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

Gestational Diabetes Mellitus (GDM) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05179798
• Other study ID #: DiaCompanion I
• Status: Recruiting
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: August 2025

Study information

• Verified date: January 2022
• Source: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
• Contact: Polina Popova, Ph. D.
• Phone: +79217424404
• Email: popova_pv[@]almazovcentre.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 216
• Est. completion date: August 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus (GDM)

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Almazov National Medical Research Centre	Saint Petersburg

Sponsors (1)

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

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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. — View 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). pii: E302. doi: 10.3390/nu12020302. — View 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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The level of HbA1c, %	Maternal metabolic parameter: The level of HbA1c, %	at gestational weeks 35-37
Secondary	Fasting insulin, mIU/mL	Maternal metabolic parameter: Fasting insulin, mIU/mL	at gestational weeks 35-37
Secondary	Fasting glucose, mmol/L	Maternal metabolic parameter: Fasting glucose, mmol/L	at gestational weeks 35-37
Secondary	HOMA-IR index	Maternal metabolic parameter: HOMA-IR index	at gestational weeks 35-37
Secondary	Serum triglyceride levels, mmol/L	Maternal metabolic parameter: Serum triglyceride levels, mmol/L	at gestational weeks 35-37
Secondary	Gestational weight change	Gestational weight change during pregnancy, kg; Gestational weight change between inclusion and delivery, kg	by the time of delivery
Secondary	Large (>90th percentile) for gestational age infant	Neonatal outcome: Large (>90th percentile) for gestational age infant	At delivery
Secondary	Small for gestational age (< 10th percentile) infant	Neonatal outcome: Small for gestational age (< 10th percentile) infant	At delivery
Secondary	Birth weight, kg	Neonatal outcome: Birth weight, kg	At delivery
Secondary	Birth weight = 4000 g; = 4500 g	Neonatal outcome: Birth weight = 4000 g; = 4500 g (yes/no)	At delivery
Secondary	Neonatal hypoglycemia	Neonatal outcome: Neonatal hypoglycemia (yes/no)	At delivery
Secondary	Shoulder dystocia	Neonatal outcome: Shoulder dystocia (yes/no)	At delivery
Secondary	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
Secondary	Preterm delivery	Neonatal outcome: Preterm delivery (yes/no)	At delivery
Secondary	Apgar score at 1 and 5 minutes from birth	Neonatal outcome: Apgar score at 1 and 5 minutes from birth	At delivery
Secondary	Low Apgar score: 5-min Apgar score < 7	Neonatal outcome: Low Apgar score: 5-min Apgar score < 7	At delivery
Secondary	Jaundice requiring phototherapy	Neonatal outcome: Jaundice requiring phototherapy (yes/no)	At delivery
Secondary	Neonatal respiratory distress syndrome	Neonatal outcome: Neonatal respiratory distress syndrome (yes/no)	At delivery
Secondary	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
Secondary	Umbilical cord blood C-peptide, ng/mL	Neonatal outcome: Umbilical cord blood C-peptide, ng/mL	At delivery
Secondary	Cesarean delivery rate	Maternal outcome: Cesarean delivery rate	At any time during pregnancy up to delivery
Secondary	Induction of labor rate	Maternal outcome: Induction of labor rate	At any time during pregnancy up to delivery
Secondary	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
Secondary	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
Secondary	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
Secondary	The number of in-patient visits to endocrinologists		from randomization to delivery
Secondary	Results of oral glucose tolerance test	The test will be performed by the women 3 months postpartum	3 months after delivery
Secondary	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
Secondary	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