Strict Versus Permissive Thresholds for Initiation of Pharmacotherapy in Gestational Diabetes (START 2)

NCT06419803 | Recruiting DMC

• 1 other identifier: iRISID-2024-3181
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of our study is to compare neonatal and maternal outcomes using different thresholds for the initiation and titration of pharmacotherapy for gestational diabetes (GDM). Our goal is to compare a Strict and permissive threshold. The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%. The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Conditions

Gestational Diabetes; Pregnancy Related

Keywords

gestational diabetes; pregnancy; insulin; Initiation of medication

Outcome Measures

Primary Outcomes (1)

• Neonatal Composite Outcome

  Neonatal composite including the following measures: large for gestational age (LGA) of neonate defined as birth weight \>90th percentile for gestational age using the Fenton growth chart, hypoglycemia o defined as glucose \<40 mg/dL \<48 hours after birth or glucose, hyperbilirubinemia, stillbirth or neonatal death, birth trauma

  First 28 days of birth

Secondary Outcomes (12)

• Neonatal Outcome: Gestational Age of Birth

  Delivery Time

• Neonatal Outcome: APGAR Score

  At 1 minute of life and at 5 min of life

• Neonatal Outcome: Birthweight

  Delivery Time

• Neonatal Outcome: Respiratory distress

  Within first 24 hours after delivery

• Neonatal Outcome: Admission to Neonatal intensive Care Unit

  From delivery to discharge from NICU

Study Arms (2)

Strict Arm

ACTIVE COMPARATOR

The Strict study arm target range will be 65-120 mg/dL, with time in range goal of 70%.

Drug: Insulin

Permissive

ACTIVE COMPARATOR

The permissive study arm target range will be 65-140 mg/dL, with target time in range goal of 70%.

Drug: Insulin

Interventions

Insulin DRUG

Insulin will be used in gestational diabetics to control blood glucose levels

Also known as: Lantus, Lispro, NPH, Levemir, Humalog

Permissive; Strict Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Live, non-anomalous fetus
• Literacy in English, Spanish, Mandarin, or Arabic
• Patients are also required to provide consent, demonstrate an understanding of the purpose of the study, and agree to the study protocol.

You may not qualify if:

• \<18 years at EDD
• pre-existing diabetes or diagnosis of GDM prior to 24 weeks
• multi-fetal gestation
• known major fetal anomaly
• known allergy to insulin
• chronic maternal corticosteroid use
• diagnosis of GDM based on finger sticks alone
• patients who have contraindication to oral glucose tolerance test
• a primary language other than English, Spanish, Mandarin, or Arabic

Sponsors & Collaborators

• Thomas Jefferson University: lead
• University of Rochester: collaborator

Study Sites (2)

University of Rochester Medical Center

Rochester, New York, 14642, United States

NOT YET RECRUITING

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Related Publications (15)

• Kunarathnam V, Vadakekut ES, Mahdy H. Gestational Diabetes. 2025 Sep 15. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK545196/

  PMID: 31424780 BACKGROUND

• Catalano PM, Hauguel-De Mouzon S. Is it time to revisit the Pedersen hypothesis in the face of the obesity epidemic? Am J Obstet Gynecol. 2011 Jun;204(6):479-87. doi: 10.1016/j.ajog.2010.11.039. Epub 2011 Feb 2.

  PMID: 21288502 BACKGROUND

• Gregory EC, Ely DM. Trends and Characteristics in Gestational Diabetes: United States, 2016-2020. Natl Vital Stat Rep. 2022 Jul;71(3):1-15.

  PMID: 35877134 BACKGROUND

• Metzger BE, Persson B, Lowe LP, Dyer AR, Cruickshank JK, Deerochanawong C, Halliday HL, Hennis AJ, Liley H, Ng PC, Coustan DR, Hadden DR, Hod M, Oats JJ, Trimble ER; HAPO Study Cooperative Research Group. Hyperglycemia and adverse pregnancy outcome study: neonatal glycemia. Pediatrics. 2010 Dec;126(6):e1545-52. doi: 10.1542/peds.2009-2257. Epub 2010 Nov 15.

  PMID: 21078733 BACKGROUND

• ACOG Practice Bulletin No. 190: Gestational Diabetes Mellitus. Obstet Gynecol. 2018 Feb;131(2):e49-e64. doi: 10.1097/AOG.0000000000002501.

