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NCT Number: NCT04422821

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

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.

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Key information

Conditions

Gestational Diabetes Mellitus Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Warsaw, Starynkiewicza Sq. 1/3, 02-015, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flash Glucose Monitoring

Device

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.

Other names: FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)

Self-monitoring of blood glucose

Device

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.

Other names: iXell®; Genexo sp; Warsaw, Poland

Primary outcomes

  1. Mean glycemia results (fasting and 1-h postprandial glucose concentrations)

    Time frame: 28 days after the recruitment visit

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

Secondary outcomes

  1. Number of patients requiring insulin therapy

    Time frame: 2, 4 and 8 weeks after the recruitment visit

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

  2. Long-term glycemic control using blood HbA1c serum concentration

    Time frame: 4 and 8 weeks after the recruitment visit

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

  3. Number of hypoglycemia episodes (glucose concentration <70 mg/dl) during one month analysis

    Time frame: 0-4 weeks after the recruitment visit

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

  4. Physical activity during one month analysis

    Time frame: 0-4 weeks after the recruitment visit

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

  5. Compliance with diet recommendations

    Time frame: 2, 4 and 8 weeks after the recruitment visit

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

  6. Gestational weight gain

    Time frame: 2, 4 and 8 weeks after the recruitment visit

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

  7. Mode of delivery (rate of vaginal delivery/ Cesarean section)

    Time frame: 24-72 hours after the delivery

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

  8. Fetal birth-weight

    Time frame: 24-72 hours after the delivery

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

  9. Neonatal glycemia

    Time frame: 24-72 hours after the delivery

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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Acronym: FLAMINGO

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 9, 2020
Registry last updated
Dec 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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