The Study of Recommendation System DiaCompanion for Women With Gestational Diabetes Mellitus

The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)

Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health

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.

gestational diabetes mellitus, glycemic targets, mHealth, personalized medicine, recommendation system, personalized nutrition, postprandial glycemic response

Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.

Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.

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.

Rate of patients requiring insulin therapy (either basal or prandial) Rate of patients requiring prandial insulin therapy

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

within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery

The proportion of women with fasting glucose values within the target The proportion of women with postprandial glucose values within the 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)

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

Gestational weight change during pregnancy, kg Gestational weight change between inclusion and delivery, kg

Neonatal outcome: Birth injury, any of the following: plexus injury, clavicle, humeral, or skull fracture (yes/no)

Neonatal outcome: Admission to neonatal intensive care unit during the three days following birth (yes/no)

Maternal outcome: Need for operative vaginal delivery rate (forceps or vacuum-assisted vaginal delivery)

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)

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

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

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

Inclusion Criteria: 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 Exclusion Criteria: 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 Impaired mobility Known fetal malformations Concomitant participation in other clinical trials

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.

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.

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.