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

Not Applicable

Not yet recruiting

• Conditions: Gestatiaonl Diabetes Mellitus; Pregnancy; Insulin Dependent Diabetes Mellitus; Diabetes in Pregnancy; Insulin

• Registration Number: NCT07165327
• Lead Sponsor: University of Texas at Austin

Brief 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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-09-02
• Last Update Submitted: 2025-09-02
• Study First Posted: 2025-09-10
• Last Update Posted: 2025-09-10
• Study Start: 2025-10-01
• Primary Completion: 2026-10
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Compliance with insulin administration	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.
Patient satisfaction	Two weeks	Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey

Secondary Outcome Measures

Name	Time	Method
Glucose control	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).
Hypoglycemia episodes	Two weeks	Patients will be assessed on the frequency of hypoglycemia episodes in each arm
Adverse reactions	Two weeks	Patients will be assessed for adverse reactions with each regimen, including allergic reactions or infections
Device malfunctions	Two weeks	In each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience

Trial Locations

Locations (1)

University of Texas at Austin, Dell Medical School; 🇺🇸 Austin, Texas, United States