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

The Ohio State University

Status and phase: Enrolling; Phase 4

Conditions: Gestational Diabetes Mellitus; Pregnancy in Diabetic; Pregnancy, High Risk

Treatments: Drug: Patient-led Insulin (intervention group); Drug: Provider-led Insulin (standard care)

Study type: Interventional

Funder types: Other

Identifiers

NCT05922033

2023H0222

Details and patient eligibility

About

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.

Full description

Gestational diabetes mellitus (GDM) is one of the most frequent medical complications of pregnancy and affects nearly 1 in 10 pregnant individuals. GDM is associated with an increased risk of adverse pregnancy outcomes for both the pregnant individual (cesarean delivery, preeclampsia) and infant (large for gestational age at birth, preterm birth <37 weeks, neonatal hypoglycemia, and hyperbilirubinemia). Improved glycemic control has been associated with reduction in the risks of these adverse pregnancy outcomes. Nearly 1 in 4 pregnant individuals with GDM will require medication to achieve glycemic control. The first-line therapy historically recommended for glycemic control is insulin and continues to be the primary recommendation of guidelines from the American College of Obstetrics and Gynecology (ACOG) and the American Diabetes Association (ADA). However current guidelines do not recommend a clear approach to insulin titration in GDM. This is an important limitation of current clinical practice. Individuals with GDM who are generally diagnosed between 24 to 28 weeks only have a short window of up to a few months to achieve glycemic control with pharmacotherapy to prevent adverse pregnancy outcomes. Traditionally, provider led titration of insulin has been the standard of care. Recommendations from outside of pregnancy and limited observational data from pregnancy have proposed patient-led self-titration of basal insulin have improved glycemic control compared to provider led titration.

We propose to conduct a pragmatic randomized controlled trial "EMPOWER: Patient versus provider-led titration of basal insulin for glycemic control in gestational diabetes" to compare pregnant individuals with GDM diagnosed >20 weeks gestation randomized to patient-led (intervention) versus provider-led insulin titration (standard of care).

OVERALL AIM: To conduct a pragmatic, non-blinded randomized controlled trial (pRCT) of patient-led insulin titration versus provider-led titration of basal insulin to improve glycemic control in the late third trimester in pregnancies complicated by gestational diabetes.

1.2 Specific Aims

PRIMARY AIM:

Compare glycemic control defined as the mean fasting glucose in the last week prior to term (36 weeks) between individuals randomized to patient-led (intervention) versus provider-led insulin titration (standard of care).

SECONDARY AIMS:

Secondary Aim 1: Compare the frequency of adverse pregnancy outcomes (cesarean delivery, preeclampsia, large for gestational age, and NICU admission) between individuals randomized to patient-led (intervention) versus provider-led insulin titration (standard of care).

Secondary Aim 2: Compare effect of concurrent metformin use on total daily insulin dose per kilogram at 36 weeks overall, and by patient-led (intervention) versus provider-led insulin titration.

Secondary Aim 3: Compare patient and provider satisfaction between patient-led (intervention) versus provider-led insulin titration.

Enrollment: 56 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Patient-led self-titration of insulin

Experimental group

Description:

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.

Treatment:

Drug: Patient-led Insulin (intervention group)

Standard of care

Active Comparator group

Description:

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

Treatment:

Drug: Provider-led Insulin (standard care)