Utility of Real Time Continuous Glucose Monitoring in the Care of Gestational Diabetes Versus Standard Care in Pregnancy Outcomes

NCT05037526 | Completed

• 1 other identifier: UCB_GDMV4.0
• Study Type: interventional
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

Once a pregnant mother is diagnosed with gestational diabetes mellitus (GDM), she will be treated with either diet, medication (i.e., insulin), or both. The most important factor in GDM management is glycemic control to reduce adverse outcomes. Blood glucose levels have become the "key player" for monitoring and directing treatment during pregnancy. Large trials have confirmed that treatment of GDM to optimize glycemic control can decrease the incidence of many of these associated adverse maternal and neonatal outcomes. Up to now, SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily. However, SMBG provides an incomplete picture of the daily glucose profile due to long intervals between finger pricking, and inaccurate self-reported measurements, which heavily rely on patients' compliance.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• Composite adverse pregnancy and neonatal outcome

  The primary endpoint is composite adverse pregnancy and neonatal outcome; the proportion of large for gestation age (LGA) newborns (birth weight \>90th centile); fetal macrosomia (estimated fetal weight over the 95th centile); incidence of polyhydramnios (maximal vertical pocket ≥ 8 cm); rate of neonatal hypoglycaemia; occurrence of stillbirth. Every each and one of these variables contributes to a better neonatal outcome and are associated. This composite endpoint includes factors influencing decisive the neonatal outcome.

  2 years

Secondary Outcomes (24)

• Initiated Therapy

  10-14 weeks

• Glycemic Outcomes 1

  10-14 weeks

• Glycemic Outcomes 2

  10-14 weeks

• Glycemic Outcomes 3

  10-14 weeks

• Glycemic Outcomes 4

  10-14 weeks

Study Arms (2)

Dexcom G System

ACTIVE COMPARATOR

The Dexcom G6 or current version intended use is for the management of diabetes. It is a small flexible device that records interstitial glucose levels every 5 min and is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. Interpretation of the Dexcom G6 or current version System results should be based on the glucose trends and several sequential readings over time. The system consists of a sensor, transmitter, receiver and mobile app.

Device: Dexcom G System

Standard care of gestational diabetes with self monitoring blood glucose (SMBG)

ACTIVE COMPARATOR

SMBG (self-monitoring of blood glucose) is recommended for women with gestational diabetes that involves finger pricking up to six times daily.

Device: Self monitoring blood glucose

Interventions

Dexcom G System DEVICE

Continuous glucose monitoring system

Dexcom G System

Self monitoring blood glucose DEVICE

Standard Care

Standard care of gestational diabetes with self monitoring blood glucose (SMBG)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent as documented by signature
• GDM diagnosis between 24 0/7- 28 0/7 weeks of pregnancy by a 75g oral glucose test (oGTT)
• Maternal age of 18 to 45 years,
• Singleton gestation
• Gestational age ≥ 24 0/7 weeks and \<32 0/7 weeks at enrollment.

You may not qualify if:

• Known hypersensitivity or allergy to the sensor
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders of the participant
• Participation in another study with investigational drug or product within the 30 days preceding and during the present study
• Maternal age \< 18 years,
• Multi-fetal gestations,
• Known fetal structural or chromosomal anomalies
• Chronic use of medications associated with hyperglycemia (steroids)
• Planned preterm delivery
• Overt diabetes mellitus type 1 or 2
• HbA1c by study entry \> 6.5%
• History of bariatric surgery or other surgeries that induce malabsorption
• Fetal growth restriction by study entry

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital of Bern, Inselspital

Bern, 3010, Switzerland

Location

Related Publications (7)

• Castorino K, Polsky S, O'Malley G, Levister C, Nelson K, Farfan C, Brackett S, Puhr S, Levy CJ. Performance of the Dexcom G6 Continuous Glucose Monitoring System in Pregnant Women with Diabetes. Diabetes Technol Ther. 2020 Dec;22(12):943-947. doi: 10.1089/dia.2020.0085.

  PMID: 32324061 RESULT

• Cosson E, Baz B, Gary F, Pharisien I, Nguyen MT, Sandre-Banon D, Jaber Y, Cussac-Pillegand C, Banu I, Carbillon L, Valensi P. Poor Reliability and Poor Adherence to Self-Monitoring of Blood Glucose Are Common in Women With Gestational Diabetes Mellitus and May Be Associated With Poor Pregnancy Outcomes. Diabetes Care. 2017 Sep;40(9):1181-1186. doi: 10.2337/dc17-0369. Epub 2017 Jul 19.

  PMID: 28724718 RESULT

• Feig DS, Donovan LE, Corcoy R, Murphy KE, Amiel SA, Hunt KF, Asztalos E, Barrett JFR, Sanchez JJ, de Leiva A, Hod M, Jovanovic L, Keely E, McManus R, Hutton EK, Meek CL, Stewart ZA, Wysocki T, O'Brien R, Ruedy K, Kollman C, Tomlinson G, Murphy HR; CONCEPTT Collaborative Group. Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial. Lancet. 2017 Nov 25;390(10110):2347-2359. doi: 10.1016/S0140-6736(17)32400-5. Epub 2017 Sep 15.

  PMID: 28923465 RESULT

• Inayama Y, Yamanoi K, Shitanaka S, Ogura J, Ohara T, Sakai M, Suzuki H, Kishimoto I, Tsunenari T, Suginami K. A novel classification of glucose profile in pregnancy based on continuous glucose monitoring data. J Obstet Gynaecol Res. 2021 Apr;47(4):1281-1291. doi: 10.1111/jog.14677. Epub 2021 Jan 27.

  PMID: 33501738 RESULT

• Polsky S, Garcetti R, Pyle L, Joshee P, Demmitt JK, Snell-Bergeon JK. Continuous glucose monitor use with and without remote monitoring in pregnant women with type 1 diabetes: A pilot study. PLoS One. 2020 Apr 16;15(4):e0230476. doi: 10.1371/journal.pone.0230476. eCollection 2020.

  PMID: 32298269 RESULT

• Battelino T, Danne T, Bergenstal RM, Amiel SA, Beck R, Biester T, Bosi E, Buckingham BA, Cefalu WT, Close KL, Cobelli C, Dassau E, DeVries JH, Donaghue KC, Dovc K, Doyle FJ 3rd, Garg S, Grunberger G, Heller S, Heinemann L, Hirsch IB, Hovorka R, Jia W, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Levine B, Mayorov A, Mathieu C, Murphy HR, Nimri R, Norgaard K, Parkin CG, Renard E, Rodbard D, Saboo B, Schatz D, Stoner K, Urakami T, Weinzimer SA, Phillip M. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019 Aug;42(8):1593-1603. doi: 10.2337/dci19-0028. Epub 2019 Jun 8.

  PMID: 31177185 RESULT

• Amylidi-Mohr S, Zennaro G, Schneider S, Raio L, Mosimann B, Surbek D. Continuous glucose monitoring in the management of gestational diabetes in Switzerland (DipGluMo): an open-label, single-centre, randomised, controlled trial. Lancet Diabetes Endocrinol. 2025 Jul;13(7):591-599. doi: 10.1016/S2213-8587(25)00063-4. Epub 2025 May 26.

  PMID: 40441173 DERIVED

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Blood Glucose Self-Monitoring

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)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Self-Testing; Self Care; Therapeutics; Investigative Techniques

Study Officials

• Sofia Amylidi-Mohr, MD

  Uniuversity Hospital and University of Bern

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: September 8, 2021
• Study Start: September 24, 2021
• Primary Completion: August 31, 2024
• Study Completion: October 30, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)