Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorEastern Virginia Medical School
About this trial
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?
Eligibility criteria
Qualifiers
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.
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Use of insulin glargine once daily
- Use of insulin glargine twice daily
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov