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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

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.