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

NCT07165327 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: STUDY00007824
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Gestatiaonl Diabetes Mellitus; Pregnancy; Diabetes in Pregnancy; Insulin Dependent Diabetes Mellitus; Insulin

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

Outcome Measures

Primary Outcomes (2)

• Compliance with insulin administration

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

  Two weeks

• Patient satisfaction

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

  Two weeks

Secondary Outcomes (4)

• Glucose control

  Two weeks

• Hypoglycemia episodes

  Two weeks

• Adverse reactions

  Two weeks

• Device malfunctions

  Two weeks

Study Arms (2)

Injection port

EXPERIMENTAL

Participants in this arm will administer all prescribed insulin doses using an injection port device for two weeks. The port will be inserted and replaced according to manufacturer instructions, typically every 3 days. Insulin will be delivered through the port using standard syringes or insulin pens, eliminating the need for multiple daily needle sticks. Participants will continue routine glucose monitoring as directed by their clinical care team.

Device: Injection Port for Insulin Administration

Single-use insulin needles

ACTIVE COMPARATOR

Participants in this arm will administer all prescribed insulin doses using standard single-use disposable needles for two weeks. Each injection will require a new sterile needle, consistent with routine clinical practice for insulin delivery in pregnancy. Participants will continue routine glucose monitoring as directed by their clinical care team.

Device: Single-Use Insulin Needles

Interventions

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.

Also known as: i-port, Insulin Port Device

Injection port

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.

Also known as: Disposable Needles, Standard Insulin Needles

Single-use insulin needles

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin, Dell Medical School

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Diabetes Mellitus, Type 1; Insulin Resistance; Patient Satisfaction

Interventions

Vascular Access Devices

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Lorie Harper

  University of Texas at Austin, Dell Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Montgomery, MD

CONTACT

734-377-8208; jessica.montgomery2@ascension.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: September 10, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: September 10, 2025

Record last verified: 2025-08

Locations

US (1)