An observational study in Diabete Type 2 and Pregnancy in Diabetic, sponsored by Mount Sinai Hospital, Canada. Recruiting at 1 site in Canada. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-03-20.
Sponsored by Mount Sinai Hospital, Canada · Observational
Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis
149 studies on the registry are indexed under Pregnancy in Diabetics; 33 are open to participants now.
This study's planned enrollment of 50 is below the median of 129 across 60 observational studies indexed under Pregnancy in Diabetics.
Browse Pregnancy in Diabetics studies →Mount Sinai Hospital, Canada is the lead sponsor of 157 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant Women with Type 2 diabetes with either a HbA1c of >6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT
Exclusion Criteria:
A continuous glucose monitor (CGM) is a wearable device that tracks blood glucose (sugar) every few minutes, throughout the day and night. The readings are relayed in real time to a device which can be read by the patient, caregiver or health-care provider, even remotely
Time in target range
To determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), overall and by trimester, by standard CGM measures and functional data analysis
Time frame: 7-9 months
Delivery outcome
delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.
Time frame: 7-9 months
Maternal outcome
Date and time of hospital admission for delivery and discharge.
Time frame: 7-9 months
Maternal outcome (HTN)
Maternal postpartum diagnosis of hypertension or pre-eclampsia.
Time frame: 7-9 months
Neonatal weight at birth
Neonatal weight measurement collected from medical chart.
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (hypoglycemia)
Proportion of babies born with hypoglycemia. The lowest recorded glucose value (mmol/L) will be collected for babies born with hypoglycemia
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (chromosomal abnormality)
Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (congenital anomaly)
Proportion of babies born with congenital anomaly and type of congenital anomaly
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (birth injury)
Proportion of babies born with neonatal birth injury and type of injury
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (hyperbilirubinemia)
Proportion of babies born with neonatal hyperbilirubinemia requiring treatment (• phototherapy \> 6 continuous hours, an exchange transfusion, intravenous gamma globulin or required re-admission into hospital during the first 7 days of life)
Time frame: 7-9 months (Delivery of neonate)
Neonatal outcomes (neonatal intensive care admission)
Proportion of babies admitted to neonatal intensive care admission
Time frame: Delivery of neonate to 6 weeks postpartum
Covariates (maternal obesity)
maternal weight will be collected/measured
Time frame: 16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
Covariates (maternal ethnicity)
maternal ethnicity will be collected
Time frame: Enrollment (16-24 weeks gestation)
Covariates (Mother's total household income)
total household income will be collected
Time frame: enrollment 16-24 weeks gestation
Adverse events
Adverse events description and time of occurrence will be recorded when applicable
Time frame: 7-9 months
Blood Insulin
blood insulin measured in pmol/L.
Time frame: at 16-24 weeks gestation
Measures of insulin resistance (HOMA-IR )
Homeostatic Model Assessment for Insulin Resistance ( HOMA-IR ) index will be calculated suing blood insulin and blood glucose
Time frame: at 16-24 weeks gestation
Mean blood glucose measurement
Blood glucose measured in mmol/L
Time frame: at 16-24 weeks gestation
Diabetes distress
Using Diabetes Distress Screening Scale (DDSS17). The scale yields an overall distress score based on the average of response on the 1-6 scale for all 18 items. The DDS-17 identifies three levels of specificity of diabetes distress information for use in clinical care, from overall emotional distress related to diabetes to highly specific sources of diabetes distress. Higher score is worse.
Time frame: at 16-24 weeks gestation and at 34 weeks gestation
Sleep quality
Using the Berlin Questionnaire. The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive
Time frame: at 16-24 weeks gestation and at 34 weeks gestation
Sleep apnea
Using the Berlin Questionnaire. The Berlin Questionnaire consists of three categories designed to elicit information regarding snoring (category 1), daytime somnolence (category 2), and the presence of obesity and/or hypertension (category 3). Categories 1 and 2 are considered positive if 2 or more responses are positive category 3 is considered positive if 1 response is positive and/or the body mass index is greater than 30 kg per meter squared. A patient is considered to have a high likelihood of sleep disordered breathing if 2 or more categories are positive
Time frame: at 16-24 weeks gestation and at 34 weeks gestation
Perceived social support
Using the Multidimensional Scale of Perceived Social Support (MSPSS). MSPSS is a 12-item scale that measures the adequacy of social support. It consists of 3 subgroups that include items about family, friends and social support from a special person. It consists of 4 items for each group and each item is graded on a 7-item likert scale. A high total score indicates a high level of perceived social support.
Time frame: 16-24 weeks gestation
Plan to share: No
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Mount Sinai Hospital, Canada