About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Type 1 diabetes mellitus
Multifetal gestation
Major fetal anomalies or conditions affecting neonatal glucose regulation
Stillbirth
Trial design
Parallel
Treatments tested in this trial
High-Protein Beverage (Genius Gourmet Sparkling Protein Water)
Dietary supplementClear, 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).
Standard Clear Liquid Diet
Other interventionStandard 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.
Continuous Glucose Monitoring (Abbott Freestyle Libre)
DeviceAbbott 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Time in Range
Percentage of CGM readings within target range during labor (70-110 mg/dL)
Glycemic Variability
Standard deviation and coefficient of variation of CGM glucose values during labor.
Hyperglycemic Excursions
Number of episodes of CGM glucose \>140 mg/dL, separated by ≥15 minutes below threshold.
Hypoglycemic Events
Number of CGM glucose values \<70 mg/dL during labor.
Other outcomes
Recruitment Rate
Proportion of eligible patients who consent to participation.
Intervention Adherence
Proportion of scheduled supplements consumed (measured as proportion of scheduled doses consumed)
CGM Data Completeness
Proportion of the intrapartum period with valid CGM data
Survey Completion Rate
Proportion of participants completing postpartum surveys (LAS and BSS-R).
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: