Insulin Dosing for Gestational Diabetes

(SUGAR Trial)

Overseen By Morgan Dunn, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Must be taking: Insulin

Disqualifiers: Pre-existing insulin use, Fetal anomaly, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: From enrollment to delivery

176 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether one daily dose of long-acting insulin (insulin glargine) can manage blood sugar levels in pregnant women with diabetes as effectively as taking insulin at meals. Researchers aim to determine if babies born to mothers using only once-daily insulin have similar health outcomes to those whose mothers use insulin with meals (insulin lispro). Participants will share their blood sugar logs with the study team weekly for adjustments. This trial suits women with type 2 or A2 gestational diabetes who need insulin during pregnancy and do not already use it. As an unphased trial, this study offers a unique opportunity to enhance understanding of insulin management in pregnancy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that insulin glargine is safe for use during pregnancy. Studies have found no increased risks for pregnant women using it to control blood sugar. It can be safely continued if already in use before pregnancy.

For those considering insulin glargine with insulin lispro, the safety information remains positive. Insulin lispro, a fast-acting insulin, has been well-studied in pregnant women and has improved blood sugar levels without additional risks to the mother or baby.

Overall, both insulin glargine alone and with insulin lispro have demonstrated good safety records for pregnant women. They are generally well-tolerated and have not shown significant negative effects in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about insulin glargine for gestational diabetes because it offers a long-acting insulin option that could simplify diabetes management during pregnancy. Unlike other treatments that require multiple daily injections, insulin glargine is administered just once a day, potentially improving convenience and adherence for expectant mothers. Additionally, the combination of insulin glargine with insulin lispro provides a comprehensive insulin regimen that tailors insulin delivery to both fasting and mealtime glucose control, aiming to enhance overall blood sugar management during pregnancy.

What evidence suggests that this trial's treatments could be effective for gestational diabetes?

Research shows that insulin glargine, which participants in this trial may receive, effectively manages blood sugar in pregnant women with diabetes. Studies have found it to be safe and to provide good blood sugar control, similar to other insulins like NPH. In this trial, some participants will receive insulin glargine alone, while others will receive a combination of insulin glargine and insulin lispro. When used with insulin lispro, it helps manage blood sugar levels around meals. Both treatments have kept average HbA1c levels low during pregnancy, indicating good blood sugar control. Additionally, using these insulins during pregnancy does not increase the risk of complications for the mother or baby. ^{1 3 4 5 6}

Who Is on the Research Team?

Emily Rosenfeld, DO

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18-50 with type 2 diabetes or A2 gestational diabetes needing insulin. Participants must speak English or Spanish and will manage their diabetes by sending weekly blood sugar logs to the study team.

Inclusion Criteria

I have type 2 diabetes or had gestational diabetes needing insulin.

I am between 18 and 50 years old.

I can speak English or Spanish.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either once daily dosing of insulin glargine or insulin glargine plus insulin lispro with meals. Blood glucose levels are monitored and insulin doses adjusted as needed.

From enrollment to delivery

Weekly virtual check-ins for blood glucose log review

Follow-up

Participants are monitored for maternal and neonatal outcomes post-delivery, including NICU admissions and maternal complications.

From delivery to discharge

What Are the Treatments Tested in This Trial?

Interventions

• Insulin glargine
• Insulin lispro

Trial Overview Researchers are testing if once-daily long-acting insulin can control blood sugar in pregnancy as effectively as a combination of long-acting and meal-time insulin. They're also looking at baby health outcomes post-birth between these two treatment methods.

How Is the Trial Designed?

Group I: Insulin glargine alone Experimental Treatment 1 Intervention

Once daily dosing of insulin glargine

Group II: Insulin glargine + Insulin lispro Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11965006/

Insulin glargine 300 U/mL safety data in pregnancy - PMC The results of our recent analysis of global PV data suggest that Gla‐300 could be used for glycaemic control in pregnant women with diabetes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3362948/

Meta-Analysis of Maternal and Neonatal Outcomes ... No significant differences in the efficacy and safety-related outcomes were found between glargine and NPH use during pregnancy.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06619301

RCT Glargine vs NPH for Treatment of DM in Pregnancy Insulin Glargine is regularly used outside of pregnancy and its efficacy is well documented. It is a current medication we regularly use in ...

4. dom-pubs.onlinelibrary.wiley.com dom-pubs.onlinelibrary.wiley.com/doi/am-pdf/10.1111/dom.16295

Insulin glargine 300 U/mL safety data in pregnancy The results of our recent analysis of global PV data suggest that. Gla-300 could be used for glycaemic control in pregnant women with diabetes.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S187140212100014X

Use of insulin glargine during pregnancy: A review Insulin glargine can be continued safely during pregnancy in women who are already taking it prior to pregnancy and have achieved good glycemic control with it.

6. diabetesjournals.org diabetesjournals.org/diabetes/article/71/Supplement_1/1056-P/146119/1056-P-Reported-Pregnancy-Outcomes-with-Insulin

Reported Pregnancy Outcomes with Insulin Glargine 100 U ... The results indicate no safety issues with insulin glargine use during pregnancy. J. Westerbacka: Employee; Sanofi, Stock/Shareholder; Sanofi.