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

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

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 Overview

• Status: Recruiting
• Conditions: Pregnancy in Diabetic; Diabete Type 2
• Intervention / Treatment: Device: Dexcom Continuous Glucose Monitoring

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Denice Feig, MD, MSc, FRCPC; Phone Number: 416-586-8590; Email: Denice.Feig@sinaihealth.ca
• Study Contact Backup: Name: Silva Darrouj, HBSc; Phone Number: 3946 416-586-4800; Email: silva.darrouj@sinaihealth.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Denice Feig, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mount Sinai Hospital, Canada
• Collaborators: University of Manitoba; Women's College Hospital
• Investigators: Principal Investigator: Denice Feig, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: November 21, 2023
• First Posted (Actual): November 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Continuous Glucose Monitoring; hypoglycemia; pregnancy; insulin resistance; CGM; glycemic control; maternal outcomes; neonatal outcomes; Dexcom; glucose range; preganant; Pregnancy in Diabetes
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus, Type 2; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 21-0065-E

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes