Pregnancy, High RiskPhase 4PRISM-T1DNCT07293715
Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
A Phase 4 study testing Insulin and DEXCOM Continuous Glucose Monitor in people with Pregnancy, High Risk and Type 1 Diabetes, run by Ohio State University at 1 site in United States.
Trial summary
PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy, High Risk, Type 1 Diabetes
- What is being tested?
- Insulin and DEXCOM Continuous Glucose Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Feb 2026to Jun 2027
- Phase
- Phase 4
- 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
- Pregnant individuals
- ≥ 18 years old
- Type 1 diabetes
- Intention for vaginal delivery and admitted to Labor and Delivery
- Singleton, non-anomalous fetus
- Gestational age greater than or equal to 35 weeks gestation.
- Cervical dilation is less than 6 cm.
- Delivering at the study institution
Who cannot join
- Scheduled cesarean delivery
- Cervical dilation ≥ 6 cm on presentation to L\&D
- Receipt of antenatal corticosteroids within 7 days of randomization
- Fetal demise
- Major fetal anomaly (attached)
- Multiple gestation
- Non-English speaking
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
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
Kartik Venkatesh, MD, PhD, 614-293-4780, kartik.venkatesh@osumc.edu
About this study
PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.
Read the detailed description
Type 1 Diabetes (T1D) affects approximately 0.5% of pregnancies in the US. Infants born to individuals with T1D are at increased risk of adverse pregnancy outcomes due to lack of glycemic control. Individuals with T1D are increasingly using hybrid closed loop therapy (HCL) for insulin delivery to achieve glycemic control. Current data highlight that less permissive intrapartum (while in labor) glycemic control is not associated with a increased risk of adverse pregnancy outcomes, including neonatal hypoglycemia and NICU admission. However, such data about permissive versus strict intrapartum glucose management has primarily been from pregnant individuals with type 2 diabetes or gestational diabetes who did not use HCL based insulin therapy. Pregnant individuals with diabetes who use HCL with continuous glucose monitoring and closed loop insulin delivery represent a unique population, and data from this population are needed to inform intrapartum obstetric management. The investigators hypothesize that permissive intrapartum glucose management using continuous glucose monitoring (70-140 mg/dL) will not be associated with neonatal dysglycemia measured as first mean neonatal glucose value within the first two hours of life compared with strict intrapartum glucose management or the current standard of care (70-110 mg/dL). The investigators will conduct a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with T1D using HCL who are admitted for labor management. The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia (first neonatal blood glucose measured within 2 hours of life) compared with strict intrapartum glucose management. The investigators will secondarily examine the association between permissive versus strict intrapartum glucose with adverse neonatal outcomes, including neonatal hypoglycemia, neonatal hyperbilirubinemia, and NICU admission, patient satisfaction, and continuous glucose monitor (CGM) metrics.
- Conditions
- Pregnancy, High Risk, Type 1 Diabetes
- Being tested
- Insulin, DEXCOM Continuous Glucose Monitor
- Keywords
- Pregnancy, Continuous Glucose Monitor, Type 1 Diabetes, Automated insulin delivery, Hybrid closed loop, Insulin pump
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InsulinDrug
Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). Participants and clinicians will be unblinded. Once randomized, an order set will be entered into the EMR that will alert pharmacy and nursing colleagues to the appropriate intrapartum glycemic control protocol.
DEXCOM Continuous Glucose MonitorDevice
Patients will be asked to wear an optional Continuous Glucose Monitor (CGM) to utilize during labor for research purposes. The CGM will be removed prior to hospital discharge and data will be extracted by trained research personnel. All participants already utilize a CGM device as part of standard of care as part of Hybrid Closed Loop (HCL) therapy. No clinical decisions will be made based upon data from the research CGM device. This data will not be extracted until after hospital discharge.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | permissive blood sugar control (70-140 mg/dL) Receives: Drug: Insulin; Device: DEXCOM Continuous Glucose Monitor |
| Standard of care | Other | strict blood sugar control (70-110 mg/dL) Receives: Drug: Insulin; Device: DEXCOM Continuous Glucose Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of first neonatal blood glucose (continuous, mean with standard deviation)
The first heel stick neonatal blood glucose (mg/dL) will be obtained within the first two hours of life utilizing a hospital-grade glucometer. This will be recorded in the electronic medical record and abstracted at study conclusion. The mean of these will be utilized as the primary outcome. A heel stick neonatal blood glucose in the first two hours of life is current standard of care for all infants of diabetic individuals.
