Clinical trial NCT05179798: The Study of Recommendation System DiaCompanion for Women With Gestational Diabetes Mellitus
Official title: The Study of Recommendation System DiaCompanion With Personalized Dietary Recommendations for Women With Gestational Diabetes Mellitus (DiaCompanion I)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Keywords: gestational diabetes mellitus
glycemic targets
mHealth
personalized medicine
recommendation system
personalized nutrition
postprandial glycemic response
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 216
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of postprandial capillary glucose values above target (>7.0 mmol/L)
timeFrame: from randomization up to delivery
Secondary outcomes:
measure: Rate of patients requiring insulin therapy during pregnancy
timeFrame: At any time during pregnancy up to delivery
measure: Capillary glucose values
timeFrame: within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery
measure: Proportion of women with glucose values within target
timeFrame: within 2 weeks after randomization, at gestational weeks 35-37 and in the period from randomization up to delivery
measure: Mean incremental area under the blood glucose curve 2 hours after meals (iAUC120) according to continuous glucose monitoring (time period: 7 days)
timeFrame: 1-2 weeks after randomization and 35-37th gestational week
measure: Hypoglycemia
timeFrame: from randomization to delivery
measure: The level of HbA1c, %
timeFrame: at gestational weeks 35-37
measure: Fasting insulin, mIU/mL
timeFrame: at gestational weeks 35-37
measure: Fasting glucose, mmol/L
timeFrame: at gestational weeks 35-37
measure: HOMA-IR index
timeFrame: at gestational weeks 35-37
measure: Serum triglyceride levels, mmol/L
timeFrame: at gestational weeks 35-37
measure: Gestational weight change
timeFrame: by the time of delivery
measure: Large (>90th percentile) for gestational age infant
timeFrame: At delivery
measure: Small for gestational age (< 10th percentile) infant
timeFrame: At delivery
measure: Birth weight, kg
timeFrame: At delivery
measure: Birth weight ≥ 4000 g; ≥ 4500 g
timeFrame: At delivery
measure: Neonatal hypoglycemia
timeFrame: At delivery
measure: Shoulder dystocia
timeFrame: At delivery
measure: Birth injury, any of the following: plexus injury, clavicle, humeral, or skull fracture
timeFrame: At delivery
measure: Preterm delivery
timeFrame: At delivery
measure: Apgar score at 1 and 5 minutes from birth
timeFrame: At delivery
measure: Low Apgar score: 5-min Apgar score < 7
timeFrame: At delivery
measure: Jaundice requiring phototherapy
timeFrame: At delivery
measure: Neonatal respiratory distress syndrome
timeFrame: At delivery
measure: Admission to neonatal intensive care unit during the three days following birth
timeFrame: At delivery
measure: Umbilical cord blood C-peptide, ng/mL
timeFrame: At delivery
measure: Cesarean delivery rate
timeFrame: At any time during pregnancy up to delivery
measure: Induction of labor rate
timeFrame: At any time during pregnancy up to delivery
measure: Need for operative vaginal delivery rate
timeFrame: At any time during pregnancy up to delivery
measure: Preeclampsia
timeFrame: At any time during pregnancy up to delivery
measure: Pregnancy-induced hypertension in women with no known hypertension before pregnancy
timeFrame: At any time during pregnancy up to delivery
measure: The number of in-patient visits to endocrinologists
timeFrame: from randomization to delivery
measure: Results of oral glucose tolerance test
timeFrame: 3 months after delivery
measure: Acceptance/satisfaction of 2 strategies: score
timeFrame: at gestational weeks 35-36
measure: Patient satisfaction evaluated through a questionnaire
timeFrame: at gestational weeks 35-36
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Almazov National Medical Research Centre
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.