RCT Glargine vs NPH for Treatment of DM in Pregnancy

Description

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

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

Study Overview

Study Details

Study overview

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.

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

RCT Glargine vs NPH for Treatment of DM in Pregnancy

Condition
Diabetes Mellitus in Pregnancy
Intervention / Treatment

-

Contacts and Locations

Maywood

Loyola University Medical Center, Maywood, Illinois, United States, 60153

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Loyola University,

Joana Lopes Perdigao, MD, PRINCIPAL_INVESTIGATOR, Loyola University

Study Record Dates

2027-01-01