Gestational DiabetesNCT01883622
Glucose Variability in Pregnancy Complicated by Diabetes
An observational study of Gestational Diabetes and Continuous Glucose Monitoring, run by University of Padova at 3 sites in Italy.
Trial summary
Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are available on glucose variability (GV) in pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Continuous Glucose Monitoring, Glycemic Variability
- How many people
- 50 participants
- Where
- 3 sitesItaly
- Study dates
- Jan 2004to Mar 2005
- 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Outpatient pregnant women enrolled at three Italian diabetes clinics (Padua, Pisa and Florence)
Who may be able to join
- diagnosis of type 1 diabetes or GDM
- able to become familiar with glucose monitoring methodologies
Who cannot join
- type 2 diabetes
- pre-gestational BMI > 35 Kg/m2
- HbA1c > 8% for type 1 diabetic pregnant women
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Department of Gynecology, Perinatology and Human Reproduction, University of Florence
Florence
Department of Medicine, University of Padua
Padova
Department of Endocrinology and Metabolic Diseases, University of Pisa
Pisa
About this study
Official title: Glucose Fluctuations During Gestation: an Additional Tool for a Better Monitoring of Pregnancy Complicated by Diabetes
Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV in normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (GDM), and its possible association with HbA1c.
Read the detailed description
Recent evidence in the literature suggests that glucose variability, characterized by extreme glucose excursions, may overlap with HbA1c levels in determining the risk of diabetes-related complications. Fluctuating blood glucose levels prompt an increase in free radicals and endothelial dysfunction, which are the links between hyperglycemia and the activation of pathological pathways that lead to tissue damage. Reece and Homko postulated an association between maternal hyperglycemia-induced oxygen free radical overproduction and fetal abnormalities, with the onset of diabetes-related embryopathy.Numerous studies have demonstrated that macrosomia and congenital malformations relate to glycemic control. In one study, 48-hour continuous glucose monitoring (CGM) of diurnal glucose profiles in pregnant women with type 1 diabetes was more sensitive than HbA1c alone in identifying an increased risk of offspring with congenital malformations. Such studies give the impression that transient hyperglycemic spikes in pregnant patients with diabetes can cause a high incidence of fetal overweight, regardless of whether or not the mother has chronic hyperglycemia. Glucose variability is still a factor that has been inadequately studied in pregnancies complicated by diabetes, and little is known about its relationship with maternal-fetal outcomes.A number of studies have demonstrated the utility of CGM for monitoring diabetes in pregnancy , but none have focused the attention on the importance of glucose fluctuations during gestation. Meanwhile, there has been a rapid increase in the number of new glucose variability indicators considered, although none of them seems to be definitively reliable.
A better understanding of the pattern of blood glucose fluctuations in all the three trimesters of pregnancy, could help us to optimize glycemic control in pregnant women with diabetes.
The aim of this study was therefore to assess glucose variability throughout the three trimesters of pregnancy in healthy women and in cases of type 1 diabetes mellitus or gestational diabetes, identifying the more representative and useful indicators of glucose fluctuations, to provide more accurate clinical informations along with HbA1c and beyond.
- Keywords
- diabetes, pregnancy, glucose variability, continuous glucose monitoring (CGM), gestational diabetes mellitus (GDM)
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetes | Pregnant women affected by type 1 diabetes mellitus | |
| GDM | Pregnant women affected by gestational diabetes mellitus | |
| Healthy | Healthy pregnant women |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose variability indexes during first, second and third trimester of pregnancy
Patients wore underwent continuous glucose monitoring for 2 days in each trimester of pregnancy. As indexes of glucose variability we considered: the mean amplitude of glucose excursion (MAGE); the total standard deviation (SD); the interquartile range (IQR); the continuous overlapping net glycemic action (CONGA1), calculated at 1 hour. The low blood glucose index (LBGI) and high blood glucose index (HBGI) were also calculated.
Measured: 9 months
Secondary outcomes (1)
Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJan 2004
- Primary completionMar 2005
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gestational DiabetesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annunziata Lapolla, MD, Study chair, Department of Medicine, University of Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883622
- Sponsor's protocol ID
- GES03
- Status last verified
- Jun 2013
- First submitted
- 18 Jun 2013
- Last updated
- 21 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dalfra MG, Sartore G, Di Cianni G, Mello G, Lencioni C, Ottanelli S, Sposato J, Valgimigli F, Scuffi C, Scalese M, Lapolla A. Glucose variability in diabetic pregnancy. Diabetes Technol Ther. 2011 Aug;13(8):853-9. doi: 10.1089/dia.2010.0145.
PubMed 21751862Kerssen A, de Valk HW, Visser GH. Forty-eight-hour first-trimester glucose profiles in women with type 1 diabetes mellitus: a report of three cases of congenital malformation. Prenat Diagn. 2006 Feb;26(2):123-7. doi: 10.1002/pd.1340.
PubMed 16463292Di Cianni G, Miccoli R, Volpe L, Lencioni C, Del Prato S. Intermediate metabolism in normal pregnancy and in gestational diabetes. Diabetes Metab Res Rev. 2003 Jul-Aug;19(4):259-70. doi: 10.1002/dmrr.390.
