RECRUITING

DETERMINE: Detemir vs NPH

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Conditions

Gestational DiabetesDiabetes Mellitus, Type 2

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.

Official Title

A Phase 2 Open Label Randomized Controlled Trial Determir Vs Neutral Protamine Hagedorn (NPH) In Pregnant Women: DETERMINE Study

Quick Facts

Study Start:2022-02-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05124457

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Inclusion criteria will include pregnant women with pre-existing T2DM and GDM who requiring insulin to manage their blood sugars in pregnancy.
  1. 1. Multiple Gestation
  2. 2. Type 1 Diabetes mellatus
  3. 3. Age \< 18
  4. 4. Known or suspected hypersensitivity to NPH or insulin detemir
  5. 5. Known fetal major malformations
  6. 6. Chronic renal or hepatic insufficiency
  7. 7. Known to be HIV, Hepatitis B, or Hepatitis C positive
  8. 8. Indication for planned premature delivery (placenta accrete, or prior classical cesarean delivery)
  9. 9. Insulin dependent before conception

Contacts and Locations

Study Contact

Michael Richley, MD
CONTACT
310-794-7274
mrichley@mednet.ucla.edu
Christina Han, MD
CONTACT
310-794-7274
cshan@mednet.ucla.edu

Principal Investigator

Christina Han, MD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Michael Richley, MD
STUDY_DIRECTOR
University of California, Los Angeles

Study Locations (Sites)

University of California, Los Angeles
Los Angeles, California, 90069
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • Christina Han, MD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles
  • Michael Richley, MD, STUDY_DIRECTOR, University of California, Los Angeles

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2022-02-01
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Gestational Diabetes
  • Diabetes Mellitus, Type 2