Here is the design of a clinical trial:

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

Included conditions:
- Gestational Diabetes Mellitus

Study Armgroups:
- {'label': 'FreeStyle Libre™', 'type': 'EXPERIMENTAL', 'description': '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.', 'interventionNames': ['Device: Flash Glucose Monitoring']}
- {'label': 'iXell®', 'type': 'ACTIVE_COMPARATOR', 'description': '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.', 'interventionNames': ['Device: Self-Monitoring of Blood Glucose']}

Interventions:
- {'type': 'DEVICE', 'name': 'Flash Glucose Monitoring', 'description': '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.', 'armGroupLabels': ['FreeStyle Libre™'], 'otherNames': ['FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)']}
- {'type': 'DEVICE', 'name': 'Self-Monitoring of Blood Glucose', 'description': '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.', 'armGroupLabels': ['iXell®'], 'otherNames': ['iXell®; Genexo sp; Warsaw, Poland']}

Primary Outcomes:
- {'measure': 'Mean glycemia results (fasting and 1-h postprandial glucose concentrations)', 'description': 'Glycemia results analysis according to Polish Society of Obstetricians and Gynecologists (PSOG) recommendations for gestational diabetes mellitus.', 'timeFrame': '28 days after the recruitment visit'}

Please estimate the sample size based on the assumption: 
Power of 80%, significance level of 5%, two-sided. Continuous data will be compared using the Mann-Whitney U test, and for categorical variables the χ2 test will be applied. The relationship between glucose, HbA1c and fructosamine concentrations, and selected maternal-fetal parameters will be examined with the use of Pearson’s correlation coefficient. Multivariable logistic regression analysis will be performed to evaluate the potential impact of selected predictors on primary outcomes. All tests will be carried out at a significance level of 0.05.
Sample size calculation and statistical analysis
        The performed power analysis (power of 80%, significance level of 5%, two-sided) estimated a required sample size of a total of 80 patients (40 patients in each group). The analysis was based on the results of a previous report comparing FGM with SMBG and estimation to detect a difference in the percentage of results in the target glycaemic range between study and control groups.21 Sample size is further increased to 100 patients to account for a potential exclusions and drop out of approximately 10%.
        Continuous data will be compared using the Mann-Whitney U test, and for categorical variables the Ï2 test will be applied. The results will be presented as medians and IQRs or as a frequency (%). For comparison between groups, Bland Altman and Passing-Bablok method will be performed. The relationship between glucose, HbA1c and fructosamine concentrations, and selected maternalâfetal parameters will be examined with the use of Pearsonâs correlation coefficient. Multivariable logistic regression analysis will be performed to evaluate the potential impact of selected predictors on primary outcomes. All tests will be carried out at a significance level of 0.05.
        Statistical analyses will be performed using SAS software, V.9.2 or later (SAS Institute).