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The purpose of the study is to compare rates of neonatal hypoglycemia with maternal NPH vs determir use.
Insulin detemir has been used and is FDA approved for type 1 diabetes in pregnancy women and its safety has been well established. At this point, the only long or intermediate acting medication that is approved for type 2 diabetes or gestational diabetes is insulin NPH. The most serious side effect of insulin detemir is hypoglycemia but the rates of hypoglycemia are lower when comparted to NPH both during pregnancy and outside of pregnancy. Diabetes mellitus (DM) is the most common diagnosis in pregnancy and its incidence is continuing to increase. Recent epidemiologic reports place the risk of pre-gestational diabetes at 1-2% and gestational diabetes (GDM) at 12.5%. Risk factors for type 2 diabetes (T2DM) and GDM include obesity, hypertension, family history of diabetes, polycystic ovarian syndrome, or excessive weight gain in pregnancy. Suboptimal control of DM in pregnancy confers significant morbidity on both the mother and fetus, including increased risk of preeclampsia, preterm delivery, perineal lacerations, cesarean delivery, neonatal hypoglycemia, and NICU admissions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Detemir | Experimental | Patients are to receive insulin detemir as long acting insulin to control blood sugars |
|
| Insulin NPH | Active Comparator | Patients are to receive insulin NPH as long acting insulin to control blood sugars |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Detemir | Drug | Patients are to receive insulin detemir |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Hypoglycemia | Rate (%) of neonatal hypoglycemia | Within the first 24 hours of life |
| Prolonged neonatal hypoglycemia | Rate (%) of prolonged neonatal hypoglycemia | Neonatal hypoglycemia after the 1st 24 hours of life but before discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Gastrin Level | Sample form cord blood | At birth |
| Neonatal C-Peptide Level | Sample from cord blood | At birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Richley, MD | Contact | 310-794-7274 | mrichley@mednet.ucla.edu | |
| Christina Han, MD | Contact | 310-794-7274 | cshan@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christina Han, MD | University of California, Los Angeles | Principal Investigator |
| Michael Richley, MD | University of California, Los Angeles | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Recruiting | Los Angeles | California | 90069 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26810997 | Background | Coton SJ, Nazareth I, Petersen I. A cohort study of trends in the prevalence of pregestational diabetes in pregnancy recorded in UK general practice between 1995 and 2012. BMJ Open. 2016 Jan 25;6(1):e009494. doi: 10.1136/bmjopen-2015-009494. | |
| 28669379 | Background | Melchior H, Kurch-Bek D, Mund M. The Prevalence of Gestational Diabetes. Dtsch Arztebl Int. 2017 Jul 16;114(24):412-418. doi: 10.3238/arztebl.2017.0412. |
| Label | URL |
|---|---|
| Abstract | View source |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 10, 2025 | Jul 29, 2025 | 3 | ||
| Nov 13, 2025 |
| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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| ID | Term |
|---|---|
| D000069057 | Insulin Detemir |
| D007336 | Insulin, Isophane |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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Randomization to receive either insulin NPH or insulin detemir
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| Insulin NPH |
| Drug |
Patients are to receive insulin NPH |
|
| Neonatal insulin level | Sample from cord blood | At birth |
| Neonatal leptin level | Sample from cord blood | At birth |
