Injection Ports vs Single-Use Needles for Gestational Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether using an injection port for insulin during pregnancy improves diabetes management compared to regular needles. Injection ports deliver insulin through the same spot, reducing the need for multiple daily injections and potentially making insulin administration easier and less painful. The trial aims to determine if this method enhances satisfaction with treatment and adherence to insulin plans. It targets pregnant individuals with type 2 or gestational diabetes who require multiple daily insulin doses. As an unphased trial, this study provides a unique opportunity to explore innovative methods for improving diabetes management during pregnancy.
Do I need to stop my current medications for this trial?
The trial information does not specify if you need to stop your current medications. It focuses on using an injection port for insulin delivery, so you may continue your insulin regimen as prescribed.
What prior data suggests that this injection port is safe for insulin use during pregnancy?
Studies have shown that injection ports are generally well-tolerated by patients, including pregnant individuals using them for medications other than insulin. These ports allow insulin administration without multiple daily needle pokes, reducing discomfort and simplifying adherence to insulin treatment plans.
No specific studies have yet examined the use of injection ports for insulin during pregnancy. However, since these devices are already used safely for other medications, experts believe they are likely safe for insulin as well. The injection port functions the same way for insulin as it does for other medicines, which supports its safety.
For those considering joining a trial using injection ports, it is reassuring to know that these devices have proven helpful and safe for many in similar situations.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the use of injection ports for managing gestational diabetes, offering a potential break from the routine of daily needle sticks. Unlike standard single-use insulin needles that require a fresh needle for each dose, injection ports allow multiple insulin doses through a single device, reducing needle pricks to just once every few days. This not only minimizes discomfort but could also enhance the convenience of managing insulin therapy during pregnancy. By comparing these two methods, researchers hope to find out if injection ports can improve the quality of life for expecting mothers who need insulin therapy.
What evidence suggests that injection ports are effective for gestational diabetes?
This trial will compare injection ports with single-use insulin needles for managing gestational diabetes. Research has shown that insulin pumps can help pregnant women with diabetes manage blood sugar levels more effectively. Specifically, women using these pumps demonstrated improved HbA1c levels, indicating better long-term blood sugar control, and experienced fewer serious episodes of low blood sugar. Although an injection port differs from an insulin pump, it also simplifies insulin administration. This could make insulin management during pregnancy easier and less painful, potentially improving health outcomes for both mother and baby.16789
Who Is on the Research Team?
Lorie Harper
Principal Investigator
University of Texas at Austin, Dell Medical School
Are You a Good Fit for This Trial?
This trial is for pregnant individuals with diabetes (gestational, type 1, or insulin resistance) who need to manage their blood sugar levels with insulin. The study aims to include those who are looking for potentially more comfortable and convenient ways of administering insulin.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants administer insulin using either injection ports or single-use needles for two weeks
Follow-up
Participants are monitored for compliance, satisfaction, glucose control, hypoglycemia episodes, adverse reactions, and device malfunctions
What Are the Treatments Tested in This Trial?
Interventions
- Injection Port
- Single-Use Insulin Needles
Trial Overview
The study is testing whether using an injection port—a device that allows repeated insulin injections through the same spot on the skin—improves adherence to treatment and patient satisfaction compared to single-use needles during pregnancy.
How Is the Trial Designed?
Participants in this arm will administer all prescribed insulin doses using an injection port device for two weeks. The port will be inserted and replaced according to manufacturer instructions, typically every 3 days. Insulin will be delivered through the port using standard syringes or insulin pens, eliminating the need for multiple daily needle sticks. Participants will continue routine glucose monitoring as directed by their clinical care team.
Participants in this arm will administer all prescribed insulin doses using standard single-use disposable needles for two weeks. Each injection will require a new sterile needle, consistent with routine clinical practice for insulin delivery in pregnancy. Participants will continue routine glucose monitoring as directed by their clinical care team.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas at Austin
Lead Sponsor
Citations
Injection Ports vs Single-Use Needles for Insulin in ...
This study aims to assess patient satisfaction with the use of injection ports for insulin administration among pregnant patients with diabetes.
Management of Diabetes in Pregnancy: A Review ...
It showed that women receiving insulin pumps had much better HbA1c levels, fewer severe hypoglycemic events by 35%, and fewer rates of neonatal ...
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Recent randomized controlled trials have demonstrated improved glycemic outcomes with use of HCL insulin pumps in pregnancy with T1D, though the results vary ...
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diabetesjournals.org/spectrum/article/34/2/119/32915/Time-in-Range-in-Pregnancy-Is-There-a-RoleTime in Range in Pregnancy: Is There a Role?
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