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

Sponsor

Mount Sinai Hospital, Canada (Other)

Overall Status

Recruiting

CT.gov ID

NCT06147466

Collaborator

University of Manitoba (Other), Women's College Hospital (Other)

Enrollment

Location

Anticipated Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Diabete Type 2 Pregnancy in Diabetic	Device: Dexcom Continuous Glucose Monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Outcome Measures

Primary Outcome Measures

Time in target range [7-9 months]
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

Secondary Outcome Measures

Delivery outcome [7-9 months]
delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.
Maternal outcome [7-9 months]
Date and time of hospital admission for delivery and discharge.
Maternal outcome (HTN) [7-9 months]
Maternal postpartum diagnosis of hypertension or pre-eclampsia.
Neonatal weight at birth [7-9 months (Delivery of neonate)]
Neonatal weight measurement collected from medical chart.
Neonatal outcomes (hypoglycemia) [7-9 months (Delivery of neonate)]
Proportion of babies born with hypoglycemia. The lowest recorded glucose value (mmol/L) will be collected for babies born with hypoglycemia
Neonatal outcomes (chromosomal abnormality) [7-9 months (Delivery of neonate)]
Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality
Neonatal outcomes (congenital anomaly) [7-9 months (Delivery of neonate)]
Proportion of babies born with congenital anomaly and type of congenital anomaly
Neonatal outcomes (birth injury) [7-9 months (Delivery of neonate)]
Proportion of babies born with neonatal birth injury and type of injury
Neonatal outcomes (hyperbilirubinemia) [7-9 months (Delivery of neonate)]
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)
Neonatal outcomes (neonatal intensive care admission) [Delivery of neonate to 6 weeks postpartum]
Proportion of babies admitted to neonatal intensive care admission
Covariates (maternal obesity) [16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum]
maternal weight will be collected/measured
Covariates (maternal ethnicity) [Enrollment (16-24 weeks gestation)]
maternal ethnicity will be collected
Covariates (Mother's total household income) [enrollment 16-24 weeks gestation]
total household income will be collected
Adverse events [7-9 months]
Adverse events description and time of occurrence will be recorded when applicable
Blood Insulin [at 16-24 weeks gestation]
blood insulin measured in pmol/L.
Measures of insulin resistance (HOMA-IR ) [at 16-24 weeks gestation]
Homeostatic Model Assessment for Insulin Resistance ( HOMA-IR ) index will be calculated suing blood insulin and blood glucose
Mean blood glucose measurement [at 16-24 weeks gestation]
Blood glucose measured in mmol/L
Diabetes distress [at 16-24 weeks gestation and at 34 weeks gestation]
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.
Sleep quality [at 16-24 weeks gestation and at 34 weeks gestation]
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
Sleep apnea [at 16-24 weeks gestation and at 34 weeks gestation]
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
Perceived social support [16-24 weeks gestation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.
≤14 weeks gestation,
age ≥18 years
Willingness to use the study devices a minimum of 10 days per trimester
Able to provide informed consent
Have access to email

Exclusion Criteria:

Non-type 2 diabetes
Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
Known or suspected allergy against insulin
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
Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
Unable to communicate effectively in English as judged by the investigator
Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results