Type 1 Diabetics Who Are Pregnant or Planning PregnancyCONCEPTTNCT01788527
Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
A study testing CGM in people with Type 1 Diabetics Who Are Pregnant or Planning Pregnancy, run by Mount Sinai Hospital, Canada at 31 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Type 1 Diabetics Who Are Pregnant or Planning Pregnancy
- What is being tested?
- CGM
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 31 sitesin 6 countries
- Study dates
- Mar 2013to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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:
Show all 12Show fewer
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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).
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
United Kingdom16 sites
University of Aberdeen
Aberdeen, Scotland, AB25 2ZP
Addenbrooke's Hospital
Cambridge
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4TJ
Glasgow Royal Infirmary
Glasgow, Scotland, G31 2ER
Ipswich Hospital NHS Trust
Ipswich, IP4 5PD
St James University Hospital
Leeds, LS9 7TF
Guys & St. Thomas'
London
Kings College Hospital
London
Manchester University Hospital NHS Trust
Manchester, M139WL
South Tees Hospital NHS Trust
Middlesbrough, TS4 3BW
Royal Victoria Infirmary
Newcastle, NE1 4EP
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
Queen's Medical Centre
Nottingham, NG72UH
Sheffield Teaching Hospitals
Sheffield, S10 2RX
Princess Anne Hospital
Southampton, SO16 6YD
Canada11 sites
Alberta Health Services - Calgary Zone
Calgary, Alberta, T2T 5C7
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
McMaster University
Hamilton, Ontario, L9H 1V1
Kingston General Hospital
Kingston, Ontario, K7L 2V7
St Joseph's Health Care
London, Ontario, N6A 4V2
St-Luc Hospital- Centre hospitalier de L'Universite de Montreal
Montreal, Quebec, H2X 3J4
The Ottawa Hospital
Ottawa, Ontario, K1H 7W9
Chuq-Chul
Québec, Quebec, G1V 4G2
Royal University Saskatoon
Saskatoon, Saskatchewan, S7N 0W8
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
United States1 site
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
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.
Read the 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.
- Being tested
- CGM
- Keywords
- Diabetes, Type 1, CGM, Continuous Glucose Monitor, HGM, HbA1c
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Real Time Continuous Glucose Monitoring
| Study group | Role | What they receive |
|---|---|---|
| CGM | Experimental | Continuous Glucose Monitoring Receives: Device: CGM |
| HGM | No intervention | Standard of care, Home Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 34 weeks gestation
Secondary outcomes (29)
Time in target in pre-pregnant group
Time in target at 12 and 24 weeks after randomization
Measured: 12 and 24 weeks after randomization
HbA1c and time in target, in pre-pregnant group who became pregnant within 24 weeks from randomization
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
Measured: 24 weeks and 34 weeks gestation
Time in target in pregnant group
Time in target at randomization, 24 weeks and 34 weeks gestation
Measured: Randomization, 24 weeks and 34 weeks gestation
HbA1c measurement in pregnant group
HbA1c at randomization, 24 weeks and 34 weeks gestation
Measured: 24 weeks and 34 weeks gestation
Hypertension in pregnant group
Incidence of worsening chronic hypertension, gestational hypertension, preeclampsia; total and individual measures
Measured: Up to 42 weeks gestation
Caesarean sections in pregnant group
Caesarean section: primary and total
Measured: At delivery
Gestational weight gain in pregnant group
Entry to 34 weeks gestation; 16 weeks to 34 weeks gestation
Measured: Up to 34 weeks gestation
AUC
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
Measured: At delivery
Incidence of Clinical events
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
Measured: Up to 42 weeks gestation
Glucose variability
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
Measured: Up to delivery
Hospital stay
Length of hospital stay
Measured: Admission until hospital discharge
Infant Outcomes
Infant birthweight >90th centile using customized growth curves; infant birthweight <10th centile using customized growth curves; infant birthweight >=4kg
Measured: At birth of infant
Infant Outcomes
Pregnancy loss (Miscarriage, stillbirth, neonatal death)
Measured: =<28 days of life
Infant Outcomes
Preterm delivery (<37 weeks and early preterm <34 weeks)
Measured: At birth
Infant Outcomes
Birth injury
Measured: Until hospital discharge
Infant outcomes
Shoulder dystocia
Measured: Until hospital discharge
Infant outcomes
Neonatal hypoglycemia with intravenous dextrose
Measured: Until hospital discharge
Infant Outcomes
Hyperbilirubinemia
Measured: Within first 7 days of life
Infant Outcomes
Respiratory Distress Syndrome (RDS)
Measured: Within first 7 days of life
Infant Outcomes
NICU admission > 24 hrs
Measured: Until hospital discharge
Infant Outcomes
Cord blood gas pH <7.0
Measured: At birth
Infant Outcomes
Hyperinsulinemia (using Cord C-peptide)
Measured: At birth
Infant Outcomes
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
Measured: Within first 7 days of life or until hospital discharge (whichever is last)
Infant Outcomes
Sum of skinfolds >90th percentile for gestational age
Measured: Within first 3 days of life
Infant Outcomes
Other anthropometric measures
Measured: Within first 3 days of life
Infant Outcomes
Length of hospital stay
Measured: Until hospital discharge
Insulin requirements
Units per kg per day
Measured: Pre-pregnant (randomization, 12 weeks, 24 weeks); Pregnant (randomization, 24 weeks and 34 weeks gestation)
Questionnaires
BGMSRQ, HFS, PAID, SF12, CGM-SAT; NWTSQ
Measured: Baseline and 24 weeks or at confirmed pregnancy (pre-pregnant); Baseline and 34 weeks (pregnant)
Study Contacts
Scheduled and unscheduled visits
Measured: Up to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetics Who Are Pregnant or Planning PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Research Institute, Jaeb Center for Health Research, Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
- Responsible party
- Sponsor
- Investigators
- Denice Feig, MD, Principal investigator, MOUNT SINAI HOSPITALHelen Murphy, MB BCh BAO FRACP MD, Principal investigator, Cambridge University Hospital NHS Foundation Trust and University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01788527
- Sponsor's protocol ID
- 12-0037-A
- Acronym
- CONCEPTT
- Status last verified
- Jul 2017
- First submitted
- 19 Dec 2012
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34088734Tundidor 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.
