 mmol/L at the 24-31st week of gestation
- Age >18 years
- Gestational age >= 12 and < 32 weeks
- No more than 4 weeks after confirmation of GDM diagnosis
- Singleton pregnancy
- The ability to navigate an app
- Provided informed consent
Who cannot join
- Preexisting diabetes of any type before the current pregnancy
- Need for insulin therapy at the time of screening
- Heart failure
- Chronic kidney disease
- History of bariatric surgery
- Use of long-term systemic corticosteroids
Show all 9Show fewer
- Impaired mobility
- Known fetal malformations
- Concomitant participation in other clinical trials
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Almazov National Medical Research Centre
Saint Petersburg, 197341
Polina Popova, Ph. D., +79217424404, popova_pv@almazovcentre.ru
About this study
Official title: The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)
This is a randomized controlled trial of a recommendation system implementation in the treatment of women with gestational diabetes mellitus (GDM). The trial assesses the aspects of system effects on maternal glucose control, the fetus and pregnancy outcomes. This study is an interventional, randomized controlled trial, open-labeled.
Read the detailed description
The study aims to clarify the effect of using DiaCompanion I (a mobile-based personalized recommendations system) on glycemic levels and pregnancy outcomes in women with GDM. Women with GDM are randomized to 2 treatment groups (utilizing and not utilizing the developed mobile-based system with data-driven personal recommendations focused primarily on postprandial glycemic response prediction). Data on glycemic levels during the study and consumption of major macro- and micronutrients will be collected using the mobile app with electronic report forms. The app provides women in the intervention group with the resulting data-driven prognosis of a 1-hour postprandial glucose level every time they input their meal data. The app also provides participants of the intervention group with a set of reminders and recommendations on the diet and lifestyle.
Apart from the assessment of the outcomes described below, biobanking of serum, plasma; cord fluid, HUVECs, faeces, and meconium will be performed. The samples may be used for further analyses in ancillary studies, which could be beneficial for GDM care based on evolution in scientific knowledge.
This biological collection is optional [Time Frame: within 15 years after the end of the study]:
- The blood samples will be collected at the same time as the sample routinely collected
- Maternal faeces will be collected within 5 days after inclusion and at gestational weeks 35-36
- Cord fluid will be collected
- HUVECs will be isolated from the cord after delivery
- Meconium will be collected within 24 hours after birth.
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Being tested
- mobile app
- Keywords
- gestational diabetes mellitus, glycemic targets, mHealth, personalized medicine, recommendation system, personalized nutrition, postprandial glycemic response
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile appDevice
Also called recommendation system
Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Mobile app | Experimental | Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations. Receives: Device: mobile app |
| Standard of care | No intervention | Lifestyle modification, insulin therapy if needed; conventional care without a mobile app. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of postprandial capillary glucose values above target (>7.0 mmol/L)
The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary.
Measured: from randomization up to delivery
Secondary outcomes (34)
Rate of patients requiring insulin therapy during pregnancy
- Rate of patients requiring insulin therapy (either basal or prandial)
- Rate of patients requiring prandial insulin therapy
Measured: At any time during pregnancy up to delivery
Capillary glucose values
The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter and from the woman's diary.
- Capillary fasting glucose values, mmol/L
- Capillary pre-prandial glucose values, mmol/L
- Capillary postprandial glucose values, mmol/L
Measured: within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery
Proportion of women with glucose values within target
- The proportion of women with fasting glucose values within the target
- The proportion of women with postprandial glucose values within the target
Measured: within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery
Mean incremental area under the blood glucose curve 2 hours after meals (iAUC120) according to continuous glucose monitoring (time period: 7 days)
Measured: 1-2 weeks after randomization and 35-37th gestational week
Hypoglycemia
- Severe hypoglycemia: requiring assistance of another person to actively correct the level of glycemia and neurological symptoms
- Documented symptomatic hypoglycemia: event during which typical symptoms of hypoglycemia are accompanied by a measured capillary glucose concentration <3.9 mmol/L
- Asymptomatic hypoglycemia: event not accompanied by typical symptoms of hypoglycemia but with a measured capillary glucose concentration <3.3 mmol/L
