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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.
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]:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mobile app | Experimental | Lifestyle 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mobile app | Device | Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from randomization up to delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients requiring insulin therapy during pregnancy |
| At any time during pregnancy up to delivery |
| Capillary glucose values |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Polina Popova, Ph. D. | Contact | +79217424404 | popova_pv@almazovcentre.ru | |
| Evgenii Pustozerov, Ph. D. | Contact | +79213684589 | pustozerov.e@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Almazov National Medical Research Centre | Recruiting | Saint Petersburg | 197341 | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31979294 | Background | 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. | |
| Background | Pustozerov 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. | ||
| 29317385 |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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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.
|
| 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 |
| 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) | 1-2 weeks after randomization and 35-37th gestational week |
| Hypoglycemia |
| from randomization to delivery |
| The level of HbA1c, % | Maternal metabolic parameter: The level of HbA1c, % | at gestational weeks 35-37 |
| Fasting insulin, mIU/mL | Maternal metabolic parameter: Fasting insulin, mIU/mL | at gestational weeks 35-37 |
| Fasting glucose, mmol/L | Maternal metabolic parameter: Fasting glucose, mmol/L | at gestational weeks 35-37 |
| HOMA-IR index | Maternal metabolic parameter: HOMA-IR index | at gestational weeks 35-37 |
| Serum triglyceride levels, mmol/L | Maternal metabolic parameter: Serum triglyceride levels, mmol/L | at gestational weeks 35-37 |
| Gestational weight change |
| by the time of delivery |
| Large (>90th percentile) for gestational age infant | Neonatal outcome: Large (>90th percentile) for gestational age infant | At delivery |
| Small for gestational age (< 10th percentile) infant | Neonatal outcome: Small for gestational age (< 10th percentile) infant | At delivery |
| Birth weight, kg | Neonatal outcome: Birth weight, kg | At delivery |
| Birth weight ≥ 4000 g; ≥ 4500 g | Neonatal outcome: Birth weight ≥ 4000 g; ≥ 4500 g (yes/no) | At delivery |
| Neonatal hypoglycemia | Neonatal outcome: Neonatal hypoglycemia (yes/no) | At delivery |
| Shoulder dystocia | Neonatal outcome: Shoulder dystocia (yes/no) | 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) | At delivery |
| Preterm delivery | Neonatal outcome: Preterm delivery (yes/no) | At delivery |
| Apgar score at 1 and 5 minutes from birth | Neonatal outcome: Apgar score at 1 and 5 minutes from birth | At delivery |
| Low Apgar score: 5-min Apgar score < 7 | Neonatal outcome: Low Apgar score: 5-min Apgar score < 7 | At delivery |
| Jaundice requiring phototherapy | Neonatal outcome: Jaundice requiring phototherapy (yes/no) | At delivery |
| Neonatal respiratory distress syndrome | Neonatal outcome: Neonatal respiratory distress syndrome (yes/no) | 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) | At delivery |
| Umbilical cord blood C-peptide, ng/mL | Neonatal outcome: Umbilical cord blood C-peptide, ng/mL | At delivery |
| Cesarean delivery rate | Maternal outcome: Cesarean delivery rate | At any time during pregnancy up to delivery |
| Induction of labor rate | Maternal outcome: Induction of labor rate | 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) | 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) | 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 | At any time during pregnancy up to delivery |
| The number of in-patient visits to endocrinologists | from randomization to delivery |
| Results of oral glucose tolerance test | The test will be performed by the women 3 months postpartum | 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 | 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 | at gestational weeks 35-36 |
| Background |
| 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. |
| 37361536 | Derived | Popova 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. |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |