RCT Glargine vs NPH for Treatment of DM in Pregnancy

Loyola University

Status and phase: Enrolling; Phase 3

Conditions: Diabetes Mellitus in Pregnancy; Type 2 Diabetes Mellitus (T2DM); Gestational Diabetes Mellitus, Class A2

Treatments: Drug: insulin NPH; Drug: Insulin glargine

Study type: Interventional

Funder types: Other

Identifiers

NCT06619301

217918

Details and patient eligibility

About

We are asking you to take part in this research study because you are diagnosed with pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin therapy in pregnancy. Currently, many hospitals differ among use of insulin for management of DM in pregnancy, with NPH, glargine and detemir being the most commonly used forms of basal insulin. Outside of pregnancy, NPH is rarely used with glargine and determir being the more common forms of insulin used due to their fewer episodes of hypoglycemia in these patients. Detemir has been well studied in pregnancy and found to be noninferior to NPH. Unfortunately, glargine has not been as well studied in pregnancy. Thus, with this study we want to compare glargine and NPH.

The purpose of this study is to compare two different forms of insulin (Glargine and NPH) that we regularly use to manage diabetes mellitus in pregnancy.

Full description

This is an open-label, noninferiority, prospective randomized study. Patients will be randomized to either be treated with NPH insulin for management of diabetes mellitus in pregnancy, or with Glargine insulin. We will include all pregnant patients managed by the Maternal Fetal Medicine team at Loyola University of Medical Center that have pregestational Type 2 Diabetes Mellitus or Gestational Diabetes Mellitus requiring insulin. Our primary outcome is hypoglycemia.

We provide patients with insulin teaching, a referral to diabetic nutrition education, and instructions for hypoglycemic events. Patients are instructed to continue monitoring blood glucose 4 times a day (fasting and 2 hours after each meal), log their blood glucose values in MyLoyola chart, continue routine prenatal care with maternal fetal medicine/high risk obstetric clinic, and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance. The study is voluntary, and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not, regardless of which arm they are in within the RCT.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient requiring initiation of insulin therapy for Gestational Diabetes Mellitus or Type 2 Diabetes Mellitus in pregnancy
• At least 18 years old
• Insulin started prior to 34 weeks gestation
• Established prenatal care by 14 weeks gestation

Exclusion criteria

• Those under the age of 18 years old
• Those unable to consent in english
• Allergy to insulin
• Controlled with only diet modification or the use of oral antihyperglycemics
• Has diagnosis of Type 1 Diabetes Mellitus
• Receiving insulin through an insulin pump

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Insulin Glargine

Active Comparator group

Description:

Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

Treatment:

Drug: Insulin glargine

Insulin NPH

Active Comparator group

Description:

Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.

Treatment:

Drug: insulin NPH