Back to resultsTime-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous glucose monitoring (CGM)
Self-Capillary Blood Glucose Monitoring (SCBG)
Sponsored by
About this trial
This is an interventional supportive care trial for Gestational Diabetes focused on measuring Female, pregnancy, gestational diabetes
Eligibility Criteria
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.
Sites / Locations
- OHSURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention Arm
Referent Arm
Arm Description
Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually.
Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks.
Outcomes
Primary Outcome Measures
Average time-in-range over a 24 hour period
Secondary Outcome Measures
Average time-in-range during waking hours
Average time-in-range while asleep
Full Information
NCT ID
NCT04605497
First Posted
October 22, 2020
Last Updated
March 23, 2023
Sponsor
Oregon Health and Science University
Collaborators
DexCom, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04605497
Brief Title
Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
DexCom, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The continual glucose is going to increase time-in-range compared to the standard method in women with gestational diabetes
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
Keywords
Female, pregnancy, gestational diabetes
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
Use of Dexcom G6 real-time CGM to monitor blood glucose levels continually.
Arm Title
Referent Arm
Arm Type
Other
Arm Description
Self-capillary blood glucose monitoring (SCBG) testing 4x/day with blinded CGM every 2 weeks.
Intervention Type
Diagnostic Test
Intervention Name(s)
Continuous glucose monitoring (CGM)
Intervention Description
Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period
Intervention Type
Diagnostic Test
Intervention Name(s)
Self-Capillary Blood Glucose Monitoring (SCBG)
Intervention Description
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
Primary Outcome Measure Information:
Title
Average time-in-range over a 24 hour period
Time Frame
From enrollment to10 days after discharge from hospital following delivery
Secondary Outcome Measure Information:
Title
Average time-in-range during waking hours
Time Frame
From enrollment to10 days after discharge from hospital following delivery
Title
Average time-in-range while asleep
Time Frame
From enrollment to10 days after discharge from hospital following delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Women's Health Research Unit Department of Ob/Gyn
Phone
503-494-3666
Email
whru@ohsu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Valent
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amy Valent
Email
valent@ohsu.edu
12. IPD Sharing Statement
Learn more about this trial
Time-in-range Using Continuous Glucose Monitoring Management of Gestational Diabetes Mellitus
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