Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management

Purpose

The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?

Conditions

  • Pregestational Diabetes
  • Pregnancy

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients older than 18 years of age; - The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study; - Type II diabetes mellitus requiring insulin; - The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists. - Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management

Exclusion Criteria

  • Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated; - Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance; - Known or suspected fetal anomaly or aneuploidy; - Prisoners; - Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Once-Daily Insulin Glargine 		Participants randomized to this arm will take insulin glargine once daily
  • Drug: Use of insulin glargine once daily
    Insulin glargine will be used once daily
Experimental
Twice-Daily Insulin Glargine 		Participants randomized to this arm will take insulin glargine twice daily
  • Drug: Use of insulin glargine twice daily
    Insulin glargine will be used twice daily

Recruiting Locations

Sentara Norfolk General Hospital, Norfolk, Virginia 23507
Norfolk, Virginia 23507
Contact:
Marwan Ma'ayeh
7574467900
maayehmg@odu.edu

More Details

Status
Recruiting
Sponsor
Eastern Virginia Medical School

Study Contact

Marwan Ma'ayeh, MD
7574467900
maayehmg@odu.edu