The SUGAR-DIP trial: Oral medication strategy versus insulin for diabetes in pregnancy

Phase 3

Recruiting

• Conditions: 10018424; 10010273; diabetes in pregnancy; Gestational diabetes

• Registration Number: NL-OMON47522
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 810

Inclusion Criteria

- Aged 18 years or over
- Singleton pregnancy
- Diagnosis of GDM as per national guidelines
- Indication for pharmacological treatment of GDM
- Gestational age between 16 and 34 weeks
- Ability to understand Dutch or English
- Ability to provide written informed consent

Exclusion Criteria

- Known pre-existent type 1 or type 2 diabetes mellitus
- Severe medical or psychiatric comorbidities
- Serious liver disease or kidney failure, or any other condition with
contraindications for the use of either metformin or glibenclamide*
- Pregnancy with a fetus affected by major congenital birth defects and/or
chromosomal abnormalities
* * e.g. hypersensitivity to glibenclamide / metformin or to any of the
excipients, hypersensitivity to other sulphonylureas, history of ketoacidosis,
impaired adrenal function, severe infection

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome measure will be large-for-gestational-age (birthweight > 90th<br /><br>percentile)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secundary outcome measures:<br /><br>• Maternal hypoglycemia (biochemical hypoglycemia <3.9 mmol/l, symptomatic<br /><br>hypoglycemia and severe hypoglycemia prompting the need for help by another<br /><br>person)<br /><br>• Primary / secondary caesarean section<br /><br>• Pregnancy related hypertensive disorders: pregnancy induced hypertension,<br /><br>preeclampsia<br /><br>• Preterm delivery (<37 weeks of gestation)<br /><br>• Neonatal hypoglycemia: moderate (serum glucose <2.6 mmol/L), severe (serum<br /><br>glucose <2.0 mmol/L)<br /><br>• Neonatal hyperbilirubinemia requiring phototherapy<br /><br>• Neonatal Medium care / NICU admission<br /><br><br /><br>Additional outcome measures:<br /><br>• Patient satisfaction and health-related quality of life<br /><br>• Cost effectivity</p><br>