Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT07224893
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-05
First Post:
2025-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management
Sponsor:
Organization:
Raw JSON
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'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-03', 'studyFirstSubmitDate': '2025-10-31', 'studyFirstSubmitQcDate': '2025-11-03', 'lastUpdatePostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weekly Time in Range', 'timeFrame': 'From Day 7 to Day 14 after study enrollment', 'description': 'The mean blood glucose time in range as measured by the continuous glucose monitor'}], 'secondaryOutcomes': [{'measure': 'Hypertensive disorders of pregnancy', 'timeFrame': 'From time of enrollment until time of delivery, up to 20 weeks following enrollment', 'description': 'Development of hypertensive disorders of pregnancy'}, {'measure': 'Preterm birth <34 weeks', 'timeFrame': 'From time of enrollment to 34 weeks gestation', 'description': 'Delivery at less than 34 weeks gestation'}, {'measure': 'Preterm birth <37 weeks', 'timeFrame': 'From time of enrollment until 37 weeks gestation', 'description': 'Delivery prior to 37 weeks gestation'}, {'measure': 'Spontaneous or Indicated Delivery', 'timeFrame': 'From time of enrollment until time of delivery, up to 20 weeks following enrollment', 'description': 'Whether delivery was spontaneous or there was an indication for induction or cesarean delivery'}, {'measure': 'Operative vaginal delivery', 'timeFrame': 'From time of enrollment to time of delivery, up to 20 weeks following enrollment', 'description': 'Whether an operative vaginal delivery was indicated'}, {'measure': 'Cesarean Delivery', 'timeFrame': 'From time of enrollment to time of delivery, up to 20 weeks following enrollment', 'description': 'Whether a cesarean delivery was indicated'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Duration of labor, up to 24 hours', 'description': 'The estimated blood loss during delivery'}, {'measure': 'Quantitative blood loss', 'timeFrame': 'Duration of labor, up to 24 hours', 'description': 'The quantified blood loss during delivery'}, {'measure': 'Blood transfusion', 'timeFrame': 'From time of enrollment until hospital discharge (up to 42 days post-delivery)', 'description': 'Whether a blood transfusion was necessary during or following delivery'}, {'measure': 'Endometritis', 'timeFrame': 'From time of enrollment to hospital discharge (up to 42 days post-delivery)', 'description': 'Incidence of endometritis (inflammation of uterine lining)'}, {'measure': 'Chorioamnionitis', 'timeFrame': 'From time of enrollment until time of hospital discharge (up to 42 days post-delivery)', 'description': 'Incidence of chorioamnionitis (placental and amniotic membrane infection)'}, {'measure': 'Wound infection', 'timeFrame': 'From time of enrollment to hospital discharge (up to 42 days post-delivery)', 'description': 'Infection of wounds left by labor'}, {'measure': 'Venous thromboembolism', 'timeFrame': 'From time of enrollment to time of hospital discharge (up to 42 days post-delivery)', 'description': 'Incidence of venous thromboembolism'}, {'measure': 'Massive transfusion and postpartum hemorrhage', 'timeFrame': 'From time of enrollment until hospital discharge (up to 42 days post-delivery)', 'description': 'Incidence of massive transfusion and postpartum hemorrhage'}, {'measure': 'ICU admission', 'timeFrame': 'From time of enrollment until hospital discharge (up to 42 days post-delivery)', 'description': 'Admission to the ICU'}, {'measure': 'Maternal death', 'timeFrame': 'From time of enrollment to hospital discharge (up to 42 days post-delivery)'}, {'measure': 'Antepartum death', 'timeFrame': 'From time of enrollment to time of delivery, up to 20 weeks following enrollment', 'description': 'Fetal death'}, {'measure': 'Intrapartum death', 'timeFrame': 'Duration of labor, up to 24 hours', 'description': 'Fetal death during labor and delivery'}, {'measure': 'Neonatal Intubation within 72 hours of birth', 'timeFrame': 'From time of delivery to 72 hours later'}, {'measure': 'Continuous positive airway pressure (CPAP) within 72 hours of birth', 'timeFrame': 'From time of delivery to 72 hours later', 'description': 'Use of CPAP for neonate within 72 hours of birth'}, {'measure': 'High-flow nasal cannula (HFNC) within 72 hours of birth', 'timeFrame': 'From time of delivery to 72 hours later'}, {'measure': 'Cardiopulmonary resuscitation within 72 hours of birth', 'timeFrame': 'From time of delivery to 72 hours later'}, {'measure': 'Neonatal Hypoglycemia (glucose <35 mg/dL) requiring IV glucose therapy', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery'}, {'measure': 'Birthweight', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Infant birthweight'}, {'measure': 'Neonatal encephalopathy', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery'}, {'measure': 'Seizures', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Incidence