FreeStyle Libre™ will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will receive subcutaneous sensor for glucose monitoring (FreeStyle Libre™; Abbott Diabetes Care, Alameda, CA) for 4 weeks.

iXell® will comprise 50 pregnant women between 24-28 weeks of gestation, diagnosed with gestational diabetes mellitus, who will monitor glycemia through use of standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) for 4 weeks.

Gestational Diabetes Mellitus

Flash Glucose Monitoring FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days.

Flash Glucose Monitoring

Self-Monitoring of Blood Glucose with a standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days.

Self-Monitoring of Blood Glucose

1st Department of Obstetrics and Gynecology, Medical University of Warsaw

Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial

Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.

Number of patients in each group requiring insulin therapy will by analyzed at the second, third and fourth follow-up visit.

Difference in HbA1c serum concentration in each group will by analyzed at the third and fourth follow-up visit.

Difference in fructosamine serum concentration in each group will by analyzed at the third and fourth follow-up visit.

Number of hypoglycemia episodes in each group will by analyzed at third visit, to check whether there is a difference between the groups.

Number of footsteps walk per day in each group will by analyzed at the third follow-up visit.

Diet assessment in each group will be performed at the second, third and fourth follow-up visit to check compliance with diet recommendations.

Gestational weight gain in each group will by analyzed at the second, third and fourth follow-up visit.

Rate of vaginal delivery versus cesarean section in each group will by analyzed at the fifth follow-up visit.

Fetal birth-weight in each group will by analyzed at the fifth follow-up visit.

Neonatal glycemia in each group will by analyzed at the fifth follow-up visit, to check the rate of neonatal hypoglycemia.

AGATA MAJEWSKA

Principal Investigator

Medical University of Warsaw

Treatment intervention will be initiated with glyburide, metformin, or insulin if 20% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.

Treatment intervention will be initiated with glyburide, metformin, or insulin if 40% cutoff of abnormal values is reached. Medication dosages will depend on the physician's discretion.

Gestational Diabetes

Only women will be randomized as this is a pregnancy-focused study

Insulin may be administered base on glucose log values. The dosing of the insulin will be decided by the provider using typical management of gestational diabetes.

Insulin

Glyburide may be administered base on glucose log values. The dosing of the glyburide will be decided by the provider using typical management of gestational diabetes.

Glyburide

Metformin may be administered base on glucose log values. The dosing of the metformin will be decided by the provider using typical management of gestational diabetes.

Metformin

Medical College of Wisconsin

Threshold for Initiation of Medical Treatment for Women With Gestational Diabetes

Threshold for Initiation of Medical Treatment for Women With Gestational Diabetes: A Single Site Randomized Trial

Our primary outcome will be a composite of neonatal macrosomia, shoulder dystocia, neonatal hypoglycemia, neonatal hyperbilirubinemia, preterm delivery, neonatal intensive care unit (NICU) admission, and stillbirth or neonatal death.

Our secondary outcome will be to compare the rates of cesarean delivery between two thresholds for medical treatment initiation for GDM.

Anna Palatnik, MD

Assistant Professor

This will be a randomized, controlled trial of 284 women with a diagnosis of GDM. Women will be consented and randomized at the time of their diagnosis. All women with GDM will receive counseling regarding diet and exercise and instructions on self-monitoring blood glucose values. The investigators will apply cutoffs of 95 mg/dL for fasting and 120 mg/dL for 2-hour post-prandial levels. Once randomized, the first treatment arm will be assigned to a limit of 20% abnormal values before we start treatment and to titrate up dosages as needed, while using the 20% threshold of abnormal CBG values at each subsequent review of glucose log. To specify, if more than 20% of values for the week are elevated, treatment would be initiated. Once treatment is initiated, the dosage of medication will be adjusted with cutoff of 20% of abnormal values per week. The second treatment arm will utilize the same protocol, however, the limit to start medications or adjust dosages will be 40% abnormal values.

Obese women will be screened at 24-28 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care.
All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.

Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care.
All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.

Routine Screening

Obese women will be randomized to be screened at 14-19.9 weeks of gestation for gestational diabetes using the standard U.S. screening method of a 1-hour, 50-g glucose challenge test followed by a 3-hour, 100-g glucose tolerance test if abnormal. Women identified as having diabetes will be treated according to standards of care. Women who do not have diabetes at 14-19.9 weeks will be re-screened at 24-28 weeks per the standard of care.
All women will have a hemoglobin A1c and 1,5-anhydroglucitol checked at 14-18 weeks and 24-28 weeks gestation.
Early Screen: Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.

