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| Name | Class |
|---|---|
| University of Manitoba | OTHER |
| Women's College Hospital | OTHER |
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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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom Continuous Glucose Monitoring | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7-9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Delivery outcome | delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination. | 7-9 months |
| Maternal outcome | Date and time of hospital admission for delivery and discharge. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Denice Feig, MD, MSc, FRCPC | Contact | 416-586-8590 | Denice.Feig@sinaihealth.ca | |
| Silva Darrouj, HBSc | Contact | 416-586-4800 | 3946 | silva.darrouj@sinaihealth.ca |
| Name | Affiliation | Role |
|---|---|---|
| Denice Feig | Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Recruiting | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D011254 | Pregnancy in Diabetics |
| D007003 | Hypoglycemia |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 7-9 months |
| Maternal outcome (HTN) | Maternal postpartum diagnosis of hypertension or pre-eclampsia. | 7-9 months |
| Neonatal weight at birth | Neonatal weight measurement collected from medical chart. | 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 | 7-9 months (Delivery of neonate) |
| Neonatal outcomes (chromosomal abnormality) | Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality | 7-9 months (Delivery of neonate) |
| Neonatal outcomes (congenital anomaly) | Proportion of babies born with congenital anomaly and type of congenital anomaly | 7-9 months (Delivery of neonate) |
| Neonatal outcomes (birth injury) | Proportion of babies born with neonatal birth injury and type of injury | 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) | 7-9 months (Delivery of neonate) |
| Neonatal outcomes (neonatal intensive care admission) | Proportion of babies admitted to neonatal intensive care admission | Delivery of neonate to 6 weeks postpartum |
| Covariates (maternal obesity) | maternal weight will be collected/measured | 16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum |
| Covariates (maternal ethnicity) | maternal ethnicity will be collected | Enrollment (16-24 weeks gestation) |
| Covariates (Mother's total household income) | total household income will be collected | enrollment 16-24 weeks gestation |
| Adverse events | Adverse events description and time of occurrence will be recorded when applicable | 7-9 months |
| Blood Insulin | blood insulin measured in pmol/L. | 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 | at 16-24 weeks gestation |
| Mean blood glucose measurement | Blood glucose measured in mmol/L | 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. | 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 | 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 | 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. | 16-24 weeks gestation |
| D004700 | Endocrine System Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006946 | Hyperinsulinism |