Continuous Glucose Monitor Use in Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Continuous Glucose Monitor, Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose).
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes Treated With Insulin, Pregnancy, High Risk. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Overview
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.
Interventions
- Device Continuous Glucose Monitor
Continuous Glucose Monitor - Device Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Routine Capillary Blood Glucose Monitoring (Fingerstick Glucose)
Primary outcome measures
- Large for Gestational Age Infant [Time frame: Within 2 hours of birth]
Secondary outcome measures (11)
- Third Trimester Hemoglobin A1c [Time frame: Between 28 weeks and delivery]
- Mode of Delivery [Time frame: At delivery]
- Hypertensive Disorders of Pregnancy [Time frame: After 20 weeks of gestation until delivery]
- Preterm Birth [Time frame: At delivery]
- Number of participants with a shoulder dystocia [Time frame: At delivery]
- Neonatal Intensive Care Unit Admission (NICU) [Time frame: At delivery and within first 2 days of life]
- Neonatal Respiratory Distress [Time frame: At delivery]
- APGAR less than 7 at 5 minutes of life [Time frame: 5 Minutes after Delivery]
- Number of participants with neonatal hypoglycemia [Time frame: Within 2 hours of birth]
- Gestational age at delivery [Time frame: At Delivery]
- Maternal Patient Satisfaction Survey with Glucose Monitoring [Time frame: postpartum day 1 after delivery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- University of Massachusetts Memorial Medical Center — Worcester
Publications
- 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
Identifiers
NCT: NCT05317585 · STUDY00001802