Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT06619301

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Led by Loyola University · Updated on 2024-10-01

160

Participants Needed

1

Research Sites

143 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Under 18 years old
  • Unable to consent in English
  • Allergy to insulin
  • Controlled with diet modification or oral antihyperglycemics only
  • Diagnosis of Type 1 Diabetes Mellitus
  • Receiving insulin through an insulin pump

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Loyola University Medical Center

Maywood, Illinois, United States, 60153

Actively Recruiting

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Research Team

J

Joana Lopes Perdigao, MD

CONTACT

N

Nuong Truong, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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