Diabetes in PregnancySUGARNCT07171684
Single vs Multi-Dose Insulin for Glycemic Control (SUGAR)
A study testing Insulin glargine alone and Insulin glargine + insulin lispro in people with Diabetes in Pregnancy and Gestational Diabetes, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Diabetes in Pregnancy, Gestational Diabetes
- What is being tested?
- Insulin glargine alone and Insulin glargine + insulin lispro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Nov 2025to 15 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
- Aged between 18-50
- Speak English or Spanish
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Emily Rosenfeld, DO contact
United States2 sites, 2 recruiting
- Recruiting
Robert Wood Johnson Univeristy Hospital
New Brunswick, New Jersey, 08901
Emily Rosenfeld, DO, 7322356632, er720@rwjms.rutgers.edu
- Not yet recruiting
Maternal-Fetal Medicine at NYU Langone Obstetrics & Gynecology Associates
New York, New York, 10022
Lucia Muzzarelli, (646) 754-2700, lucia.muzzarelli@nyulangone.org
About this study
Official title: Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
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:
- Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin?
- 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.
Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.
Read the detailed description
Purpose/Specific Aims
The purpose of this study is to determine if a single dose of long-acting insulin is non-inferior to long-acting insulin plus prandial insulin to manage diabetes in pregnancy, measured by a composite neonatal outcome of NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia, stillbirth, and neonatal death.
- Objectives:
This study aims to compare neonatal outcomes of patients with diabetes in pregnancy to determine if a single dose of long-acting insulin is non-inferior to long-acting insulin plus prandial insulin.
- Hypotheses / Research Question(s):
The hypothesis is that once-daily long-acting insulin glargine is noninferior to long-acting insulin glargine in combination with prandial short-acting insulin lispro, which is the current standard of care at our institution, for glycemic management of gestational diabetes mellitus and type 2 diabetes mellitus in pregnancy, as measured by a composite neonatal outcome. The composite outcome includes NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death, which are associated with inadequate glycemic management during pregnancy.
Research Procedure:
Individuals will be recruited for the study during routine prenatal care visits or during initial, standard of care consults with Robert Wood Johnson or NYU Langone Maternal Fetal Medicine Specialists when insulin use is suggested for glycemic management. Gestational age at enrollment will vary from patient to patient, but all patients will be enrolled when insulin is clinically indicated to manage their diabetes. If patients choose to participate in the study, they will be randomized to standard of care (long-acting insulin glargine plus prandial insulin lispro) or the experimental group (long-acting insulin glargine only). This study is a noninferiority study between standard of care dosing strategies. This question is best investigated via a noninferiority design, given the potential to improve the currently accepted treatment by reducing patient burden. During this initial consult, a review of medical records is completed, regardless of study participation.
After randomization, both groups will receive dosing instructions per the Insulin Dosing Algorithm. The study utilizes a similar process to the MFM clinical workflow. Patients test their blood glucose at home, and send their blood glucose logs to MFM nurse or study team member, which includes an MFM fellow. If insulin dose adjustments are needed due to hyper- or hypoglycemia, these dose modifications will be made based off the Insulin Dosing Algorithm (Figure 1), and be recorded in the Insulin Dosing Log and communicated with the patients.
Patients will remain in their randomized group unless participation in the experimental group with insulin glargine alone is not sufficient to achieve glycemic targets, as evidenced by three dose increases with persistent hyperglycemia. In that case, patients revert to standard of care group but remain in the study.
The final study procedure is data abstraction and survey administration following childbirth. The Delivery Outcomes form on REDCap will be utilized to abstract relevant maternal and neonatal outcomes from the labor and delivery hospitalization, as well as any hospitalizations indicative of maternal complications prior to childbirth. Finally, the Diabetes Treatment and Satisfaction Questionnaire - Status (DTSQs) will be administered around the time of delivery, optimally at 38 weeks gestation to assess differences in perspective based on frequency of insulin injection between the two groups. This survey has been well-validated for assessing patient satisfaction with insulin treatment. Importantly, the DTSQs is appropriately sensitive to detect changes based on this study's independent variable, as it has been used in a similar study to analyze satisfaction changes in standard insulin versus analogue insulins, as well as changes in long-term and short-term insulin. Study participation ends with the completion of the DTSQs.
