Who is sponsoring NCT03981328?

NCT03981328 is sponsored by Medical University of Vienna.

What condition does NCT03981328 study?

NCT03981328 studies Cgm, Gestational Diabetes, Pregnancy Complications, Blood Glucose, GDM.

Is NCT03981328 still recruiting?

NCT03981328 is currently completed. Last updated 2 April 2025.

Last reviewed 2025-04-02 · How we verify

NCT03981328: GRACE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Real-time Continuous Glucose Monitoring for Reduced Adverse Complications and Events in Women With Gestational Diabetes (GRACE): a Multicentre International Randomized Controlled Trial

Completed NA Last updated 2 April 2025

What this trial tests

NA trial testing Dexcom G6 Continuous Glucose Monitoring System in Cgm in 375 participants. Completed in 28 February 2025.

Timeline

24 August 2020

Primary endpoint
24 August 2024

28 February 2025

Quick facts

Lead sponsor	Medical University of Vienna
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	375
Start date	24 August 2020
Primary completion	24 August 2024
Estimated completion	28 February 2025
Sites	1 location across Austria

Drugs / interventions tested

Dexcom G6 Continuous Glucose Monitoring System
self-monitored blood glucose

Conditions studied

Cgm — all drugs for Cgm →
Gestational Diabetes — all drugs for Gestational Diabetes →
Pregnancy Complications — all drugs for Pregnancy Complications →
Blood Glucose — all drugs for Blood Glucose →

Sponsor

Medical University of Vienna

Who can join

Adults 18 to 55, female only, with Cgm or Gestational Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Real-time continuous glucose monitoring (CGM) systems provide users with information about current glucose levels and alert the patient before the upper or lower glucose threshold is reached or when glucose levels change rapidly. Hence, glycaemic excursions can be early identified and accordingly adapted by behavioural change or pharmacologic intervention. Randomized controlled studies adequately powered to evaluate the impact of long-term application of real-time CGM systems on the risk reduction of adverse obstetric outcomes are missing.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Effectiveness of real-time continuous glucose monitoring to improve glycaemic control and pregnancy outcome in patients with gestational diabetes mellitus: a study protocol for a randomised controlled trial.
Huhn EA, Linder T, Eppel D, Weißhaupt K, et al · · 2020 · cited 11× · PMID 33257486 · DOI 10.1136/bmjopen-2020-040498
Glycaemic control and pregnancy outcomes with real-time continuous glucose monitoring in gestational diabetes (GRACE): an open-label, multicentre, multinational, randomised controlled trial.
Linder T, Dressler-Steinbach I, Wegener S, Schellong K, et al · · 2026 · PMID 41308662 · DOI 10.1016/s2213-8587(25)00288-8

Verify or expand the search:

Other Medical University of Vienna trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03981328 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical University of Vienna
Last refreshed: 2 April 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03981328.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing