Gestatiaonl Diabetes MellitusNCT07165327
Injection Ports vs Single-Use Needles for Insulin in Pregnancy: Effects on Adherence and Satisfaction
A study testing Injection Port for Insulin Administration and Single-Use Insulin Needles in people with Gestatiaonl Diabetes Mellitus and Pregnancy, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestatiaonl Diabetes Mellitus, Pregnancy, Diabetes in Pregnancy
- What is being tested?
- Injection Port for Insulin Administration and Single-Use Insulin Needles
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen
Who cannot join
- T1DM, primary language non-English or Spanish, use of an insulin pump
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Texas at Austin, Dell Medical School
Austin, Texas, 78705
Jessica Montgomery, MD, 734-377-8208, jessica.montgomery2@ascension.org
About this study
Official title: Injection Ports Versus Single-Use Needles for Insulin Administration in Diabetic Pregnancies: Impact on Dose Adherence and Patient 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.
Read more
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.
Read the 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.
- Conditions
- Gestatiaonl Diabetes Mellitus, Pregnancy, Diabetes in Pregnancy, Insulin Dependent Diabetes Mellitus, Insulin
- Being tested
- Injection Port for Insulin Administration, Single-Use Insulin Needles
- 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
- Medical subject headings
- Diabetes, Gestational, Diabetes Mellitus, Type 1, Insulin Resistance, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection Port for Insulin AdministrationDevice
Also called i-port, Insulin Port 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.
Single-Use Insulin NeedlesDevice
Also called Disposable Needles, Standard 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Single-Use Insulin Needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two weeks
Patient satisfaction
Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey
Measured: Two weeks
Secondary outcomes (4)
Glucose control
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).
Measured: Two weeks
Hypoglycemia episodes
Patients will be assessed on the frequency of hypoglycemia episodes in each arm
Measured: Two weeks
Adverse reactions
Patients will be assessed for adverse reactions with each regimen, including allergic reactions or infections
Measured: Two weeks
Device malfunctions
In each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience
Measured: Two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestatiaonl Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lorie Harper, Principal investigator, University of Texas at Austin, Dell Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165327
- Sponsor's protocol ID
- STUDY00007824
- Status last verified
- Aug 2025
- First submitted
- 20 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Injection Ports Versus Single-Use Needles for Insulin Administration in Diabetic Pregnancies: Impact on Dose Adherence and Patient Satisfaction
- ClinicalTrials.gov ID
- NCT07165327
- Acronym / sponsor ID
- STUDY00007824
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injection port | Experimental | Device: Injection Port for Insulin AdministrationParticipants 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. |
| Single-use insulin needles | Active comparator | Device: Single-Use Insulin NeedlesParticipants 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen
Key exclusion criteria (1 listed)
- T1DM, primary language non-English or Spanish, use of an insulin pump
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection Port for Insulin AdministrationAlso: i-port, Insulin Port DeviceFor 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 | Injection port |
| Single-Use Insulin NeedlesAlso: Disposable Needles, Standard Insulin NeedlesFor 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. | Device | Single-use insulin needles |
Primary outcome
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.
Patient satisfaction
Time frame: Two weeks
Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey
4 secondary outcomes
Glucose control
Time frame: Two weeks
Hypoglycemia episodes
Time frame: Two weeks
Adverse reactions
Time frame: Two weeks
Device malfunctions
Time frame: Two weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorie Harper principal investigator
University of Texas at Austin, Dell Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Injection Port for Insulin Administration and Single-Use Insulin Needles in people with Gestatiaonl Diabetes Mellitus and Pregnancy, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Montgomery, MD (734-377-8208, jessica.montgomery2@ascension.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance with insulin administration (time frame: Two weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.