Clinical trial NCT06147466: Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy
Official title: Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabete Type 2
Pregnancy in Diabetic
Keywords: glucose range
neonatal outcomes
glycemic control
hypoglycemia
insulin resistance
preganant
pregnancy
CGM
Continuous Glucose Monitoring
Dexcom
maternal outcomes
Pregnancy in Diabetes
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: University of Manitoba
name: Women's College Hospital
First posted: 2023-11-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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


Eligibility criteria: 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

Primary outcomes:
measure: Time in target range
timeFrame: 7-9 months
Secondary outcomes:
measure: Delivery outcome
timeFrame: 7-9 months
measure: Maternal outcome
timeFrame: 7-9 months
measure: Maternal outcome (HTN)
timeFrame: 7-9 months
measure: Neonatal weight at birth
timeFrame: 7-9 months (Delivery of neonate)
measure: Neonatal outcomes (hypoglycemia)
timeFrame: 7-9 months (Delivery of neonate)
measure: Neonatal outcomes (chromosomal abnormality)
timeFrame: 7-9 months (Delivery of neonate)
measure: Neonatal outcomes (congenital anomaly)
timeFrame: 7-9 months (Delivery of neonate)
measure: Neonatal outcomes (birth injury)
timeFrame: 7-9 months (Delivery of neonate)
measure: Neonatal outcomes (hyperbilirubinemia)
timeFrame: 7-9 months (Delivery of neonate)
measure: Neonatal outcomes (neonatal intensive care admission)
timeFrame: Delivery of neonate to 6 weeks postpartum
measure: Covariates (maternal obesity)
timeFrame: 16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
measure: Covariates (maternal ethnicity)
timeFrame: Enrollment (16-24 weeks gestation)
measure: Covariates (Mother's total household income)
timeFrame: enrollment 16-24 weeks gestation
measure: Adverse events
timeFrame: 7-9 months
measure: Blood Insulin
timeFrame: at 16-24 weeks gestation
measure: Measures of insulin resistance (HOMA-IR )
timeFrame: at 16-24 weeks gestation
measure: Mean blood glucose measurement
timeFrame: at 16-24 weeks gestation
measure: Diabetes distress
timeFrame: at 16-24 weeks gestation and at 34 weeks gestation
measure: Sleep quality
timeFrame: at 16-24 weeks gestation and at 34 weeks gestation
measure: Sleep apnea
timeFrame: at 16-24 weeks gestation and at 34 weeks gestation
measure: Perceived social support
timeFrame: 16-24 weeks gestation
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital
name: Denice Feig
role: PRINCIPAL_INVESTIGATOR
References: