Type 1 Diabetics Who Are Pregnant or Planning Pregnancy Clinical Trial
— CONCEPTTOfficial title:
Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial
| Verified date | July 2017 |
| Source | Mount Sinai Hospital, Canada |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 325 |
| Est. completion date | March 2016 |
| Est. primary completion date | March 2016 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 40 Years |
| Eligibility |
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). |
| Country | Name | City | State |
|---|---|---|---|
| Canada | 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 | St-Luc Hospital- Centre hospitalier de L'Universite de Montreal | Montreal | Quebec |
| Canada | The Ottawa Hospital | Ottawa | Ontario |
| Canada | Chuq-Chul | Quebec City | Quebec |
| Canada | Royal University Saskatoon | Saskatoon | Saskatchewan |
| Canada | Mount Sinai Hospital | Toronto | Ontario |
| Canada | Sunnybrook Health Sciences Centre | Toronto | Ontario |
| Ireland | Galway University Hospital | Galway | |
| Italy | Niguarda Ca' Granda Hospital | Milan | |
| Spain | Hospital De La Santa Creu I Sant Pau | Barcelona | |
| United Kingdom | University of Aberdeen | Aberdeen | Scotland |
| United Kingdom | Addenbrooke's Hospital | Cambridge | |
| United Kingdom | Russells Hall Hospital | Dudley | West Midlands |
| United Kingdom | Royal Infirmary of Edinburgh | Edinburgh | Scotland |
| United Kingdom | Glasgow Royal Infirmary | Glasgow | Scotland |
| 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 States | Sansum Diabetes Research Institute | Santa Barbara | California |
| Lead Sponsor | Collaborator |
|---|---|
| Mount Sinai Hospital, Canada | Cambridge University Hospitals NHS Foundation Trust, Jaeb Center for Health Research, Sunnybrook Research Institute, University of Cambridge |
United States, Canada, Ireland, Italy, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | |
| Primary | 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 | Time in target in pre-pregnant group | Time in target at 12 and 24 weeks after randomization | 12 and 24 weeks after randomization | |
| Secondary | 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 | 24 weeks and 34 weeks gestation | |
| Secondary | Time in target in pregnant group | Time in target at randomization, 24 weeks and 34 weeks gestation | Randomization, 24 weeks and 34 weeks gestation | |
| Secondary | HbA1c measurement in pregnant group | HbA1c at randomization, 24 weeks and 34 weeks gestation | 24 weeks and 34 weeks gestation | |
| Secondary | Hypertension in pregnant group | Incidence of worsening chronic hypertension, gestational hypertension, preeclampsia; total and individual measures | Up to 42 weeks gestation | |
| Secondary | Caesarean sections in pregnant group | Caesarean section: primary and total | At delivery | |
| Secondary | Gestational weight gain in pregnant group | Entry to 34 weeks gestation; 16 weeks to 34 weeks gestation | Up to 34 weeks gestation | |
| Secondary | 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 | At delivery | |
| Secondary | 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 | Up to 42 weeks gestation | |
| Secondary | 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 | Up to delivery | |
| Secondary | Hospital stay | Length of hospital stay | Admission until hospital discharge | |
| Secondary | Infant Outcomes | Infant birthweight >90th centile using customized growth curves; infant birthweight <10th centile using customized growth curves; infant birthweight >=4kg | At birth of infant | |
| Secondary | Infant Outcomes | Pregnancy loss (Miscarriage, stillbirth, neonatal death) | =<28 days of life | |
| Secondary | Infant Outcomes | Preterm delivery (<37 weeks and early preterm <34 weeks) | At birth | |
| Secondary | Infant Outcomes | Birth injury | Until hospital discharge | |
| Secondary | Infant outcomes | Shoulder dystocia | Until hospital discharge | |
| Secondary | Infant outcomes | Neonatal hypoglycemia with intravenous dextrose | Until hospital discharge | |
| Secondary | Infant Outcomes | Hyperbilirubinemia | Within first 7 days of life | |
| Secondary | Infant Outcomes | Respiratory Distress Syndrome (RDS) | Within first 7 days of life | |
| Secondary | Infant Outcomes | NICU admission > 24 hrs | Until hospital discharge | |
| Secondary | Infant Outcomes | Cord blood gas pH <7.0 | At birth | |
| Secondary | Infant Outcomes | Hyperinsulinemia (using Cord C-peptide) | At birth | |
| Secondary | 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 | Within first 7 days of life or until hospital discharge (whichever is last) | |
| Secondary | Infant Outcomes | Sum of skinfolds >90th percentile for gestational age | Within first 3 days of life | |
| Secondary | Infant Outcomes | Other anthropometric measures | Within first 3 days of life | |
| Secondary | Infant Outcomes | Length of hospital stay | Until hospital discharge | |
| Secondary | Insulin requirements | Units per kg per day | Pre-pregnant (randomization, 12 weeks, 24 weeks); Pregnant (randomization, 24 weeks and 34 weeks gestation) | |
| Secondary | Questionnaires | BGMSRQ, HFS, PAID, SF12, CGM-SAT; NWTSQ | Baseline and 24 weeks or at confirmed pregnancy (pre-pregnant); Baseline and 34 weeks (pregnant) | |
| Secondary | Study Contacts | Scheduled and unscheduled visits | Up to delivery |