Early Screening

Total

Sex/Gender, Customized

Race/Ethnicity, Customized

Region of Enrollment

Body Mass index at randomization

Medicaid/no insurance

Married

High School education or greater

Parous

Any Smoking

Any alcohol use

Any drug use

Hypertension

Asthma

Depression

Hemoglobin A1c at 14-20 weeks

Gestational age at Randomization

Any one of the following: Macrosomia (birth weight > 4000 g), primary cesarean, gestational hypertension, preeclampsia, shoulder dystocia, neonatal hyperbilirubinemia, neonatal hypoglycemia (<40 mg/dL)

Number of Participants With a Composite Perinatal Outcome

Number of infants with Birth weight >4000 g

Number of Participants With Macrosomia

Primary cesarean : delivery via cesarean, first cesarean (does not include repeat cesarean deliveries)

Primary Cesarean Delivery

Includes gestational hypertension and preeclampsia

Pregnancy Induced Hypertension

Shoulder dystocia as identified by delivering physician

Shoulder Dystocia

serum bilirubin level above the 95th percentile for gestational age

Neonatal Hyperbilirubinemia

Neonatal Hypoglycemia

Gestational age in weeks as calculated by ACOG criteria

Gestational Age at Delivery

includes the use of any diabetic medication

Any Diabetic Medication

Insulin Medication

defined as >= the 90th percentile by Duryea et al

Large for Gestational Age

Overall Study

Lorie M. Harper, MD, MSCI

Obesity

Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.

Early Screen

University of Alabama at Birmingham

Ochsner Health System

Early Gestational Diabetes Screening in the Gravid Obese Woman

Lorie M Harper

Associate Professor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

blood sample

Assitance Publique Hôpitaux de Marseille

Lipophilic Micronutrients, Adipokines and Gestational Diabetes Mellitus

Assistance Publique Hopitaux De Marseille

Supervised exercise training at the hospital during pregnancy: the women will attend at least 2 weekly sessions consisting of aerobic exercise (walking on treadmills), strength training (for upper body, back, abdomen and legs) as well as pelvic floor muscle exercises. Each session is 60 minutes and lead by a physiotherapist or experienced exercise physiologist. The women will also go through motivational interviewing sessions throughout the intervention period and are encouraged to do home exercise training in addition to the exercise at the hospital

Usual care as provided by the health services in Norway. The investigators will not advice the women to be inactive

Pregnancy

Exercise

Norwegian University of Science and Technology

Exercise Training in Pregnancy for Obese Mothers

Exercise Training in Pregnancy. Good for the Mother - Good for the Child?

Blood samples to determine the fasting glucose after an overnight fast (>10 hours)

2 hour 75 mg per-oral glucose tolerance test. Gestational diabetes is diagnosed as fasting glucose = or > 6.9 mmol/L or 2h concentration = or > 7.8 mmol/L.

Skinfold measurements, done by an experienced investigator using Harpenden kaliper. At the 3 months postpartum testing, also dual energy x-ray absorptiometry (DEXA scan) will be used.

Inflammation markers, cytokines (leptin, resistin, adiponectin, tnf-alfa). Blood will be collected and stored for later analyses.

Clinical assessment (active straight leg raising, pelvic provocation test), and validated questionnaire.

Pelvic floor muscle function will be assessed by clinical assessment and by 2D and 3D ultrasound. The prevalence and severity of urin- and fecal incontinence will also be assessed by a validated questionnaire

Level of physical activity will be assessed by activity registration (armbands) and by validated questionnaires

Vaginal or caesarean delivery, and recorded complications during the delivery

Cord blood will be sampled and stored for later analysis of relevant markers of inflammation and metabolism (including resistin, leptin, adiponectin)

shoulder dystocia/lihavuus

Flash Glucose Monitoring in Gestational Diabetes Mellitus: Study Protocol for a Randomized Controlled Trial

Threshold for Initiation of Medical Treatment for Women With Gestational Diabetes

Early Gestational Diabetes Screening in the Gravid Obese Woman

Lipophilic Micronutrients, Adipokines and Gestational Diabetes Mellitus

Exercise Training in Pregnancy for Obese Mothers

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