PubMed 12879403
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose Fluctuations During Gestation: an Additional Tool for a Better Monitoring of Pregnancy Complicated by Diabetes
- ClinicalTrials.gov ID
- NCT01883622
- Acronym / sponsor ID
- GES03
- Keywords
- diabetes, pregnancy, glucose variability, continuous glucose monitoring (CGM), gestational diabetes mellitus (GDM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of PadovaUniversity, hospital or other
- Study start
- Jan 2004
- Primary completion
- Mar 2005 (actual)
- Study completion
- Mar 2005 (actual)
- First posted
- 21 Jun 2013 (estimated)
- 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.
Continuous glucose monitoring (CGM) methods provide details of magnitude and duration of glucose fluctuations, giving a unique insight on daily blood sugar control. Limited data are available on glucose variability (GV) in pregnancy. The aim of this study was to assess GV in normal pregnant women and cases of type 1 diabetes mellitus or gestational diabetes (GDM), and its possible association with HbA1c.
Detailed description
Recent evidence in the literature suggests that glucose variability, characterized by extreme glucose excursions, may overlap with HbA1c levels in determining the risk of diabetes-related complications. Fluctuating blood glucose levels prompt an increase in free radicals and endothelial dysfunction, which are the links between hyperglycemia and the activation of pathological pathways that lead to tissue damage. Reece and Homko postulated an association between maternal hyperglycemia-induced oxygen free radical overproduction and fetal abnormalities, with the onset of diabetes-related embryopathy.Numerous studies have demonstrated that macrosomia and congenital malformations relate to glycemic control. In one study, 48-hour continuous glucose monitoring (CGM) of diurnal glucose profiles in pregnant women with type 1 diabetes was more sensitive than HbA1c alone in identifying an increased risk of offspring with congenital malformations. Such studies give the impression that transient hyperglycemic spikes in pregnant patients with diabetes can cause a high incidence of fetal overweight, regardless of whether or not the mother has chronic hyperglycemia. Glucose variability is still a factor that has been inadequately studied in pregnancies complicated by diabetes, and little is known about its relationship with maternal-fetal outcomes.A number of studies have demonstrated the utility of CGM for monitoring diabetes in pregnancy , but none have focused the attention on the importance of glucose fluctuations during gestation. Meanwhile, there has been a rapid increase in the number of new glucose variability indicators considered, although none of them seems to be definitively reliable.
A better understanding of the pattern of blood glucose fluctuations in all the three trimesters of pregnancy, could help us to optimize glycemic control in pregnant women with diabetes.
The aim of this study was therefore to assess glucose variability throughout the three trimesters of pregnancy in healthy women and in cases of type 1 diabetes mellitus or gestational diabetes, identifying the more representative and useful indicators of glucose fluctuations, to provide more accurate clinical informations along with HbA1c and beyond.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetes | – | –Pregnant women affected by type 1 diabetes mellitus |
| GDM | – | –Pregnant women affected by gestational diabetes mellitus |
| Healthy | – | –Healthy pregnant women |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Outpatient pregnant women enrolled at three Italian diabetes clinics (Padua, Pisa and Florence)
Key inclusion criteria (2 listed)
- diagnosis of type 1 diabetes or GDM
- able to become familiar with glucose monitoring methodologies
Key exclusion criteria (3 listed)
- type 2 diabetes
- pre-gestational BMI > 35 Kg/m2
- HbA1c > 8% for type 1 diabetic pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glucose variability indexes during first, second and third trimester of pregnancy
Time frame: 9 months
Patients wore underwent continuous glucose monitoring for 2 days in each trimester of pregnancy. As indexes of glucose variability we considered: the mean amplitude of glucose excursion (MAGE); the total standard deviation (SD); the interquartile range (IQR); the continuous overlapping net glycemic action (CONGA1), calculated at 1 hour. The low blood glucose index (LBGI) and high blood glucose index (HBGI) were also calculated.
1 secondary outcome
Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women
Time frame: 9 months
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 21 Jun 2013.
- Background: PubMed 21751862Dalfra MG, Sartore G, Di Cianni G, Mello G, Lencioni C, Ottanelli S, Sposato J, Valgimigli F, Scuffi C, Scalese M, Lapolla A. Glucose variability in diabetic pregnancy. Diabetes Technol Ther. 2011 Aug;13(8):853-9. doi: 10.1089/dia.2010.0145.
- Background: PubMed 16463292Kerssen A, de Valk HW, Visser GH. Forty-eight-hour first-trimester glucose profiles in women with type 1 diabetes mellitus: a report of three cases of congenital malformation. Prenat Diagn. 2006 Feb;26(2):123-7. doi: 10.1002/pd.1340.
- Background: PubMed 12879403Di Cianni G, Miccoli R, Volpe L, Lencioni C, Del Prato S. Intermediate metabolism in normal pregnancy and in gestational diabetes. Diabetes Metab Res Rev. 2003 Jul-Aug;19(4):259-70. doi: 10.1002/dmrr.390.
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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.
Annunziata Lapolla, MD study chair
Department of Medicine, University of Padova
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Continuous Glucose Monitoring, run by University of Padova at 3 sites 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 3 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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Glucose variability indexes during first, second and third trimester of pregnancy (time frame: 9 months). 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 NCT01883622, which also lists 3 linked publications.
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 21 Jun 2013.