Measured: from randomization to delivery
The level of HbA1c, %
Maternal metabolic parameter: The level of HbA1c, %
Measured: at gestational weeks 35-37
Fasting insulin, mIU/mL
Maternal metabolic parameter: Fasting insulin, mIU/mL
Measured: at gestational weeks 35-37
Fasting glucose, mmol/L
Maternal metabolic parameter: Fasting glucose, mmol/L
Measured: at gestational weeks 35-37
HOMA-IR index
Maternal metabolic parameter: HOMA-IR index
Measured: at gestational weeks 35-37
Serum triglyceride levels, mmol/L
Maternal metabolic parameter: Serum triglyceride levels, mmol/L
Measured: at gestational weeks 35-37
Gestational weight change
- Gestational weight change during pregnancy, kg
- Gestational weight change between inclusion and delivery, kg
Measured: by the time of delivery
Large (>90th percentile) for gestational age infant
Neonatal outcome: Large (>90th percentile) for gestational age infant
Measured: At delivery
Small for gestational age (< 10th percentile) infant
Neonatal outcome: Small for gestational age (< 10th percentile) infant
Measured: At delivery
Birth weight, kg
Neonatal outcome: Birth weight, kg
Measured: At delivery
Birth weight ≥ 4000 g; ≥ 4500 g
Neonatal outcome: Birth weight ≥ 4000 g; ≥ 4500 g (yes/no)
Measured: At delivery
Neonatal hypoglycemia
Neonatal outcome: Neonatal hypoglycemia (yes/no)
Measured: At delivery
Shoulder dystocia
Neonatal outcome: Shoulder dystocia (yes/no)
Measured: At delivery
Birth injury, any of the following: plexus injury, clavicle, humeral, or skull fracture
Neonatal outcome: Birth injury, any of the following: plexus injury, clavicle, humeral, or skull fracture (yes/no)
Measured: At delivery
Preterm delivery
Neonatal outcome: Preterm delivery (yes/no)
Measured: At delivery
Apgar score at 1 and 5 minutes from birth
Neonatal outcome: Apgar score at 1 and 5 minutes from birth
Measured: At delivery
Low Apgar score: 5-min Apgar score < 7
Neonatal outcome: Low Apgar score: 5-min Apgar score < 7
Measured: At delivery
Jaundice requiring phototherapy
Neonatal outcome: Jaundice requiring phototherapy (yes/no)
Measured: At delivery
Neonatal respiratory distress syndrome
Neonatal outcome: Neonatal respiratory distress syndrome (yes/no)
Measured: At delivery
Admission to neonatal intensive care unit during the three days following birth
Neonatal outcome: Admission to neonatal intensive care unit during the three days following birth (yes/no)
Measured: At delivery
Umbilical cord blood C-peptide, ng/mL
Neonatal outcome: Umbilical cord blood C-peptide, ng/mL
Measured: At delivery
Cesarean delivery rate
Maternal outcome: Cesarean delivery rate
Measured: At any time during pregnancy up to delivery
Induction of labor rate
Maternal outcome: Induction of labor rate
Measured: At any time during pregnancy up to delivery
Need for operative vaginal delivery rate
Maternal outcome: Need for operative vaginal delivery rate (forceps or vacuum-assisted vaginal delivery)
Measured: At any time during pregnancy up to delivery
Preeclampsia
Maternal outcome: Preeclampsia (blood pressure ≥ 140/90 mmHg on two measurements four hours apart and proteinuria of at least 300 mg/24 hours or 3+ or more on dipstick testing or proteinuria/creatinuria >30 in a random urine sample)
Measured: At any time during pregnancy up to delivery
Pregnancy-induced hypertension in women with no known hypertension before pregnancy
Maternal outcome: Pregnancy-induced hypertension in women with no known hypertension before pregnancy, blood pressure ≥ 140/90 mmHg on two measurements four hours apart without proteinuria and having needed to begin anti-hypertensive therapy
Measured: At any time during pregnancy up to delivery
The number of in-patient visits to endocrinologists
Measured: from randomization to delivery
Results of oral glucose tolerance test
The test will be performed by the women 3 months postpartum
Measured: 3 months after delivery
Acceptance/satisfaction of 2 strategies: score
Evaluation of the patient's satisfaction about their treatment for GDM with a scale: give a score of 0 to 100: 0 not satisfied; 100 totally satisfied
Measured: at gestational weeks 35-36
Patient satisfaction evaluated through a questionnaire
10-question questionnaire with multiple-choice questions, questions with numeric answers on the scale from 0 (fully unsatisfied) to 10 (fully satisfied) and open-ended questions
Measured: at gestational weeks 35-36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start12 Jan 2022
- Primary completionJan 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus (GDM)Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Polina Popova, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05179798
- Sponsor's protocol ID
- DiaCompanion I
- Status last verified
- Jan 2022
- First submitted
- 30 Oct 2021
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pustozerov E, Tkachuk A, Vasukova E, Dronova A, Shilova E, Anopova A, Piven F, Pervunina T, Vasilieva E, Grineva E, Popova P. The Role of Glycemic Index and Glycemic Load in the Development of Real-Time Postprandial Glycemic Response Prediction Models for Patients With Gestational Diabetes. Nutrients. 2020 Jan 23;12(2):302. doi: 10.3390/nu12020302.
