A Novel Care Pathway in Women With "Low-risk" Gestational Diabetes Mellitus

Unity Health Toronto

Status: Enrolling

Conditions: Gestational Diabetes Mellitus in Pregnancy

Treatments: Other: New Care Pathway

Study type: Interventional

Funder types: Other

Identifiers

NCT05596812

22-065

Details and patient eligibility

About

This study is a randomized controlled trial to study the effect of the use of a risk stratification screening tool for high- and low-risk gestational diabetes mellitus (GDM), and the implementation of a new low-impact care pathway for women with low-risk GDM. The study will measure how well the screening tool and new care pathway are used, and the effect of the new low-impact care pathway on glycemic control, perinatal outcomes (large for gestational age, rate of labor induction, mode of delivery, obstetric anal sphincter injury, neonatal hypoglycemia, neonatal anthropometry) and health resource utilization in women with GDM that are at low-risk of dietary therapy failure.

Enrollment: 150 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women able to understand and sign the study consent form
• singleton pregnancy
• planning to give birth to at St. Michael's Hospital
• diagnosed with GDM between 24-32 weeks' gestation based on a positive GCT or GTT result as defined by the Canadian Diabetes Association Clinical Practice Guidelines

Exclusion criteria

• Women with preexisting diabetes (Type 1 or 2 diabetes)
• multiple gestation, or a diagnosis of GDM before 24 weeks' or after 32 weeks' gestation
• not continuing care at St. Michael's Hospital after the DIP clinic visit

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups

Intervention (Risk Stratification Pathway)

Experimental group

Description:

Those randomized to Intervention (Risk Stratification Pathway) will have their demographic and clinical data entered into the risk stratification screening calculator, and will be assigned to either "Low Risk" (Novel (Low Impact) Care Pathway) or "High Risk" (Routine Care Pathway) groups. Women in the Routine Care Pathway group will be followed in the DIP clinic according to routine care protocols and will provide bi-weekly glucometer data. Women in the Novel (Low Impact) Care Pathway group will be followed in the New Care Pathway, which will include continuation of lifestyle and dietary modification, continuation of capillary self blood glucose monitoring, and routine prenatal care.

Treatment:

Other: New Care Pathway

Control (Routine Care)

No Intervention group

Description:

Those randomized to Control (Routine Care) will continue in-person and virtual visits as per routine care protocols. This group will also provide bi-weekly glucometer data.