No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
200 (estimated)
Sponsor
Eastern Virginia Medical School · Other
Who this trial is looking for
This trial is looking for pregnant women with type 2 diabetes who require insulin. Participants will either take insulin glargine once a day or twice a day, and their blood sugar levels will be monitored continuously.
Are You a Good Fit for This Trial?
You may be able to join if
I am older than 18 years old.
I can speak and read English well.
I have been diagnosed with type 2 diabetes requiring insulin.
I am between 24 and 28 weeks pregnant.
I will use a continuous glucose monitor.
You may not be able to join if
I am allergic to insulin glargine.
I cannot use a continuous glucose monitor or I don't want to.
I have a known fetal anomaly.
I am a prisoner.
I am receiving prenatal care outside of EVMS.
I plan to deliver outside Sentara Norfolk General Hospital.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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?
Trial Locations
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Eligibility Criteria
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…
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.
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