Clinical Trial: Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial

Brief Summary: The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose Monitoring) can improve glycemic control in women with T1D who are pregnant or planning pregnancy without substantially increasing the rate of hypoglycemia.

Detailed Summary:

In women with diabetes, hyperglycemia is associated with increased rates of numerous maternal and fetal adverse outcomes. Mothers are at increased risk of preeclampsia, polyhydramnios, and caesarean sections. Infants of mothers with diabetes have increased rates of congenital anomalies, premature delivery, macrosomia, stillbirth and NICU admissions. Macrosomia itself is associated with numerous adverse fetal outcomes including shoulder dystocia, birth injury, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome and NICU admissions, asphyxia and death. Postprandial blood sugars in particular have been associated with increased macrosomia rates.

Numerous studies have shown that pregnancy outcomes can be reduced with improved glycemic control. In particular, pre-pregnancy care has been shown to assist women improve glucose control during the crucial period of organogenesis, and is associated with reduced rates of adverse pregnancy outcome including major congenital malformation, stillbirth and neonatal death.

Technological advances aimed at reducing glycemic excursions and improving glucose control in patients with diabetes include the continuous glucose monitoring (CGM) system. We hypothesize that real-time CGM will assist women with type 1 diabetes to improve their glycemic control before and during pregnancy.


Sponsor: Mount Sinai Hospital, Canada

Current Primary Outcome:

  • Glycemic Control in pre-pregnant group [ Time Frame: 24 weeks or at conception ]
    Glycemic control as measured by HbA1c at 24 weeks or at conception. If the patient becomes pregnant, than a HbA1c will be measured post-confirmation of a positive pregnancy test and will contribute to the primary outcome.
  • Glycemic Control in pregnant group [ Time Frame: 34 weeks gestation ]
    Glycemic control as measured by HbA1c at 34 weeks gestation. In women who do not progress to 34 weeks gestation, the latest measured HbA1c will be used to contribute to the primary outcome.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time in target in pre-pregnant group [ Time Frame: 12 and 24 weeks after enrollment ]
    Time in target at 12 and 24 weeks after enrollment
  • HbA1c and time in target, in pre-pregnant group [ Time Frame: 24 weeks and 34 weeks gestation ]
    HbA1c and Time in target at post-confirmation of a positive pregnancy test, 24 and 34 weeks gestation for those who start pre-pregnant and become pregnant compared to those who start pregnant
  • Time in target in pregnant group [ Time Frame: 12, 24 and 34 weeks ]
    Time in target at 12, 24 and 34 weeks gestation after enrollment
  • HbA1c measurement in pregnant group [ Time Frame: 24 and 34 weeks ]
    HbA1c at entry, 24 and 34 weeks gestation
  • Hypertension in pregnant group [ Time Frame: Up to 42 weeks gestation ]
    Incidence of gestational hypertension/preeclampsia
  • Caesarean sections in pregnant group [ Time Frame: At delivery ]
    Caesarean section: primary and total
  • Weight gain in pregnant group [ Time Frame: Up to 42 weeks gestation ]
    Gestational weight gain
  • AUC [ Time Frame: At delivery ]
    Area under the curve for blood sugars (a) >7.8 mmol/l or 140 mg/dl (b)>6.7 mmol/l or 120 mg/dl (c) <3.5 mmol/L or <63 mg/dl (d) <2.8 mmol/L or <50 mg/dl
  • Incidence of Clinical events [ Time Frame: Up to 42 weeks gestation ]
    Episodes of 'severe hypoglycemia' requiring assistance; mild-moderate episodes of hypoglycemia <3.5 (mild) and <2.8 (moderate) from CGM data defined as AUC <3.5 or AUC less than or equal to 2.8 for 20 minutes duration; nocturnal hypoglycemia (NH) defined as CGM glucose <3.5 (mild) and <2.8 (moderate) between the hours of 23.00-07.00
  • Glucose variability [ Time Frame: Up to 42 weeks gestation ]
    Mean amplitude of glycemic excursions (MAGE); SD of CGM measurements; mean absolute rate of change of CGM based on one week of sensor values
  • Hospital stay [ Time Frame: Admission until hospital discharge ]
    Length of hospital stay
  • Safety Outcome [ Time Frame: Up to 42 weeks gestation ]
    A substantial increase in hypoglycemia will be defined as >10% increase in hypoglycemic episodes (<63 mg/dl for at least 20 minutes duration) over and above the control group
  • Infant Outcomes [ Time Frame: At birth of infant ]
    Infant birthweight >90th centile using local national growth curves, infant birthweight >90th centile using customized centiles; infant birthweight >10th centile using national growth curves; infant birthweight >=4kg
  • Infant Outcomes [ Time Frame: =<28 days of life ]
    Pregnancy loss (Miscarriage, stillbirth, neonatal death)
  • Infant Outcomes [ Time Frame: At birth ]
    Preterm delivery (<37 weeks and early preterm <34 weeks)
  • Infant Outcomes [ Time Frame: Until hospital discharge ]
    Birth injury
  • Infant outcomes [ Time Frame: Until hospital discharge ]
    Shoulder dystocia
  • Infant outcomes [ Time Frame: Until hospital discharge ]
    Neonatal hypoglycemia
  • Infant Outcomes [ Time Frame: Within first 7 days of life ]
    Hyperbilirubinemia
  • Infant Outcomes [ Time Frame: Within first 7 days of life ]
    Respiratory Distress Syndrome (RDS)
  • Infant Outcomes [ Time Frame: Until hospital discharge ]
    NICU admission
  • Infant Outcomes [ Time Frame: At birth ]
    Cord blood gas pH <7.0
  • Infant Outcomes [ Time Frame: At birth ]
    Hyperinsulinemia (using Cord C-peptide)
  • Infant Outcomes [ Time Frame: Within first 7 days of life or until hospital discharge (whichever is last) ]
    Composite fetal outcome: pregnancy loss:miscarriage, stillbirth, neonatal death (death<=28 days

    Original Secondary Outcome: Same as current

    Information By: Mount Sinai Hospital, Canada

    Dates:
    Date Received: December 19, 2012
    Date Started: March 2013
    Date Completion:
    Last Updated: November 18, 2016
    Last Verified: November 2016