RecruitingPhase 3NCT06619301

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Randomized Controlled Trial of Glargine Versus Neutral Protamine Hagedorn Insulin for the Treatment of Diabetes Mellitus in Pregnancy

Sponsor

Loyola University

Enrollment

160 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This randomized trial is comparing two types of long-acting insulin — glargine (a newer insulin analog) versus NPH (an older, intermediate-acting insulin) — for managing blood sugar in pregnant women who require insulin therapy for gestational diabetes or type 2 diabetes during pregnancy. The study aims to find which insulin type is safer and more effective during pregnancy. **You may be eligible if...** - You are at least 18 years old and pregnant - You have gestational diabetes or type 2 diabetes and need to start insulin therapy - You started insulin before 34 weeks of pregnancy - You established prenatal care by 14 weeks of pregnancy **You may NOT be eligible if...** - You are under 18 years old - You cannot give consent in English - You have a known allergy to insulin - Your diabetes is controlled with diet alone or oral medications without needing insulin - You have Type 1 diabetes - You are using an insulin pump Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInsulin glargine

Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in pregnancy, however, there is limited data for comparison to the standard, NPH.

DRUGinsulin NPH

Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.

Locations(1)

Loyola University Medical Center

Maywood, Illinois, United States

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NCT06619301

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