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NCT Number: NCT07165327

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

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.

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Key information

About this study

Diabetes management during pregnancy is crucial for both maternal and fetal health, requiring frequent blood glucose monitoring and insulin administration. Traditional methods of insulin injection involve up to 5 insulin injections per day. These methods, while effective, can be burdensome, and many patients desire to avoid frequent injections.

Injection ports are small, single-use, prescription medical devices designed to simplify insulin or other subcutaneous medication delivery. They consist of a soft cannula that sits under the skin for up to 72 hours and a resealable septum through which multiple injections can be administered without repeated needle sticks. The I-port is an injection port that is FDA approved for use in the United States, but is rarely used in clinical practice, largely because it is not typically covered by insurance.

Given the importance of management of diabetes throughout pregnancy, patient satisfaction with insulin delivery methods may play a significant role in treatment adherence and overall health outcomes. The use of injection ports has been shown to improve patient satisfaction in pregnant patients requiring heparin administration in pregnancy, as well as improve patient experiences for insulin administration in non-pregnant populations. However, there are no studies that have evaluated the use of injection ports for insulin administration in pregnancy. This study aims to assess patient satisfaction with the use of injection ports for insulin administration among pregnant patients with diabetes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • T1DM, primary language non-English or Spanish, use of an insulin pump

Treatment and study plan

Injection Port for Insulin Administration

Device

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.

Other names: i-port, Insulin Port Device

Single-Use Insulin Needles

Device

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.

Other names: Disposable Needles, Standard Insulin Needles

Primary outcomes

  1. Compliance with insulin administration

    Time frame: Two weeks

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

  2. Patient satisfaction

    Time frame: Two weeks

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

Secondary outcomes

  1. Glucose control

    Time frame: Two weeks

    In each arm, patients' overall glucose control will be assessed by determining their percent time in range, mean fasting glucose (mg/dL), and mean postprandial glucose (mg/dL).

  2. Hypoglycemia episodes

    Time frame: Two weeks

    Patients will be assessed on the frequency of hypoglycemia episodes in each arm

  3. Adverse reactions

    Time frame: Two weeks

    Patients will be assessed for adverse reactions with each regimen, including allergic reactions or infections

  4. Device malfunctions

    Time frame: Two weeks

    In each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Montgomery, MD

CONTACT

[email protected]

734-377-8208

Sponsors and collaborators

Lead sponsor

University of Texas at Austin

Other

Registry information

Official study title

Injection Ports Versus Single-Use Needles for Insulin Administration in Diabetic Pregnancies: Impact on Dose Adherence and Patient Satisfaction

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2025
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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