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

This study is currently recruiting participants.
Verified March 2014 by Mount Sinai Hospital, Canada
Sponsor:
Collaborators:
Sunnybrook Research Institute
Jaeb Center for Health Research
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01788527
First received: December 19, 2012
Last updated: March 20, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetics Who Are Pregnant or Planning Pregnancy
Device: CGM
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial

Resource links provided by NLM:


Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Glycemic Control in pre-pregnant group [ Time Frame: 24 weeks or at conception ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Time in target in pre-pregnant group [ Time Frame: 12 and 24 weeks after enrollment ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Time in target at 12, 24 and 34 weeks gestation after enrollment

  • HbA1c measurement in pregnant group [ Time Frame: 24 and 34 weeks ] [ Designated as safety issue: Yes ]
    HbA1c at entry, 24 and 34 weeks gestation

  • Hypertension in pregnant group [ Time Frame: Up to 42 weeks gestation ] [ Designated as safety issue: Yes ]
    Incidence of gestational hypertension/preeclampsia

  • Caesarean sections in pregnant group [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    Caesarean section: primary and total

  • Weight gain in pregnant group [ Time Frame: Up to 42 weeks gestation ] [ Designated as safety issue: No ]
    Gestational weight gain

  • AUC [ Time Frame: At delivery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Length of hospital stay

  • Safety Outcome [ Time Frame: Up to 42 weeks gestation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Pregnancy loss (Miscarriage, stillbirth, neonatal death)

  • Infant Outcomes [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
    Preterm delivery (<37 weeks and early preterm <34 weeks)

  • Infant Outcomes [ Time Frame: Until hospital discharge ] [ Designated as safety issue: Yes ]
    Birth injury

  • Infant outcomes [ Time Frame: Until hospital discharge ] [ Designated as safety issue: Yes ]
    Shoulder dystocia

  • Infant outcomes [ Time Frame: Until hospital discharge ] [ Designated as safety issue: Yes ]
    Neonatal hypoglycemia

  • Infant Outcomes [ Time Frame: Within first 7 days of life ] [ Designated as safety issue: Yes ]
    Hyperbilirubinemia

  • Infant Outcomes [ Time Frame: Within first 7 days of life ] [ Designated as safety issue: Yes ]
    Respiratory Distress Syndrome (RDS)

  • Infant Outcomes [ Time Frame: Until hospital discharge ] [ Designated as safety issue: Yes ]
    NICU admission

  • Infant Outcomes [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
    Cord blood gas pH <7.0

  • Infant Outcomes [ Time Frame: At birth ] [ Designated as safety issue: Yes ]
    Hyperinsulinemia (using Cord C-peptide)

  • Infant Outcomes [ Time Frame: Within first 7 days of life or until hospital discharge (whichever is last) ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Sum of skinfolds >90th percentile for gestational age

  • Infant Outcomes [ Time Frame: Within first 3 days of life ] [ Designated as safety issue: No ]
    Other anthropometric measures

  • Infant Outcomes [ Time Frame: Until hospital discharge ] [ Designated as safety issue: No ]
    Length of hospital stay


Estimated Enrollment: 324
Study Start Date: March 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CGM
Continuous Glucose Monitoring
Device: CGM
Real Time Continuous Glucose Monitoring
Placebo Comparator: HGM
Standard of care, Home Glucose Monitoring

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  • Regular home user of RT-CGM in the previous 3 months
  • 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01788527

Contacts
Contact: Sonya Mergler, BSc 416-480-5627 conceptt@sunnybrook.ca
Contact: Aquila Farrell, MPH 416-480-6100 ext 87539 conceptt@sunnybrook.ca

Locations
United States, California
Sansum Diabetes Research Institute Not yet recruiting
Santa Barbara, California, United States, 93105
Principal Investigator: Lois Jovanovic, MD         
Canada, Alberta
Alberta Health Services - Calgary Zone Not yet recruiting
Calgary, Alberta, Canada, T2T 5C7
Principal Investigator: Lois Donovan, MD         
Canada, Ontario
McMaster University Not yet recruiting
Hamilton, Ontario, Canada, L9H 1V1
Principal Investigator: John Booth, MD         
Kingston General Hospital Not yet recruiting
Kingston, Ontario, Canada, K7L 2V7
Principal Investigator: Robyn Houlden, MD         
St Joseph's Health Care Not yet recruiting
London, Ontario, Canada, N6A 4V2
Principal Investigator: Ruth McManus, MD         
The Ottawa Hospital Not yet recruiting
Ottawa, Ontario, Canada, K1H 7W9
Principal Investigator: Erin Keely, MD         
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Barbara Cleave, RN    416-586-4800 ext 2622    bcleave@mtsinai.on.ca   
Principal Investigator: Denice Feig, MD         
Sunnybrook Health Sciences Centre Not yet recruiting
Toronto, Ontario, Canada, M4N 3M5
Principal Investigator: Julia Lowe, MD         
St Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5C 2T2
Principal Investigator: Maria Wolfs, MD         
Israel
Rabin Medical Center Not yet recruiting
Petah-Tiqva, Israel, 49100
Principal Investigator: Yoel Toledano, MD         
Italy
Ospedale Niguarda Ca. Granda Not yet recruiting
Milano, Italy, 20126
Principal Investigator: Mattea A. Bonomo, MD         
Padova University - UOC Diabetologia e Dietetica Not yet recruiting
Padova, Italy
Principal Investigator: Annunziata Lapolla, MD         
Ospedale di Cisanello Not yet recruiting
Pisa, Italy
Principal Investigator: Graziano DiCianni, MD         
Spain
Hospital De La Santa Creu I Sant Pau Not yet recruiting
Barcelona, Spain, 08025
Principal Investigator: Rosa orcoy, MD         
United Kingdom
Addenbrooke's Hospital Recruiting
Cambridge, United Kingdom
Principal Investigator: Helen Murphy, MD         
Ipswich Hospital NHS Trust Not yet recruiting
Ipswich, United Kingdom, IP4 5PD
Principal Investigator: Damian Morris, MD         
Kings College Hospital Not yet recruiting
London, United Kingdom
Principal Investigator: Stephanie Amiel, MD         
Norfolk and Norwich University Hospital Not yet recruiting
Norwich, United Kingdom, NR4 7UY
Principal Investigator: Rosemary Temple, MD         
Sub-Investigator: Tara Wallace, MD         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Sunnybrook Research Institute
Jaeb Center for Health Research
Investigators
Principal Investigator: Denice Feig, MD Mount Sinai Hospital, New York
  More Information

Additional Information:
No publications provided

Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01788527     History of Changes
Obsolete Identifiers: NCT01734031
Other Study ID Numbers: 12-0037-A
Study First Received: December 19, 2012
Last Updated: March 20, 2014
Health Authority: United States: Institutional Review Board
Canada: Canadian Institutes of Health Research

Keywords provided by Mount Sinai Hospital, Canada:
Diabetes
Type 1
CGM
Continuous Glucose Monitor
HGM
HbA1c

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Pregnancy in Diabetics
Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications

ClinicalTrials.gov processed this record on April 22, 2014