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?

This trial tests a new method for screening gestational diabetes, a type of diabetes that can develop during pregnancy. Researchers aim to determine if eating 10 Twizzlers (a type of strawberry candy) is more effective than the usual glucose drink, known as the Standard Glucola GCT, in detecting gestational diabetes. Pregnant women between 24 and 28 weeks, expecting one or more babies, and without pre-existing diabetes are eligible for this trial. As an unphased trial, this study provides an opportunity to contribute to innovative research that could enhance gestational diabetes screening methods.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that strawberry-flavored candy twists, such as Twizzlers, can safely replace the usual glucola drink for testing gestational diabetes. Studies indicate that these candy twists are effective and easy for participants to manage. No major negative effects have been reported from consuming the candy twists in these studies.

Although detailed information on side effects is limited, the absence of major issues in the studies suggests that Twizzlers are safe for most people. Participants should discuss any concerns with their healthcare providers before joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard glucola drink used for gestational diabetes screening, the Twizzlers challenge offers a fun and potentially more palatable alternative. Researchers are excited about this approach because it could improve patient compliance and comfort during testing. The Twizzlers challenge also provides a familiar and enjoyable way to screen for gestational diabetes, which may make the process less daunting for expectant mothers. This innovative method could lead to better screening experiences and outcomes for both patients and healthcare providers.

What evidence suggests that this trial's treatments could be effective for gestational diabetes?

This trial will compare the effectiveness of the Twizzlers challenge with the traditional glucola drink for screening gestational diabetes. Research has shown that Twizzlers can effectively identify all cases of gestational diabetes, similar to the glucola drink. Participants in this trial will either undergo the Twizzlers challenge or receive the standard glucola GCT. Some may prefer the Twizzlers challenge due to its better taste compared to the glucola drink. The key finding is that Twizzlers work equally well in detecting gestational diabetes. ^{1 2 3 4 6}

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

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]

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]

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]

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 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 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]

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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/261112/strawberry-candy-twists-as-an-alternative-screen-for-gestational-diabetes-a-prospective-trial/

Strawberry Candy Twists as an Alternative Screen for ... The goal of this prospective study is to determine whether there is superiority of 10 Twizzlers to the 50 gram glucola beverage for screening ...

2. ajog.org ajog.org/article/S0002-9378(14)02209-1/abstract

Candy twists as an alternative to the glucola beverage in ... Our results indicate that strawberry-flavored candy twists are potentially an equally effective screening test, compared with the gold standard glucola ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3781564/

Twizzlers as a Cost-Effective and Equivalent Alternative to ... Screening for gestational diabetes mellitus requires an oral glucose challenge test with a 50-g glucola beverage and venous blood sample after 1 h.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002937814022091

Candy twists as an alternative to the glucola beverage in ... Our results indicate that strawberry-flavored candy twists are potentially an equally effective screening test, compared with the gold standard glucola ...

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-3-2015-6f414

Strawberry Candy Twist Challenge for Gestational Diabetes Using 10 Twizzlers as a glucose source for screening gestational diabetes showed 100% sensitivity, matching the effectiveness of the traditional 50-g glucola ...

6. empr.com empr.com/home/news/drug-news/an-alternative-to-glucola-for-gdm-screening/

An Alternative to Glucola for GDM Screening? - MPR “Strawberry-flavored candy twists are potentially an equally effective screening test, compared with the gold standard glucola beverage but lead ...