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

NCT07165327 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2025-09-10

No results posted yet for this study

Summary

This study wants to find out if using an injection port to give insulin during pregnancy helps people take their insulin more regularly and feel better about their care.

When someone has diabetes during pregnancy, it's very important to keep their blood sugar levels in a healthy range. This usually means checking blood sugar often and giving insulin through shots. But giving many shots each day can be hard and uncomfortable.

An injection port is a small device placed on the skin that lets patients give insulin through the same spot without poking themselves each time. This may make taking insulin easier and less painful.

Feeling comfortable with how insulin is given may help people stick to their treatment plan and have better health during pregnancy. Injection ports have already helped other patients, including pregnant people who needed other medications, but they haven't been studied for insulin use during pregnancy. This study will look at how pregnant patients with diabetes feel about using injection ports for insulin.

Conditions

  • Gestatiaonl Diabetes Mellitus
  • Pregnancy
  • Diabetes in Pregnancy
  • Insulin Dependent Diabetes Mellitus
  • Insulin

Interventions

DEVICE

Injection Port for Insulin Administration

For two weeks, participants will use an injection port device for all prescribed insulin doses during pregnancy. The port is inserted and replaced approximately every 3 days. Insulin is delivered through the port using standard syringes or insulin pens, eliminating the need for multiple daily needle sticks.

DEVICE

Single-Use Insulin Needles

For two weeks, participants will use standard single-use disposable needles for all prescribed insulin doses during pregnancy. A new sterile needle will be used for each injection, consistent with routine clinical practice.

Sponsors & Collaborators

  • University of Texas at Austin

    lead OTHER

Principal Investigators

  • Lorie Harper · University of Texas at Austin, Dell Medical School

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07165327 on ClinicalTrials.gov