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Efficacy of FGM in Pregestational Diabetes (FlashMom)

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ClinicalTrials.gov Identifier: NCT04666818
Recruitment Status : Completed
First Posted : December 14, 2020
Last Update Posted : December 14, 2020
Sponsor:
Information provided by (Responsible Party):
Laura Sciacca, University of Catania

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.


Condition or disease Intervention/treatment
Diabetes Mellitus in Pregnancy Device: Use of Flash Glucose Monitoring

Detailed Description:

Specific Aims Aim 1: To compare the glycemic control and glucose variability during pregnancy and at first postpartum visit in the two randomized groups. This was accomplished by the evaluation of the mean glycated hemoglobin (HbA1c) levels and of several glucose variability indices during gestation and 1 month after delivery. Hypothesis: the real-time information provided by the FGM system improves glucose control and glycemic excursions during pregnancy and after delivery.

Aim 2: To compare the maternal and neonatal adverse outcomes in the two randomized groups at the time of delivery. This was accomplished by the evaluation of the rate of all the most important maternal and fetal-neonatal adverse outcomes (e.g. cesarean section, macrosomia, neonatal hypoglycemia) at the end of gestation. Hypothesis: the use of FGM reduces the rates of those adverse pregnancy outcomes related to maternal hyperglycemia.

Significance and Background Pre-gestational diabetes is still associated with adverse perinatal outcomes largely attributed to maternal hyperglycemia. The risk of adverse outcomes increases with HbA1c higher than 6-6.5% during gestation. Conversely, mean HbA1c levels <6% during the second and third trimester are associated with better outcomes and with the lowest risk of large-forgestational-age infants. Unfortunately, this goal is often difficult to achieve during pregnancy considering that approximately 60% of all pre-gestational diabetic women are poorly controlled at the time of conception and that maternal hypoglycemia should be avoided. Fasting and post-prandial SMBG are recommended in pre-gestational diabetic women to achieve glycemic control during gestation. Additional useful information on direction, frequency and duration of glycemic oscillations could be provided by the CGM. This system, in fact, allows the patients to prevent hypoglycemia and to reduce glucose oscillations measuring interstitial glucose levels continuously. Despite initial controversial results on the efficacy of the CGM technology during pregnancy, a recently published trial demonstrated that Real-Time use of CGM is associated with improved neonatal outcomes (which are likely to be attributed to reduced exposure to maternal hyperglycemia).

Unfortunately the existing CGM devices still need to be frequently calibrated, using a minimum of 2-5 daily monitored capillary blood glucose. The recent introduction of FGM using the factory-calibrated meter has emerged as a novel method to study glycemic patterns. FGM does not require finger prick calibration. The data are extrapolated using the inbuilt software to summarize the glycemic variability over 2 weeks. The glucose profile obtained using this system is called Ambulatory Glucose Profile (AGP). The usefulness of AGP has been studied in adults and pediatric patients affected by diabetes.

Nevertheless, to date there are no studies looking into the efficacy of this tool in women affected by pre-gestational (Type 1 and Type 2) diabetes during pregnancy. The investigators aim to evaluate the effectiveness of antenatal FGM on maternal glycemic control and pregnancy related morbidity in the offspring of mothers with poorly controlled Type 1 and Type 2 diabetes at the time of conception (peri-conception HbA1c ≥6.5%).

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Efficacy of Flash Glucose Monitoring in Pregnant Women With Poorly Controlled Pregestational Diabetes (FlashMom): A Randomized Pilot Study
Actual Study Start Date : November 26, 2020
Actual Primary Completion Date : November 26, 2020
Actual Study Completion Date : November 26, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Group/Cohort Intervention/treatment
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
Participants in the intervention group were advised to monitor glucose levels by means of flash glucose system.




Primary Outcome Measures :
  1. Glycosylated Hemoglobin (HbA1c) concentration in blood samples [ Time Frame: 38 weeks ]
    To compare the efficacy of FGM on HbA1c reduction during pregnancy

  2. coefficient of variation (CV): Adimensional coefficient calculated as the Standard Deviation divided by the mean of all glucose values expressed [ Time Frame: 33 weeks ]
    To compare the efficacy of FGM on glucose CV reduction during pregnancy

  3. Mean amplitude of glycemic excursions (MAGE)= Adimensional coefficient calculated mean amplitude of glycemic excursions [ Time Frame: 33 weeks ]
    o compare the efficacy of FGM on MAGE reduction during pregnancy

  4. Continuous overlapping net glycemic action (CONGA)= Adimensional coefficient calculated at 1 hour time interval [ Time Frame: 33 weeks ]
    To compare the efficacy of FGM on CONGA reduction during pregnancy

  5. MODD= Adimensional coefficient calculated as mean of the daily serum glucose difference. [ Time Frame: 33 weeks ]
    To compare the efficacy of FGM on MODD reduction during pregnancy


Secondary Outcome Measures :
  1. Macrosomia: Birth weight above 4000 grams regardless gestational age [ Time Frame: At birth ]
    Rate of macrosomic newborn

  2. Large for Gestational Age (LGA)= weight at birth above the 90th percentile for gestational age [ Time Frame: At birth ]
    Rate of LGA newborn

  3. Neonatal Hypoglycemia= plasma glucose level of less than 36 mg/dl [ Time Frame: At birth ]
    Rate of neonatal hypoglycemia

  4. Premature delivery: <37 weeks of gestation [ Time Frame: At birth ]
    Rate of premature delivery

  5. Cesarean section [ Time Frame: At delivery ]
    Rate of Cesarean section



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Pregnant women with pregestational diabetes
  • HbA1c >6.5%

Exclusion Criteria

  • Gestational Diabetes
  • HbA1c <6.5%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04666818


Locations
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Italy
University of Catania, Endocrinology Section, Garibaldi-Nesima Hospital
Catania, Italy, 95122
Sponsors and Collaborators
University of Catania
Investigators
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Principal Investigator: Laura Laura, MD, PhD University of Catania
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Responsible Party: Laura Sciacca, Associate Professor, University of Catania
ClinicalTrials.gov Identifier: NCT04666818    
Other Study ID Numbers: FlashMomStudy
First Posted: December 14, 2020    Key Record Dates
Last Update Posted: December 14, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Laura Sciacca, University of Catania:
Flash glucose monitoring
Pregestational diabetes
Glucose control
HbA1c
Glycemic variability
Adverse pregnancy outcomes
Additional relevant MeSH terms:
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Pregnancy in Diabetics
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications