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Insulin

Patient vs Provider-led Insulin Titration for Gestational Diabetes

Phase 4

Recruiting

Led By Kartik Venkatesh, MD, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

English or Spanish speaking

Timeline

Screening 3 weeks

Treatment Varies

Follow Up any nicu admission for 48 hours or greater duration up to 2-3 months

Awards & highlights

Study Summary

This trial studies pregnant women with GDM to compare rapid basal insulin titration to standard therapy. Subgroup analysis will include those with/without metformin use. Patients will continue routine clinic visits & sign informed consent.

Who is the study for?

This trial is for pregnant individuals diagnosed with Gestational Diabetes Mellitus (GDM) between 20 to 32 weeks of gestation, needing basal insulin. Participants must be over 18, speak English or Spanish, and receive care at OSU or affiliated clinics. Those with pre-existing Type 1 or Type 2 diabetes, insulin allergies, or non-English/Spanish speakers are excluded.Check my eligibility

What is being tested?

The EMPOWER study is testing whether patients can effectively manage their own insulin levels compared to the standard provider-led approach in controlling blood sugar during pregnancy. It's a randomized control trial involving routine clinic visits and subgroup analysis for those also taking metformin.See study design

What are the potential side effects?

While not explicitly listed in the provided information, typical side effects of insulin use may include low blood sugar episodes (hypoglycemia), weight gain, injection site reactions, and possibly swelling of arms and legs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not using insulin or have started it within the last 7 days.

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I speak English or Spanish.

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I am pregnant, diagnosed with gestational diabetes needing insulin, and between 20 to 32 weeks along.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ any nicu admission for 48 hours or greater duration up to 2-3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~any nicu admission for 48 hours or greater duration up to 2-3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and any nicu admission for 48 hours or greater duration up to 2-3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Fasting glycemic control

Secondary outcome measures

Average fasting blood glucose

Average postprandial blood glucose

Birth weight in grams

+14 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Patient-led self-titration of insulinExperimental Treatment1 Intervention

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.

Group II: Standard of careActive Control1 Intervention

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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

830 Previous Clinical Trials

505,564 Total Patients Enrolled

Kartik Venkatesh, MD, PhDPrincipal InvestigatorOhio State University

Xiao-Yu Wang, MDPrincipal InvestigatorOhio State University

Media Library

Patient-led Insulin (Insulin) Clinical Trial Eligibility Overview. Trial Name: NCT05922033 — Phase 4

Pregnancies Research Study Groups: Patient-led self-titration of insulin, Standard of care

Pregnancies Clinical Trial 2023: Patient-led Insulin Highlights & Side Effects. Trial Name: NCT05922033 — Phase 4

Patient-led Insulin (Insulin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05922033 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this scientific research currently have openings for participants?

"Based on the clinicaltrials.gov registry, this medical trial is no longer accepting patients; its commencement date was August 1st 2023 and it has not been modified since June 26th 2023. Despite the lack of recruitment for this study, there are currently 1220 other trials that still require volunteers to participate."

Answered by AI