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)

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus (GDM)
• Intervention / Treatment: Device: mobile app

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 Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Polina Popova, Ph. D.; Phone Number: +79217424404; Email: popova_pv@almazovcentre.ru
• Study Contact Backup: Name: Evgenii Pustozerov, Ph. D.; Phone Number: +79213684589; Email: pustozerov.e@gmail.com

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 197341
    • Recruiting
    • Almazov National Medical Research Centre
    • Contact: Polina Popova, Ph. D.; Phone Number: +79217424404; Email: popova_pv@almazovcentre.ru

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile app; Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.	Device: mobile app; Lifestyle modification, insulin therapy if needed, utilization of a mobile app with personalized recommendations.; Other Names: recommendation system
No Intervention: Standard of care; Lifestyle modification, insulin therapy if needed; conventional care without a mobile app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	Gestational weight change during pregnancy, kg; Gestational weight change between inclusion and delivery, kg	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

Collaborators and Investigators

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

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): January 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 8, 2022
• Last Update Submitted That Met QC Criteria: January 25, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: mHealth; personalized nutrition; personalized medicine; gestational diabetes mellitus; postprandial glycemic response; glycemic targets; recommendation system
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: DiaCompanion I

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No