Diabetes During PregnancyNCT07571343
Fueling Labor: Protein Supplementation for Intrapartum Glucose Control
A study testing High-Protein Beverage (Genius Gourmet Sparkling Protein Water), Standard Clear Liquid Diet and Continuous Glucose Monitoring (Abbott Freestyle Libre) in people with Diabetes During Pregnancy, run by Medical College of Wisconsin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Diabetes During Pregnancy
- What is being tested?
- High-Protein Beverage (Genius Gourmet Sparkling Protein Water), Standard Clear Liquid Diet and Continuous Glucose Monitoring (Abbott Freestyle Libre)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2026to 30 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Froedtert Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Fueling Labor: A Pilot Randomized Controlled Trial of High-Protein Supplementation During Labor to Improve Glucose Control in Insulin-Treated Diabetes Using Continuous Glucose Monitoring
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?
Read more
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
Read the 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:
- Assess feasibility and acceptability of implementing a CGM-guided intrapartum nutritional protocol
- 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
- 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.
- Conditions
- Diabetes During Pregnancy
- Being tested
- High-Protein Beverage (Genius Gourmet Sparkling Protein Water), Standard Clear Liquid Diet, Continuous Glucose Monitoring (Abbott Freestyle Libre)
- Keywords
- Intrapartum glucose control, continuous glucose monitoring, Protein supplementation, diabetes in pregnancy, time above range
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
Standard Clear Liquid DietOther
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard Clear Liquid Diet; Device: Continuous Glucose Monitoring (Abbott Freestyle Libre) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From admission to delivery (expected ≤72 hours)
Secondary outcomes (27)
Time in Range
Percentage of CGM readings within target range during labor (70-110 mg/dL)
Measured: From admission to delivery (expected ≤72 hours)
Glycemic Variability
Standard deviation and coefficient of variation of CGM glucose values during labor.
Measured: From admission to delivery (expected ≤72 hours)
Hyperglycemic Excursions
Number of episodes of CGM glucose >140 mg/dL, separated by ≥15 minutes below threshold.
Measured: From admission to delivery (expected ≤72 hours)
Hypoglycemic Events
Number of CGM glucose values <70 mg/dL during labor.
Measured: From admission to delivery (expected ≤72 hours)
Total Insulin Use During Labor
Total insulin administered (units)
Measured: From admission to delivery (expected ≤72 hours)
Maternal Fatigue Score (VAS)
Visual Analog Scale for fatigue (0-10), where higher scores indicate greater fatigue.
Measured: Admission and every 4 hours until delivery (expected ≤72 hours)
Labor Agentry Scale Score (LAS)
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.
Measured: 24-48 hours postpartum
Birth Satisfaction Scale-Revised Score
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.
Measured: 24-48 hours postpartum
Maternal Emesis
Number of vomiting episodes during labor documented by clinical record or participant report.
Measured: From admission to delivery (expected ≤72 hours)
Mode of Delivery
Mode of delivery categorized as spontaneous vaginal, operative vaginal, or cesarean delivery.
Measured: At delivery
Neonatal Hypoglycemia
Blood glucose <40 mg/dL.
Measured: First 24 hours of life
Neonatal Intensive Care Unit (NICU) Admission
Admission to neonatal intensive care unit (yes/no).
Measured: From birth through hospital discharge (expected ≤28 days)
Neonatal Glucose Supplementation
Requirement for oral or IV glucose.
Measured: First 24 hours of life
Postpartum Time in Range
Percentage of CGM readings within postpartum target range (70-140 mg/dL).
Measured: Delivery to 7 days postpartum
Composite Maternal Morbidity
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.
Measured: Up to 6 weeks postpartum
Umbilical Cord Blood Gas Values
Umbilical arterial cord blood gas values (pH, partial pressure of carbon dioxide (pCO₂), and base excess)
Measured: At delivery
Infant Healthcare Utilization
Healthcare utilization including hospitalizations, emergency department visits, urgent care visits, and primary care visits assessed via medical record and parental report.
Measured: Birth to 1 year of life
Labor Duration
Duration of first, second, and third stages of labor measured in hours
Measured: From admission to delivery (expected ≤72 hours)
Infant Weight
Infant weight in kilograms
Measured: Birth to 1 year of life
Infant Length
Infant length in centimeters
Measured: Birth to 1 year of life
NICU Length of Stay
Duration of NICU hospitalization measured in days.
Measured: From birth through hospital discharge (expected ≤28 days)
Respiratory Support
Requirement for respiratory support including supplemental oxygen, continuous positive airway pressure (CPAP), or mechanical ventilation (intubation).
Measured: From birth through hospital discharge (expected ≤28 days)
Neonatal Jaundice Requiring Phototherapy
Need for phototherapy for neonatal hyperbilirubinemia.
Measured: From birth through hospital discharge (expected ≤28 days)
Neonatal Hypoglycemia Treatment
Requirement for glucose supplementation (oral or intravenous).
