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

NCT01788527 | Completed DMC

• 1 other identifier: 12-0037-A
• Study Type: interventional
• Target: 325
• Locations: 6 countries
• Sites: 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.

Conditions

Type 1 Diabetics Who Are Pregnant or Planning Pregnancy

Keywords

Diabetes; Type 1; CGM; Continuous Glucose Monitor; HGM; HbA1c

Outcome Measures

Primary Outcomes (2)

• Glycemic Control in pre-pregnant group

  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.

  24 weeks or at conception

• Glycemic Control in pregnant group

  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.

  34 weeks gestation

Secondary Outcomes (29)

• Time in target in pre-pregnant group

  12 and 24 weeks after randomization

• HbA1c and time in target, in pre-pregnant group who became pregnant within 24 weeks from randomization

  24 weeks and 34 weeks gestation

• Time in target in pregnant group

  Randomization, 24 weeks and 34 weeks gestation

• HbA1c measurement in pregnant group

  24 weeks and 34 weeks gestation

• Hypertension in pregnant group

  Up to 42 weeks gestation

Study Arms (2)

CGM

EXPERIMENTAL

Continuous Glucose Monitoring

Device: CGM

HGM

NO INTERVENTION

Standard of care, Home Glucose Monitoring

Interventions

CGM DEVICE

Real Time Continuous Glucose Monitoring

CGM

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• Sunnybrook Research Institute: collaborator
• Jaeb Center for Health Research: collaborator
• Cambridge University Hospitals NHS Foundation Trust: collaborator
• University of Cambridge: collaborator

Study Sites (31)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Alberta Health Services - Calgary Zone

Calgary, Alberta, T2T 5C7, Canada

Location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

McMaster University

Hamilton, Ontario, L9H 1V1, Canada

Location

Kingston General Hospital

Kingston, Ontario, K7L 2V7, Canada

Location

St Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

The Ottawa Hospital

Ottawa, Ontario, K1H 7W9, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

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

Montreal, Quebec, H2X 3J4, Canada

Location

Chuq-Chul

Québec, Quebec, G1V 4G2, Canada

Location

Royal University Saskatoon

Saskatoon, Saskatchewan, S7N 0W8, Canada

Location

Galway University Hospital

Galway, Ireland

Location

Niguarda Ca' Granda Hospital

Milan, 20162, Italy

Location

Hospital De La Santa Creu I Sant Pau

Barcelona, 08025, Spain

Location

University of Aberdeen

Aberdeen, Scotland, AB25 2ZP, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4TJ, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, United Kingdom

Location

Ipswich Hospital NHS Trust

Ipswich, IP4 5PD, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Guys & St. Thomas'

London, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Manchester University Hospital NHS Trust

Manchester, M139WL, United Kingdom

Location

South Tees Hospital NHS Trust

Middlesbrough, TS4 3BW, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, NE1 4EP, United Kingdom

Location

Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Queen's Medical Centre

Nottingham, NG72UH, United Kingdom

Location

Sheffield Teaching Hospitals

Sheffield, S10 2RX, United Kingdom

Location

Princess Anne Hospital

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (7)

• 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.

  PMID: 34088734 DERIVED

• 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.

  PMID: 33945304 DERIVED

• 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.

  PMID: 33514342 DERIVED

• 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.

  PMID: 33495292 DERIVED

• 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.

  PMID: 31694860 DERIVED

• 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.

  PMID: 28923465 DERIVED

• 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.

  PMID: 27430714 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Denice Feig, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Helen Murphy, MB BCh BAO FRACP MD

  Cambridge University Hospital NHS Foundation Trust and University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2012
• First Posted: February 11, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: July 19, 2017

Record last verified: 2017-07

Locations

IT (1); US (1); IE (1); CA (11); ES (1); GB (16)