Continuous glucose monitoring in pregnant women with type 1 diabetes (CONCEPTT): a multicentre international randomised controlled trial.
Denice S Feig, Lois E Donovan, Rosa Corcoy...
https://pubmed.ncbi.nlm.nih.gov/28923465Actively Recruiting
Phase Not Applicable
Age: 18Years +
FEMALE
ID05317585
Continuous Glucose Monitor Use and Perinatal Outcomes Among Pregnant Women With Type 2 Diabetes Mellitus: A Randomized Controlled Trial
Led by University of Massachusetts, Worcester · Updated on 2025-10-01
180
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a randomized controlled trial to study pregnant women with type 2 diabetes mellitus (T2DM). The trial aims to compare the use of a continuous glucose monitor (CGM) against the standard care of multiple daily fingerstick glucose checks. The study focuses on how these methods affect the rate of large for gestational age infants, maternal blood sugar control, patient satisfaction, and other pregnancy-related outcomes. Participants are divided into two groups: one using a CGM device throughout pregnancy until delivery, and the other following the standard fingerstick glucose monitoring multiple times daily. Those in the CGM group will apply the device at the clinic and learn how to download glucose data to their smartphones or device readers. The fingerstick group will monitor blood sugar fasting in the morning and two hours after meals. During the study, researchers will evaluate infant size at birth, maternal blood sugar levels during the third trimester, delivery method, and pregnancy complications such as hypertension and preterm birth. They will also monitor newborn health measures including respiratory distress, hypoglycemia, NICU admission, and APGAR scores. Patient satisfaction with glucose monitoring will be assessed postpartum. The study is sponsored by the University of Massachusetts, Worcester, and enrollment includes 180 pregnant women.
CONDITIONS
Brief Title
Continuous Glucose Monitor Use in Pregnancy
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female, age 18 years or older
- Pregnant with a single baby less than or equal to 14 weeks gestation at first obstetric visit
- Diagnosed with type 2 diabetes mellitus by lab criteria (hemoglobin A1c ≥6.5%, oral glucose tolerance test ≥200 mg/dL, or fasting plasma glucose ≥126 mg/dL)
- Receiving prenatal care and planning to deliver at University of Massachusetts Memorial Health Care
- Able and willing to provide informed consent
You will not qualify if you...
- Diagnosed with type 1 diabetes or gestational diabetes
- Planning prenatal care or delivery outside of University of Massachusetts Memorial Health Care
- Unable to provide informed consent
- Pregnant with more than one baby (multifetal gestation)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Implementation
Duration - From enrollment until delivery
Participants are randomized to either use a continuous glucose monitor (CGM) or perform routine fingerstick glucose monitoring for the duration of their pregnancy until delivery.
1 visit to apply the CGM device or receive fingerstick monitoring instructions, with ongoing use until delivery
Follow-up
Duration - Up to postpartum day 1 after delivery
Participants are assessed for perinatal outcomes and maternal satisfaction after delivery.
1 visit at delivery and 1 visit postpartum day 1
Trial Site Locations
Total: 1 location
1
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, United States, 01605
Actively Recruiting
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Research Team
G
Gianna L Wilkie, MD
H
Heidi Leftwich, DO
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Published Research Related To This Trial
Continuous glucose monitoring during diabetic pregnancy (GlucoMOMS): A multicentre randomized controlled trial.
Daphne N Voormolen, J Hans DeVries, Rieneke M E Sanson...
https://pubmed.ncbi.nlm.nih.gov/29603547The effect of real-time continuous glucose monitoring in pregnant women with diabetes: a randomized controlled trial.
Anna L Secher, Lene Ringholm, Henrik U Andersen...
https://pubmed.ncbi.nlm.nih.gov/23349548Effectiveness of continuous glucose monitoring in pregnant women with diabetes: randomised clinical trial.
Helen R Murphy, Gerry Rayman, Karen Lewis...
https://pubmed.ncbi.nlm.nih.gov/18818254