Measured: From birth through hospital discharge (expected ≤28 days)
Neonatal Sepsis
Documented clinical suspicion or laboratory-confirmed neonatal sepsis.
Measured: From birth through hospital discharge (expected ≤28 days)
Perinatal Death
Fetal or neonatal death occurring from birth through hospital discharge.
Measured: From birth through hospital discharge (expected ≤28 days)
Neonatal Resuscitation Level
Level of resuscitation at birth categorized as none, stimulation only, positive pressure ventilation, or advanced resuscitation.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start1 Jul 2026
- Primary completion30 Jul 2028 (estimated)
- Study completion30 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes During PregnancyStudies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brock E. Polnaszek, MD MPH, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571343
- Sponsor's protocol ID
- PRO00057233
- Status last verified
- Oct 2026
- First submitted
- 25 Mar 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fueling Labor: A Pilot Randomized Controlled Trial of High-Protein Supplementation During Labor to Improve Glucose Control in Insulin-Treated Diabetes Using Continuous Glucose Monitoring
- ClinicalTrials.gov ID
- NCT07571343
- Acronym / sponsor ID
- PRO00057233
- Conditions
- Diabetes During Pregnancy
- Keywords
- Intrapartum glucose control, continuous glucose monitoring, Protein supplementation, diabetes in pregnancy, time above range
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Study start
- 1 Jul 2026 (actual)
- Primary completion
- 30 Jul 2028 (estimated)
- Study completion
- 30 Jul 2028 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assess feasibility and acceptability of implementing a CGM-guided intrapartum nutritional protocol
- 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
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Protein Supplementation | Experimental | Dietary Supplement: High-Protein Beverage (Genius Gourmet Sparkling Protein Water), Device: Continuous Glucose Monitoring (Abbott Freestyle Libre)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. |
| Standard Clear Liquid Diet | Active comparator | Other: Standard Clear Liquid Diet, Device: Continuous Glucose Monitoring (Abbott Freestyle Libre)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Type 1 diabetes mellitus
- Multifetal gestation
- Major fetal anomalies or conditions affecting neonatal glucose regulation
- Stillbirth
- Planned cesarean delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-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). | Dietary supplement | High-Protein Supplementation |
| Standard Clear Liquid DietStandard 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. | Other | Standard Clear Liquid Diet |
| Continuous 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. | Device | High-Protein Supplementation, Standard Clear Liquid Diet |
Primary outcome
Percent Time Above Range (TAR >110 mg/dL) During Labor
Time frame: 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.
27 secondary outcomes
Time in Range
Time frame: From admission to delivery (expected ≤72 hours)
Glycemic Variability
Time frame: From admission to delivery (expected ≤72 hours)
Hyperglycemic Excursions
Time frame: From admission to delivery (expected ≤72 hours)
Hypoglycemic Events
Time frame: From admission to delivery (expected ≤72 hours)
Total Insulin Use During Labor
Time frame: From admission to delivery (expected ≤72 hours)
Maternal Fatigue Score (VAS)
Time frame: Admission and every 4 hours until delivery (expected ≤72 hours)
Labor Agentry Scale Score (LAS)
Time frame: 24-48 hours postpartum
Birth Satisfaction Scale-Revised Score
Time frame: 24-48 hours postpartum
Maternal Emesis
Time frame: From admission to delivery (expected ≤72 hours)
Mode of Delivery
Time frame: At delivery
Neonatal Hypoglycemia
Time frame: First 24 hours of life
Neonatal Intensive Care Unit (NICU) Admission
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Glucose Supplementation
Time frame: First 24 hours of life
Postpartum Time in Range
Time frame: Delivery to 7 days postpartum
Composite Maternal Morbidity
Time frame: Up to 6 weeks postpartum
Umbilical Cord Blood Gas Values
Time frame: At delivery
Infant Healthcare Utilization
Time frame: Birth to 1 year of life
Labor Duration
Time frame: From admission to delivery (expected ≤72 hours)
Infant Weight
Time frame: Birth to 1 year of life
Infant Length
Time frame: Birth to 1 year of life
NICU Length of Stay
Time frame: From birth through hospital discharge (expected ≤28 days)
Respiratory Support
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Jaundice Requiring Phototherapy
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Hypoglycemia Treatment
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Sepsis
Time frame: From birth through hospital discharge (expected ≤28 days)
Perinatal Death
Time frame: From birth through hospital discharge (expected ≤28 days)
Neonatal Resuscitation Level
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Protein Beverage (Genius Gourmet Sparkling Protein Water), Standard Clear Liquid Diet and Continuous Glucose Monitoring (Abbott Freestyle Libre) in people with Diabetes During Pregnancy, run by Medical College of Wisconsin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sukanya Skandarajah (4148055337, sskandarajah@mcw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Time Above Range (TAR >110 mg/dL) During Labor (time frame: From admission to delivery (expected ≤72 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.