Continuous Glucose Monitor Use in Pregnancy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Continuous Glucose Monitor
  Continuous Glucose Monitor
• Устройство Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
  Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)

Первичные конечные точки

• Large for Gestational Age Infant [Срок оценки: Within 2 hours of birth]

Вторичные конечные точки (11)

• Third Trimester Hemoglobin A1c [Срок оценки: Between 28 weeks and delivery]
• Mode of Delivery [Срок оценки: At delivery]
• Hypertensive Disorders of Pregnancy [Срок оценки: After 20 weeks of gestation until delivery]
• Preterm Birth [Срок оценки: At delivery]
• Number of participants with a shoulder dystocia [Срок оценки: At delivery]
• Neonatal Intensive Care Unit Admission (NICU) [Срок оценки: At delivery and within first 2 days of life]
• Neonatal Respiratory Distress [Срок оценки: At delivery]
• APGAR less than 7 at 5 minutes of life [Срок оценки: 5 Minutes after Delivery]
• Number of participants with neonatal hypoglycemia [Срок оценки: Within 2 hours of birth]
• Gestational age at delivery [Срок оценки: At Delivery]
• Maternal Patient Satisfaction Survey with Glucose Monitoring [Срок оценки: postpartum day 1 after delivery]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• University of Massachusetts Memorial Medical Center — Worcester

Публикации

• 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 co PMID 28923465
• 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 (Glu PMID 29603547
• 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
• 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

Идентификаторы

NCT: NCT05317585 · STUDY00001802

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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