Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management

Официальное название

Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin

Обзор

The purpose of this study is to determine if taking insulin glargine twice a day instead of once a day will better manage pregestational diabetes in pregnant patients. Participants in this study will be randomly assigned to one of two groups: a group that takes insulin glargine once a day, and a group that takes it twice. Continuous glucose monitoring will be used to track blood sugar levels. The main question the study aims to answer is: Will using insulin glargine twice a day instead of once lead to a better glucose time in range?

Вмешательства

• Препарат Use of insulin glargine once daily
  Insulin glargine will be used once daily
• Препарат Use of insulin glargine twice daily
  Insulin glargine will be used twice daily

Первичные конечные точки

• Weekly Time in Range [Срок оценки: From Day 7 to Day 14 after study enrollment]

Вторичные конечные точки (12)

• Hypertensive disorders of pregnancy [Срок оценки: From time of enrollment until time of delivery, up to 20 weeks following enrollment]
• Preterm birth <34 weeks [Срок оценки: From time of enrollment to 34 weeks gestation]
• Preterm birth <37 weeks [Срок оценки: From time of enrollment until 37 weeks gestation]
• Spontaneous or Indicated Delivery [Срок оценки: From time of enrollment until time of delivery, up to 20 weeks following enrollment]
• Operative vaginal delivery [Срок оценки: From time of enrollment to time of delivery, up to 20 weeks following enrollment]
• Cesarean Delivery [Срок оценки: From time of enrollment to time of delivery, up to 20 weeks following enrollment]
• Estimated blood loss [Срок оценки: Duration of labor, up to 24 hours]
• Quantitative blood loss [Срок оценки: Duration of labor, up to 24 hours]
• Blood transfusion [Срок оценки: From time of enrollment until hospital discharge (up to 42 days post-delivery)]
• Endometritis [Срок оценки: From time of enrollment to hospital discharge (up to 42 days post-delivery)]
• Chorioamnionitis [Срок оценки: From time of enrollment until time of hospital discharge (up to 42 days post-delivery)]
• Wound infection [Срок оценки: From time of enrollment to hospital discharge (up to 42 days post-delivery)]

Критерии участия

Критерии включения

• Patients older than 18 years of age;
• The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;
• Type II diabetes mellitus requiring insulin;
• The patient is between 24 weeks 0 days and 28 weeks 0 days of gestation at the time of enrollment. Gestational age will be determined by last menstrual period, confirmed with a first trimester ultrasound, per the recommended guidelines by the American College of Obstetricians and Gynecologists.
• Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management

Критерии исключения

• Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;
• Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;
• Known or suspected fetal anomaly or aneuploidy;
• Prisoners;
• Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Sentara Norfolk General Hospital, Norfolk, Virginia 23507 — Norfolk

Публикации

• Gabbe SG, Calfas J, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies. Elsevier; 2017. doi:10.1016/C2013-0-00408-2
• Fishel Bartal M, Ashby Cornthwaite JA, Ghafir D, Ward C, Ortiz G, Louis A, Cornthwaite J, Chauhan SSP, Sibai BM. Time in Range and Pregnancy Outcomes in People with Diabetes Using Continuous Glucose Monitoring. Am J Perinatol. 2023 Apr;40(5):461-466. doi: 10.1055/a-1904-9279. Epub 2022 Jul 20. PMID 35858653
• Jethwani P, Saboo B, Jethwani L, Chawla R, Maheshwari A, Agarwal S, Jaggi S. Use of insulin glargine during pregnancy: A review. Diabetes Metab Syndr. 2021 Jan-Feb;15(1):379-384. doi: 10.1016/j.dsx.2021.01.012. Epub 2021 Jan 22. PMID 33540243
• Feghali M, Venkataramanan R, Caritis S. Pharmacokinetics of drugs in pregnancy. Semin Perinatol. 2015 Nov;39(7):512-9. doi: 10.1053/j.semperi.2015.08.003. PMID 26452316
• Eledrisi M, Suleiman NN, Salameh O, Khair Hamad M, Rabadi O, Mohamed A, Al Adawi R, Salam A. Twice-daily insulin glargine for patients with uncontrolled type 2 diabetes mellitus. J Clin Transl Endocrinol. 2018 Dec 11;15:35-36. doi: 10.1016/j.jcte.2018.12.002. eCollection 2019 Mar. No abstract available. PMID 30619716
• Ashwell SG, Gebbie J, Home PD. Twice-daily compared with once-daily insulin glargine in people with Type 1 diabetes using meal-time insulin aspart. Diabet Med. 2006 Aug;23(8):879-86. doi: 10.1111/j.1464-5491.2006.01913.x. PMID 16911626
• Lepore M, Pampanelli S, Fanelli C, Porcellati F, Bartocci L, Di Vincenzo A, Cordoni C, Costa E, Brunetti P, Bolli GB. Pharmacokinetics and pharmacodynamics of subcutaneous injection of long-acting human insulin analog glargine, NPH insulin, and ultralente human insulin and continuous subcutaneous infusion of insulin lispro. Diabetes. 2000 Dec;49(12):2142-8. doi: 10.2337/diabetes.49.12.2142. PMID 11118018
• Heinemann L, Linkeschova R, Rave K, Hompesch B, Sedlak M, Heise T. Time-action profile of the long-acting insulin analog insulin glargine (HOE901) in comparison with those of NPH insulin and placebo. Diabetes Care. 2000 May;23(5):644-9. doi: 10.2337/diacare.23.5.644. PMID 10834424

Идентификаторы

NCT: NCT07224893 · 25-09-FB-0214

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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