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

Official title

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

Overview

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?

Interventions

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

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

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

Publications

• 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

Identifiers

NCT: NCT07224893 · 25-09-FB-0214

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