Continuous Glucose Monitor Use in Pregnancy

NCT05317585 | Recruiting DMC FDA Device

• 1 other identifier: STUDY00001802
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to perform a randomized controlled trial among 180 pregnant women with type 2 diabetes mellitus (T2DM) comparing continuous glucose monitor (CGM) use to the standard of care of multiple daily fingerstick glucose monitoring and its impact on large for gestational age infants, maternal glycemic control, patient satisfaction, and additional adverse perinatal outcomes.

Conditions

Type 2 Diabetes Treated With Insulin; Pregnancy, High Risk

Keywords

Type 2 diabetes; Pregnancy

Outcome Measures

Primary Outcomes (1)

• Large for Gestational Age Infant

  The neonatal birthweight will be used to calculate large for gestational age size based on the gestational age at delivery.

  Within 2 hours of birth

Secondary Outcomes (11)

• Third Trimester Hemoglobin A1c

  Between 28 weeks and delivery

• Mode of Delivery

  At delivery

• Hypertensive Disorders of Pregnancy

  After 20 weeks of gestation until delivery

• Preterm Birth

  At delivery

• Number of participants with a shoulder dystocia

  At delivery

Study Arms (2)

Continuous Glucose Monitoring (CGM)

EXPERIMENTAL

Patients will be randomized to application of a continuous glucose monitor (CGM). They will apply the device in the clinical setting and be instructed how to download their information onto their smartphones or using the CGM device reader. They will use the CGM for the duration of the pregnancy until delivery.

Device: Continuous Glucose Monitor

Fingerstick Glucose Monitoring

ACTIVE COMPARATOR

Patients will be randomized to checking their blood glucose with fingerstick monitors at time of fasting in the AM, and 2 hours after each meal. This is the standard of care for patients in the pregnancy diabetes clinic.

Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Interventions

Continuous Glucose Monitor DEVICE

Continuous Glucose Monitor

Continuous Glucose Monitoring (CGM)

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose) DEVICE

Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Fingerstick Glucose Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) age greater than or equal to 18 years old
• \) singleton gestation less than or equal to 14 weeks at initial obstetric visit
• \) established diagnosis of T2DM by laboratory criteria including hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL
• \) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
• \) able and willing to provide informed consent

You may not qualify if:

• \) known diagnosis of type 1 diabetes or gestational diabetes
• \) plan to receive prenatal care or delivery outside of UMMHC
• \) inability to provide informed consent
• \) multifetal gestation

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

University of Massachusetts Memorial Medical Center

Worcester, Massachusetts, 01605, United States

RECRUITING

Related Publications (4)

• 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 BACKGROUND

• Voormolen DN, DeVries JH, Sanson RME, Heringa MP, de Valk HW, Kok M, van Loon AJ, Hoogenberg K, Bekedam DJ, Brouwer TCB, Porath M, Erdtsieck RJ, NijBijvank B, Kip H, van der Heijden OWH, Elving LD, Hermsen BB, Potter van Loon BJ, Rijnders RJP, Jansen HJ, Langenveld J, Akerboom BMC, Kiewiet RM, Naaktgeboren CA, Mol BWJ, Franx A, Evers IM. Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1894-1902. doi: 10.1111/dom.13310. Epub 2018 May 8.

  PMID: 29603547 BACKGROUND

• Secher AL, Ringholm L, Andersen HU, Damm P, Mathiesen ER. The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial. Diabetes Care. 2013 Jul;36(7):1877-83. doi: 10.2337/dc12-2360. Epub 2013 Jan 24.

  PMID: 23349548 BACKGROUND

• Murphy HR, Rayman G, Lewis K, Kelly S, Johal B, Duffield K, Fowler D, Campbell PJ, Temple RC. Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial. BMJ. 2008 Sep 25;337:a1680. doi: 10.1136/bmj.a1680.

  PMID: 18818254 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Gianna L Wilkie, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gianna L Wilkie, MD

CONTACT

7743642523; Gianna.Wilkie@umassmemorial.org

Heidi Leftwich, DO

CONTACT

Heidi.Leftwich@umassmemorial.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Fellow in Maternal Fetal Medicine

Model Details: This is a prospective, single center, randomized study evaluating pregnancy glycemic monitoring strategies between women with continuous glucose monitors and standard of care fingerstick glucose monitoring.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 8, 2022
• Study Start: May 23, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)