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

NCT ID: NCT01788527

Last Updated: 2017-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-03-31

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.

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.

Conditions

Type 1 Diabetics Who Are Pregnant or Planning Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CGM

Continuous Glucose Monitoring

Group Type: EXPERIMENTAL

CGM

Intervention Type: DEVICE

Real Time Continuous Glucose Monitoring

HGM

Standard of care, Home Glucose Monitoring

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

CGM

Real Time Continuous Glucose Monitoring

Intervention Type: DEVICE

Eligibility 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

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Research Institute

OTHER

Sponsor Role: collaborator

Jaeb Center for Health Research

OTHER

Sponsor Role: collaborator

Cambridge University Hospitals NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University of Cambridge

OTHER

Sponsor Role: collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denice Feig, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Helen Murphy, MB BCh BAO FRACP MD

Role: PRINCIPAL_INVESTIGATOR

Cambridge University Hospital NHS Foundation Trust and University of Cambridge

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Alberta Health Services - Calgary Zone

Calgary, Alberta, Canada

IWK Health Centre

Halifax, Nova Scotia, Canada

McMaster University

Hamilton, Ontario, Canada

Kingston General Hospital

Kingston, Ontario, Canada

St Joseph's Health Care

London, Ontario, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

St-Luc Hospital- Centre hospitalier de L'Universite de Montreal

Montreal, Quebec, Canada

Chuq-Chul

Québec, Quebec, Canada

Royal University Saskatoon

Saskatoon, Saskatchewan, Canada

Galway University Hospital

Galway, , Ireland

Niguarda Ca' Granda Hospital

Milan, , Italy

Hospital De La Santa Creu I Sant Pau

Barcelona, , Spain

University of Aberdeen

Aberdeen, Scotland, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Glasgow Royal Infirmary

Glasgow, Scotland, United Kingdom

Russells Hall Hospital

Dudley, West Midlands, United Kingdom

Addenbrooke's Hospital

Cambridge, , United Kingdom

Ipswich Hospital NHS Trust

Ipswich, , United Kingdom

St James University Hospital

Leeds, , United Kingdom

Guys & St. Thomas'

London, , United Kingdom

Kings College Hospital

London, , United Kingdom

Manchester University Hospital NHS Trust

Manchester, , United Kingdom

South Tees Hospital NHS Trust

Middlesbrough, , United Kingdom

Royal Victoria Infirmary

Newcastle, , United Kingdom

Norfolk and Norwich University Hospital

Norwich, , United Kingdom

Queen's Medical Centre

Nottingham, , United Kingdom

Sheffield Teaching Hospitals

Sheffield, , United Kingdom

Princess Anne Hospital

Southampton, , United Kingdom

Countries

United States; Canada; Ireland; Italy; Spain; United Kingdom

References

Ahmed RJ, Gafni A, Hutton EK, Hu ZJ, Sanchez JJ, Murphy HR, Feig DS; CONCEPTT Collaborative Group. The cost implications of continuous glucose monitoring in pregnant women with type 1 diabetes in 3 Canadian provinces: a posthoc cost analysis of the CONCEPTT trial. CMAJ Open. 2021 Jun 4;9(2):E627-E634. doi: 10.9778/cmajo.20200128. Print 2021 Apr-Jun.

Reference Type: DERIVED

PMID: 34088734 (View on PubMed)

Tundidor D, Meek CL, Yamamoto J, Martinez-Bru C, Gich I, Feig DS, Murphy HR, Corcoy R; CONCEPTT Collaborative Group. Continuous Glucose Monitoring Time-in-Range and HbA1c Targets in Pregnant Women with Type 1 Diabetes. Diabetes Technol Ther. 2021 Oct;23(10):710-714. doi: 10.1089/dia.2021.0073. Epub 2021 May 25.

Reference Type: DERIVED

PMID: 33945304 (View on PubMed)

Meek CL, Corcoy R, Asztalos E, Kusinski LC, Lopez E, Feig DS, Murphy HR; CONCEPTT collaborative group. Which growth standards should be used to identify large- and small-for-gestational age infants of mothers with type 1 diabetes? A pre-specified analysis of the CONCEPTT trial. BMC Pregnancy Childbirth. 2021 Jan 29;21(1):96. doi: 10.1186/s12884-021-03554-6.

Reference Type: DERIVED

PMID: 33514342 (View on PubMed)

Meek CL, Tundidor D, Feig DS, Yamamoto JM, Scott EM, Ma DD, Halperin JA, Murphy HR, Corcoy R; CONCEPTT Collaborative Group. Novel Biochemical Markers of Glycemia to Predict Pregnancy Outcomes in Women With Type 1 Diabetes. Diabetes Care. 2021 Mar;44(3):681-689. doi: 10.2337/dc20-2360. Epub 2021 Jan 25.

Reference Type: DERIVED

PMID: 33495292 (View on PubMed)

Neoh SL, Yamamoto JM, Feig DS, Murphy HR; CONCEPTT Collaborative Group. Dietary Patterns of Insulin Pump and Multiple Daily Injection Users During Type 1 Diabetes Pregnancy. Diabetes Care. 2020 Jan;43(1):e5-e7. doi: 10.2337/dc19-1908. Epub 2019 Nov 6. No abstract available.

Reference Type: DERIVED

PMID: 31694860 (View on PubMed)

Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.

Reference Type: DERIVED

PMID: 28923465 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 27430714 (View on PubMed)

Other Identifiers

12-0037-A

Identifier Type: -

Identifier Source: org_study_id

NCT01734031

Identifier Type: -

Identifier Source: nct_alias