  PMID: 29370047 BACKGROUND

• Crowther CA, Hiller JE, Moss JR, McPhee AJ, Jeffries WS, Robinson JS; Australian Carbohydrate Intolerance Study in Pregnant Women (ACHOIS) Trial Group. Effect of treatment of gestational diabetes mellitus on pregnancy outcomes. N Engl J Med. 2005 Jun 16;352(24):2477-86. doi: 10.1056/NEJMoa042973. Epub 2005 Jun 12.

  PMID: 15951574 BACKGROUND

• Landon MB, Spong CY, Thom E, Carpenter MW, Ramin SM, Casey B, Wapner RJ, Varner MW, Rouse DJ, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Lain KY, Sorokin Y, Peaceman AM, Tolosa JE, Anderson GB; Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. A multicenter, randomized trial of treatment for mild gestational diabetes. N Engl J Med. 2009 Oct 1;361(14):1339-48. doi: 10.1056/NEJMoa0902430.

  PMID: 19797280 BACKGROUND

• Hartling L, Dryden DM, Guthrie A, Muise M, Vandermeer B, Donovan L. Benefits and harms of treating gestational diabetes mellitus: a systematic review and meta-analysis for the U.S. Preventive Services Task Force and the National Institutes of Health Office of Medical Applications of Research. Ann Intern Med. 2013 Jul 16;159(2):123-9. doi: 10.7326/0003-4819-159-2-201307160-00661.

  PMID: 23712381 BACKGROUND

• Davitt C, Flynn KE, Harrison RK, Pan A, Palatnik A. Current practices in gestational diabetes mellitus diagnosis and management in the United States: survey of maternal-fetal medicine specialists. Am J Obstet Gynecol. 2021 Aug;225(2):203-204. doi: 10.1016/j.ajog.2021.04.263. Epub 2021 May 14. No abstract available.

  PMID: 34000260 BACKGROUND

• Caissutti C, Saccone G, Ciardulli A, Berghella V. Very tight vs. tight control: what should be the criteria for pharmacologic therapy dose adjustment in diabetes in pregnancy? Evidence from randomized controlled trials. Acta Obstet Gynecol Scand. 2018 Mar;97(3):235-247. doi: 10.1111/aogs.13257. Epub 2017 Dec 14.

  PMID: 29125636 BACKGROUND

• Harrison RK, Cruz M, Wong A, Davitt C, Palatnik A. The timing of initiation of pharmacotherapy for women with gestational diabetes mellitus. BMC Pregnancy Childbirth. 2020 Dec 11;20(1):773. doi: 10.1186/s12884-020-03449-y.

  PMID: 33308193 BACKGROUND

• Landy HJ, Gomez-Marin O, O'Sullivan MJ. Diagnosing gestational diabetes mellitus: use of a glucose screen without administering the glucose tolerance test. Obstet Gynecol. 1996 Mar;87(3):395-400. doi: 10.1016/0029-7844(95)00460-2.

  PMID: 8598962 BACKGROUND

• Harper LM, Mele L, Landon MB, Carpenter MW, Ramin SM, Reddy UM, Casey B, Wapner RJ, Varner MW, Thorp JM Jr, Sciscione A, Catalano P, Harper M, Saade G, Caritis SN, Sorokin Y, Peaceman AM, Tolosa JE; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Maternal-Fetal Medicine Units (MFMU) Network. Carpenter-Coustan Compared With National Diabetes Data Group Criteria for Diagnosing Gestational Diabetes. Obstet Gynecol. 2016 May;127(5):893-898. doi: 10.1097/AOG.0000000000001383.

  PMID: 27054932 BACKGROUND

• Blum AK. Insulin Use in Pregnancy: An Update. Diabetes Spectr. 2016 May;29(2):92-7. doi: 10.2337/diaspect.29.2.92.

  PMID: 27182178 BACKGROUND

• Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.

  PMID: 23601190 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Insulin Resistance

Interventions

Insulin; Insulin Glargine; Insulin Lispro; Insulin Detemir

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting; Insulin, Short-Acting

Central Study Contacts

Kavisha Khanuja, MD

CONTACT

2159555000; kxk334@jefferson.edu

Rodney McLaren Jr, MD

CONTACT

2159555000; rodney.mclaren@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 17, 2024
• Study Start: September 1, 2024
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

US (2)