Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04666818 |
| Other study ID # |
FlashMomStudy |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
November 26, 2020 |
| Est. completion date |
November 26, 2020 |
Study information
| Verified date |
December 2020 |
| Source |
University of Catania |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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%).
