ClinicalTrials.gov
ClinicalTrials.gov Menu

Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02610179
Recruitment Status : Recruiting
First Posted : November 20, 2015
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):
Kjersti Aagaard, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus Dietary Supplement: Standard Glucola GCT Dietary Supplement: Twizzlers challenge Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 617 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Strawberry Candy Twists as an Alternative Screen for Gestational Diabetes: A Prospective Trial
Study Start Date : April 2015
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard Glucola GCT
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.
Dietary Supplement: Standard Glucola GCT
Participants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.

Experimental: Twizzlers challenge
At a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.
Dietary Supplement: Twizzlers challenge
Participants will consume the Twizzlers equivalent (10 strawberry flavored Twizzlers) and have their venous blood glucose checked in 1 hour.




Primary Outcome Measures :
  1. The serum glucose levels will be measured in response to oral glucose challenge and compared between Twizzlers and glucola beverage. [ Time Frame: 24 to 28 weeks gestation ]
    Each participant will have a blood draw to check the serum glucose level.


Secondary Outcome Measures :
  1. Cost-effectiveness [ Time Frame: 24 to 28 weeks gestation ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02610179


Contacts
Contact: Kjersti Aagaard, MD, PhD 713-798-8467 aagaardt@bcm.edu

Locations
United States, Texas
Ben Taub General Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Kjersti Aagaard, MD, PhD    713-798-8467    aagaardt@bcm.edu   
Sponsors and Collaborators
Baylor College of Medicine
Investigators
Principal Investigator: Kjersti Aagaard, MD, PhD Baylor College of Medicine

Responsible Party: Kjersti Aagaard, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02610179     History of Changes
Other Study ID Numbers: H-35564
First Posted: November 20, 2015    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications