|

RCT Glargine vs NPH for Treatment of DM in Pregnancy

RECRUITINGPhase 3Sponsored by Loyola University
Actively Recruiting
PhasePhase 3
SponsorLoyola University
Started2024-04-01
Est. completion2026-04-01
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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

Conditions4

DiabetesDiabetes Mellitus in PregnancyGestational Diabetes Mellitus, Class A2Type 2 Diabetes Mellitus (T2DM)

Locations1 site

Loyola University Medical Center
Maywood, Illinois, 60153
Joana Lopes Perdigao, MD708-216-4033joana.perdigao@lumc.edu

Browse More Trials

Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.