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

Diabete Type 2 Clinical Trial

— Timely  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06147466
• Other study ID #: 21-0065-E
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: June 1, 2026

Study information

• Verified date: March 2023
• Source: Mount Sinai Hospital, Canada
• Contact: Denice Feig, MD, MSc, FRCPC
• Phone: 416-586-8590
• Email: Denice.Feig[@]sinaihealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabete Type 2
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Pregnancy in Diabetic
• Pregnancy in Diabetics

Intervention

Device:
• Dexcom Continuous Glucose Monitoring
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

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada	University of Manitoba, Women's College Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	Delivery outcome	delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.	7-9 months
Secondary	Maternal outcome	Date and time of hospital admission for delivery and discharge.	7-9 months
Secondary	Maternal outcome (HTN)	Maternal postpartum diagnosis of hypertension or pre-eclampsia.	7-9 months
Secondary	Neonatal weight at birth	Neonatal weight measurement collected from medical chart.	7-9 months (Delivery of neonate)
Secondary	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)
Secondary	Neonatal outcomes (chromosomal abnormality)	Proportion of babies born with chromosomal abnormality and type of chromosomal abnormality	7-9 months (Delivery of neonate)
Secondary	Neonatal outcomes (congenital anomaly)	Proportion of babies born with congenital anomaly and type of congenital anomaly	7-9 months (Delivery of neonate)
Secondary	Neonatal outcomes (birth injury)	Proportion of babies born with neonatal birth injury and type of injury	7-9 months (Delivery of neonate)
Secondary	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)
Secondary	Neonatal outcomes (neonatal intensive care admission)	Proportion of babies admitted to neonatal intensive care admission	Delivery of neonate to 6 weeks postpartum
Secondary	Covariates (maternal obesity)	maternal weight will be collected/measured	16-24 weeks gestation, 34 weeks gestation, 4-6 weeks postpartum
Secondary	Covariates (maternal ethnicity)	maternal ethnicity will be collected	Enrollment (16-24 weeks gestation)
Secondary	Covariates (Mother's total household income)	total household income will be collected	enrollment 16-24 weeks gestation
Secondary	Adverse events	Adverse events description and time of occurrence will be recorded when applicable	7-9 months
Secondary	Blood Insulin	blood insulin measured in pmol/L.	at 16-24 weeks gestation
Secondary	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
Secondary	Mean blood glucose measurement	Blood glucose measured in mmol/L	at 16-24 weeks gestation
Secondary	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
Secondary	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
Secondary	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
Secondary	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