Measured: From birth to 2 hours after birth
Secondary outcomes (7)
Neonatal C-peptide (continuous, mean with standard deviation)
Umbilical cord C-peptide levels will be analyzed from cord blood collected at the time of delivery.
Measured: At birth
Neonatal hypoglycemia
Neonatal hypoglycemia: blood glucose < 40mg/dl in birth to 4 hours of life, < 45mg/dl in 4-24 hours of life, and < 50mg/dl after 24 hours of life, or need for oral or IV glucose therapy.
Measured: At birth, up to 24 hours
Neonatal hyperbilirubinemia
Neonatal jaundice requiring phototherapy
Measured: Within the first 48 hours after birth
NICU admission
Admitted to NICU during delivery admission
Measured: Within the first 48 hours after birth
Birth experience satisfaction per Birth Satisfaction Survey-Revised (BSS-R) (continuous, mean with standard deviation)
The Birth Satisfaction Survey-Revised (BSS-R) is a validated patient satisfaction survey describing L\&D birthing experiences. This survey will be administered at any time during their postpartum admission. This measure will be analyzed as a continuous mean score.
Measured: Day 1 through study completion (at hospital discharge), up to 4 weeks
Maternal IV insulin maximum dose and duration
Maternal IV insulin maximum IV insulin dose (units) and duration (hours) will be measured as continuous variables (mean and SD).
Measured: Day 1 through study completion, up to 4 weeks
Maternal Hypoglycemia
Maternal blood glucose less than 70 mg/dL, as measured by capillary blood glucose via hospital-grade glucometer.
Measured: Day 1 through study completion, up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2025
- Study start25 Feb 2026
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, High RiskStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kartik K Venkatesh, Ohio State University
- Investigators
- Anna Brewton, MD, Principal investigator, Ohio State UniversityKartik K Venkatesh, MD, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07293715
- Sponsor's protocol ID
- STUDY 20252532
- Acronym
- PRISM-T1D
- Status last verified
- Apr 2026
- First submitted
- 2 Dec 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
- ClinicalTrials.gov ID
- NCT07293715
- Acronym / sponsor ID
- PRISM-T1D / STUDY 20252532
- Conditions
- Pregnancy, High Risk, Type 1 Diabetes
- Keywords
- Pregnancy, Continuous Glucose Monitor, Type 1 Diabetes, Automated insulin delivery, Hybrid closed loop, Insulin pump
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 25 Feb 2026 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 19 Dec 2025 (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.
PRISM-TID is a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with type 1 diabetes (T1D) using hybrid closed loop therapy (HCL) who are admitted for labor management. Participants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia compared with strict intrapartum glucose management.
