Continuous Glucose Monitor Use in Pregnancy

Pregnancy, High Risk Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05317585
• Other study ID #: STUDY00001802
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2024
• Est. completion date: July 1, 2027

Study information

• Verified date: April 2024
• Source: University of Massachusetts, Worcester
• Contact: Gianna L Wilkie, MD
• Phone: 7743642523
• Email: Gianna.Wilkie[@]umassmemorial.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Pregnancy, High Risk
• Type 2 Diabetes Treated With Insulin

Intervention

Device:
• Continuous Glucose Monitor
Continuous Glucose Monitor
• Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Locations

Country	Name	City	State
United States	University of Massachusetts Memorial Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Worcester

Country where clinical trial is conducted

United States, 

References & 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. Erratum In: Lancet. 2017 Nov 25;390(10110):2346. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Third Trimester Hemoglobin A1c	Third Trimester Hemoglobin A1c	Between 28 weeks and delivery
Secondary	Mode of Delivery	Mode of delivery (vaginal versus cesarean)	At delivery
Secondary	Hypertensive Disorders of Pregnancy	Development of gestational hypertension or pre-eclampsia after 20 weeks of gestation	After 20 weeks of gestation until delivery
Secondary	Preterm Birth	Preterm birth (delivery less than 37 weeks gestation)	At delivery
Secondary	Number of participants with a shoulder dystocia	Number of participants with a shoulder dystocia	At delivery
Secondary	Neonatal Intensive Care Unit Admission (NICU)	Neonatal Intensive Care Unit Admission (NICU)	At delivery and within first 2 days of life
Secondary	Neonatal Respiratory Distress	Neonatal Respiratory Distress requiring respiratory support	At delivery
Secondary	APGAR less than 7 at 5 minutes of life	APGAR score less than 7 at 5 minutes of life	5 Minutes after Delivery
Secondary	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
Secondary	Gestational age at delivery	Gestational age at delivery	At Delivery
Secondary	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