title: CONCEPTT: Continuous Glucose Monitoring in Women with Type 1 Diabetes in Pregnancy Trial: A multi-center, multi-national, randomized controlled trial - Study protocol.
abstract: Women with type 1 diabetes strive for optimal glycemic control before and during pregnancy to avoid adverse obstetric and perinatal outcomes. For most women, optimal glycemic control is challenging to achieve and maintain. The aim of this study is to determine whether the use of real-time continuous glucose monitoring (RT-CGM) will improve glycemic control in women with type 1 diabetes who are pregnant or planning pregnancy.
  
  
  
  A multi-center, open label, randomized, controlled trial of women with type 1 diabetes who are either planning pregnancy with an HbA1c of 7.0 % to ≤10.0 % (53 to ≤ 86 mmol/mol) or are in early pregnancy (<13 weeks 6 days) with an HbA1c of 6.5 % to ≤10.0 % (48 to ≤ 86 mmol/mol). Participants will be randomized to either RT-CGM alongside conventional intermittent home glucose monitoring (HGM), or HGM alone. Eligible women will wear a CGM which does not display the glucose result for 6 days during the run-in phase. To be eligible for randomization, a minimum of 4 HGM measurements per day and a minimum of 96 hours total with 24 hours overnight (11 pm-7 am) of CGM glucose values are required. Those meeting these criteria are randomized to RT- CGM or HGM. A total of 324 women will be recruited (110 planning pregnancy, 214 pregnant). This takes into account 15 and 20 % attrition rates for the planning pregnancy and pregnant cohorts and will detect a clinically relevant 0.5 % difference between groups at 90 % power with 5 % significance. Randomization will stratify for type of insulin treatment (pump or multiple daily injections) and baseline HbA1c. Analyses will be performed according to intention to treat. The primary outcome is the change in glycemic control as measured by HbA1c from baseline to 24 weeks or conception in women planning pregnancy, and from baseline to 34 weeks gestation during pregnancy. Secondary outcomes include maternal hypoglycemia, CGM time in, above and below target (3.5-7.8 mmol/l), glucose variability measures, maternal and neonatal outcomes.
  
  
  
  This will be the first international multicenter randomized controlled trial to evaluate the impact of RT- CGM before and during pregnancy in women with type 1 diabetes.
  
  
  
  ClinicalTrials.gov Identifier: NCT01788527 Registration Date: December 19, 2012.
authors.affiliation: Mt Sinai Hospital, Toronto, Ontario, Canada. d.feig@utoronto.ca.|Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada. d.feig@utoronto.ca.|Department of Medicine, University of Toronto, Toronto, Canada. d.feig@utoronto.ca.|Department of Medicine, Leadership Sinai Centre for Diabetes, Mt Sinai Hospital, 60 Murray St. #5027, Toronto, Ontario, M5T 3 L9, Canada. d.feig@utoronto.ca.
authors.forename: Denice S
authors.initials: DS
authors.lastname: Feig
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.|Sunnybrook Research Institute, Toronto, Ontario, Canada.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Asztalos
authors.affiliation: Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.|CIBER-BBN, Zaragoza, Spain.
authors.forename: Rosa
authors.initials: R
authors.lastname: Corcoy
authors.affiliation: Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.|CIBER-BBN, Zaragoza, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: De Leiva
authors.affiliation: University of Calgary, Calgary, Alberta, Canada.
authors.forename: Lois
authors.initials: L
authors.lastname: Donovan
authors.affiliation: Helen Schneider Hospital for Women, Rabin Medical Center, Petah Tikva, Israel.
authors.forename: Moshe
authors.initials: M
authors.lastname: Hod
authors.affiliation: , 30-1 Barranca Avenue, Santa Barbara, California, USA.
authors.forename: Lois
authors.initials: L
authors.lastname: Jovanovic
authors.affiliation: The Ottawa Hospital, Riverside Campus, Ottawa, Ontario, Canada.
authors.forename: Erin
authors.initials: E
authors.lastname: Keely
authors.affiliation: Jaeb Center For Health Research, Tampa, Florida, USA.
authors.forename: Craig
authors.initials: C
authors.lastname: Kollman
authors.affiliation: St. Joseph Health Care London, London, Ontario, Canada.
authors.forename: Ruth
authors.initials: R
authors.lastname: McManus
authors.affiliation: Mt Sinai Hospital, Toronto, Ontario, Canada.|Lunenfeld-Tanenbaum Research Institute, Toronto, Ontario, Canada.
authors.forename: Kellie
authors.initials: K
authors.lastname: Murphy
authors.affiliation: Jaeb Center For Health Research, Tampa, Florida, USA.
authors.forename: Katrina
authors.initials: K
authors.lastname: Ruedy
authors.affiliation: Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.|Sunnybrook Research Institute, Toronto, Ontario, Canada.
authors.forename: J Johanna
authors.initials: JJ
authors.lastname: Sanchez
authors.affiliation: University Health Network, Toronto General Hospital, Toronto, Ontario, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Tomlinson
authors.affiliation: Institute of Metabolic Science, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.|Norwich Medical School, University of East Anglia, Norwich, UK.
authors.forename: Helen R
authors.initials: HR
authors.lastname: Murphy
mesh_terms: D000293:Adolescent; D000328:Adult; D001724:Birth Weight; D001786:Blood Glucose / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring; D003922:Diabetes Mellitus, Type 1 / Q000097:blood* / Q000188:drug therapy; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007003:Hypoglycemia / Q000097:blood / Q000175:diagnosis; D007004:Hypoglycemic Agents / Q000627:therapeutic use; D007231:Infant, Newborn; D007328:Insulin / Q000627:therapeutic use; D018670:Monitoring, Ambulatory / Q000379:methods*; D011247:Pregnancy; D011248:Pregnancy Complications / Q000097:blood / Q000175:diagnosis; D011254:Pregnancy in Diabetics / Q000097:blood*; D012107:Research Design; D055815:Young Adult
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; C517652:hemoglobin A1c protein, human
keywords: Continuous glucose monitoring; Diabetes mellitus type 1; Preconception; Pregnancy; Randomized controlled trial