- Conditions
- Diabetes in Pregnancy, Gestational Diabetes
- Being tested
- Insulin glargine alone, Insulin glargine + insulin lispro
- Keywords
- insulin glargine, insulin lispro, gestational diabetes, diabetes, pregnancy, noninferiority
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin glargine aloneDrug
Once daily dosing of insulin glargine
Insulin glargine + insulin lisproDrug
Once daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals
| Study group | Role | What they receive |
|---|---|---|
| Insulin glargine alone | Experimental | Once daily dosing of insulin glargine Receives: 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 Receives: Drug: Insulin glargine + insulin lispro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite outcome
NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death
Measured: From enrollment to delivery
Secondary outcomes (9)
Compliance with medication
How often participant is taking the prescribed insulin regimen
Measured: From enrollment to delivery
% of patients in experimental group who are able to remain on insulin glargine only
Percentage of patients who remain on insulin glargine only throughout their pregnancy instead of switching to standard of care due to uncontrolled blood sugars
Measured: From enrollment to delivery
Maternal complication rates
Maternal complications include cesarean section, hypertensive disorders of pregnancy, use of insulin during labor, pre-eclampsia, number of days spent in hospital
Measured: From enrollment to maternal discharge from delivery hospitalization
Birth complications
Pre-term delivery, shoulder dystocia, stillbirth rate. All will be reported as yes/no
Measured: Delivery to discharge of infant from birth hospitalization
Neonatal complications
Temperature regulation issues, polycythemia vera, admission to NICU. All will be measured as yes/no
Measured: Delivery to discharge during birth hospitalization
Birthweight
Neonatal birthweight in grams
Measured: Delivery, first weight recorded
APGAR Scores
APGAR score at 1 and 5 minutes after delivery
Measured: Delivery to 5 minutes after delivery
Neonatal hospital stay
Number of days the neonate is admitted to the hospital during birth hospitalization
Measured: Delivery of neonate to discharge from birth hospitalization
Patient satisfaction
Patient satisfaction with randomized treatment group, as assessed through Diabetes Treatment Satisfaction Questionnaire.
Treatment Satisfaction scale total has a minimum of 0 and a maximum of 36. A score of 36 indicates a patient is very satisfied with their treatment and a score of 0 indicates a patient is very unsatisfied with their treatment. Perceived frequency of hyperglycemia (item 2) and perceived frequency of hypoglycemia (item 3) are treated individually in data analysis.
Measured: From enrollment to delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start26 Nov 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion15 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Diabetes in PregnancyStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Principal investigator, Emily B. Rosenfeld, DO, Rutgers, The State University of New Jersey
- Investigators
- Emily Rosenfeld, DO, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07171684
- Sponsor's protocol ID
- Pro2025001063
- Acronym
- SUGAR
- Status last verified
- Apr 2026
- First submitted
- 30 Aug 2025
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 2142043Senat 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.
PubMed 29715355Figueroa 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.
PubMed 28092062Hartling 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.
PubMed 23712381Crowther 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.
PubMed 15951574Scholtens 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.
PubMed 30617141HAPO 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.
PubMed 19011170Ainuddin 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.
PubMed 25874236Hickman 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.
PubMed 23096052Lain KY, Catalano PM. Metabolic changes in pregnancy. Clin Obstet Gynecol. 2007 Dec;50(4):938-48. doi: 10.1097/GRF.0b013e31815a5494.
PubMed 17982337American 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.
PubMed 38078583
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single vs Multi-Dose Insulin for Glycemic Control (SUGAR): A Randomized Noninferiority Trial
- ClinicalTrials.gov ID
- NCT07171684
- Acronym / sponsor ID
- SUGAR / Pro2025001063
- Conditions
- Diabetes in Pregnancy, Gestational Diabetes
- Keywords
- insulin glargine, insulin lispro, gestational diabetes, diabetes, pregnancy, noninferiority
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- 26 Nov 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 15 May 2027 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can a once daily dose of long-acting insulin control blood sugars as well as long-acting insulin plus meal-time insulin?
- 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.
Participants will send their blood sugar logs to the study staff weekly, instead of to their OB/GYN, for adjustments to their insulin dosing.
Detailed description
Purpose/Specific Aims
The purpose of this study is to determine if a single dose of long-acting insulin is non-inferior to long-acting insulin plus prandial insulin to manage diabetes in pregnancy, measured by a composite neonatal outcome of NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia, stillbirth, and neonatal death.
- Objectives:
This study aims to compare neonatal outcomes of patients with diabetes in pregnancy to determine if a single dose of long-acting insulin is non-inferior to long-acting insulin plus prandial insulin.
- Hypotheses / Research Question(s):
The hypothesis is that once-daily long-acting insulin glargine is noninferior to long-acting insulin glargine in combination with prandial short-acting insulin lispro, which is the current standard of care at our institution, for glycemic management of gestational diabetes mellitus and type 2 diabetes mellitus in pregnancy, as measured by a composite neonatal outcome. The composite outcome includes NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death, which are associated with inadequate glycemic management during pregnancy.
