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

Summary

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.

Conditions

• Cgm
• Gestational Diabetes
• Pregnancy Complications
• Blood Glucose
• GDM

Interventions

DEVICE

Dexcom G6 Continuous Glucose Monitoring System

Users insert a tiny sensor wire just under their skin using an automatic applicator. The sensor can measure glucose readings in interstitial fluid throughout the day and night.

DEVICE

self-monitored blood glucose

Each participant in the control group will be assigned a study blood glucose meter to measure and store their blood glucose values during the study. Therefore, the Contour® Next One system (or a comparable device) will be used. The meter has CE Mark clearance and is commercially available in Europe. Participants will receive an ample supply of meter test materials based on quantities routinely used.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland

  collaborator OTHER

• Charite University, Berlin, Germany

  collaborator OTHER

• CNR Institute of Neurosceince, Padova, Italy

  collaborator UNKNOWN

• Università Politecnica delle Marche

  collaborator OTHER

• DexCom, Inc.

  collaborator INDUSTRY

• Jena University Hospital

  collaborator OTHER

• German Diabetes Center

  collaborator OTHER

• Medical University of Vienna

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-08-24

Primary Completion

2024-08-24

Completion

2025-02-28

FDA Device

Yes

Countries

• Austria

Study Locations