| Rates of pregnancy induced hypertension | Maternal rates of preeclampsia, eclampsia, or gestational hypertension | 1 year |
| Mode of delivery | Spontaneous vaginal, operative vaginal, cesarean | At delivery |
| Gestational Age at delivery | Gestational Age at delivery | At delivery |
| Maternal glycemic control | Rate (%) of in range maternal blood glucose control in antepartum period | 1 year |
| Total daily insulin | Total daily insulin dose in patient | 1 year |
| Fetal anomolies | Rate (%) of fetal anomolies | At birth |
| Macrosomia | Rate (%) of macrosomia | At birth |
| Polyhydramnios | Rate (%) of polyhydramnios | At birth |
| Neonatal weight | Neonatal weight | At birth |
| Need for supplemental oxygen | Rate of supplemental oxygen use (%) in neonate | 1 year |
| Need for dextrose infusion in neonate | Rate of dextrose infusion use (%) in neonate | 1 year |
| Rates of respiratory distress syndrome | Rate of RDS (%) in neonate | 1 year |
| 5 Minute APGAR | 5 Minute APGAR | At birth |
| 22851598 | Background | Mathiesen ER, Hod M, Ivanisevic M, Duran Garcia S, Brondsted L, Jovanovic L, Damm P, McCance DR; Detemir in Pregnancy Study Group. Maternal efficacy and safety outcomes in a randomized, controlled trial comparing insulin detemir with NPH insulin in 310 pregnant women with type 1 diabetes. Diabetes Care. 2012 Oct;35(10):2012-7. doi: 10.2337/dc11-2264. Epub 2012 Jul 30. |
| 32396624 | Background | Hirsch IB, Juneja R, Beals JM, Antalis CJ, Wright EE. The Evolution of Insulin and How it Informs Therapy and Treatment Choices. Endocr Rev. 2020 Oct 1;41(5):733-55. doi: 10.1210/endrev/bnaa015. |
| 26070699 | Background | Herrera KM, Rosenn BM, Foroutan J, Bimson BE, Al Ibraheemi Z, Moshier EL, Brustman LE. Randomized controlled trial of insulin detemir versus NPH for the treatment of pregnant women with diabetes. Am J Obstet Gynecol. 2015 Sep;213(3):426.e1-7. doi: 10.1016/j.ajog.2015.06.010. Epub 2015 Jun 9. |
| 11924935 | Background | Dalgic N, Ergenekon E, Soysal S, Koc E, Atalay Y, Gucuyener K. Transient neonatal hypoglycemia--long-term effects on neurodevelopmental outcome. J Pediatr Endocrinol Metab. 2002 Mar;15(3):319-24. doi: 10.1515/jpem.2002.15.3.319. |
| 28156005 | Background | O'Neill SM, Kenny LC, Khashan AS, West HM, Smyth RM, Kearney PM. Different insulin types and regimens for pregnant women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Feb 3;2(2):CD011880. doi: 10.1002/14651858.CD011880.pub2. |
| 31498869 | Background | Kadakia R, Talbot O, Kuang A, Bain JR, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM, Lowe WL; HAPO Study Cooperative Research Group. Cord Blood Metabolomics: Association With Newborn Anthropometrics and C-Peptide Across Ancestries. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4459-4472. doi: 10.1210/jc.2019-00238. |
| 28637888 | Background | Lowe WL Jr, Bain JR, Nodzenski M, Reisetter AC, Muehlbauer MJ, Stevens RD, Ilkayeva OR, Lowe LP, Metzger BE, Newgard CB, Scholtens DM; HAPO Study Cooperative Research Group. Maternal BMI and Glycemia Impact the Fetal Metabolome. Diabetes Care. 2017 Jul;40(7):902-910. doi: 10.2337/dc16-2452. |
| 33865836 | Background | Fishel Bartal M, Ward C, Blackwell SC, Ashby Cornthwaite JA, Zhang C, Refuerzo JS, Pedroza C, Lee KH, Chauhan SP, Sibai BM. Detemir vs neutral protamine Hagedorn insulin for diabetes mellitus in pregnancy: a comparative effectiveness, randomized controlled trial. Am J Obstet Gynecol. 2021 Jul;225(1):87.e1-87.e10. doi: 10.1016/j.ajog.2021.04.223. Epub 2021 Apr 15. |
| 31168280 | Background | Chun J, Strong J, Urquhart S. Insulin Initiation and Titration in Patients With Type 2 Diabetes. Diabetes Spectr. 2019 May;32(2):104-111. doi: 10.2337/ds18-0005. |
| Abstract | View source |
| Nov 25, 2025 |
| 4 |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |