Diabetes Mellitus in PregnancyFlashMomNCT04666818
Efficacy of FGM in Pregestational Diabetes
An observational study of Diabetes Mellitus in Pregnancy, run by University of Catania at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes Mellitus in Pregnancy
- What is being tested?
- Use of Flash Glucose Monitoring
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 26 Nov 2020to 26 Nov 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Pregnant women with pregestational diabetes
- HbA1c >6.5%
Who cannot join
- Gestational Diabetes
- HbA1c <6.5%
Trial locations and contacts
1 site in 1 country.
Italy1 site
University of Catania, Endocrinology Section, Garibaldi-Nesima Hospital
Catania, 95122
About this study
Official title: Efficacy of Flash Glucose Monitoring in Pregnant Women With Poorly Controlled Pregestational Diabetes (FlashMom): A Randomized Pilot Study
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.
Read the 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%).
- Conditions
- Diabetes Mellitus in Pregnancy
- Being tested
- Use of Flash Glucose Monitoring
- Keywords
- Flash glucose monitoring, Pregestational diabetes, Glucose control, HbA1c, Glycemic variability, Adverse pregnancy outcomes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Flash Glucose MonitoringDevice
Participants in the intervention group were advised to monitor glucose levels by means of flash glucose system.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Use of Flash Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycosylated Hemoglobin (HbA1c) concentration in blood samples
To compare the efficacy of FGM on HbA1c reduction during pregnancy
Measured: 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
Measured: 33 weeks
Mean amplitude of glycemic excursions (MAGE)= Adimensional coefficient calculated mean amplitude of glycemic excursions
- compare the efficacy of FGM on MAGE reduction during pregnancy
Measured: 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
Measured: 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
Measured: 33 weeks
Secondary outcomes (5)
Macrosomia: Birth weight above 4000 grams regardless gestational age
Rate of macrosomic newborn
Measured: At birth
Large for Gestational Age (LGA)= weight at birth above the 90th percentile for gestational age
Rate of LGA newborn
Measured: At birth
Neonatal Hypoglycemia= plasma glucose level of less than 36 mg/dl
Rate of neonatal hypoglycemia
Measured: At birth
Premature delivery: <37 weeks of gestation
Rate of premature delivery
Measured: At birth
Cesarean section
Rate of Cesarean section
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2020
- Study start26 Nov 2020
- Primary completion26 Nov 2020
- Study completion26 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Sciacca, University of Catania
- Investigators
- Laura Laura, MD, PhD, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04666818
- Sponsor's protocol ID
- FlashMomStudy
- Acronym
- FlashMom
- Status last verified
- Dec 2020
- First submitted
- 26 Nov 2020
- Last updated
- 14 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 33975741
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flash Glucose Monitoring in Pregnant Women With Poorly Controlled Pregestational Diabetes (FlashMom): A Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT04666818
- Acronym / sponsor ID
- FlashMom / FlashMomStudy
- Conditions
- Diabetes Mellitus in Pregnancy
- Keywords
- Flash glucose monitoring, Pregestational diabetes, Glucose control, HbA1c, Glycemic variability, Adverse pregnancy outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Study start
- 26 Nov 2020 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 26 Nov 2020 (actual)
- First posted
- 14 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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%).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self Monitoring Blood Glucose (SMBG) | – | –Women used self-monitoring of blood glucose= Control group (CG) |
| Flash Glucose Monitoring (FGM) | – | Device: Use of Flash Glucose MonitoringWomen used flash glucose monitoring= FGM group (FG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Pregnant women with pregestational diabetes
- HbA1c >6.5%
Key exclusion criteria (2 listed)
- Gestational Diabetes
- HbA1c <6.5%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Flash Glucose MonitoringParticipants in the intervention group were advised to monitor glucose levels by means of flash glucose system. | Device | Flash Glucose Monitoring (FGM) |
Primary outcome
Glycosylated Hemoglobin (HbA1c) concentration in blood samples
Time frame: 38 weeks
To compare the efficacy of FGM on HbA1c reduction during pregnancy
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
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
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
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
5 secondary outcomes
Macrosomia: Birth weight above 4000 grams regardless gestational age
Time frame: At birth
Large for Gestational Age (LGA)= weight at birth above the 90th percentile for gestational age
Time frame: At birth
Neonatal Hypoglycemia= plasma glucose level of less than 36 mg/dl
Time frame: At birth
Premature delivery: <37 weeks of gestation
Time frame: At birth
Cesarean section
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2020.
- Derived from this study: PubMed 33975741Tumminia 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura Laura, MD, PhD principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus in Pregnancy, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycosylated Hemoglobin (HbA1c) concentration in blood samples (time frame: 38 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04666818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2020.