Permissive Versus Strict Intrapartum Glucose Management in Type 1 Diabetes (PRISM-T1D)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorOhio State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Pregnant individuals
≥ 18 years old
Type 1 diabetes
Intention for vaginal delivery and admitted to Labor and Delivery
Disqualifiers
Scheduled cesarean delivery
Cervical dilation ≥ 6 cm on presentation to L&D
Receipt of antenatal corticosteroids within 7 days of randomization
Fetal demise
Trial design
Design model
Parallel
Treatments tested in this trial
Insulin
DrugParticipants 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 Monitor
DevicePatients 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.
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Intervention groupExperimental treatment 2 interventions
Group B: Standard of careOther 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From birth to 2 hours after birthSecondary outcomes
1
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.
Time frame
At birth2
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.
Time frame
At birth, up to 24 hours3
Neonatal hyperbilirubinemia
Neonatal jaundice requiring phototherapy
Time frame
Within the first 48 hours after birth4
NICU admission
Admitted to NICU during delivery admission
Time frame
Within the first 48 hours after birthSponsors and contacts
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Source ClinicalTrials.gov