Metabolic Analysis for Treatment Choice in Gestational Diabetes Mellitus

What Was Tested

The trial (phase 4) is built around Insulin (regular human).

Without adequate treatment, women with GDM and their infants are at risk for substantial morbidity.

It had two arms (groups): Usual Care (active comparator) and Individualized Treatment (active comparator).

Participants will undergo standard counseling and be prescribed a treatment for their GDM. Treatments include insulin, glyburide, and metformin.

Participants will undergo standard counseling and be matched to therapy based on their GDM mechanism. Treatments include insulin, glyburide, and metformin.

The registry classes the interventions as drug.

Who Took Part

The registry lists 54 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

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

Examples of who could join: Pregnant women beyond 24 weeks of gestation who are scheduled for a 3-hour oral glucose tolerance test.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: fetal anomaly; pregestational diabetes; GDM diagnosis without a 3-hour OGTT.

How the Study Was Run

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

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind Insulin (regular human) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-02-28 with completion listed for 2023-08-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Proportion of Women Who Are Eligible, Screened, Enroll and Remain in the Study (time frame: Through study completion, an average of 16 weeks). Proportion of Participants Who Report Suitability of the Study Procedures (time frame: Through study completion, an average of 16 weeks).

It also tracked 9 secondary outcomes, for example Proportion of Participants With Consistent GDM Mechanism Before and and After Treatment Initiation, Proportion of Women Who Remain on Same Treatment During Study, Maternal Glucose Control, Proportion of Participants Who Deliver by Primary Cesarean, Proportion of Participants Who Developed Hypertensive Diseases in Pregnancy and Birthweight.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 54 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.