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Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial (CONCEPTT)

This study has been completed.
Sponsor:
Collaborators:
Sunnybrook Research Institute
Jaeb Center for Health Research
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01788527
First received: December 19, 2012
Last updated: July 14, 2017
Last verified: July 2017
December 19, 2012
July 14, 2017
March 2013
March 2016   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01788527 on ClinicalTrials.gov Archive Site
  • Time in target in pre-pregnant group [ Time Frame: 12 and 24 weeks after randomization ]
    Time in target at 12 and 24 weeks after randomization
  • HbA1c and time in target, in pre-pregnant group who became pregnant within 24 weeks from randomization [ Time Frame: 24 weeks and 34 weeks gestation ]
    HbA1c and Time in target at post-confirmation of a positive pregnancy test, 24 weeks and 34 weeks gestation for those who start pre-pregnant and become pregnant
  • Time in target in pregnant group [ Time Frame: Randomization, 24 weeks and 34 weeks gestation ]
    Time in target at randomization, 24 weeks and 34 weeks gestation
  • HbA1c measurement in pregnant group [ Time Frame: 24 weeks and 34 weeks gestation ]
    HbA1c at randomization, 24 weeks and 34 weeks gestation
  • Hypertension in pregnant group [ Time Frame: Up to 42 weeks gestation ]
    Incidence of worsening chronic hypertension, gestational hypertension, preeclampsia; total and individual measures
  • Caesarean sections in pregnant group [ Time Frame: At delivery ]
    Caesarean section: primary and total
  • Gestational weight gain in pregnant group [ Time Frame: Up to 34 weeks gestation ]
    Entry to 34 weeks gestation; 16 weeks to 34 weeks gestation
  • 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 delivery ]
    Mean amplitude of glycemic excursions (MAGE); Coefficient of Variation (CV); Standard deviation (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
  • Infant Outcomes [ Time Frame: At birth of infant ]
    Infant birthweight >90th centile using customized growth curves; infant birthweight <10th centile using customized 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 with intravenous dextrose
  • 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 > 24 hrs
  • 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 of life), birth injury, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome requiring therapy, NICU admission >24 hours
  • Infant Outcomes [ Time Frame: Within first 3 days of life ]
    Sum of skinfolds >90th percentile for gestational age
  • Infant Outcomes [ Time Frame: Within first 3 days of life ]
    Other anthropometric measures
  • Infant Outcomes [ Time Frame: Until hospital discharge ]
    Length of hospital stay
  • Insulin requirements [ Time Frame: Pre-pregnant (randomization, 12 weeks, 24 weeks); Pregnant (randomization, 24 weeks and 34 weeks gestation) ]
    Units per kg per day
  • Questionnaires [ Time Frame: Baseline and 24 weeks or at confirmed pregnancy (pre-pregnant); Baseline and 34 weeks (pregnant) ]
    BGMSRQ, HFS, PAID, SF12, CGM-SAT; NWTSQ
  • Study Contacts [ Time Frame: Up to delivery ]
    Scheduled and unscheduled visits
  • 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 of life), birth injury, neonatal hypoglycemia, hyperbilirubinemia, respiratory distress syndrome requiring therapy, NICU admission >24 hours
  • Infant Outcomes [ Time Frame: Within first 3 days of life ]
    Sum of skinfolds >90th percentile for gestational age
  • Infant Outcomes [ Time Frame: Within first 3 days of life ]
    Other anthropometric measures
  • Infant Outcomes [ Time Frame: Until hospital discharge ]
    Length of hospital stay
Not Provided
Not Provided
 
Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Type 1 Diabetics Who Are Pregnant or Planning Pregnancy
Device: CGM
Real Time Continuous Glucose Monitoring
  • Experimental: CGM
    Continuous Glucose Monitoring
    Intervention: Device: CGM
  • No Intervention: HGM
    Standard of care, Home Glucose Monitoring
Feig DS, Asztalos E, Corcoy R, De Leiva A, Donovan L, Hod M, Jovanovic L, Keely E, Kollman C, McManus R, Murphy K, Ruedy K, Sanchez JJ, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol. BMC Pregnancy Childbirth. 2016 Jul 18;16(1):167. doi: 10.1186/s12884-016-0961-5. Erratum in: BMC Pregnancy Childbirth. 2016;16:249.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
325
March 2016
March 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
  • Age 18-40 years
  • Insulin regimen involves either the use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day). Subjects using premixed fixed doses of insulin at the time of enrolment will not be eligible. Insulin regimen must be stable for at least 4 weeks (i.e. on multiple insulin injections or on insulin pump) prior to randomization.
  • No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center
  • Informed Consent Form signed by the subject

In addition, specific eligibility criteria apply to the respective groups:

Pre-pregnancy Group:

  • Patients who are planning pregnancy and wish to optimise glycemic control before conception

Pregnancy Group:

  • Pregnancy gestation ≤13 weeks, 6 days at time of randomization
  • Live singleton fetus
  • Dating ultrasound (US) done to confirm gestational age, viability and rule out multiples. Gestational age will be based on the last menstrual period (LMP) provided there is a ≤5 day discrepancy with US dates in the first trimester and ≤10 day discrepancy with US dates in the second trimester. If the dates from LMP are outside these limits, the US dates will be used as the best estimate of gestational age.

Exclusion Criteria:

  • Type 2 diabetes
  • Gestational diabetes
  • Previous participation in the study
  • Estimated GFR <60 ml/min/1.73
  • The presence of a significant medical disorder or use of a medication such as oral glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.

If the investigator is uncertain whether the patient would be eligible; i.e. if the medical disorder would constitute an exclusion, the Steering Committee will be asked to make the decision.

  • Inpatient psychiatric treatment in the past 6 months
  • Subjects using premixed fixed doses of insulin at the time of enrolment

In addition, specific exclusion criteria apply to the respective groups:

Pre-pregnancy Group:

  • HbA1c <7.0% or >10.0%

Pregnancy Group:

  • HbA1c <6.5% or >10.0%
  • Known current higher order pregnancies (twins, triplets, etc.) These women will be excluded as they have a higher rate of adverse outcomes and could lead to inequalities if they are unequally distributed between the groups.
  • Known potentially major fetal anomaly (as per EUROCAT criteria).
Sexes Eligible for Study: Female
18 Years to 40 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Ireland,   Italy,   Spain,   United Kingdom,   United States
Israel
 
NCT01788527
12-0037-A
Yes
Not Provided
Not Provided
Mount Sinai Hospital, Canada
Mount Sinai Hospital, Canada
  • Sunnybrook Research Institute
  • Jaeb Center for Health Research
  • Cambridge University Hospitals NHS Foundation Trust
  • University of Cambridge
Principal Investigator: Denice Feig, MD Mount Sinai Hospital, New York
Principal Investigator: Helen Murphy, MB BCh BAO FRACP MD Cambridge University Hospital NHS Foundation Trust and University of Cambridge
Mount Sinai Hospital, Canada
July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP