DIAgnosing GDM usiNg Oral Sugar InStead
Key facts
- Who runs it
- Sunnybrook Health Sciences Centre
- Where
- Canada1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- Phase
- Phase 2
- People taking part
- 31 people enrolled
- Started
- 1 Oct 2022
- Ended
- 30 Sept 2025
- Type of study
- Interventional, 2 groups
- Treatments tested
- Dex4/ dextrose
- Glucose beverage
- Record updated
- 29 December 2025
Who can take part
- Sex
- Women only
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- Positive 50g GCT result between 7.8-11.0 mmol/L
- Female
- Singleton pregnancy
- Informed consent obtained and signed
Who cannot take part
- Use of steroids, terbutaline, or metformin within the last 4 weeks
- Previous diagnosis of diabetes type 1 or 2 outside of pregnancy or diagnosis with any form of diabetes prior to 20 weeks of pregnancy
- Allergy to any ingredients (including the non-medicinal ingredients) in Dex4® tablets or Glucodex solution
Other criteria
- Eligibility criteria must be met by 32 weeks' gestation to allow enrollment in the study
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
The purpose of this study is to compare the positive and negative effects of Dex4® tablets, as an alternative form of fast acting carbohydrate, compared to the current standard diagnostic test, glucose beverage. The investigators hypothesis that because of their availability in solid, chewable form, variety of flavours and lack of carbonation, Dex4® tablets may result in fewer side effects than glucose beverage and provide an equivalent carbohydrate challenge for diagnosis of gestational diabetes.
The 2 groups in the trial
- 2-hr OGTT with glucose beverageOther group
For the 2 hour oral glucose tolerance test (OGTT), women fast for 8 hours and then consume 75g of glucose beverage, and serum glucose levels are taken at fasting, 1 and 2 hours after drinking the glucose beverage. The 75g OGTT is the gold standard and is performed for GDM diagnosis.
Treatment: Glucose beverage
- 2-hr OGTT with Dex4® tabletsTreatment being tested
Participants will be asked to ingest 21 Dex4® tablets and no more than 300ml of water within 5 minutes. Blood draws will be performed at fasting (before ingesting the dextrose monohydrate tablets), as well as 1 hour after (+/- 15 minutes) and 2 hours (+/- 15 minutes) after ingesting the dextrose monohydrate tablets.
Treatment: Dex4/ dextrose
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Randomized Crossover Study Comparing the Standard Glucose Beverage and Dex4® Tablets for 2 Hour Oral Glucose Tolerance Testing in Pregnant Women With a Positive Screen on the 50g Glucose Tolerance Challenge for Gestational Diabetes
- Record updated
- 29 December 2025