Insulin Dosing for Gestational Diabetes
(SUGAR Trial)
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.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it does require that you start using insulin if you are not already. If you are currently using insulin, you cannot participate in the trial.
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.12345Why 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.13456
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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.
Follow-up
Participants are monitored for maternal and neonatal outcomes post-delivery, including NICU admissions and maternal complications.
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?
2
Treatment groups
Experimental Treatment
Active Control
Once daily dosing of insulin glargine
Once daily dosing of insulin glargine plus three times per day dosing of insulin lispro with each meal
Find a Clinic Near You
Who Is Running the Clinical Trial?
Rutgers, The State University of New Jersey
Lead Sponsor
Citations
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.
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.
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 ...
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.
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-InsulinReported 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.
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