Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
1 other identifier
interventional
617
1 country
1
Brief Summary
The goal of this prospective study is to determine whether there is superiority of 10 Twizzlers to the 50 gram glucola beverage for screening for GDM in a population based study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2015
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
November 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
ExpectedMay 11, 2023
May 1, 2023
9.8 years
November 13, 2015
May 9, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
The serum glucose levels will be measured in response to oral glucose challenge and compared between Twizzlers and glucola beverage.
Each participant will have a blood draw to check the serum glucose level.
24 to 28 weeks gestation
Secondary Outcomes (1)
Cost-effectiveness
24 to 28 weeks gestation
Study Arms (2)
Standard Glucola GCT
ACTIVE COMPARATORA prospective cohort of 617 women who will undergo screening for gestational diabetes with the standard glucola GCT between 24 and 28 weeks gestational age.
Twizzlers challenge
EXPERIMENTALAt a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.
Interventions
Participants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.
Participants will consume the Twizzlers equivalent (10 strawberry flavored Twizzlers) and have their venous blood glucose checked in 1 hour.
Eligibility Criteria
You may qualify if:
- Pregnant
- to 28 weeks gestation
- Singleton or twin or triplet gestation
- Willing to participate in the study
You may not qualify if:
- Known Type II DM
- Known Type I DM
- On oral or injectable corticosteroids
- gram glucola beverage GCT of greater than or equal to 190 mg/dl
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ben Taub General Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kjersti Aagaard, MD, PhD
Baylor College of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 13, 2015
First Posted
November 20, 2015
Study Start
April 1, 2015
Primary Completion
January 1, 2025
Study Completion (Estimated)
March 1, 2027
Last Updated
May 11, 2023
Record last verified: 2023-05