Research Procedure:
Individuals will be recruited for the study during routine prenatal care visits or during initial, standard of care consults with Robert Wood Johnson or NYU Langone Maternal Fetal Medicine Specialists when insulin use is suggested for glycemic management. Gestational age at enrollment will vary from patient to patient, but all patients will be enrolled when insulin is clinically indicated to manage their diabetes. If patients choose to participate in the study, they will be randomized to standard of care (long-acting insulin glargine plus prandial insulin lispro) or the experimental group (long-acting insulin glargine only). This study is a noninferiority study between standard of care dosing strategies. This question is best investigated via a noninferiority design, given the potential to improve the currently accepted treatment by reducing patient burden. During this initial consult, a review of medical records is completed, regardless of study participation.
After randomization, both groups will receive dosing instructions per the Insulin Dosing Algorithm. The study utilizes a similar process to the MFM clinical workflow. Patients test their blood glucose at home, and send their blood glucose logs to MFM nurse or study team member, which includes an MFM fellow. If insulin dose adjustments are needed due to hyper- or hypoglycemia, these dose modifications will be made based off the Insulin Dosing Algorithm (Figure 1), and be recorded in the Insulin Dosing Log and communicated with the patients.
Patients will remain in their randomized group unless participation in the experimental group with insulin glargine alone is not sufficient to achieve glycemic targets, as evidenced by three dose increases with persistent hyperglycemia. In that case, patients revert to standard of care group but remain in the study.
The final study procedure is data abstraction and survey administration following childbirth. The Delivery Outcomes form on REDCap will be utilized to abstract relevant maternal and neonatal outcomes from the labor and delivery hospitalization, as well as any hospitalizations indicative of maternal complications prior to childbirth. Finally, the Diabetes Treatment and Satisfaction Questionnaire - Status (DTSQs) will be administered around the time of delivery, optimally at 38 weeks gestation to assess differences in perspective based on frequency of insulin injection between the two groups. This survey has been well-validated for assessing patient satisfaction with insulin treatment. Importantly, the DTSQs is appropriately sensitive to detect changes based on this study's independent variable, as it has been used in a similar study to analyze satisfaction changes in standard insulin versus analogue insulins, as well as changes in long-term and short-term insulin. Study participation ends with the completion of the DTSQs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Insulin glargine alone | Experimental | Drug: Insulin glargine aloneOnce daily dosing of insulin glargine |
| Insulin glargine + Insulin lispro | Active comparator | Drug: Insulin glargine + insulin lisproOnce daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosed with type 2 diabetes mellitus or A2 gestational diabetes mellitus requiring insulin use during pregnancy
- Aged between 18-50
- Speak English or Spanish
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin glargine aloneOnce daily dosing of insulin glargine | Drug | Insulin glargine alone |
| Insulin glargine + insulin lisproOnce daily dosing of insulin glargine + three times daily dosing of insulin lispro with meals | Drug | Insulin glargine + Insulin lispro |
Primary outcome
Composite outcome
Time frame: From enrollment to delivery
NICU admission, neonatal hyperglycemia, neonatal hypoglycemia, large for gestational age, shoulder dystocia, hyperbilirubinemia stillbirth, and neonatal death
9 secondary outcomes
Compliance with medication
Time frame: From enrollment to delivery
% of patients in experimental group who are able to remain on insulin glargine only
Time frame: From enrollment to delivery
Maternal complication rates
Time frame: From enrollment to maternal discharge from delivery hospitalization
Birth complications
Time frame: Delivery to discharge of infant from birth hospitalization
Neonatal complications
Time frame: Delivery to discharge during birth hospitalization
Birthweight
Time frame: Delivery, first weight recorded
APGAR Scores
Time frame: Delivery to 5 minutes after delivery
Neonatal hospital stay
Time frame: Delivery of neonate to discharge from birth hospitalization
Patient satisfaction
Time frame: From enrollment to delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Background: PubMed 2142043Bradley 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.
- Background: PubMed 29715355Senat 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.
- Background: PubMed 28092062Figueroa 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.
- Background: PubMed 23712381Hartling 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.
- Background: PubMed 15951574Crowther 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.
- Background: PubMed 30617141Scholtens 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.
- Background: PubMed 19011170HAPO 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.
- Background: PubMed 25874236Ainuddin 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.
- Background: PubMed 23096052Hickman 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.
- Background: PubMed 17982337Lain KY, Catalano PM. Metabolic changes in pregnancy. Clin Obstet Gynecol. 2007 Dec;50(4):938-48. doi: 10.1097/GRF.0b013e31815a5494.
- Background: PubMed 38078583American 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Emily Rosenfeld, DO contact
Emily Rosenfeld, DO principal investigator
Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Insulin glargine alone and Insulin glargine + insulin lispro in people with Diabetes in Pregnancy and Gestational Diabetes, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Morgan Dunn, MD ((732) 235-6632, mcd189@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite outcome (time frame: From enrollment to delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07171684, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.