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

Gestational Diabetes Mellitus Clinical Trial

— FLAMINGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04422821
• Other study ID #: 931156
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: November 10, 2022

Study information

• Verified date: December 2022
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 10, 2022
• Est. primary completion date: October 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus

Intervention

Device:
• Flash Glucose Monitoring
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.
• Self-Monitoring of Blood Glucose
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.

Locations

Country	Name	City	State
Poland	1st Department of Obstetrics and Gynecology, Medical University of Warsaw	Warsaw	Starynkiewicza Sq. 1/3

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (4)

Bolinder J, Antuna R, Geelhoed-Duijvestijn P, Kroger J, Weitgasser R. Novel glucose-sensing technology and hypoglycaemia in type 1 diabetes: a multicentre, non-masked, randomised controlled trial. Lancet. 2016 Nov 5;388(10057):2254-2263. doi: 10.1016/S0140-6736(16)31535-5. Epub 2016 Sep 12. — View Citation

Dunn TC, Xu Y, Hayter G, Ajjan RA. Real-world flash glucose monitoring patterns and associations between self-monitoring frequency and glycaemic measures: A European analysis of over 60 million glucose tests. Diabetes Res Clin Pract. 2018 Mar;137:37-46. doi: 10.1016/j.diabres.2017.12.015. Epub 2017 Dec 24. — View Citation

Mancini G, Berioli MG, Santi E, Rogari F, Toni G, Tascini G, Crispoldi R, Ceccarini G, Esposito S. Flash Glucose Monitoring: A Review of the Literature with a Special Focus on Type 1 Diabetes. Nutrients. 2018 Jul 29;10(8):992. doi: 10.3390/nu10080992. — View Citation

Scott EM, Bilous RW, Kautzky-Willer A. Accuracy, User Acceptability, and Safety Evaluation for the FreeStyle Libre Flash Glucose Monitoring System When Used by Pregnant Women with Diabetes. Diabetes Technol Ther. 2018 Mar;20(3):180-188. doi: 10.1089/dia.2017.0386. Epub 2018 Feb 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fetal birth-weight	Fetal birth-weight in each group will by analyzed at the fifth follow-up visit.	24-72 hours after the delivery
Secondary	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