Efficacy of FGM in Pregestational Diabetes

NCT04666818 | Completed FDA Device

• 1 other identifier: FlashMomStudy
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus in Pregnancy

Keywords

Flash glucose monitoring; Pregestational diabetes; Glucose control; HbA1c; Glycemic variability; Adverse pregnancy outcomes

Outcome Measures

Primary Outcomes (5)

• Glycosylated Hemoglobin (HbA1c) concentration in blood samples

  To compare the efficacy of FGM on HbA1c reduction during pregnancy

  38 weeks

• coefficient of variation (CV): Adimensional coefficient calculated as the Standard Deviation divided by the mean of all glucose values expressed

  To compare the efficacy of FGM on glucose CV reduction during pregnancy

  33 weeks

• Mean amplitude of glycemic excursions (MAGE)= Adimensional coefficient calculated mean amplitude of glycemic excursions

  o compare the efficacy of FGM on MAGE reduction during pregnancy

  33 weeks

• Continuous overlapping net glycemic action (CONGA)= Adimensional coefficient calculated at 1 hour time interval

  To compare the efficacy of FGM on CONGA reduction during pregnancy

  33 weeks

• MODD= Adimensional coefficient calculated as mean of the daily serum glucose difference.

  To compare the efficacy of FGM on MODD reduction during pregnancy

  33 weeks

Secondary Outcomes (5)

• Macrosomia: Birth weight above 4000 grams regardless gestational age

  At birth

• Large for Gestational Age (LGA)= weight at birth above the 90th percentile for gestational age

  At birth

• Neonatal Hypoglycemia= plasma glucose level of less than 36 mg/dl

  At birth

• Premature delivery: <37 weeks of gestation

  At birth

• Cesarean section

  At delivery

Study Arms (2)

Self Monitoring Blood Glucose (SMBG)

Women used self-monitoring of blood glucose= Control group (CG)

Flash Glucose Monitoring (FGM)

Women used flash glucose monitoring= FGM group (FG)

Device: Use of Flash Glucose Monitoring

Interventions

Use of Flash Glucose Monitoring DEVICE

Participants in the intervention group were advised to monitor glucose levels by means of flash glucose system.

Flash Glucose Monitoring (FGM)

Eligibility Criteria

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

Study Population

The investigators carried out a multicenter randomized pilot trial by prospectively recruiting poorly controlled (peri-conception HbA1c \>6.5%) pregestational T1D or T2D outpatients in 5 Italian Diabetes Medical Centers. Enrolling Centers were selected on the basis of the experience in following women with pregestational diabetes and on the presence of the neonatal intensive care unit. Randomization was electronically generated at the first pregnancy visit according to a predefined randomization sequence. Women were assigned to either the control group (CG, using the standard SMBG at least 6 times daily) or Flash group (FG, using the FGM system continuously throughout gestation) in a 1:1 ratio.

You may qualify if:

• Pregnant women with pregestational diabetes
• HbA1c \>6.5%

You may not qualify if:

• Gestational Diabetes
• HbA1c \<6.5%

Sponsors & Collaborators

• University of Catania: lead

Study Sites (1)

University of Catania, Endocrinology Section, Garibaldi-Nesima Hospital

Catania, 95122, Italy

Location

Related Publications (1)

• Tumminia A, Milluzzo A, Festa C, Fresa R, Pintaudi B, Scavini M, Vitacolonna E, Napoli A, Sciacca L. Efficacy of flash glucose monitoring in pregnant women with poorly controlled pregestational diabetes (FlashMom): A randomized pilot study. Nutr Metab Cardiovasc Dis. 2021 Jun 7;31(6):1851-1859. doi: 10.1016/j.numecd.2021.03.013. Epub 2021 Mar 24.

  PMID: 33975741 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

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

Study Officials

• Laura Laura, MD, PhD

  University of Catania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 26, 2020
• First Posted: December 14, 2020
• Study Start: November 26, 2020
• Primary Completion: November 26, 2020
• Study Completion: November 26, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)