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

NCT03981328 | Completed DMC FDA Device

• 1 other identifier: 20181101
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• LGA newborns

  To assess differences in the proportion of LGA newborns (birth weight \>90. pct) in women with GDM using real-time CGM as compared to women with GDM using SMBG via capillary blood glucose monitoring.

  postpartum - up to 48 hours after delivery

Secondary Outcomes (12)

• neonatal hypoglycaemia

  postpartum - up to 48 hours after delivery

• rate of caesarean section

  postpartum - up to 48 hours after delivery

• shoulder dystocia

  postpartum - up to 48 hours after delivery

• neonatal anthropometry

  postpartum - up to 48 hours after delivery

• differences in neonatal hyperinsulinemia

  postpartum - up to 48 hours after delivery

Study Arms (2)

self-monitored blood glucose

ACTIVE COMPARATOR

The control group participants will perform self-monitored blood glucose testing with a study-provided blood glucose meter, including testing supplies. They will perform capillary blood glucose monitoring as routinely used for patients with GDM i.e. at least four capillary blood glucose values daily including measurements at fasting as well as 1h after starting each meal by using a routinely available blood glucose measurement device.

Device: self-monitored blood glucose

Continuous glucose monitoring

EXPERIMENTAL

Patients randomized to the intervention group will be equipped with a real-time CGM sensor (Dexcom G6 sensor, a small flexible device that records interstitial glucose levels every five minutes). The sensor will be inserted into the subcutaneous tissue of the anterior abdomen wall. Additionally, patients will be advised to record capillary blood glucose values if glucose alerts or readings do not match with symptoms or expectations. Participants will be educated how to exchange the sensor (has to be exchanged every ten days) and will be equipped with a real-time CGM monitor and instructed in its use. The monitor provides the user with information about current glucose levels and notifies the patient before she reaches her upper or lower glucose threshold and when glucose levels change rapidly. All patients in the intervention group will specifically trained how to use the system.

Device: Dexcom G6 Continuous Glucose Monitoring System

Interventions

Dexcom G6 Continuous Glucose Monitoring System DEVICE

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.

Continuous glucose monitoring

self-monitored blood glucose DEVICE

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.

self-monitored blood glucose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients between 18 and 55 years
• gestational diabetes mellitus in accordance with the IADPSG criteria between 24 and 31+6 weeks of gestation by a 2h 75g OGTT
• If the GDM diagnosis is made before 24+0 weeks of gestation in accordance with the local guideline (i.e. when IADPSG cut-offs for fasting and post-load glucose are exceeded) patients can be included if no insulin treatment was started until 24+0

You may not qualify if:

• Overt diabetes (i.e. pregestationally known type 1 or type 2 diabetes or fasting plasma glucose during the OGTT ≥126 mg/dl \[7.0 mmol/l\] or HbA1c ≥6.5% \[44 mmol/l\] or 2h post-load OGTT levels ≥200 mg/dl \[11.1 mmol/l\] assessed before 24+0 weeks of gestation
• history of bariatric surgery or other surgeries that induce malabsorption
• long-term use (\>2 weeks) of systemic steroids prior to enrolment
• multiple pregnancy
• Patients already using glucose lowering medications (metformin or insulin) before study entry
• fetal growth restriction due to placental dysfunction at study entry - Inpatient psychiatric treatment up to 1 year before enrolment
• Participation in this study in previous pregnancy

Sponsors & Collaborators

• Medical University of Vienna: lead
• University Hospital, Basel, Switzerland: collaborator
• Charite University, Berlin, Germany: collaborator
• CNR Institute of Neurosceince, Padova, Italy: collaborator
• Università Politecnica delle Marche: collaborator
• DexCom, Inc.: collaborator
• Jena University Hospital: collaborator
• German Diabetes Center: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology, Division of Obstetrics and Feto-maternal Medicine, Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• Linder T, Dressler-Steinbach I, Wegener S, Schellong K, Schmidt S, Eppel D, Monod C, Heinzl F, Redling K, Winzeler B, Mosimann B, Weschenfelder F, Groten T, Mittlbock M, Jendle J, Henrich W, Morettini M, Bozkurt L, Tura A, Gobl C; GRACE study collaborative group. Glycaemic control and pregnancy outcomes with real-time continuous glucose monitoring in gestational diabetes (GRACE): an open-label, multicentre, multinational, randomised controlled trial. Lancet Diabetes Endocrinol. 2026 Jan;14(1):50-61. doi: 10.1016/S2213-8587(25)00288-8. Epub 2025 Nov 24.

  PMID: 41308662 DERIVED

• Huhn EA, Linder T, Eppel D, Weisshaupt K, Klapp C, Schellong K, Henrich W, Yerlikaya-Schatten G, Rosicky I, Husslein P, Chalubinski K, Mittlbock M, Rust P, Hoesli I, Winzeler B, Jendle J, Fehm T, Icks A, Vomhof M, Greiner GG, Szendrodi J, Roden M, Tura A, Gobl CS. 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. BMJ Open. 2020 Nov 30;10(11):e040498. doi: 10.1136/bmjopen-2020-040498.

  PMID: 33257486 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational; Pregnancy Complications

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Privatdozent, MD, PhD, MSc

Study Record Dates

• First Submitted: February 15, 2019
• First Posted: June 10, 2019
• Study Start: August 24, 2020
• Primary Completion: August 24, 2024
• Study Completion: February 28, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)