Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

What Was Tested

In this not phased trial, researchers set out to test Insulin Glargine and Insulin Lispro.

The main question this study aims to answer is: 1.

It had two arms (groups): Insulin glargine alone (experimental) and Insulin glargine + Insulin lispro (active comparator).

The registry classes the interventions as drug.

More on the Plan

Gestational age at enrollment will vary from patient to patient, but all patients will be enrolled when insulin is clinically indicated to manage their diabetes.

If patients choose to participate in the study, they will be randomized to standard of care (long-acting insulin glargine plus prandial insulin lispro) or the experimental group (long-acting insulin glargine only).

During this initial consult, a review of medical records is completed, regardless of study participation.

The study utilizes a similar process to the MFM clinical workflow.

Who Took Part

The registry lists 176 planned participants were the target.

It was open to women only aged from 18 years up to 50 years.

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

Examples of who could join: Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy. Aged between 18-50. Speak English or Spanish.

The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: pre-existing use of insulin; gestational age \> or = 35w0d; unwilling or unable to upload or email weekly blood sugar logs.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2025-11-26 with completion listed for 2026-10-01.

It ran at 2 sites in United States (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Composite outcome (time frame: From enrollment to delivery).

It also tracked 9 secondary outcomes, for example Compliance with medication, % of patients in experimental group who are able to remain on insulin glargine only, Maternal complication rates, Birth complications, Neonatal complications and Birthweight.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Glargine and Insulin Lispro in 176 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 and the Insulin Lispro compound page, all human trials.