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

NCT06147466 | Recruiting FDA Device

• 1 other identifier: 21-0065-E
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Delivery outcome

  7-9 months

• Maternal outcome

  7-9 months

• Maternal outcome (HTN)

  7-9 months

• Neonatal weight at birth

  7-9 months (Delivery of neonate)

• Neonatal outcomes (hypoglycemia)

  7-9 months (Delivery of neonate)

Interventions

Dexcom Continuous Glucose Monitoring DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• University of Manitoba: collaborator
• Women's College Hospital: collaborator

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Pregnancy in Diabetics; Hypoglycemia; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hyperinsulinism

Study Officials

• Denice Feig

  Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Denice Feig, MD, MSc, FRCPC

CONTACT

416-586-8590; Denice.Feig@sinaihealth.ca

Silva Darrouj, HBSc

CONTACT

416-586-4800; silva.darrouj@sinaihealth.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2023
• First Posted: November 27, 2023
• Study Start: March 1, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 20, 2024

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)