Fueling Labor: Protein Supplementation for Intrapartum Glucose Control

NCT07571343 | Not Yet Recruiting FDA Device

• 1 other identifier: PRO00057233
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn if high-protein drinks during labor can improve blood sugar control in pregnant women with insulin-treated diabetes. It will also help us learn if this approach is acceptable and well-tolerated by patients. The main questions it aims to answer are:

• Does drinking high-protein beverages during labor keep blood sugar in a healthier range compared to drinking standard clear liquids?
• How do participants feel about drinking protein beverages during labor, and does it affect their energy levels and birth experience?
• Is the baby less likely to have low blood sugar after birth when the mother drinks protein beverages during labor? Researchers will compare women who drink high-protein beverages to women who drink standard clear liquids (like juice, broth, and popsicles) to see if protein drinks help keep blood sugar more stable during labor. Participants will:
• Wear a small, painless glucose sensor on their arm from when labor starts until about one week after giving birth
• Be randomly assigned to either drink a clear protein beverage every 4 hours during labor OR drink standard clear liquids as usual
• Complete short surveys about how tired they feel during labor, their overall birth experience, and their overall experience with the glucose sensor

Conditions

Diabetes During Pregnancy

Keywords

Intrapartum glucose control; continuous glucose monitoring; Protein supplementation; diabetes in pregnancy; time above range

Outcome Measures

Primary Outcomes (1)

• Percent Time Above Range (TAR >110 mg/dL) During Labor

  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.

  From admission to delivery (expected ≤72 hours)

Secondary Outcomes (27)

• Time in Range

  From admission to delivery (expected ≤72 hours)

• Glycemic Variability

  From admission to delivery (expected ≤72 hours)

• Hyperglycemic Excursions

  From admission to delivery (expected ≤72 hours)

• Hypoglycemic Events

  From admission to delivery (expected ≤72 hours)

• Total Insulin Use During Labor

  From admission to delivery (expected ≤72 hours)

Other Outcomes (11)

• Recruitment Rate

  Recruitment period (up to 18 months)

• Intervention Adherence

  From admission to delivery (expected ≤72 hours)

• CGM Data Completeness

  From admission to delivery (expected ≤72 hours)

Study Arms (2)

High-Protein Supplementation

EXPERIMENTAL

Participants will be offered Genius Gourmet Sparkling Protein Water (approximately 30 g protein, 0 g carbohydrate, 0 g fat, 130 kcal per 12-ounce serving) every 4 hours beginning at randomization until delivery. Consumption is voluntary. All participants will wear a blinded CGM from admission through 7 days postpartum.

Dietary Supplement: High-Protein Beverage (Genius Gourmet Sparkling Protein Water); Device: Continuous Glucose Monitoring (Abbott Freestyle Libre)

Standard Clear Liquid Diet

ACTIVE COMPARATOR

Participants will receive standard institutional clear liquid diet (water, ice chips, clear fruit juices, clear carbonated beverages, popsicles, clear broth, gelatin) ad libitum throughout labor per routine institutional practice. All participants will wear a blinded CGM from admission through 7 days postpartum.

Other: Standard Clear Liquid Diet; Device: Continuous Glucose Monitoring (Abbott Freestyle Libre)

Interventions

Standard Clear Liquid Diet OTHER

Standard institutional clear liquid diet including water, ice chips, clear fruit juices (e.g., apple juice), clear carbonated beverages (e.g., ginger ale), popsicles, clear broth, and gelatin. Carbohydrate-containing clear liquids permitted per standard practice.

Standard Clear Liquid Diet

Continuous Glucose Monitoring (Abbott Freestyle Libre) DEVICE

Abbott Freestyle Libre 2 or Libre 3 CGM sensor placed on upper arm upon admission. Sensor remains in place through delivery and up to 7 days postpartum. CGM data blinded to participants and clinical staff during labor.

High-Protein Supplementation; Standard Clear Liquid Diet

High-Protein Beverage (Genius Gourmet Sparkling Protein Water) DIETARY_SUPPLEMENT

Clear, carbonated, commercially available high-protein nutritional supplement containing approximately 30 g protein, 0 g carbohydrate, 0 g fat, and 130 kcal per 12-ounce serving. Offered every 4 hours during labor. Multiple flavors available (participant's choice).

High-Protein Supplementation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Central Study Contacts

Sukanya Skandarajah

CONTACT

4148055337; sskandarajah@mcw.edu

Brock Polnaszek, MD

CONTACT

4148056624; bpolnaszek@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and clinical care providers cannot be blinded to group assignment due to the nature of the nutritional intervention. CGM data will be blinded to participants, nursing staff, and obstetric providers during labor to prevent CGM-guided clinical decisions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor & Clinical Investigator

Study Record Dates

• First Submitted: March 25, 2026
• First Posted: May 6, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)