Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients.

Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice.

Continuous glucose monitoring will be used to track blood sugar levels.

It had two arms (groups): Once-Daily Insulin Glargine (active comparator) and Twice-Daily Insulin Glargine (experimental).

Participants randomized to this arm will take insulin glargine once daily.

Participants randomized to this arm will take insulin glargine twice daily.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 200 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patients older than 18 years of age;. The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;. Type II diabetes mellitus requiring insulin;. Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: contraindication to cgm use, patient declines cgm use, or cgm not covered by patient's insurance;; known or suspected fetal anomaly or aneuploidy;; ongoing prenatal care outside evms or planned delivery outside sentara norfolk general hospital.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Insulin Glargine study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2026-05-18 with completion listed for 2027-12-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Weekly Time in Range (time frame: From Day 7 to Day 14 after study enrollment).

It also tracked 31 secondary outcomes, for example Hypertensive disorders of pregnancy, Preterm birth <34 weeks, Preterm birth <37 weeks, Spontaneous or Indicated Delivery, Operative vaginal delivery and Cesarean Delivery.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 200 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.