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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Once-Daily Insulin Glargine | Active Comparator | Participants randomized to this arm will take insulin glargine once daily |
|
| Twice-Daily Insulin Glargine | Experimental | Participants randomized to this arm will take insulin glargine twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of insulin glargine once daily | Drug | Insulin glargine will be used once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hypertensive disorders of pregnancy | Development of hypertensive disorders of pregnancy | From time of enrollment until time of delivery, up to 20 weeks following enrollment |
| Preterm birth <34 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marwan Ma'ayeh, MD | Contact | 7574467900 | maayehmg@odu.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sentara Norfolk General Hospital, Norfolk, Virginia 23507 | Recruiting | Norfolk | Virginia | 23507 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Gabbe SG, Calfas J, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies. Elsevier; 2017. doi:10.1016/C2013-0-00408-2 | ||
| 35858653 | 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. | |
| 33540243 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 8, 2025 | Oct 31, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2025 | Oct 31, 2025 | ICF_001.pdf |
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| Use of insulin glargine twice daily | Drug | Insulin glargine will be used twice daily |
|
Delivery at less than 34 weeks gestation
| From time of enrollment to 34 weeks gestation |
| Preterm birth <37 weeks | Delivery prior to 37 weeks gestation | From time of enrollment until 37 weeks gestation |
| Spontaneous or Indicated Delivery | Whether delivery was spontaneous or there was an indication for induction or cesarean delivery | From time of enrollment until time of delivery, up to 20 weeks following enrollment |
| Operative vaginal delivery | Whether an operative vaginal delivery was indicated | From time of enrollment to time of delivery, up to 20 weeks following enrollment |
| Cesarean Delivery | Whether a cesarean delivery was indicated | From time of enrollment to time of delivery, up to 20 weeks following enrollment |
| Estimated blood loss | The estimated blood loss during delivery | Duration of labor, up to 24 hours |
| Quantitative blood loss | The quantified blood loss during delivery | Duration of labor, up to 24 hours |
| Blood transfusion | Whether a blood transfusion was necessary during or following delivery | From time of enrollment until hospital discharge (up to 42 days post-delivery) |
| Endometritis | Incidence of endometritis (inflammation of uterine lining) | From time of enrollment to hospital discharge (up to 42 days post-delivery) |
| Chorioamnionitis | Incidence of chorioamnionitis (placental and amniotic membrane infection) | From time of enrollment until time of hospital discharge (up to 42 days post-delivery) |
| Wound infection | Infection of wounds left by labor | From time of enrollment to hospital discharge (up to 42 days post-delivery) |
| Venous thromboembolism | Incidence of venous thromboembolism | From time of enrollment to time of hospital discharge (up to 42 days post-delivery) |
| Massive transfusion and postpartum hemorrhage | Incidence of massive transfusion and postpartum hemorrhage | From time of enrollment until hospital discharge (up to 42 days post-delivery) |
| ICU admission | Admission to the ICU | From time of enrollment until hospital discharge (up to 42 days post-delivery) |
| Maternal death | From time of enrollment to hospital discharge (up to 42 days post-delivery) |
| Antepartum death | Fetal death | From time of enrollment to time of delivery, up to 20 weeks following enrollment |
| Intrapartum death | Fetal death during labor and delivery | Duration of labor, up to 24 hours |
| Neonatal Intubation within 72 hours of birth | From time of delivery to 72 hours later |
| Continuous positive airway pressure (CPAP) within 72 hours of birth | Use of CPAP for neonate within 72 hours of birth | From time of delivery to 72 hours later |
| High-flow nasal cannula (HFNC) within 72 hours of birth | From time of delivery to 72 hours later |
| Cardiopulmonary resuscitation within 72 hours of birth | From time of delivery to 72 hours later |
| Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Birthweight | Infant birthweight | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Neonatal encephalopathy | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Seizures | Incidence of neonatal seizures | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Shoulder dystocia | Incidence of shoulder dystocia | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Birth trauma | Incidence of neonatal birth trauma | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Intracranial hemorrhage | Incidence of neonatal intracranial hemorrhage | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| Hyperbilirubinemia requiring phototherapy or exchange transfusion | Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| NICU admission | Admission of neonate to the neonatal intensive care unit | From time of delivery to time of hospital discharge, up to 1 year following delivery |
| 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. |
| 26452316 | 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. |
| 30619716 | 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. |
| 16911626 | 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. |
| 11118018 | 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. |
| 10834424 | 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. |
| 29654514 | 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. |
| 40105254 | 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. |
| 30461693 | 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. |