Strawberry Candy Twist Challenge for Gestational Diabetes

Overseen By Kjersti Aagaard, MD, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Baylor College of Medicine

Must not be taking: Corticosteroids

Disqualifiers: Type II DM, Type I DM, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

617 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications, but if you are on oral or injectable corticosteroids, you cannot participate.

How is the Strawberry Candy Twist Challenge treatment different from other treatments for gestational diabetes?

The Strawberry Candy Twist Challenge uses Twizzlers candy as a cost-effective and more tolerable alternative to the standard glucola drink for gestational diabetes screening, offering the same glucose load without the side effects and expense associated with the traditional beverage. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Strawberry Candy Twist Challenge for Gestational Diabetes?

Research suggests that candy twists like Twizzlers can be a cost-effective and tolerable alternative to the traditional glucola beverage used in gestational diabetes screening, providing an equivalent glucose load without significant side effects. ^{1 3 6 7 8}

Who Is on the Research Team?

Kjersti Aagaard, MD, PhD

Principal Investigator

Baylor College of Medicine

Are You a Good Fit for This Trial?

This trial is for pregnant individuals between 24 to 28 weeks of gestation, carrying one or more babies (up to triplets), and willing to participate. It's not for those on steroids, with known Type I or II Diabetes, or a previous high blood sugar level after a glucose challenge test.

Inclusion Criteria

I am between 24 and 28 weeks pregnant.

Singleton or twin or triplet gestation

I am willing to participate in the study.

Exclusion Criteria

Your blood sugar level is higher than 190 mg/dl after drinking a 50 gram glucola beverage.

I have Type 2 diabetes.

I have Type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Twizzlers Challenge

Participants consume 10 strawberry Twizzlers and have their venous blood glucose checked 1 hour post consumption

1 day

1 visit (in-person)

Standard Glucola GCT

Participants undergo screening for gestational diabetes with the standard glucola GCT

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any abnormal values on their GCT and scheduled for a 3 hour GTT if necessary

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Standard Glucola GCT
• Twizzlers challenge

Trial Overview The study is testing if eating 10 Twizzlers can be as effective as drinking the standard glucola beverage in screening for gestational diabetes. Participants will be given either Twizzlers or glucola and their blood sugar levels will be compared.

How Is the Trial Designed?

Group I: Twizzlers challenge Experimental Treatment 1 Intervention

At a later date, the same prospective cohort of 617 women Participants will receive their Twizzlers challenge between 24 and 28 weeks gestational age.

Group II: Standard Glucola GCT Active Control 1 Intervention

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.

Standard Glucola GCT is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Glucola for:

• Screening for Gestational Diabetes Mellitus (GDM)

Approved in European Union as 50g Oral Glucose Tolerance Test for:

• Screening for Gestational Diabetes Mellitus (GDM)

Approved in Canada as 50g OGTT for:

• Screening for Gestational Diabetes Mellitus (GDM)

Who Is Running the Clinical Trial?

Baylor College of Medicine

Lead Sponsor

Trials

1,044

Recruited

6,031,000+

Published Research Related to This Trial

Using 10 Twizzlers as a glucose source for screening gestational diabetes showed 100% sensitivity, matching the effectiveness of the traditional 50-g glucola beverage, based on a study involving pregnant women with abnormal screening results.

The Twizzlers alternative resulted in a significantly lower false-referral rate (82% vs 90%) and higher positive predictive value (18% vs 10%), suggesting it could be a more reliable and cost-effective option for screening gestational diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Candy twists as an alternative to the glucola beverage in gestational diabetes mellitus screening. Racusin, DA., Antony, K., Showalter, L., et al.[2015]

The new non-carbonated lemon-lime flavored beverage for the oral glucose tolerance test (OGTT) was found to be more palatable and better accepted by participants compared to the traditional 75-gram glucose beverage, with an overall satisfaction score of 7.1 versus 4.7.

Despite the improved acceptability, the new beverage did not show any significant differences in plasma glucose levels or insulin responses compared to the traditional OGTT, indicating that it is equally effective for diagnosing impaired glucose tolerance and diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of New Lemon-Lime Flavored Beverage for OGTT: Acceptability and Reproducibility. Chotwanvirat, P., Thewjitcharoen, Y., Parksook, W., et al.[2018]

The 50g-glucose challenge test (50g-GCT) has a positive predictive value (PPV) of approximately 23% for detecting gestational diabetes in twin pregnancies, based on a systematic review of 7 studies involving over 55,000 participants.