of neonatal seizures'}, {'measure': 'Shoulder dystocia', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Incidence of shoulder dystocia'}, {'measure': 'Birth trauma', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Incidence of neonatal birth trauma'}, {'measure': 'Intracranial hemorrhage', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Incidence of neonatal intracranial hemorrhage'}, {'measure': 'Hyperbilirubinemia requiring phototherapy or exchange transfusion', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Incidence of neonatal hyperbilirubinemia requiring phototherapy or exchange transfusion'}, {'measure': 'NICU admission', 'timeFrame': 'From time of delivery to time of hospital discharge, up to 1 year following delivery', 'description': 'Admission of neonate to the neonatal intensive care unit'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['continuous glucose monitoring'], 'conditions': ['Pregestational Diabetes', 'Pregnancy']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Gabbe SG, Calfas J, Simpson JL, et al. Obstetrics: Normal and Problem Pregnancies. Elsevier; 2017. doi:10.1016/C2013-0-00408-2'}, {'pmid': '35858653', 'type': 'BACKGROUND', 'citation': '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': '33540243', 'type': 'BACKGROUND', 'citation': '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': '26452316', 'type': 'BACKGROUND', 'citation': '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': '30619716', 'type': 'BACKGROUND', 'citation': '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': '16911626', 'type': 'BACKGROUND', 'citation': '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': '11118018', 'type': 'BACKGROUND', 'citation': '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': '10834424', 'type': 'BACKGROUND', 'citation': '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': '29654514', 'type': 'BACKGROUND', 'citation': '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': '40105254', 'type': 'BACKGROUND', 'citation': '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': '30461693', 'type': 'BACKGROUND', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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?'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients older than 18 years of age;\n* The patient is fluent in English, physically and mentally able to understand the informed consent, and is willing to participate in this study;\n* Type II diabetes mellitus requiring insulin;\n* 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.\n* Currently using or willing to use a clinically indicated continuous glucose monitor for glycemic management\n\nExclusion Criteria:\n\n* Known allergy or reaction to insulin glargine, or concurrent medical condition where the use of insulin glargine is contraindicated;\n* Contraindication to CGM use, patient declines CGM use, or CGM not covered by patient's insurance;\n* Concomitant use of other anti-diabetic medication (such as metformin); use of a short-acting insulin will not be considered an exclusion;\n* Known or suspected fetal anomaly or aneuploidy;\n* Prisoners;\n* Ongoing prenatal care outside EVMS or planned delivery outside Sentara Norfolk General Hospital."}, 'identificationModule': {'nctId': 'NCT07224893', 'briefTitle': 'Once-Daily vs Twice-Daily Insulin Glargine in Pregestational Diabetes Management', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Once-Daily Versus Twice-Daily Insulin Glargine in the Management of Patients With Pregestational Diabetes Requiring Insulin', 'orgStudyIdInfo': {'id': '25-09-FB-0214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Once-Daily Insulin Glargine', 'description': 'Participants randomized to this arm will take insulin glargine once daily', 'interventionNames': ['Drug: Use of insulin glargine once daily']}, {'type': 'EXPERIMENTAL', 'label': 'Twice-Daily Insulin Glargine', 'description': 'Participants randomized to this arm will take insulin glargine twice daily', 'interventionNames': ['Drug: Use of insulin glargine twice daily']}], 'interventions': [{'name': 'Use of insulin glargine once daily', 'type': 'DRUG', 'description': 'Insulin glargine will be used once daily', 'armGroupLabels': ['Once-Daily Insulin Glargine']}, {'name': 'Use of insulin glargine twice daily', 'type': 'DRUG', 'description': 'Insulin glargine will be used twice daily', 'armGroupLabels': ['Twice-Daily Insulin Glargine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'contacts': [{'name': "Marwan Ma'ayeh", 'role': 'CONTACT', 'email': 'maayehmg@odu.edu', 'phone': '7574467900'}], 'facility': 'Sentara Norfolk General Hospital, Norfolk, Virginia 23507', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'centralContacts': [{'name': "Marwan Ma'ayeh, MD", 'role': 'CONTACT', 'email': 'maayehmg@odu.edu', 'phone': '7574467900'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': "Marwan Ma'ayeh", 'investigatorAffiliation': 'Eastern Virginia Medical School'}}}}