Hybrid Closed Loop Insulin Delivery for Diabetes in Pregnancy
(PRAM-T1D Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial targets pregnant individuals in the U.S. living with type 1 diabetes (T1D). It focuses on understanding T1D management during pregnancy by collecting real-world data through online surveys and device data, such as continuous glucose monitors (CGMs) and insulin usage. The study aims to improve diabetes management and outcomes during pregnancy. Participants should have had T1D for at least six months, be less than 15 weeks pregnant, and regularly use a CGM. As an unphased trial, this study provides a unique opportunity to contribute to valuable research that could enhance diabetes care for pregnant individuals.
Do I need to stop my current medications for this trial?
The trial does not specify if you need to stop taking your current medications. However, it requires you to continue using a continuous glucose monitor and follow an intensive insulin therapy regimen.
What prior data suggests that this study's methods are safe for pregnant individuals with type 1 diabetes?
Research has shown that hybrid closed-loop (HCL) systems, which automatically help manage insulin levels, are generally safe for pregnant women with type 1 diabetes. One study found no safety issues for women using HCL systems compared to those receiving standard care, and they spent more time with their blood sugar in a healthy range. Another study demonstrated that HCL systems improved blood sugar control with manageable side effects. While these systems appear well-tolerated, further research is needed to fully understand their safety.12345
Why are researchers excited about this trial?
Researchers are excited about the T1D Pregnancy & Me trial because it explores how hybrid closed-loop (HCL) systems can help pregnant individuals with type 1 diabetes manage their blood sugar levels. Unlike traditional methods like multiple daily insulin injections or continuous insulin pumps without automation, HCL systems automatically adjust insulin delivery based on real-time glucose readings. This means potentially smoother and more accurate glycemic control, which is crucial during pregnancy to prevent complications for both the mother and the baby. By comparing outcomes between those using HCL systems and those who aren't, researchers hope to find out if HCL systems offer significant benefits in managing diabetes during pregnancy.
What evidence suggests that this trial's treatments could be effective for managing type 1 diabetes during pregnancy?
Research has shown that hybrid closed-loop (HCL) systems effectively manage blood sugar in pregnant women with type 1 diabetes. In this trial, some participants will use HCL systems for glycemic management, while others will not. Studies have found that these systems can improve blood sugar control compared to standard care. For example, one study found that using HCL systems helped pregnant women maintain better blood sugar levels with a manageable risk of side effects. Another review reported that HCL systems were more effective in keeping blood sugar stable during pregnancy than other methods. Overall, these findings suggest HCL systems are a promising option for pregnant women with type 1 diabetes.14567
Who Is on the Research Team?
Robin Gal, MSPH
Principal Investigator
Jaeb Center for Health Research
Camille Powe, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Data Collection
Participants share diabetes and pregnancy details, and device data from continuous glucose monitors and insulin delivery systems
Follow-up
Participants are monitored for pregnancy outcomes and glycemic management effectiveness
What Are the Treatments Tested in This Trial?
Interventions
- Hybrid Closed Loop Insulin Delivery System
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Pregnant individuals with type 1 diabetes (T1D) using HCL systems for glycemic management in pregnancy
Pregnant individuals with type 1 diabetes (T1D) not using HCL systems for glycemic management in pregnancy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jaeb Center for Health Research
Lead Sponsor
The Leona M. and Harry B. Helmsley Charitable Trust
Collaborator
Citations
Hybrid closed loop insulin therapy versus standard ...
Conclusions: HCL systems can improve glycemic control in pregnant women with T1DM with a tolerable adverse event profile, however more research ...
Review article Hybrid closed loop insulin therapy versus ...
This study is the largest and the most updated overview of the role of HCL systems in pregnant women with T1DM. · Results favored HCL over SC in one primary ...
Cost-effectiveness of advanced hybrid closed loop therapy ...
A decision tree model was developed to estimate the cost-effectiveness of AHCL compared to SoC in pregnant women with T1D, covering pregnancy to ...
Treatment of Type 1 Diabetes Mellitus During Pregnancy ...
This article presents a narrative review of the evidence on advanced hybrid closed loop (AHCL) insulin delivery systems in pregnancy, with a focus on maternal ...
5.
evidence.nihr.ac.uk
evidence.nihr.ac.uk/alert/closed-loop-insulin-systems-are-effective-for-pregnant-women-with-type-1-diabetes/Closed-loop insulin system effective for pregnant women ...
In this study, closed-loop effectively controlled blood sugar levels in pregnant women with type 1 diabetes. Previous research has linked 5% ...
2084-LB: A Randomized Multicenter Trial of Hybrid Closed ...
Conclusion: This HCL resulted in 3 more hours/day spent in TIRp in T1D pregnancy compared to standard care. No safety concerns arose.
Automated Insulin Delivery in Women with Pregnancy ...
Hybrid closed-loop therapy significantly improved maternal glycemic control during pregnancy complicated by type 1 diabetes.
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