Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
160 participants
INTERVENTIONAL
2024-04-01
2027-01-01
Brief Summary
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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.
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Detailed Description
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We provide patients with insulin teaching, a referral to diabetic nutrition education, and instructions for hypoglycemic events. Patients are instructed to continue monitoring blood glucose 4 times a day (fasting and 2 hours after each meal), log their blood glucose values in MyLoyola chart, continue routine prenatal care with maternal fetal medicine/high risk obstetric clinic, and continue routine ultrasound with serial growth ultrasounds and antenatal fetal surveillance. The study is voluntary, and the patients will receive the same care and number of visits regardless of whether they choose to participate in the study or not, regardless of which arm they are in within the RCT.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Insulin Glargine
Insulin Glargine dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
Insulin 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.
Insulin NPH
Insulin NPH dosed 1-2 times daily throughout pregnancy for management of diabetes mellitus.
insulin NPH
Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.
Interventions
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Insulin 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.
insulin NPH
Insulin NPH is a current medication used in pregnancy for diabetes mellitus. It has been used as the standard form of insulin.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* Insulin started prior to 34 weeks gestation
* Established prenatal care by 14 weeks gestation
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Loyola University
OTHER
Responsible Party
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Joana Perdigao
Assistant Professor
Principal Investigators
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Joana Lopes Perdigao, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.
Smith JG, Manuck TA, White J, Merrill DC. Insulin glargine versus neutral protamine Hagedorn insulin for treatment of diabetes in pregnancy. Am J Perinatol. 2009 Jan;26(1):57-62. doi: 10.1055/s-0028-1095181. Epub 2008 Oct 31.
Negrato CA, Rafacho A, Negrato G, Teixeira MF, Araujo CA, Vieira L, Silva CA, Date SK, Demarchi AC, Gomes MB. Glargine vs. NPH insulin therapy in pregnancies complicated by diabetes: an observational cohort study. Diabetes Res Clin Pract. 2010 Jul;89(1):46-51. doi: 10.1016/j.diabres.2010.03.015. Epub 2010 Apr 7.
Lv S, Wang J, Xu Y. Safety of insulin analogs during pregnancy: a meta-analysis. Arch Gynecol Obstet. 2015 Oct;292(4):749-56. doi: 10.1007/s00404-015-3692-3. Epub 2015 Apr 9.
Fang YM, MacKeen D, Egan JF, Zelop CM. Insulin glargine compared with Neutral Protamine Hagedorn insulin in the treatment of pregnant diabetics. J Matern Fetal Neonatal Med. 2009 Mar;22(3):249-53. doi: 10.1080/14767050802638170.
Egerman RS, Ramsey RD, Kao LW, Bringman JJ, Haerian H, Kao JL, Bush AJ. Perinatal outcomes in pregnancies managed with antenatal insulin glargine. Am J Perinatol. 2009 Sep;26(8):591-5. doi: 10.1055/s-0029-1220782. Epub 2009 Apr 15.
Price N, Bartlett C, Gillmer M. Use of insulin glargine during pregnancy: a case-control pilot study. BJOG. 2007 Apr;114(4):453-7. doi: 10.1111/j.1471-0528.2006.01216.x. Epub 2007 Jan 25.
Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15.
Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9.
Barnett AH. A review of basal insulins. Diabet Med. 2003 Nov;20(11):873-85. doi: 10.1046/j.1464-5491.2003.00996.x.
Hirsch IB. Insulin analogues. N Engl J Med. 2005 Jan 13;352(2):174-83. doi: 10.1056/NEJMra040832. No abstract available.
ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.
American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics. ACOG Practice Bulletin No. 201: Pregestational Diabetes Mellitus. Obstet Gynecol. 2018 Dec;132(6):e228-e248. doi: 10.1097/AOG.0000000000002960.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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217918
Identifier Type: -
Identifier Source: org_study_id
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