Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)

NCT07171684 | Recruiting DMC

• 1 other identifier: Pro2025001063
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to see if diabetes in pregnancy can be treated with once daily dosing of insulin instead of once daily dosing plus insulin with meals. The main question this study aims to answer is:

1. 1.Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin?
2. 2.Do babies born to mothers who take one dose of long-acting insulin have more complications after birth than babies born to mothers who take long-acting and meal-time insulin? Researchers will compare one dose of long-acting insulin per day to this plus three doses of short-acting insulin with each meal to see if blood sugars are controlled.

Conditions

Gestational Diabetes; Diabetes in Pregnancy

Keywords

insulin glargine; insulin lispro; gestational diabetes; diabetes; pregnancy; noninferiority

Outcome Measures

Primary Outcomes (1)

• Composite outcome

  NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death

  From enrollment to delivery

Secondary Outcomes (9)

• Compliance with medication

  From enrollment to delivery

• % of patients in experimental group who are able to remain on insulin glargine only

  From enrollment to delivery

• Maternal complication rates

  From enrollment to maternal discharge from delivery hospitalization

• Birth complications

  Delivery to discharge of infant from birth hospitalization

• Neonatal complications

  Delivery to discharge during birth hospitalization

Study Arms (2)

Insulin glargine alone

EXPERIMENTAL

Once daily dosing of insulin glargine

Drug: Insulin glargine alone

Insulin glargine + Insulin lispro

ACTIVE COMPARATOR

Once daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal

Drug: Insulin glargine + insulin lispro

Interventions

Insulin glargine alone DRUG

Once daily dosing of insulin glargine

Insulin glargine alone

Insulin glargine + insulin lispro DRUG

Once daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals

Insulin glargine + Insulin lispro

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
• Aged between 18-50
• Speak English or Spanish

You may not qualify if:

• Pre-existing use of insulin
• Gestational Age \> or = 35w0d
• Planning to follow-up with a doctor not associated with RWJ Barnabas or NYU Langone Health and/or deliver at a hospital other than RWJUH or NYU
• Unwilling or unable to upload or email weekly blood sugar logs
• Contraindication to Lispro or Lantus insulin, or patient chooses to not utilize insulin therapy
• Fetal anomaly present

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• NYU Langone Health: collaborator

Study Sites (2)

Robert Wood Johnson Univeristy Hospital

New Brunswick, New Jersey, 08901, United States

RECRUITING

Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates

New York, New York, 10022, United States

NOT YET RECRUITING

Related Publications (11)

• Bradley C, Lewis KS. Measures of psychological well-being and treatment satisfaction developed from the responses of people with tablet-treated diabetes. Diabet Med. 1990 Jun;7(5):445-51. doi: 10.1111/j.1464-5491.1990.tb01421.x.

  PMID: 2142043 BACKGROUND

• Senat MV, Affres H, Letourneau A, Coustols-Valat M, Cazaubiel M, Legardeur H, Jacquier JF, Bourcigaux N, Simon E, Rod A, Heron I, Castera V, Sentilhes L, Bretelle F, Rolland C, Morin M, Deruelle P, De Carne C, Maillot F, Beucher G, Verspyck E, Desbriere R, Laboureau S, Mitanchez D, Bouyer J; Groupe de Recherche en Obstetrique et Gynecologie (GROG). Effect of Glyburide vs Subcutaneous Insulin on Perinatal Complications Among Women With Gestational Diabetes: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1773-1780. doi: 10.1001/jama.2018.4072.

  PMID: 29715355 BACKGROUND

• Figueroa Gray M, Hsu C, Kiel L, Dublin S. "It's a Very Big Burden on Me": Women's Experiences Using Insulin for Gestational Diabetes. Matern Child Health J. 2017 Aug;21(8):1678-1685. doi: 10.1007/s10995-017-2261-8.

  PMID: 28092062 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

• 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

• Scholtens DM, Kuang A, Lowe LP, Hamilton J, Lawrence JM, Lebenthal Y, Brickman WJ, Clayton P, Ma RC, McCance D, Tam WH, Catalano PM, Linder B, Dyer AR, Lowe WL Jr, Metzger BE; HAPO Follow-up Study Cooperative Research Group; HAPO Follow-Up Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome Follow-up Study (HAPO FUS): Maternal Glycemia and Childhood Glucose Metabolism. Diabetes Care. 2019 Mar;42(3):381-392. doi: 10.2337/dc18-2021. Epub 2019 Jan 7.

  PMID: 30617141 BACKGROUND

• HAPO Study Cooperative Research Group. Hyperglycemia and Adverse Pregnancy Outcome (HAPO) Study: associations with neonatal anthropometrics. Diabetes. 2009 Feb;58(2):453-9. doi: 10.2337/db08-1112. Epub 2008 Nov 14.

  PMID: 19011170 BACKGROUND

• Ainuddin JA, Karim N, Zaheer S, Ali SS, Hasan AA. Metformin treatment in type 2 diabetes in pregnancy: an active controlled, parallel-group, randomized, open label study in patients with type 2 diabetes in pregnancy. J Diabetes Res. 2015;2015:325851. doi: 10.1155/2015/325851. Epub 2015 Mar 22.

  PMID: 25874236 BACKGROUND

• Hickman MA, McBride R, Boggess KA, Strauss R. Metformin compared with insulin in the treatment of pregnant women with overt diabetes: a randomized controlled trial. Am J Perinatol. 2013 Jun;30(6):483-90. doi: 10.1055/s-0032-1326994. Epub 2012 Oct 24.

  PMID: 23096052 BACKGROUND

• Lain KY, Catalano PM. Metabolic changes in pregnancy. Clin Obstet Gynecol. 2007 Dec;50(4):938-48. doi: 10.1097/GRF.0b013e31815a5494.

  PMID: 17982337 BACKGROUND

• American Diabetes Association Professional Practice Committee. 15. Management of Diabetes in Pregnancy: Standards of Care in Diabetes-2024. Diabetes Care. 2024 Jan 1;47(Suppl 1):S282-S294. doi: 10.2337/dc24-S015.

  PMID: 38078583 BACKGROUND

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus

Interventions

Insulin Glargine; Insulin Lispro

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Emily Rosenfeld, DO

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Morgan Dunn, MD

CONTACT

(732) 235-6632; mcd189@rwjms.rutgers.edu

Emily Rosenfeld, DO

CONTACT

er720@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 12, 2025
• Study Start: November 26, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)