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

Study Overview
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Brief Summary
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Gestational diabetes mellitus (GDM) is glucose intolerance diagnosed for the first time in pregnancy. According to literature GDM affects 3-10% of pregnant women and is a risk factor for multiple maternal and fetal complications. During pregnancy GDM significantly increases the risk of fetal macrosomia, shoulder dystocia, birth trauma and Cesarean section. Furthermore, the long-term complications of GDM include increased risk of development of diabetes mellitus type 2 in the mother, as well as increased risk of obesity, diabetes and metabolic syndrome occurrence in their children. It has been well-documented that the risk of above-mentioned complications increases with the level of maternal hyperglycemia. Proper glycemia control is one of the key elements in the effective treatment of GDM. Until recently, glucose monitoring was solely performed using glucose meters, which required multiple fingerpricks. Nowadays, due to the glycemia monitoring systems development, such as flash glucose monitoring (FGM), glucose levels may be measured less invasively through subcutaneous sensor application. As shown in one of the studies, FGM due to the ease of use, was 3 times more often applied as a method of glycemia control than SMBG. As a result, patients from FGM group had significantly better blood glucose control. The main purpose of our study is to evaluate the impact of new method of glycemia control (FGM) on the efficacy of treatment of GDM. By analyzing results of this study, such as mean glycemia levels, number of women requiring insulin therapy and maternal-fetal perinatal outcomes the investigators will provide a scientific basis for more common use of FGM in the population of pregnant women affected by GDM.

Detailed Description
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This is a randomized controlled trial performed at the 1st Department of Obstetrics and Gynecology of Medical University of Warsaw. The study will recruit 100 women at 24-28 weeks of gestation . Women diagnosed with GDM, who will meet the inclusion criteria, will be individually randomized to Flash Glucose Monitoring (n=50) or Self-Monitoring of Blood Glucose (n=50) group. The study group will obtain instruction for using Freestyle Libre app to measure and collect glycemia results using a mobile phone. The control group will be informed about proper use of glucose meters. All participants will be obliged to measure fasting and 1-h postprandial glucose concentrations in a daily manner, together with once per week midnight measurement. All participants will obtain dietary recommendations for gestational diabetes mellitus and recommendations about daily physical activity in pregnancy. In order to assess daily physical activity all participants will obtain a wristband allowing for footsteps measurement. An evaluation of patient's dietary habits will be based on Eating Assessment Test prepared by the Polish National Institute of Public Health - National Institute of Hygiene. Clinical and laboratory results of the mother and their newborns will be collected for analysis during the course of pregnancy. After delivery, at the follow-up visit research staff will retrieve maternal and neonatal outcomes from patients medical history.

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

Conditions
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Gestational Diabetes Mellitus

Intervention / Treatment
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* Device: Flash Glucose Monitoring
* Device: Self-Monitoring of Blood Glucose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age ≥ 18 years singleton pregnancy between 24-28 weeks of gestation gestational diabetes mellitus diagnosis Exclusion Criteria: multiple pregnancy fetal malformations pre-gestational diabetes mellitus chronic or pregnancy-induced hypertension chronic renal or hepatic disease, in-vitro fertilization delivery <37 weeks of gestation pre-mature rupture of membranes placenta previa stillbirth smoking in pregnancy intake of medications including: methyldopa, tetracyclin, acetylosalicylic acid, acetaminofen, ibuprofen, L-dopa, tolazamide, tolbutamide

Ages Eligible for Study
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Minimum Age: 18 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FreeStyle Libre™<br>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. | Device: Flash Glucose Monitoring<br>* 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.<br>* Other names: FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA);|
| Active Comparator: iXell®<br>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. | Device: Self-Monitoring of Blood Glucose<br>* 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.<br>* Other names: iXell®; Genexo sp; Warsaw, Poland;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean glycemia results (fasting and 1-h postprandial glucose concentrations) | Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus. | 28 days after the recruitment visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients requiring insulin therapy | Number of patients in each group requiring insulin therapy will by analyzed at the second, third and fourth follow-up visit. | 2, 4 and 8 weeks after the recruitment visit | 
| Long-term glycemic control using blood HbA1c serum concentration | Difference in HbA1c serum concentration in each group will by analyzed at the third and fourth follow-up visit. | 4 and 8 weeks after the recruitment visit | 
| Number of hypoglycemia episodes (glucose concentration <70 mg/dl) during one month analysis | Number of hypoglycemia episodes in each group will by analyzed at third visit, to check whether there is a difference between the groups. | 0-4 weeks after the recruitment visit | 
| Physical activity during one month analysis | Number of footsteps walk per day in each group will by analyzed at the third follow-up visit. | 0-4 weeks after the recruitment visit | 
| Compliance with diet recommendations | Diet assessment in each group will be performed at the second, third and fourth follow-up visit to check compliance with diet recommendations. | 2, 4 and 8 weeks after the recruitment visit | 
| Gestational weight gain | Gestational weight gain in each group will by analyzed at the second, third and fourth follow-up visit. | 2, 4 and 8 weeks after the recruitment visit | 
| Mode of delivery (rate of vaginal delivery/ Cesarean section) | Rate of vaginal delivery versus cesarean section in each group will by analyzed at the fifth follow-up visit. | 24-72 hours after the delivery | 
| Fetal birth-weight | Fetal birth-weight in each group will by analyzed at the fifth follow-up visit. | 24-72 hours after the delivery | 
| Neonatal glycemia | Neonatal glycemia in each group will by analyzed at the fifth follow-up visit, to check the rate of neonatal hypoglycemia. | 24-72 hours after the delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gestational diabetes mellitus, flash glucose monitoring, glycemia