Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04422821
Study type Interventional
Source Medical University of Warsaw
Contact
Status Completed
Phase N/A
Start date September 1, 2020
Completion date November 10, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT06099574 - A Study on the Oral Health Status of Pregnant Women With Gestational Diabetes and Its Correlation With Oral Flora
Completed NCT02744300 - Balance After Baby Intervention for Women With Recent Gestational Diabetes N/A
Completed NCT02890693 - Improving Cardio-metabolic and Mental Health in Women With Gestational Diabetes Mellitus and Their Offspring N/A
Completed NCT02436551 - Gestational Diabetes in Central Asia: Prevalence and Management
Completed NCT02384226 - User Testing and Feedback for a Mobile Health Program for Postpartum Women: A Pilot Study
Recruiting NCT02275845 - Medico-GDM Trial - Metformine to Prevent Gestational Diabetes Mellitus Phase 3
Recruiting NCT04621396 - The Next Generation Longitudinal Birth Cohort Diabetes Study
Completed NCT01916694 - Trial of Remote Evaluation and Treatment of Gestational Diabetes Mellitus N/A
Completed NCT01931280 - A Transgenerational e-Intervention for Gestational Diabetics and Their Offspring N/A
Not yet recruiting NCT01637727 - Long Term Effects of Gestational Diabetes Mellitus in a Population of Parous Women N/A
Completed NCT01565564 - Randomized Translational Study to Examine the Effects of Shared Care in Management of Gestational Diabetes N/A
Recruiting NCT00550979 - Gestational Diabetes Mellitus and Implications for Cardiovascular Disease Risk N/A
Completed NCT00460018 - Diet, Exercise, and Breastfeeding Intervention Program for Women With Gestational Diabetes (DEBI Trial) Phase 2
Not yet recruiting NCT04915716 - Effect of Fasting Time Before Cesarean Section on Neonatal Blood Glucose in Pregnant Women With Gestational Diabetes Mellitus
Recruiting NCT04369313 - Effect of DCC on Neonatal Jaundice and Blood Gas Analysis in Infants Born to GDM Mothers N/A
Recruiting NCT05348863 - SPARK- a Digital Platform to Improve Self-management of Gestational Diabetes N/A
Recruiting NCT04272840 - The Impact of Glycemic Index Education on Lowering Dietary GI in Gestational Diabetes Mellitus N/A
Completed NCT02588729 - A Mobile Smartphone Application to Promote a Healthy Diet and Physical Activity Among Pregnant Women With GDM - RCT N/A
Completed NCT01922791 - Nutrition and Pregnancy Intervention Study N/A
Completed NCT01589757 - MAIN STUDY: Low Glycaemic Index (GI) Diet in the Management of GDM SUB-STUDY: The Breast Milk Sub-Study Phase 2/Phase 3