PubMed 31979294Pustozerov E.A., Tkachuck A.S., Vasukova E.A., Anopova A.D., Kokina M.A., Gorelova I.V., Pervunina T.M., Grineva E.N., Popova P.V. Machine Learning Approach for Postprandial Blood Glucose Prediction in Gestational Diabetes Mellitus. IEEE Access, vol. 8, pp. 219308-219321, 2020, doi: 10.1109/ACCESS.2020.3042483.
Pustozerov E, Popova P, Tkachuk A, Bolotko Y, Yuldashev Z, Grineva E. Development and Evaluation of a Mobile Personalized Blood Glucose Prediction System for Patients With Gestational Diabetes Mellitus. JMIR Mhealth Uhealth. 2018 Jan 9;6(1):e6. doi: 10.2196/mhealth.9236.
PubMed 29317385Popova P, Anopova A, Vasukova E, Isakov A, Eriskovskaya A, Degilevich A, Pustozerov E, Tkachuk A, Pashkova K, Krasnova N, Kokina M, Nemykina I, Pervunina T, Li O, Grineva E, Shlyakhto E. Trial protocol for the study of recommendation system DiaCompanion with personalized dietary recommendations for women with gestational diabetes mellitus (DiaCompanion I). Front Endocrinol (Lausanne). 2023 Jun 7;14:1168688. doi: 10.3389/fendo.2023.1168688. eCollection 2023.
PubMed 37361536
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)
- ClinicalTrials.gov ID
- NCT05179798
- Acronym / sponsor ID
- DiaCompanion I
- Conditions
- Gestational Diabetes Mellitus (GDM)
- Keywords
- gestational diabetes mellitus, glycemic targets, mHealth, personalized medicine, recommendation system, personalized nutrition, postprandial glycemic response
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 5 Jan 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.
This is a randomized controlled trial of a recommendation system implementation in the treatment of women with gestational diabetes mellitus (GDM). The trial assesses the aspects of system effects on maternal glucose control, the fetus and pregnancy outcomes. This study is an interventional, randomized controlled trial, open-labeled.
Detailed description
The study aims to clarify the effect of using DiaCompanion I (a mobile-based personalized recommendations system) on glycemic levels and pregnancy outcomes in women with GDM. Women with GDM are randomized to 2 treatment groups (utilizing and not utilizing the developed mobile-based system with data-driven personal recommendations focused primarily on postprandial glycemic response prediction). Data on glycemic levels during the study and consumption of major macro- and micronutrients will be collected using the mobile app with electronic report forms. The app provides women in the intervention group with the resulting data-driven prognosis of a 1-hour postprandial glucose level every time they input their meal data. The app also provides participants of the intervention group with a set of reminders and recommendations on the diet and lifestyle.
Apart from the assessment of the outcomes described below, biobanking of serum, plasma; cord fluid, HUVECs, faeces, and meconium will be performed. The samples may be used for further analyses in ancillary studies, which could be beneficial for GDM care based on evolution in scientific knowledge.
This biological collection is optional [Time Frame: within 15 years after the end of the study]:
- The blood samples will be collected at the same time as the sample routinely collected
- Maternal faeces will be collected within 5 days after inclusion and at gestational weeks 35-36
- Cord fluid will be collected
- HUVECs will be isolated from the cord after delivery
- Meconium will be collected within 24 hours after birth.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobile app | Experimental | Device: mobile appLifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations. |
| Standard of care | No intervention | –Lifestyle modification, insulin therapy if needed; conventional care without a mobile app. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Women diagnosed with GDM according to IADPSG (International Association of the Diabetes and Pregnancy Study Groups) criteria, i.e. fasting plasma glucose between 5.1 mmol/L and 6.9 mmol/L after the 6th week of gestation and/or 1-hour plasma glucose value after 75 g oral glucose tolerance test (OGTT) ≥ 10.0 mmol/L and/or 2-hour plasma glucose value between 8.5 mmol/L and 11.0 mmol/L at the 24-31st week of gestation
- Age >18 years
- Gestational age >= 12 and < 32 weeks
- No more than 4 weeks after confirmation of GDM diagnosis
- Singleton pregnancy
Key exclusion criteria (9 listed)
- Preexisting diabetes of any type before the current pregnancy
- Need for insulin therapy at the time of screening
- Heart failure
- Chronic kidney disease
- History of bariatric surgery
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 |
|---|---|---|
| mobile appAlso: recommendation systemLifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations. | Device | Mobile app |
Primary outcome
Percentage of postprandial capillary glucose values above target (>7.0 mmol/L)
Time frame: from randomization up to delivery
The women will be asked to perform 6 measures a day. Capillary glucose values will be retrieved from the glucose meter, and if not available, from the woman's diary.
