Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus

Study Overview
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Brief Summary
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The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes

Official Title
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A Single Center Open-label Randomized Control Pilot Study to Assess the Efficacy of Real-time Continuous Glucose Monitoring in Subjects With Gestational Diabetes to Increase Glucose Time-in-range

Conditions
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Gestational Diabetes

Intervention / Treatment
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* Diagnostic Test: Continuous glucose monitoring (CGM)
* Diagnostic Test: Self-Capillary Blood Glucose Monitoring (SCBG)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-55 years Singleton pregnancy ≥20 weeks gestation Diagnosed with GDM by either 1-step (IADPSG) or 2-Step (Carpenter-Coustan) Compatible, validated phone and operating system to support Dexcom G6 CGM App (See Supplementary Table 1) or option to use receiver Exclusion Criteria: Chronic immunosuppression Concomitant disease or condition that may compromise patient safety or the ability to complete study tasks including and not limited to: severe mental illness or a diagnosed or suspected eating disorder Known allergy to medical grade adhesives Pre-gestational diabetes Multifetal gestation Current alcohol or illicit drug use Simultaneous participation in another clinical study with investigational medicinal product(s) that might have an impact on the study objectives.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually. | Diagnostic Test: Continuous glucose monitoring (CGM)<br>* Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period<br>|
| Other: Referent Arm<br>Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks. | Diagnostic Test: Self-Capillary Blood Glucose Monitoring (SCBG)<br>* Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average time-in-range over a 24 hour period |  | From enrollment to10 days after discharge from hospital following delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average time-in-range during waking hours |  | From enrollment to10 days after discharge from hospital following delivery | 
| Average time-in-range while asleep |  | From enrollment to10 days after discharge from hospital following delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, pregnancy, gestational diabetes