Detailed description
Type 1 Diabetes (T1D) affects approximately 0.5% of pregnancies in the US. Infants born to individuals with T1D are at increased risk of adverse pregnancy outcomes due to lack of glycemic control. Individuals with T1D are increasingly using hybrid closed loop therapy (HCL) for insulin delivery to achieve glycemic control. Current data highlight that less permissive intrapartum (while in labor) glycemic control is not associated with a increased risk of adverse pregnancy outcomes, including neonatal hypoglycemia and NICU admission. However, such data about permissive versus strict intrapartum glucose management has primarily been from pregnant individuals with type 2 diabetes or gestational diabetes who did not use HCL based insulin therapy. Pregnant individuals with diabetes who use HCL with continuous glucose monitoring and closed loop insulin delivery represent a unique population, and data from this population are needed to inform intrapartum obstetric management. The investigators hypothesize that permissive intrapartum glucose management using continuous glucose monitoring (70-140 mg/dL) will not be associated with neonatal dysglycemia measured as first mean neonatal glucose value within the first two hours of life compared with strict intrapartum glucose management or the current standard of care (70-110 mg/dL). The investigators will conduct a single center non-inferiority randomized controlled trial of permissive intrapartum glucose management (intervention) versus strict intrapartum glucose management (standard of care) among pregnant individuals with T1D using HCL who are admitted for labor management. The primary aim of this trial it to demonstrate that permissive intrapartum glucose management is not associated with an increased risk of neonatal dysglycemia (first neonatal blood glucose measured within 2 hours of life) compared with strict intrapartum glucose management. The investigators will secondarily examine the association between permissive versus strict intrapartum glucose with adverse neonatal outcomes, including neonatal hypoglycemia, neonatal hyperbilirubinemia, and NICU admission, patient satisfaction, and continuous glucose monitor (CGM) metrics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Drug: Insulin, Device: DEXCOM Continuous Glucose Monitorpermissive blood sugar control (70-140 mg/dL) |
| Standard of care | Other | Drug: Insulin, Device: DEXCOM Continuous Glucose Monitorstrict blood sugar control (70-110 mg/dL) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pregnant individuals
- ≥ 18 years old
- Type 1 diabetes
- Intention for vaginal delivery and admitted to Labor and Delivery
- Singleton, non-anomalous fetus
Key exclusion criteria (7 listed)
- Scheduled cesarean delivery
- Cervical dilation ≥ 6 cm on presentation to L\&D
- Receipt of antenatal corticosteroids within 7 days of randomization
- Fetal demise
- Major fetal anomaly (attached)
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 |
|---|---|---|
| InsulinParticipants will be randomized in a 1:1 fashion to one of two intrapartum glycemic control options: permissive (70-140 mg/dL) or strict (70-110 mg/dL). Participants and clinicians will be unblinded. Once randomized, an order set will be entered into the EMR that will alert pharmacy and nursing colleagues to the appropriate intrapartum glycemic control protocol. | Drug | Intervention group, Standard of care |
| DEXCOM Continuous Glucose MonitorPatients will be asked to wear an optional Continuous Glucose Monitor (CGM) to utilize during labor for research purposes. The CGM will be removed prior to hospital discharge and data will be extracted by trained research personnel. All participants already utilize a CGM device as part of standard of care as part of Hybrid Closed Loop (HCL) therapy. No clinical decisions will be made based upon data from the research CGM device. This data will not be extracted until after hospital discharge. | Device | Intervention group, Standard of care |
Primary outcome
Mean of first neonatal blood glucose (continuous, mean with standard deviation)
Time frame: From birth to 2 hours after birth
The first heel stick neonatal blood glucose (mg/dL) will be obtained within the first two hours of life utilizing a hospital-grade glucometer. This will be recorded in the electronic medical record and abstracted at study conclusion. The mean of these will be utilized as the primary outcome. A heel stick neonatal blood glucose in the first two hours of life is current standard of care for all infants of diabetic individuals.
7 secondary outcomes
Neonatal C-peptide (continuous, mean with standard deviation)
Time frame: At birth
Neonatal hypoglycemia
Time frame: At birth, up to 24 hours
Neonatal hyperbilirubinemia
Time frame: Within the first 48 hours after birth
NICU admission
Time frame: Within the first 48 hours after birth
Birth experience satisfaction per Birth Satisfaction Survey-Revised (BSS-R) (continuous, mean with standard deviation)
Time frame: Day 1 through study completion (at hospital discharge), up to 4 weeks
Maternal IV insulin maximum dose and duration
Time frame: Day 1 through study completion, up to 4 weeks
Maternal Hypoglycemia
Time frame: Day 1 through study completion, up to 4 weeks
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 29 Apr 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.
Anna Brewton, MD principal investigator
Ohio State University
Kartik K Venkatesh, MD, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin and DEXCOM Continuous Glucose Monitor in people with Pregnancy, High Risk and Type 1 Diabetes, run by Ohio State University 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 8 inclusion and 7 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 29 Apr 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Anna Brewton, MD (614-293-8045, Anna.Brewton@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of first neonatal blood glucose (continuous, mean with standard deviation) (time frame: From birth to 2 hours after birth). 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 29 Apr 2026.