Diabetes During Pregnancy
Conditions
Keywords
Intrapartum glucose control, continuous glucose monitoring, Protein supplementation, diabetes in pregnancy, time above range
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
Detailed description
Background and Rationale: Optimal nutrition during labor for patients with insulin-treated diabetes in pregnancy remains poorly defined. While current guidelines support clear liquid intake during labor, the metabolic effects of different nutritional strategies-particularly high-protein supplementation-have not been studied. Maintaining stable maternal glucose levels during labor is essential to reducing neonatal complications, including hypoglycemia. However, standard clear liquids may cause glucose excursions, while prolonged fasting may contribute to maternal fatigue and metabolic stress. Continuous glucose monitoring (CGM) technology provides real-time assessment of glucose patterns during labor, offering a novel opportunity to evaluate how targeted nutritional interventions influence maternal glycemic stability. Recent evidence suggests that maternal time above glucose target range during labor is associated with neonatal hypoglycemia, yet no studies have examined whether protein-based oral supplementation can improve intrapartum glucose control compared to standard clear liquids. Study Objectives: This pilot randomized controlled trial evaluates the feasibility and metabolic impact of high-protein oral supplementation during labor in patients with insulin-treated gestational or type 2 diabetes undergoing induction of labor. The study aims to: 1. Assess feasibility and acceptability of implementing a CGM-guided intrapartum nutritional protocol 2. Compare CGM-derived glycemic metrics (including percent time above range \>110 mg/dL, time in range, and glycemic excursions) between high-protein supplementation and standard clear liquids 3. Explore associations with maternal experience (fatigue, birth satisfaction) and neonatal outcomes Study Design: Sixty participants with insulin-treated gestational diabetes (GDM A2) or type 2 diabetes will be randomized 1:1 to receive either high-protein nutritional supplements (30g protein, 0g carbohydrate) every 4 hours during labor or standard institutional clear liquid diet. All participants will wear a blinded CGM (Abbott Freestyle Libre) from admission through delivery and for up to 7 days postpartum. The primary outcome is percent time above glucose range (\>110 mg/dL) during labor. Secondary outcomes include other CGM metrics, maternal fatigue and satisfaction scores, labor outcomes, and neonatal hypoglycemia. Significance: This pilot study will generate critical preliminary data on the metabolic effects, patient-centered outcomes, and feasibility of high-protein intrapartum supplementation, informing the design of future larger trials to optimize evidence-based nutritional management during labor for patients with insulin-treated diabetes.
Interventions
DIETARY_SUPPLEMENTHigh-Protein Beverage (Genius Gourmet Sparkling Protein Water)
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).
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.
DEVICEContinuous Glucose Monitoring (Abbott Freestyle Libre)
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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time Above Range (TAR >110 mg/dL) During Labor | From 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range | From admission to delivery (expected ≤72 hours) | Percentage of CGM readings within target range during labor (70-110 mg/dL) |
| Glycemic Variability | From admission to delivery (expected ≤72 hours) | Standard deviation and coefficient of variation of CGM glucose values during labor. |
| Hyperglycemic Excursions | From admission to delivery (expected ≤72 hours) | Number of episodes of CGM glucose \>140 mg/dL, separated by ≥15 minutes below threshold. |
| Hypoglycemic Events | From admission to delivery (expected ≤72 hours) | Number of CGM glucose values \<70 mg/dL during labor. |
| Total Insulin Use During Labor | From admission to delivery (expected ≤72 hours) | Total insulin administered (units) |
| Maternal Fatigue Score (VAS) | Admission and every 4 hours until delivery (expected ≤72 hours) | Visual Analog Scale for fatigue (0-10), where higher scores indicate greater fatigue. |
| Labor Agentry Scale Score (LAS) | 24-48 hours postpartum | Labor Agentry Scale (LAS), a 29-item validated measure of perceived control during labor. Each item is scored on a 7-point Likert scale. Total scores range from 29 to 203, with higher scores indicating greater perceived control. |
| Birth Satisfaction Scale-Revised Score | 24-48 hours postpartum | A 10-item validated measure of overall birth satisfaction. Each item is scored on a 0-4 scale. Total scores range from 0 to 40, with higher scores indicating greater birth satisfaction. |
| Maternal Emesis | From admission to delivery (expected ≤72 hours) | Number of vomiting episodes during labor documented by clinical record or participant report. |
| Mode of Delivery | At delivery | Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery. |
| Neonatal Hypoglycemia | First 24 hours of life | Blood glucose \<40 mg/dL. |
| Neonatal Intensive Care Unit (NICU) Admission | From birth through hospital discharge (expected ≤28 days) | Admission to neonatal intensive care unit (yes/no). |
| Neonatal Glucose Supplementation | First 24 hours of life | Requirement for oral or IV glucose. |
| Postpartum Time in Range | Delivery to 7 days postpartum | Percentage of CGM readings within postpartum target range (70-140 mg/dL). |
| Composite Maternal Morbidity | Up to 6 weeks postpartum | Composite maternal morbidity defined as occurrence of any of the following conditions: postpartum hemorrhage requiring intervention such as estimated blood loss \>1000 milliliters (mL) or uterotonics, tranexamic acid, blood transfusion or surgical interventions (dilation and curettage, Bakri, Jada, laparotomy, interventional radiology), endometritis, intraamniotic infection, obstetric anal sphincter injury (OASIS), ICU admission, amniotic fluid embolism, and death. |
| Umbilical Cord Blood Gas Values | At delivery | Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess) |
| Infant Healthcare Utilization | Birth to 1 year of life | Healthcare utilization including hospitalizations, emergency department visits, urgent care visits, and primary care visits assessed via medical record and parental report. |
| Labor Duration | From admission to delivery (expected ≤72 hours) | Duration of first, second, and third stages of labor measured in hours |
| Infant Weight | Birth to 1 year of life | Infant weight in kilograms |
| Infant Length | Birth to 1 year of life | Infant length in centimeters |
| NICU Length of Stay | From birth through hospital discharge (expected ≤28 days) | Duration of NICU hospitalization measured in days. |
| Respiratory Support | From birth through hospital discharge (expected ≤28 days) | Requirement for respiratory support including supplemental oxygen, continuous positive airway pressure (CPAP), or mechanical ventilation (intubation). |
| Neonatal Jaundice Requiring Phototherapy | From birth through hospital discharge (expected ≤28 days) | Need for phototherapy for neonatal hyperbilirubinemia. |
| Neonatal Hypoglycemia Treatment | From birth through hospital discharge (expected ≤28 days) | Requirement for glucose supplementation (oral or intravenous). |
| Neonatal Sepsis | From birth through hospital discharge (expected ≤28 days) | Documented clinical suspicion or laboratory-confirmed neonatal sepsis. |
| Perinatal Death | From birth through hospital discharge (expected ≤28 days) | Fetal or neonatal death occurring from birth through hospital discharge. |
| Neonatal Resuscitation Level | At delivery | Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation. |
Countries
United States
Contacts
CONTACTSukanya Skandarajah
CONTACTBrock Polnaszek, MD
Outcome results
None listed