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 \[Time Frame: within 15 years after the end of the study\]: * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.
Almazov National Medical Research Centre
Saint Petersburg, Russia
RECRUITINGPercentage 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.
Time frame: from randomization up to delivery
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
Time frame: 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
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
* The proportion of women with fasting glucose values within the target * The proportion of women with postprandial glucose values within the 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
* 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
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Time frame: from randomization to delivery
The level of HbA1c, %
Maternal metabolic parameter: The level of HbA1c, %
Time frame: at gestational weeks 35-37
Fasting insulin, mIU/mL
Maternal metabolic parameter: Fasting insulin, mIU/mL
Time frame: at gestational weeks 35-37
Fasting glucose, mmol/L
Maternal metabolic parameter: Fasting glucose, mmol/L
Time frame: at gestational weeks 35-37
HOMA-IR index
Maternal metabolic parameter: HOMA-IR index
Time frame: at gestational weeks 35-37
Serum triglyceride levels, mmol/L
Maternal metabolic parameter: Serum triglyceride levels, mmol/L
Time frame: at gestational weeks 35-37
Gestational weight change
* Gestational weight change during pregnancy, kg * Gestational weight change between inclusion and delivery, kg
Time frame: by the time of delivery
Large (>90th percentile) for gestational age infant
Neonatal outcome: Large (\>90th percentile) for gestational age infant
Time frame: At delivery
Small for gestational age (< 10th percentile) infant
Neonatal outcome: Small for gestational age (\< 10th percentile) infant
Time frame: At delivery
Birth weight, kg
Neonatal outcome: Birth weight, kg
Time frame: At delivery
Birth weight ≥ 4000 g; ≥ 4500 g
Neonatal outcome: Birth weight ≥ 4000 g; ≥ 4500 g (yes/no)
Time frame: At delivery
Neonatal hypoglycemia
Neonatal outcome: Neonatal hypoglycemia (yes/no)
Time frame: At delivery
Shoulder dystocia
Neonatal outcome: Shoulder dystocia (yes/no)
Time frame: 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)
Time frame: At delivery
Preterm delivery
Neonatal outcome: Preterm delivery (yes/no)
Time frame: At delivery
Apgar score at 1 and 5 minutes from birth
Neonatal outcome: Apgar score at 1 and 5 minutes from birth
Time frame: At delivery
Low Apgar score: 5-min Apgar score < 7
Neonatal outcome: Low Apgar score: 5-min Apgar score \< 7
Time frame: At delivery
Jaundice requiring phototherapy
Neonatal outcome: Jaundice requiring phototherapy (yes/no)
Time frame: At delivery
Neonatal respiratory distress syndrome
Neonatal outcome: Neonatal respiratory distress syndrome (yes/no)
Time frame: 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)
Time frame: At delivery
Umbilical cord blood C-peptide, ng/mL
Neonatal outcome: Umbilical cord blood C-peptide, ng/mL
Time frame: At delivery
Cesarean delivery rate
Maternal outcome: Cesarean delivery rate
Time frame: At any time during pregnancy up to delivery
Induction of labor rate
Maternal outcome: Induction of labor rate
Time frame: 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)
Time frame: 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)
Time frame: 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
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
The test will be performed by the women 3 months postpartum
Time frame: 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
Time frame: 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
Time frame: at gestational weeks 35-36