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

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ClinicalTrials.gov Identifier: NCT01788527
Recruitment Status : Completed
First Posted : February 11, 2013
Last Update Posted : July 19, 2017
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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetics Who Are Pregnant or Planning Pregnancy Device: CGM Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 325 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
Study Start Date : March 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
Experimental: CGM
Continuous Glucose Monitoring
Device: CGM
Real Time Continuous Glucose Monitoring
No Intervention: HGM
Standard of care, Home Glucose Monitoring



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. HbA1c measurement in pregnant group [ Time Frame: 24 weeks and 34 weeks gestation ]
    HbA1c at randomization, 24 weeks and 34 weeks gestation

  5. Hypertension in pregnant group [ Time Frame: Up to 42 weeks gestation ]
    Incidence of worsening chronic hypertension, gestational hypertension, preeclampsia; total and individual measures

  6. Caesarean sections in pregnant group [ Time Frame: At delivery ]
    Caesarean section: primary and total

  7. Gestational weight gain in pregnant group [ Time Frame: Up to 34 weeks gestation ]
    Entry to 34 weeks gestation; 16 weeks to 34 weeks gestation

  8. 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

  9. 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

  10. 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

  11. Hospital stay [ Time Frame: Admission until hospital discharge ]
    Length of hospital stay

  12. 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

  13. Infant Outcomes [ Time Frame: =<28 days of life ]
    Pregnancy loss (Miscarriage, stillbirth, neonatal death)

  14. Infant Outcomes [ Time Frame: At birth ]
    Preterm delivery (<37 weeks and early preterm <34 weeks)

  15. Infant Outcomes [ Time Frame: Until hospital discharge ]
    Birth injury

  16. Infant outcomes [ Time Frame: Until hospital discharge ]
    Shoulder dystocia

  17. Infant outcomes [ Time Frame: Until hospital discharge ]
    Neonatal hypoglycemia with intravenous dextrose

  18. Infant Outcomes [ Time Frame: Within first 7 days of life ]
    Hyperbilirubinemia

  19. Infant Outcomes [ Time Frame: Within first 7 days of life ]
    Respiratory Distress Syndrome (RDS)

  20. Infant Outcomes [ Time Frame: Until hospital discharge ]
    NICU admission > 24 hrs

  21. Infant Outcomes [ Time Frame: At birth ]
    Cord blood gas pH <7.0

  22. Infant Outcomes [ Time Frame: At birth ]
    Hyperinsulinemia (using Cord C-peptide)

  23. 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

  24. Infant Outcomes [ Time Frame: Within first 3 days of life ]
    Sum of skinfolds >90th percentile for gestational age

  25. Infant Outcomes [ Time Frame: Within first 3 days of life ]
    Other anthropometric measures

  26. Infant Outcomes [ Time Frame: Until hospital discharge ]
    Length of hospital stay

  27. Insulin requirements [ Time Frame: Pre-pregnant (randomization, 12 weeks, 24 weeks); Pregnant (randomization, 24 weeks and 34 weeks gestation) ]
    Units per kg per day

  28. 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

  29. Study Contacts [ Time Frame: Up to delivery ]
    Scheduled and unscheduled visits



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes 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
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01788527


  Hide Study Locations
Locations
United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Canada, Alberta
Alberta Health Services - Calgary Zone
Calgary, Alberta, Canada, T2T 5C7
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
McMaster University
Hamilton, Ontario, Canada, L9H 1V1
Kingston General Hospital
Kingston, Ontario, Canada, K7L 2V7
St Joseph's Health Care
London, Ontario, Canada, N6A 4V2
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 7W9
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Canada, Quebec
St-Luc Hospital- Centre hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada, H2X 3J4
Chuq-Chul
Quebec City, Quebec, Canada, G1V 4G2
Canada, Saskatchewan
Royal University Saskatoon
Saskatoon, Saskatchewan, Canada, S7N 0W8
Ireland
Galway University Hospital
Galway, Ireland
Italy
Niguarda Ca' Granda Hospital
Milan, Italy, 20162
Spain
Hospital De La Santa Creu I Sant Pau
Barcelona, Spain, 08025
United Kingdom
University of Aberdeen
Aberdeen, Scotland, United Kingdom, AB25 2ZP
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom, EH16 4TJ
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom, G31 2ER
Russells Hall Hospital
Dudley, West Midlands, United Kingdom, DY1 2HQ
Addenbrooke's Hospital
Cambridge, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, United Kingdom, IP4 5PD
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Guys & St. Thomas'
London, United Kingdom
Kings College Hospital
London, United Kingdom
Manchester University Hospital NHS Trust
Manchester, United Kingdom, M139WL
South Tees Hospital NHS Trust
Middlesbrough, United Kingdom, TS4 3BW
Royal Victoria Infirmary
Newcastle, United Kingdom, NE1 4EP
Norfolk and Norwich University Hospital
Norwich, United Kingdom, NR4 7UY
Queen's Medical Centre
Nottingham, United Kingdom, NG72UH
Sheffield Teaching Hospitals
Sheffield, United Kingdom, S10 2RX
Princess Anne Hospital
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Sunnybrook Research Institute
Jaeb Center for Health Research
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01788527     History of Changes
Obsolete Identifiers: NCT01734031
Other Study ID Numbers: 12-0037-A
First Posted: February 11, 2013    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

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