Clinical trial NCT05317585: Continuous Glucose Monitor Use in Pregnancy
Official title: Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Pregnancy, High Risk
Keywords: Type 2 diabetes
Pregnancy
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Large for Gestational Age Infant
timeFrame: Within 2 hours of birth
Secondary outcomes:
measure: Third Trimester Hemoglobin A1c
timeFrame: Between 28 weeks and delivery
measure: Mode of Delivery
timeFrame: At delivery
measure: Hypertensive Disorders of Pregnancy
timeFrame: After 20 weeks of gestation until delivery
measure: Preterm Birth
timeFrame: At delivery
measure: Number of participants with a shoulder dystocia
timeFrame: At delivery
measure: Neonatal Intensive Care Unit Admission (NICU)
timeFrame: At delivery and within first 2 days of life
measure: Neonatal Respiratory Distress
timeFrame: At delivery
measure: APGAR less than 7 at 5 minutes of life
timeFrame: 5 Minutes after Delivery
measure: Number of participants with neonatal hypoglycemia
timeFrame: Within 2 hours of birth
measure: Gestational age at delivery
timeFrame: At Delivery
measure: Maternal Patient Satisfaction Survey with Glucose Monitoring
timeFrame: postpartum day 1 after delivery
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Gianna L Wilkie, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.
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.