NCT04666818: FlashMom

Efficacy of FGM in Pregestational Diabetes

Completed Last updated 14 December 2020

What this trial tests

trial testing Use of Flash Glucose Monitoring in Diabetes Mellitus in Pregnancy in 40 participants. Completed in 26 November 2020.

Timeline

26 November 2020

Primary endpoint
26 November 2020

26 November 2020

Quick facts

Lead sponsor	University of Catania
Status	Completed
Study type	OBSERVATIONAL
Enrollment	40
Start date	26 November 2020
Primary completion	26 November 2020
Estimated completion	26 November 2020
Sites	1 location across Italy

Drugs / interventions tested

• Use of Flash Glucose Monitoring

Conditions studied

• Diabetes Mellitus in Pregnancy — all drugs for Diabetes Mellitus in Pregnancy →

Sponsor

University of Catania

Who can join

18 and older, female only, with Diabetes Mellitus in Pregnancy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetes is the most common metabolic disease complicating pregnancy, and the number of women in childbearing age facing this problem is rising worldwide. The clinical and social significance of pre-gestational diabetes has become an important issue in the area of public health because this disease can cause maternal complications and influence the development of the offspring during the pregnancy and later in life. Pregnancy in women with pregestational diabetes is indeed associated with adverse perinatal outcomes including large-for gestational- age infants (ranging from 48.8 to 62.5%), preterm delivery, and other perinatal complications. Large-for-gestational-age infants to mothers with diabetes are at increased risk for birth trauma, transient tachypnea, and neonatal hypoglycemia. For all these reasons, the medical costs and social burdens caused by this disease are problematic. The mainstay of managing diabetes during pregnancy is glucose monitoring. Conventionally, glucose monitoring is by self-monitoring of blood glucose (SMBG) involving multiple pricks to the patients. The limitations of these pricks include pain and a point-in-time assessment without evaluation of the complete glycemic profile before making therapeutic adjustments.

Introduction of continuous glucose monitoring (CGM) by measuring interstitial fluid glucose has overcome the deficits in SMBG by providing an overview of the glycemic profiles in patients. In most recent years another promising tool became available: the Flash Glucose Monitoring (FGM) system. Unlike traditional sensor systems, its wired enzyme sensor is calibrated in the factory and therefore requires no user calibrations (fingerstick blood glucose measurements) during the 14 days of wear. Recent studies demonstrated that FGM is effective in reducing glucose fluctuations and preventing hypoglycemic events in Type 1 and Type 2 diabetic patients. No evidence is to date available on the efficacy of FGM on the reduction of the perinatal adverse outcomes during pregnancy in women with pre-gestational diabetes.

The investigators propose to randomize a group of women with poorly controlled pregestational diabetes to receive SMBG (standard antenatal care) or FGM plus SMBG during pregnancy.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Efficacy of flash glucose monitoring in pregnant women with poorly controlled pregestational diabetes (FlashMom): A randomized pilot study.
   Tumminia A, Milluzzo A, Festa C, Fresa R, et al · · 2021 · cited 16× · PMID 33975741 · DOI 10.1016/j.numecd.2021.03.013