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

NCT04422821 | Completed

• 1 other identifier: 931156
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes Mellitus

Keywords

gestational diabetes mellitus; flash glucose monitoring; glycemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of patients requiring insulin therapy

  2, 4 and 8 weeks after the recruitment visit

• Long-term glycemic control using blood HbA1c serum concentration

  4 and 8 weeks after the recruitment visit

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

  0-4 weeks after the recruitment visit

• Physical activity during one month analysis

  0-4 weeks after the recruitment visit

• Compliance with diet recommendations

  2, 4 and 8 weeks after the recruitment visit

Study Arms (2)

FreeStyle Libre™

EXPERIMENTAL

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.

Device: Flash Glucose Monitoring

iXell®

ACTIVE COMPARATOR

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.

Device: Self-Monitoring of Blood Glucose

Interventions

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.

Also known as: FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA)

FreeStyle Libre™

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.

Also known as: iXell®; Genexo sp; Warsaw, Poland

iXell®

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• singleton pregnancy between 24-28 weeks of gestation
• gestational diabetes mellitus diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

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

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

Location

Related Publications (6)

• 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.

  PMID: 29470094 BACKGROUND

• 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.

  PMID: 27634581 BACKGROUND

• 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.

  PMID: 30060632 BACKGROUND

• 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.

  PMID: 29278709 BACKGROUND

• 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.

  PMID: 37160787 DERIVED

• 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.

  PMID: 33653744 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Glucose Self-Monitoring

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Mirosław Wielgoś, MD PhD, Prof.

  Medical University of Warsaw

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 31, 2020
• First Posted: June 9, 2020
• Study Start: September 1, 2020
• Primary Completion: October 31, 2022
• Study Completion: November 10, 2022
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: The deidentified participant data will become available upon publishing the protocol and results of the study. Study protocol will be available immediately following publication.
• Access Criteria: The data will be provided on reasonable request for anyone after methodologically sound proposal (contact details: amajewska2@wum.edu.pl).

Locations

PL (1)