Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy

Mount Sinai Hospital, Canada50 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabete Type 2 Pregnancy in Diabetic

Interventions

Dexcom Continuous Glucose MonitoringDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of \>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above. 2. ≤14 weeks gestation, 3. age ≥18 years 4. Willingness to use the study devices a minimum of 10 days per trimester 5. Able to provide informed consent 6. Have access to email Exclusion Criteria: 1. Non-type 2 diabetes 2. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids 3. Known or suspected allergy against insulin 4. Women with nephropathy (eGFR\<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results 5. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance 6. Unable to communicate effectively in English as judged by the investigator 7. Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results

Locations (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Central Contacts

Denice Feig, MD, MSc, FRCPC

CONTACT

416-586-8590 Denice.Feig@sinaihealth.ca

Silva Darrouj, HBSc

CONTACT

416-586-4800 silva.darrouj@sinaihealth.ca

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

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