DIAgnosing GDM usiNg Oral Sugar InStead

NCT05115188 | Completed Phase 2

• 1 other identifier: REB 418-2018
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes, Gestational

Outcome Measures

Primary Outcomes (1)

• Glucose values in the oral glucose tolerance test

  To determine if Dex4® tablets is equivalent to glucose beverage for use in the 75g OGTT in pregnant women between 24-30 weeks gestation who have screened positive for GDM. Fasting, 1hr, and 2 hr levels from the Dex4 OGTT are within 20% of the levels from the glucose beverage OGTT.

  Within 7 days

Secondary Outcomes (7)

• Adverse effect - nausea (qualitative measurement)

  Within 2 hours after glucose ingestion

• Adverse effect - vomiting (qualitative measurement)

  Within 2 hours after glucose ingestion

• Adverse effect - dizziness (qualitative measurement)

  Within 2 hours after glucose ingestion

• Adverse effect - headache (qualitative measurement)

  Within 2 hours after glucose ingestion

• Adverse effect - sweating (qualitative measurement)

  Within 2 hours after glucose ingestion

Study Arms (2)

2-hr OGTT with glucose beverage

OTHER

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.

Dietary Supplement: Glucose beverage

2-hr OGTT with Dex4® tablets

EXPERIMENTAL

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.

Dietary Supplement: Dex4/ dextrose

Interventions

Dex4/ dextrose DIETARY_SUPPLEMENT

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.

2-hr OGTT with Dex4® tablets

Glucose beverage DIETARY_SUPPLEMENT

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.

2-hr OGTT with glucose beverage

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Positive 50g GCT result between 7.8-11.0 mmol/L
• Female
• Singleton pregnancy
• Informed consent obtained and signed

You may not qualify if:

• 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

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Glucose

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a population-based, prospective randomized crossover study. Women who fall into the screen positive group of the 50g GCT (1 hour serum glucose of 7.8-11 mmol/L) will be offered participation in the study. 28 Participants will be recruited and will be randomly assigned using a pre-populated allocation table to take either the standard OGTT test (75g of glucose beverage) first or the alternative OGTT test (21 Dex4® tablets) first. The first test will be referred to as OGTT-1 and the second test will be referred to as OGTT-2.

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: November 10, 2021
• Study Start: October 1, 2022
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)