34 secondary outcomes
Rate of patients requiring insulin therapy during pregnancy
Time frame: At any time during pregnancy up to delivery
Capillary glucose values
Time frame: within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery
Proportion of women with glucose values within target
Time frame: within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery
Mean incremental area under the blood glucose curve 2 hours after meals (iAUC120) according to continuous glucose monitoring (time period: 7 days)
Time frame: 1-2 weeks after randomization and 35-37th gestational week
Hypoglycemia
Time frame: from randomization to delivery
The level of HbA1c, %
Time frame: at gestational weeks 35-37
Fasting insulin, mIU/mL
Time frame: at gestational weeks 35-37
Fasting glucose, mmol/L
Time frame: at gestational weeks 35-37
HOMA-IR index
Time frame: at gestational weeks 35-37
Serum triglyceride levels, mmol/L
Time frame: at gestational weeks 35-37
Gestational weight change
Time frame: by the time of delivery
Large (>90th percentile) for gestational age infant
Time frame: At delivery
Small for gestational age (< 10th percentile) infant
Time frame: At delivery
Birth weight, kg
Time frame: At delivery
Birth weight ≥ 4000 g; ≥ 4500 g
Time frame: At delivery
Neonatal hypoglycemia
Time frame: At delivery
Shoulder dystocia
Time frame: At delivery
Birth injury, any of the following: plexus injury, clavicle, humeral, or skull fracture
Time frame: At delivery
Preterm delivery
Time frame: At delivery
Apgar score at 1 and 5 minutes from birth
Time frame: At delivery
Low Apgar score: 5-min Apgar score < 7
Time frame: At delivery
Jaundice requiring phototherapy
Time frame: At delivery
Neonatal respiratory distress syndrome
Time frame: At delivery
Admission to neonatal intensive care unit during the three days following birth
Time frame: At delivery
Umbilical cord blood C-peptide, ng/mL
Time frame: At delivery
Cesarean delivery rate
Time frame: At any time during pregnancy up to delivery
Induction of labor rate
Time frame: At any time during pregnancy up to delivery
Need for operative vaginal delivery rate
Time frame: At any time during pregnancy up to delivery
Preeclampsia
Time frame: At any time during pregnancy up to delivery
Pregnancy-induced hypertension in women with no known hypertension before pregnancy
Time frame: At any time during pregnancy up to delivery
The number of in-patient visits to endocrinologists
Time frame: from randomization to delivery
Results of oral glucose tolerance test
Time frame: 3 months after delivery
Acceptance/satisfaction of 2 strategies: score
Time frame: at gestational weeks 35-36
Patient satisfaction evaluated through a questionnaire
Time frame: at gestational weeks 35-36
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 31979294Pustozerov E, Tkachuk A, Vasukova E, Dronova A, Shilova E, Anopova A, Piven F, Pervunina T, Vasilieva E, Grineva E, Popova P. The Role of Glycemic Index and Glycemic Load in the Development of Real-Time Postprandial Glycemic Response Prediction Models for Patients With Gestational Diabetes. Nutrients. 2020 Jan 23;12(2):302. doi: 10.3390/nu12020302.
- BackgroundPustozerov E.A., Tkachuck A.S., Vasukova E.A., Anopova A.D., Kokina M.A., Gorelova I.V., Pervunina T.M., Grineva E.N., Popova P.V. Machine Learning Approach for Postprandial Blood Glucose Prediction in Gestational Diabetes Mellitus. IEEE Access, vol. 8, pp. 219308-219321, 2020, doi: 10.1109/ACCESS.2020.3042483.
- Background: PubMed 29317385Pustozerov E, Popova P, Tkachuk A, Bolotko Y, Yuldashev Z, Grineva E. Development and Evaluation of a Mobile Personalized Blood Glucose Prediction System for Patients With Gestational Diabetes Mellitus. JMIR Mhealth Uhealth. 2018 Jan 9;6(1):e6. doi: 10.2196/mhealth.9236.
- Derived from this study: PubMed 37361536Popova P, Anopova A, Vasukova E, Isakov A, Eriskovskaya A, Degilevich A, Pustozerov E, Tkachuk A, Pashkova K, Krasnova N, Kokina M, Nemykina I, Pervunina T, Li O, Grineva E, Shlyakhto E. Trial protocol for the study of recommendation system DiaCompanion with personalized dietary recommendations for women with gestational diabetes mellitus (DiaCompanion I). Front Endocrinol (Lausanne). 2023 Jun 7;14:1168688. doi: 10.3389/fendo.2023.1168688. eCollection 2023.
Related trials for Gestational Diabetes Mellitus (GDM)
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile app in people with Gestational Diabetes Mellitus (GDM), run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
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 7 inclusion and 9 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 8 Feb 2022. 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 Russia. 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 Polina Popova, Ph. D. (+79217424404, popova_pv@almazovcentre.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of postprandial capillary glucose values above target (>7.0 mmol/L) (time frame: from randomization up to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05179798, which also lists 4 linked publications.
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 8 Feb 2022.