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

Recruiting

• Conditions: Pregnancy in Diabetic; Diabete Type 2

• Registration Number: NCT06147466
• Lead Sponsor: Mount Sinai Hospital, Canada

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-03
• Study Start: 2023-03-01
• Study First Submitted: 2023-04-03
• Study First Submitted QC: 2023-11-21
• Study First Posted: 2023-11-27
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-20
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Delivery outcome	7-9 months	delivery outcome will be reported as ,full term birth, pre-term birth, spontaneous abortion, miscarriage or termination.
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 (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
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
Blood Insulin	at 16-24 weeks gestation	blood insulin measured in pmol/L.
Neonatal outcomes (birth injury)	7-9 months (Delivery of neonate)	Proportion of babies born with neonatal birth injury and type of injury
Adverse events	7-9 months	Adverse events description and time of occurrence will be recorded when applicable
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
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.
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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada