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PRISM-T1D

NCT07293715Phase 4

Key facts

Status: Recruiting
Start: Feb 2026
Primary completion: Jun 2027
Countries: 1
Sponsor: The Ohio State University
Modality: Recombinant Proteins and Enzymes

Drugs: human insulin
Conditions: type 1 diabetes mellitus (T1D)

Overview

Phase 4, randomised, open-label trial of human insulin in type 1 diabetes mellitus (T1D) (2 arms), sponsored by The Ohio State University. Primary endpoint: Mean of first neonatal blood glucose. Started Feb 2026; status: recruiting.

Design

2 arms

Study design: RandomizedOpen-label

Intervention group
Permissive blood sugar control (70-140 mg/dL) using insulin and DEXCOM CGM
Standard of care
Strict blood sugar control (70-110 mg/dL) using insulin and DEXCOM CGM

Who it enrols

Pregnant individuals >= 18 years old with Type 1 diabetes, intending vaginal delivery, with a singleton, non-anomalous fetus at >= 35 weeks gestation and cervical dilation < 6 cm.

Endpoints

Primary

Mean of first neonatal blood glucoseFrom birth to 2 hours after birth

Secondary

Neonatal C-peptideAt birth
Incidence of neonatal hypoglycemiaAt birth, up to 24 hours
Incidence of neonatal hyperbilirubinemiaWithin the first 48 hours after birth
Incidence of NICU admissionWithin the first 48 hours after birth
Birth experience satisfaction per Birth Satisfaction Survey-Revised
Maternal IV insulin maximum dose and durationDay 1 through study completion, up to 4 weeks
Incidence of Maternal HypoglycemiaDay 1 through study completion, up to 4 weeks

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