Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER)

PHASE4CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

October 19, 2023

Primary Completion Date

March 30, 2025

Study Completion Date

May 1, 2025

Conditions
Gestational Diabetes MellitusPregnancy in DiabeticPregnancy, High Risk
Interventions
DRUG

Patient-led Insulin (intervention group)

Individuals randomized to this arm will initiate night-time insulin of 10 units. The type of basal insulin will be left to the discretion of the provider with levemir or glargine preferred over NPH. On day 0 of initiation of insulin, the patient will initiate night-time (or prior to sleep if alternate sleep schedule) insulin of 10 units (glargine, detemir, or NPH). Patient will check their fasting blood glucose in the morning and record their values. If the value is below 70 they will decrease their insulin dosage that night by 2 units; if the value is above 95 they will increase their insulin dosage that night by 2 units; and if the value is between 70 and 95, they will maintain the same insulin dosage that night. The patients will continue this algorithm for the remainder of the pregnancy. If the patient does not have a fasting blood glucose, the patient will maintain the dose of basal insulin at the prior dose.

DRUG

Provider-led Insulin (standard care)

Individuals randomized to this arm will receive standard care and titration of insulin will be determined by the individual providers.

Trial Locations (1)

43210

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine, Columbus

All Listed Sponsors
lead

Ohio State University

OTHER

NCT05922033 - Patient Versus Provider-led Titration of Insulin for Glycemic Control in Gestational Diabetes (EMPOWER) | Biotech Hunter | Biotech Hunter