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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07165327
Enrollment
44
Registered
2025-09-10
Start date
2025-10-31
Completion date
2026-10-31
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes in Pregnancy, Gestatiaonl Diabetes Mellitus, Insulin, Insulin Dependent Diabetes Mellitus, Pregnancy

Keywords

Gestational diabetes, Type 2 diabetes in pregnancy, Insulin administration, Injection port, Single-use needles, Dose adherence, Patient satisfaction, Insulin delivery devices, Pregnancy diabetes management

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.

Interventions

DEVICEInjection 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.

DEVICESingle-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

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compliance with insulin administrationTwo weeksPatients' compliance with their insulin administration during each arm will be assessed by determining the total number of insulin doses that were missed.
Patient satisfactionTwo weeksPatients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey

Secondary

MeasureTime frameDescription
Glucose controlTwo weeksIn 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 episodesTwo weeksPatients will be assessed on the frequency of hypoglycemia episodes in each arm
Adverse reactionsTwo weeksPatients will be assessed for adverse reactions with each regimen, including allergic reactions or infections
Device malfunctionsTwo weeksIn each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience

Countries

United States

Contacts

Primary ContactJessica Montgomery, MD
jessica.montgomery2@ascension.org734-377-8208

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026