NCT01883622

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2004

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
8.3 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 21, 2013

Completed
Last Updated

June 21, 2013

Status Verified

June 1, 2013

Enrollment Period

1.2 years

First QC Date

June 18, 2013

Last Update Submit

June 18, 2013

Conditions

Gestational DiabetesContinuous Glucose MonitoringGlycemic Variability

Keywords

diabetespregnancyglucose variabilitycontinuous glucose monitoring (CGM)gestational diabetes mellitus (GDM)

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (1)

  • Association between HbA1c and glucose variability indicators in the three trimesters pf pregnancy, in the three groups of women

    9 months

Study Arms (3)

Type 1 diabetes

Pregnant women affected by type 1 diabetes mellitus

GDM

Pregnant women affected by gestational diabetes mellitus

Healthy

Healthy pregnant women

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Outpatient pregnant women enrolled at three Italian diabetes clinics (Padua, Pisa and Florence)

You may qualify if:

  • diagnosis of type 1 diabetes or GDM
  • able to become familiar with glucose monitoring methodologies

You may not qualify if:

  • type 2 diabetes
  • pre-gestational BMI \> 35 Kg/m2
  • HbA1c \> 8% for type 1 diabetic pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Gynecology, Perinatology and Human Reproduction, University of Florence

Florence, Italy

Location

Department of Medicine, University of Padua

Padua, Italy

Location

Department of Endocrinology and Metabolic Diseases, University of Pisa

Pisa, Italy

Location

Related Publications (3)

  • 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.

    PMID: 21751862BACKGROUND

  • Kerssen 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.

    PMID: 16463292BACKGROUND

  • Di 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.

    PMID: 12879403BACKGROUND

MeSH Terms

Conditions

Diabetes, GestationalDiabetes Mellitus

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Annunziata Lapolla, MD

    Department of Medicine, University of Padova

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 18, 2013

First Posted

June 21, 2013

Study Start

January 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

June 21, 2013

Record last verified: 2013-06

Locations

IT(3)