Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
Primary Purpose
Gestational Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Glucola GCT
Twizzlers challenge
Sponsored by
About this trial
This is an interventional screening trial for Gestational Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
- Pregnant
- 24 to 28 weeks gestation
- Singleton or twin or triplet gestation
- Willing to participate in the study
Exclusion Criteria:
- Known Type II DM
- Known Type I DM
- On oral or injectable corticosteroids
- 50 gram glucola beverage GCT of greater than or equal to 190 mg/dl
Sites / Locations
- Ben Taub General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard Glucola GCT
Twizzlers challenge
Arm Description
A prospective cohort of 617 women who will undergo screening for gestational diabetes with the standard glucola GCT between 24 and 28 weeks gestational age.
At a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Cost-effectiveness
The cost-effectiveness of Twizzlers over the glucola beverage will be measured in a small gravid cohort by taking into account the cost per unit of Twizzlers versus glucola.
Full Information
NCT ID
NCT02610179
First Posted
November 13, 2015
Last Updated
May 9, 2023
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT02610179
Brief Title
Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
Official Title
Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 2015 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The aim now is to perform a large, prospective trial to test Twizzlers® as a cost effective glucola alternative in a gravid population to determine its sensitivity, specificity, PPV (positive predictive value) and NPV (negative predictive value) alongside ROC (receiver operating curve) from a population-based cohort.
Participants will be enrolled among the pregnant patients in the Harris Health System Obstetrics Clinics who are either due for the standard glucola GCT (glucose challenge test) or who have had their glucola screening but have not had the 3 hour GTT (glucose tolerance test). These women will be offered the opportunity to consume the Twizzler equivalent of the 50 gm glucola beverage (10 strawberry flavored Twizzlers) and to have their venous blood glucose checked 1 hour post consumption. This will all be done while the patient is in clinic and will not necessitate any extra clinic visits on their behalf. They will then go on to be scheduled for their confirmatory 3 hour glucose tolerance tests if indicated by any abnormality in either their glucola GCT or their Twizzlers challenge. The efficacy of Twizzlers will then be compared to the 50 gm glucola beverage as a screen for gestational diabetes. Specifically, the sensitivity, specificity, PPV, NPV, NNT (number needed to treat), ROC, and referral rates for each mode of screening will be calculated.
For the Twizzler portion of the study, the subjects will consume 10 strawberry Twizzlers within 5 minutes. One hour after consumption begins each participant will have a blood draw to check a serum glucose level. Within the same day, the samples will be delivered to Dr. Morey Haymond's lab for analysis.
Serum glucose and insulin levels will be tested on each sample. The amount of each blood sample will be approximately 10 ml of blood (2 teaspoons). Sample collection (blood draws; venipuncture) will allow for testing the serum glucose levels of subjects after consumption of Twizzlers. These values will be used for analysis to determine if Twizzlers are truly equivalent to the Glucola beverage. Ultimately, the patient's will only undergo 1 extra venipuncture than what they would have had as part of their routine prenatal care if both screening tests are normal. There is a possibility of undergoing a 3 hour GTT that would not have otherwise been performed if the subjects Twizzlers screen is elevated but glucola was normal.
Participants will receive a phone call to report any abnormal values on their GCT as per standard clinical operating measures, and will have their GTT scheduled with the nursing staff. Based on prior studies, a notable rate of false-positives is not anticipated with the Twizzler GCT. In the rare occasion that such occurs (i.e., screen positive by Twizzler but not by glucola beverage) they will be informed of the need for a 3 hour GTT. This will be covered by the study costs, and their insurance will not be charged.
Pregnancy outcomes data for subjects will be collected, including gestational age at delivery, mode of delivery and any complications, maternal weight gain, and infant birthweight. This will all be acquired as data abstraction from the EMR and maintained in a secure coded database.
Otherwise, there will be no further contact or requirements of the subject.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
617 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Glucola GCT
Arm Type
Active Comparator
Arm Description
A prospective cohort of 617 women who will undergo screening for gestational diabetes with the standard glucola GCT between 24 and 28 weeks gestational age.
Arm Title
Twizzlers challenge
Arm Type
Experimental
Arm Description
At a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.
Intervention Type
Dietary Supplement
Intervention Name(s)
Standard Glucola GCT
Intervention Description
Participants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.
Intervention Type
Dietary Supplement
Intervention Name(s)
Twizzlers challenge
Intervention Description
Participants will consume the Twizzlers equivalent (10 strawberry flavored Twizzlers) and have their venous blood glucose checked in 1 hour.
Primary Outcome Measure Information:
Title
The serum glucose levels will be measured in response to oral glucose challenge and compared between Twizzlers and glucola beverage.
Description
Each participant will have a blood draw to check the serum glucose level.
Time Frame
24 to 28 weeks gestation
Secondary Outcome Measure Information:
Title
Cost-effectiveness
Description
The cost-effectiveness of Twizzlers over the glucola beverage will be measured in a small gravid cohort by taking into account the cost per unit of Twizzlers versus glucola.
Time Frame
24 to 28 weeks gestation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Pregnant
24 to 28 weeks gestation
Singleton or twin or triplet gestation
Willing to participate in the study
Exclusion Criteria:
Known Type II DM
Known Type I DM
On oral or injectable corticosteroids
50 gram glucola beverage GCT of greater than or equal to 190 mg/dl
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kjersti Aagaard, MD, PhD
Phone
713-798-8467
Email
aagaardt@bcm.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjersti Aagaard, MD, PhD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kjersti Aagaard, MD, PhD
Phone
713-798-8467
Email
aagaardt@bcm.edu
12. IPD Sharing Statement
Learn more about this trial
Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
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