Overview

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

Status:
Recruiting

Trial end date:
2025-01-01

Target enrollment:
0

Participant gender:
Female

Summary

We propose a pragmatic, unblinded, randomized controlled, single center trial of 56 pregnant individuals with Gestational diabetes mellitus (GDM). Our study proposes a pragmatic randomized control trial of patient led rapid titration of basal insulin compared to standard therapy. There is a planned subgroup analysis of patients with and without concomitant metformin usage. Patients will continue routine clinic visits. Patients who are initiated on basal insulin or started on night-time basal insulin within 7 days will be approached about the study. Patients who agree to be enrolled will sign informed consent.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ohio State University

Treatments:

Insulin
Insulin, Globin Zinc

Criteria

Inclusion Criteria:

- Pregnant individuals with a diagnosis of Gestational diabetes mellitus (GDM) between
20 0/7 to 31 6/7 - 32 6/7 weeks and requiring initiation of basal insulin initiation
as determined by provider

- Patients not on insulin or insulin initiation within 7 days of consent and
randomization

- ≥ 18 years old with the ability to give informed consent

- Diagnosed with GDM during pregnancy by a one-hour 50-gram glucose challenge test ≥200
mg/dL at greater than 20 weeks of gestation or two elevated values on a 3-hour or a
100-gram glucose tolerance test at greater than 20 weeks of gestation.

- English or Spanish speaking

- Receiving prenatal care at OSU or an affiliated clinic where Electronic Health Records
(EHR) can be accessed

Exclusion criteria:

- Type 1 or 2 diabetes

- Insulin allergy

- Not English or Spanish speaking