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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Other: New Care Pathway

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Howard Berger, MD; Phone Number: 2395 416 864 6060; Email: Howard.Berger@unityhealth.to
• Study Contact Backup: Name: Klaudia Szczech; Phone Number: 49092 416 867 7460; Email: Klaudia.Szczech@unityhealth.to

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St. Michael's Hospital (Unity Health Toronto)
      • Contact: Howard Berger, MD; Phone Number: 2395 416 864 6060; Email: Howard.Berger@unityhealth.to
      • Contact: Klaudia Szczech; Phone Number: 49092 416 867 7460; Email: Klaudia.Szczech@unityhealth.to

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Risk Stratification Pathway); 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.	Other: New Care Pathway; The New Care Pathway will include continuation of lifestyle and dietary modification, self-blood glucose monitoring, and routine prenatal care.
No Intervention: Control (Routine Care); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of the novel risk stratification screening tool	number of patients screened, recruited, consented and randomized as documented in the study recruitment log	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the GDM risk stratification tool	With regards to identification of women with GDM who maintain euglycemia on lifestyle modification alone in the "Low-risk GDM" group. Sensitivity, specificity, and accuracy will be calculated.	2 years
Glycemic control - blood glucose (units)	mean Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG) in mg/dL	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Glycemic control - blood glucose (percent above target)	percent above target Fasting Plasma Glucose (FPG) and Post-Prandial Glucose (PPG)	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Gestational weight gain	in kilograms (kg)	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Development of hypertensive disorders of pregnancy	documented as recorded from patient charts (Yes/No)	approximately 9 months (from recruitment at 24-32 weeks gestation to 3-months postpartum)
Delivery outcomes - gestational age at delivery	measured in weeks	recorded at time of delivery
Delivery outcomes - mode of delivery	vaginal/caesarean/spontaneous/instrumental/forceps/vacuum/combined	recorded at time of delivery
Neonatal outcomes - size for gestational age	measured in grams	recorded at time of delivery
Neonatal outcomes - Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score	Appearance, Pulse, Grimace, Activity, Respiration (APGAR) score is based on a total score of 1 to 10; The Apgar score comprises five components: 1) color, 2) heart rate, 3) reflexes, 4) muscle tone, and 5) respiration, each of which is given a score of 0, 1, or 2. A score of 7 or above on the test is considered in good health. A lower score does not mean that the baby is unhealthy, but that the baby may need some immediate medical care, such as suctioning of the airways or oxygen to help him or her breathe better.	recorded at delivery (at 1 minute and 5 minutes of age)
Health service outcomes - health resource utilization	total number of care encounters (categorized by department - endocrine, obstetric)	2 years
Health service outcomes - Short-form Patient Satisfaction Questionnaire (PSQ-18)	Short-form Patient Satisfaction Questionnaire (PSQ-18); responses to items are measured on a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Minimum score is 18, maximum score is 90. Higher scores indicate satisfaction with medical care.	2 years; administered to each participant at 6-weeks postpartum

Collaborators and Investigators

• Sponsor: Unity Health Toronto

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: October 24, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Diabetes Mellitus; Diabetes, Gestational; Pregnancy in Diabetics
• Other Study ID Numbers: 22-065

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No