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

NCT07224893 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: 25-09-FB-0214
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Pregestational Diabetes; Pregnancy

Keywords

continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Weekly Time in Range

  The mean blood glucose time in range as measured by the continuous glucose monitor

  From Day 7 to Day 14 after study enrollment

Secondary Outcomes (31)

• Hypertensive disorders of pregnancy

  From time of enrollment until time of delivery, up to 20 weeks following enrollment

• Preterm birth <34 weeks

  From time of enrollment to 34 weeks gestation

• Preterm birth <37 weeks

  From time of enrollment until 37 weeks gestation

• Spontaneous or Indicated Delivery

  From time of enrollment until time of delivery, up to 20 weeks following enrollment

• Operative vaginal delivery

  From time of enrollment to time of delivery, up to 20 weeks following enrollment

Study Arms (2)

Once-Daily Insulin Glargine

ACTIVE COMPARATOR

Participants randomized to this arm will take insulin glargine once daily

Drug: Use of insulin glargine once daily

Twice-Daily Insulin Glargine

EXPERIMENTAL

Participants randomized to this arm will take insulin glargine twice daily

Drug: Use of insulin glargine twice daily

Interventions

Use of insulin glargine once daily DRUG

Insulin glargine will be used once daily

Once-Daily Insulin Glargine

Use of insulin glargine twice daily DRUG

Insulin glargine will be used twice daily

Twice-Daily Insulin Glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eastern Virginia Medical School: lead

Study Sites (1)

Sentara Norfolk General Hospital, Norfolk, Virginia 23507

Norfolk, Virginia, 23507, United States

Location

Related Publications (11)

• Gabbe SG, Calfas J, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies. Elsevier; 2017. doi:10.1016/C2013-0-00408-2

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Candido R, Wyne K, Romoli E. A Review of Basal-Bolus Therapy Using Insulin Glargine and Insulin Lispro in the Management of Diabetes Mellitus. Diabetes Ther. 2018 Jun;9(3):927-949. doi: 10.1007/s13300-018-0422-4. Epub 2018 Apr 13.

  PMID: 29654514 BACKGROUND

• Westerbacka J, Duverne M, Grulovic N, Thummisetti S, Doder Z. Insulin glargine 300 U/mL safety data in pregnancy. Diabetes Obes Metab. 2025 May;27(5):2322-2325. doi: 10.1111/dom.16295. Epub 2025 Mar 19. No abstract available.

  PMID: 40105254 BACKGROUND

• 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.

  PMID: 30461693 BACKGROUND

Central Study Contacts

Marwan Ma'ayeh, MD

CONTACT

7574467900; maayehmg@odu.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 5, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)