Protein Supplementation for Blood Sugar Control During Labor

This study is looking at whether drinking a high-protein beverage called Genius Gourmet Sparkling Protein Water during labor can help manage blood sugar levels in pregnant women with diabetes. You might be able to join if you are at least 18 years old, have a single pregnancy, are at least 37 weeks pregnant, and have gestational diabetes (GDM A2) or Type 2 diabetes that requires insulin. The study wants to see if the protein drink keeps blood sugar in a healthier range compared to a standard clear liquid diet, how you feel about the drink, and if it affects your baby's blood sugar after birth. The main goal is to measure the percentage of time your blood sugar is above 110 mg/dL during labor. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This is a pilot randomized controlled trial, meaning participants will be randomly assigned to receive either the high-protein beverage or a standard clear liquid diet. Continuous glucose monitoring (CGM) will be used, but the data will be hidden from you and your care team during labor.
What's involved
You would have a Continuous Glucose Monitoring (CGM) sensor placed on your arm upon admission, which stays in place through delivery and up to 7 days postpartum. If assigned to the protein beverage group, you would be offered the drink every 4 hours during labor.
Compensation
Not stated in the trial record.
Follow-up
The Continuous Glucose Monitoring (CGM) sensor remains in place up to 7 days postpartum.

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NCT07571343

Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

Not Yet Recruiting
NAAges 18+InterventionalPrevention
Medical College of Wisconsin
~60 participants
Updated 2026-05-06 on ClinicalTrials.gov
What's tested:High-Protein Beverage (Genius Gourmet Sparkling Protein Water)Standard Clear Liquid DietContinuous Glucose Monitoring (Abbott Freestyle Libre)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Time Above Range (TAR >110 mg/dL) During Labor
Measured over From admission to delivery (expected ≤72 hours)
Diabetes During Pregnancy
1 sites across 1 states
Wisconsin1

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Eligibility criteria

Inclusion

Age ≥18 years
Singleton pregnancy
Gestational age ≥37 0/7 weeks at time of induction
Diagnosis of gestational diabetes requiring insulin therapy (GDM A2) or pre-existing Type 2 diabetes managed with insulin during pregnancy
Admission to labor and delivery for induction of labor
Able and willing to provide informed consent

Exclusion

Type 1 diabetes mellitus
Multifetal gestation
Major fetal anomalies or conditions affecting neonatal glucose regulation
Stillbirth
Planned cesarean delivery
Inability to provide consent
Contraindication to oral intake (e.g., NPO status for clinical indication)
Known allergy or intolerance to study materials, including components of the high-protein supplement or CGM device
  • Percent Time Above Range (TAR >110 mg/dL) During LaborFrom admission to delivery (expected ≤72 hours)

    Percentage of CGM readings exceeding 110 mg/dL during labor, calculated as the proportion of valid CGM readings \>110 mg/dL divided by total valid readings, expressed as a percentage.