Continuous Glucose Monitor Use in Pregnancy

Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy, High Risk; Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Continuous Glucose Monitor; Device: Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Detailed Description

A continuous glucose monitor (CGM) can provide detailed insight into daily glucose fluctuations and individual glucose patterns, and it is advised for patients with type 1 diabetes mellitus and advanced type 2 diabetes mellitus (T2DM). Despite this recommendation, pregnant women are not receiving the same standard of care. It has been studied minimally in pregnant women with T2DM, despite preliminary studies showing improvement in adverse perinatal outcomes and glycemic control among pregnant women with type 1 diabetes. Therefore, there is a paucity of data regarding CGM use among pregnant women with T2DM, and significant potential to reduce the significant multigenerational effects associated with diabetes in pregnancy with this technology.

The study team therefore propose to perform a randomized controlled trial among 180 pregnant women with T2DM comparing 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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Heidi Leftwich, DO; Email: Heidi.Leftwich@umassmemorial.org
• Study Contact Backup: Name: Gianna L Wilkie, MD; Phone Number: 7743642523; Email: Gianna.Wilkie@umassmemorial.org

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • Recruiting
      • University of Massachusetts Memorial Medical Center
      • Contact: Gianna L Wilkie, MD; Phone Number: 508-334-4067; Email: Gianna.Wilkie@umassmemorial.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria: Women will be deemed eligible for the study by the following inclusion criteria:

• 1) age greater than or equal to 18 years old
• 2) singleton gestation less than or equal to 14 weeks at initial obstetric visit
• 3) 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
• 4) receiving prenatal care at UMASS Memorial Health Care (UMMHC) and plans to deliver at UMMHC
• 5) able and willing to provide informed consent

Exclusion Criteria: Women will be deemed ineligible for the study based on the following exclusion criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Continuous Glucose Monitoring (CGM); 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; Continuous Glucose Monitor
Active Comparator: Fingerstick Glucose Monitoring; 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); Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Third Trimester Hemoglobin A1c	Third Trimester Hemoglobin A1c	Between 28 weeks and delivery
Mode of Delivery	Mode of delivery (vaginal versus cesarean)	At delivery
Hypertensive Disorders of Pregnancy	Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation	After 20 weeks of gestation until delivery
Preterm Birth	Preterm birth (delivery less than 37 weeks gestation)	At delivery
Number of participants with a shoulder dystocia	Number of participants with a shoulder dystocia	At delivery
Neonatal Intensive Care Unit Admission (NICU)	Neonatal Intensive Care Unit Admission (NICU)	At delivery and within first 2 days of life
Neonatal Respiratory Distress	Neonatal Respiratory Distress requiring respiratory support	At delivery
APGAR less than 7 at 5 minutes of life	APGAR score less than 7 at 5 minutes of life	5 Minutes after Delivery
Number of participants with neonatal hypoglycemia	Number of participants with neonatal hypoglycemia as defined by first neonatal blood sugar obtained within 2 hours of birth	Within 2 hours of birth
Gestational age at delivery	Gestational age at delivery	At Delivery
Maternal Patient Satisfaction Survey with Glucose Monitoring	This will be assessed by the glucose monitoring satisfaction survey (GMSS) version 2. Participants will complete the survey, which contains 4 subscales and a total score. The subscales assess openness, emotional burden, behavioral burden, and worthwhileness. The higher the score the greater the satisfaction, with a total maximum score 75.	postpartum day 1 after delivery

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Investigators: Principal Investigator: Gianna L Wilkie, MD, University of Massachusetts, Worcester

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 8, 2022

Study Record Updates

• Last Update Posted (Estimated): October 1, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Pregnancy; Type 2 diabetes
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY00001802

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes