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

NCT ID: NCT04422821

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2022-11-10

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.

Conditions

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Gestational Diabetes Mellitus

Keywords

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gestational diabetes mellitus flash glucose monitoring glycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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FreeStyle Libre™

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.

Group Type EXPERIMENTAL

Flash Glucose Monitoring

Intervention Type 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.

iXell®

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.

Group Type ACTIVE_COMPARATOR

Self-Monitoring of Blood Glucose

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Other Intervention Names

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FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) iXell®; Genexo sp; Warsaw, Poland

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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AGATA MAJEWSKA

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mirosław Wielgoś, MD PhD, Prof.

Role: STUDY_DIRECTOR

Medical University of Warsaw

Locations

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

Warsaw, Starynkiewicza Sq. 1/3, Poland

Site Status

Countries

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Poland

References

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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.

Reference Type BACKGROUND
PMID: 29470094 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27634581 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30060632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29278709 (View on PubMed)

Majewska A, Stanirowski PJ, Tatur J, Wojda B, Radosz I, Wielgos M, Bomba-Opon DA. Flash glucose monitoring in gestational diabetes mellitus (FLAMINGO): a randomised controlled trial. Acta Diabetol. 2023 Sep;60(9):1171-1177. doi: 10.1007/s00592-023-02091-2. Epub 2023 May 10.

Reference Type DERIVED
PMID: 37160787 (View on PubMed)

Majewska A, Stanirowski P, Wielgos M, Bomba-Opon D. Flash glucose monitoring in gestational diabetes mellitus: study protocol for a randomised controlled trial. BMJ Open. 2021 Mar 2;11(3):e041486. doi: 10.1136/bmjopen-2020-041486.

Reference Type DERIVED
PMID: 33653744 (View on PubMed)

Other Identifiers

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931156

Identifier Type: -

Identifier Source: org_study_id