PubMed 33945304Meek 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.
PubMed 33514342Meek 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.
PubMed 33495292Neoh 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.
PubMed 31694860Feig 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.
PubMed 28923465Feig 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.
PubMed 27430714
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
- ClinicalTrials.gov ID
- NCT01788527
- Acronym / sponsor ID
- CONCEPTT / 12-0037-A
- Keywords
- Diabetes, Type 1, CGM, Continuous Glucose Monitor, HGM, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Collaborators
- Sunnybrook Research Institute, Jaeb Center for Health Research, Cambridge University Hospitals NHS Foundation Trust, University of Cambridge
- Study start
- Mar 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM | Experimental | Device: CGMContinuous Glucose Monitoring |
| HGM | No intervention | –Standard of care, Home Glucose Monitoring |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGMReal Time Continuous Glucose Monitoring | Device | CGM |
Primary outcome
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.
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.
29 secondary outcomes
Time in target in pre-pregnant group
Time frame: 12 and 24 weeks after randomization
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
Time in target in pregnant group
Time frame: Randomization, 24 weeks and 34 weeks gestation
HbA1c measurement in pregnant group
Time frame: 24 weeks and 34 weeks gestation
Hypertension in pregnant group
Time frame: Up to 42 weeks gestation
Caesarean sections in pregnant group
Time frame: At delivery
Gestational weight gain in pregnant group
Time frame: Up to 34 weeks gestation
AUC
Time frame: At delivery
Incidence of Clinical events
Time frame: Up to 42 weeks gestation
Glucose variability
Time frame: Up to delivery
Hospital stay
Time frame: Admission until hospital discharge
Infant Outcomes
Time frame: At birth of infant
Infant Outcomes
Time frame: =<28 days of life
Infant Outcomes
Time frame: At birth
Infant Outcomes
Time frame: Until hospital discharge
Infant outcomes
Time frame: Until hospital discharge
Infant outcomes
Time frame: Until hospital discharge
Infant Outcomes
Time frame: Within first 7 days of life
Infant Outcomes
Time frame: Within first 7 days of life
Infant Outcomes
Time frame: Until hospital discharge
Infant Outcomes
Time frame: At birth
Infant Outcomes
Time frame: At birth
Infant Outcomes
Time frame: Within first 7 days of life or until hospital discharge (whichever is last)
Infant Outcomes
Time frame: Within first 3 days of life
Infant Outcomes
Time frame: Within first 3 days of life
Infant Outcomes
Time frame: Until hospital discharge
Insulin requirements
Time frame: Pre-pregnant (randomization, 12 weeks, 24 weeks); Pregnant (randomization, 24 weeks and 34 weeks gestation)
Questionnaires
Time frame: Baseline and 24 weeks or at confirmed pregnancy (pre-pregnant); Baseline and 34 weeks (pregnant)
Study Contacts
Time frame: Up to delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 34088734Ahmed 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.
- Derived from this study: PubMed 33945304Tundidor 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.
- Derived from this study: PubMed 33514342Meek 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.
- Derived from this study: PubMed 33495292Meek 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.
- Derived from this study: PubMed 31694860Neoh 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.
- Derived from this study: PubMed 28923465Feig 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.
- Derived from this study: PubMed 27430714Feig 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denice Feig, MD principal investigator
MOUNT SINAI HOSPITAL
Helen Murphy, MB BCh BAO FRACP MD principal investigator
Cambridge University Hospital NHS Foundation Trust and University of Cambridge
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM in people with Type 1 Diabetics Who Are Pregnant or Planning Pregnancy, run by Mount Sinai Hospital, Canada at 31 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United Kingdom, Canada, United States, Ireland, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control in pre-pregnant group (time frame: 24 weeks or at conception). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01788527, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.