Injection Ports vs. Single-Use Needles for Insulin in Pregnancy

This study is looking at whether using an injection port for insulin during pregnancy helps people take their insulin more regularly and feel better about their care. When you have diabetes during pregnancy, it's very important to keep blood sugar levels healthy, which often means many insulin shots each day. An injection port is a small device placed on your skin that lets you give insulin through the same spot without needing a new needle stick each time. This study wants to see if using an injection port (which is replaced about every 3 days) for two weeks, compared to using single-use needles for two weeks, improves how well you stick to your insulin plan and how satisfied you are. You might be able to join if you are a woman between 18 and 50 years old with type 2 diabetes or gestational diabetes who needs multiple insulin doses. The study is currently unclear on its recruitment status.

Study design
This is an interventional study with a planned enrollment of 44 participants. It compares two methods of insulin delivery: an injection port versus single-use insulin needles.
What's involved
Participants will use either an injection port or single-use needles for all insulin doses for two weeks. The injection port is inserted and replaced approximately every 3 days.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints, compliance with insulin administration and patient satisfaction, are measured at two weeks.

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NCT07165327

Injection Ports vs Single-Use Needles for Insulin in Pregnancy: Effects on Adherence and Satisfaction

Not Yet Recruiting
NAAges 18–50InterventionalTreatment
University of Texas at Austin
~44 participants
Updated 2025-09-10 on ClinicalTrials.gov
What's tested:Injection Port for Insulin AdministrationSingle-Use Insulin Needles

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compliance with insulin administration
Measured over Two weeks
+1 more outcome measured
Gestatiaonl Diabetes Mellitus
Pregnancy
Diabetes in Pregnancy
Insulin Dependent Diabetes Mellitus
Insulin
1 sites across 1 states
Texas1
  • Lorie Harper · PRINCIPAL_INVESTIGATOR · University of Texas at Austin, Dell Medical School

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Eligibility criteria

Inclusion

Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen

Exclusion

T1DM, primary language non-English or Spanish, use of an insulin pump
  • Compliance with insulin administrationTwo weeks

    Patients' compliance with their insulin administration during each arm will be assessed by determining the total number of insulin doses that were missed.

  • Patient satisfactionTwo weeks

    Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey