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

Eastern Virginia Medical School (EVMS)

Status and phase: Not yet enrolling; Phase 4

Conditions: Pregestational Diabetes; Pregnancy

Treatments: Drug: Use of insulin glargine once daily; Drug: Use of insulin glargine twice daily

Study type: Interventional

Funder types: Other

Identifiers

NCT07224893

25-09-FB-0214

Details and patient eligibility

About

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?

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;
• Concomitant use of other anti-diabetic medication (such as metformin); use of a short-acting insulin will not be considered an exclusion;
• Known or suspected fetal anomaly or aneuploidy;
• Prisoners;
• Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Once-Daily Insulin Glargine

Active Comparator group

Description:

Participants randomized to this arm will take insulin glargine once daily

Treatment:

Drug: Use of insulin glargine once daily

Twice-Daily Insulin Glargine

Experimental group

Description:

Participants randomized to this arm will take insulin glargine twice daily

Treatment:

Drug: Use of insulin glargine twice daily