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

Study Overview
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Brief Summary
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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.

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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Other: New Care Pathway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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