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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gestational Diabetes Mellitus (GDM)

Intervention / Treatment
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* Device: mobile app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes mellitus, glycemic targets, mHealth, personalized medicine, recommendation system, personalized nutrition, postprandial glycemic response