The screening rate for gestational diabetes using the 50g-GCT is higher in twin pregnancies compared to singleton pregnancies, indicating that the test may perform differently in this population, although data on sensitivity and specificity is lacking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The screening performance of glucose challenge test for gestational diabetes in twin pregnancies: a systematic review and meta-analysis. Zhao, G., Murphy, KE., Berger, H., et al.[2022]

A modified 100-g oral glucose tolerance test (OGTT) can effectively diagnose gestational diabetes mellitus (GDM) using fewer glucose measurements, improving efficiency in testing.

The combination of fasting plasma glucose (FPG) with 1-hour and 2-hour glucose values achieved 100% sensitivity and 92% accuracy, making it a promising alternative for GDM diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of a modified 100-gram oral glucose tolerance test for diagnosis of gestational diabetes mellitus and its diagnostic accuracy. Ruangvutilert, P., Chaemsaithong, P., Ruangrongmorakot, K., et al.[2022]

In a study of 14,797 women, those with twin pregnancies had significantly higher glucose challenge test (GCT) results compared to singleton pregnancies, indicating a greater likelihood of elevated glucose levels.

However, the positive predictive value for identifying abnormal results in the subsequent oral glucose tolerance test (OGTT) was lower in twin pregnancies, suggesting that the GCT may lead to more false positives in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The performance of the screening test for gestational diabetes in twin versus singleton pregnancies. Yogev, Y., Eisner, M., Hiersch, L., et al.[2015]

In a study of 13,901 women screened for gestational diabetes, those with a glucose challenge test (GCT) result of 130-139 mg/dL and >=140 mg/dL were found to have a higher risk of perinatal complications, including preeclampsia and operative deliveries.

Women with GCT results of 130-139 mg/dL had increased odds of adverse outcomes for their newborns, such as lower Apgar scores, shoulder dystocia, and birth trauma, suggesting that further diagnostic testing for gestational diabetes should be considered for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glucose challenge test: screening threshold for gestational diabetes mellitus and associated outcomes. Cheng, YW., McLaughlin, GB., Esakoff, TF., et al.[2007]

In a study of 62,877 pregnancies over 10 years, a 50g-glucose challenge test (GCT) with a cut-off of 12 mmol/l showed a very high positive predictive value (PPV) of 95.3% for diagnosing gestational diabetes (GDM), suggesting that GCT alone can be sufficient for diagnosis in cases of very elevated results.

The study also found that performing the GCT in the morning increased the PPV for GDM, indicating that the timing of the test can significantly impact its diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyperglycaemia following glucose challenge test during pregnancy: when can a screening test become diagnostic? Wong, VW., Garden, F., Jalaludin, B.[2009]

In a study of 289 pregnant women, the 50g oral glucose challenge test (GCT) effectively identified 16.96% of participants with elevated glucose levels, leading to further testing for gestational diabetes mellitus (GDM).

The study found that mothers with gestational impaired glucose tolerance (GIGT) and GDM had higher rates of complications such as preeclampsia and cesarean sections, indicating the importance of early screening with the 50g GCT for better maternal and fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Carbohydrate intolerance and pregnancy outcome]. Sun, BZ., Wang, XG., Wang, YL.[2006]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Candy twists as an alternative to the glucola beverage in gestational diabetes mellitus screening. [2015]

2. Thailand pubmed.ncbi.nlm.nih.gov

Development of New Lemon-Lime Flavored Beverage for OGTT: Acceptability and Reproducibility. [2018]

3. England pubmed.ncbi.nlm.nih.gov

The screening performance of glucose challenge test for gestational diabetes in twin pregnancies: a systematic review and meta-analysis. [2022]

4. Thailand pubmed.ncbi.nlm.nih.gov

Development of a modified 100-gram oral glucose tolerance test for diagnosis of gestational diabetes mellitus and its diagnostic accuracy. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The performance of the screening test for gestational diabetes in twin versus singleton pregnancies. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Glucose challenge test: screening threshold for gestational diabetes mellitus and associated outcomes. [2007]

7. Ireland pubmed.ncbi.nlm.nih.gov

Hyperglycaemia following glucose challenge test during pregnancy: when can a screening test become diagnostic? [2009]

8. China pubmed.ncbi.nlm.nih.gov

[Carbohydrate intolerance and pregnancy outcome]. [2006]