[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07165327":3,"trial-entities:NCT07165327":114,"trial-summary:NCT07165327":119},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":34,"primary_purpose":35,"phases":36,"enrollment_info":38,"interventions":41,"primary_outcomes":58,"secondary_outcomes":65,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":88,"locations":90,"central_contacts":106,"overall_officials":108,"references":112,"see_also_links":113},"NCT07165327","STUDY00007824","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","NOT_YET_RECRUITING","2026-10","2025-08","2025-09-10","2025-10","University of Texas at Austin","OTHER",true,"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.\n\nWhen 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.\n\nAn 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.\n\nFeeling 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.","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.\n\nInjection 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.\n\nGiven 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.",[19,20,21,22,23],"Gestatiaonl Diabetes Mellitus","Pregnancy","Diabetes in Pregnancy","Insulin Dependent Diabetes Mellitus","Insulin",[25,26,27,28,29,30,31,32,33],"Gestational diabetes","Type 2 diabetes in pregnancy","Insulin administration","Injection port","Single-use needles","Dose adherence","Patient satisfaction","Insulin delivery devices","Pregnancy diabetes management","INTERVENTIONAL","TREATMENT",[37],"NA",{"count":39,"type":40},44,"ESTIMATED",[42,50],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DEVICE","Injection 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.",[28],[48,49],"i-port","Insulin Port Device",{"type":43,"name":51,"description":52,"armGroupLabels":53,"otherNames":55},"Single-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.",[54],"Single-use insulin needles",[56,57],"Disposable Needles","Standard Insulin Needles",[59,63],{"measure":60,"description":61,"timeFrame":62},"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",{"measure":31,"description":64,"timeFrame":62},"Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey",[66,69,72,75],{"measure":67,"description":68,"timeFrame":62},"Glucose control","In each arm, patients' overall glucose control will be assessed by determining their percent time in range, mean fasting glucose (mg\u002FdL), and mean postprandial glucose (mg\u002FdL).",{"measure":70,"description":71,"timeFrame":62},"Hypoglycemia episodes","Patients will be assessed on the frequency of hypoglycemia episodes in each arm",{"measure":73,"description":74,"timeFrame":62},"Adverse reactions","Patients will be assessed for adverse reactions with each regimen, including allergic reactions or infections",{"measure":76,"description":77,"timeFrame":62},"Device malfunctions","In each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience","FEMALE","18 Years","50 Years",false,{"inclusion":83,"exclusion":85,"raw_text":87},[84],"Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen",[86],"T1DM, primary language non-English or Spanish, use of an insulin pump","Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus or gestational diabetes who require a multi-dose insulin regimen\n\nExclusion Criteria:\n\n* T1DM, primary language non-English or Spanish, use of an insulin pump",[89],"ADULT",[91],{"facility":92,"city":93,"state":94,"zip":95,"country":96,"contacts":97,"geoPoint":103},"University of Texas at Austin, Dell Medical School","Austin","Texas","78705","United States",[98],{"name":99,"role":100,"phone":101,"email":102},"Jessica Montgomery, MD","CONTACT","734-377-8208","jessica.montgomery2@ascension.org",{"lat":104,"lon":105},30.26715,-97.74306,[107],{"name":99,"role":100,"phone":101,"email":102},[109],{"name":110,"affiliation":92,"role":111},"Lorie Harper","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":115,"biomarkers":118},[116,117],"Gestational Diabetes","Type 2 Diabetes Mellitus",[],{"nct_id":4,"found":15,"summary":120,"prompt_version":130},{"design":121,"status":122,"heading":123,"summary":124,"follow_up":125,"word_count":126,"commitments":127,"compensation":128,"drugs_mentioned":129},"This is an interventional study with a planned enrollment of 44 participants. It compares two methods of insulin delivery: an injection port versus single-use insulin needles.","completed","Injection Ports vs. Single-Use Needles for Insulin in Pregnancy","This study is looking at whether using an injection port for insulin during pregnancy helps people take their insulin more regularly and feel better about their care. When you have diabetes during pregnancy, it's very important to keep blood sugar levels healthy, which often means many insulin shots each day. An injection port is a small device placed on your skin that lets you give insulin through the same spot without needing a new needle stick each time. This study wants to see if using an injection port (which is replaced about every 3 days) for two weeks, compared to using single-use needles for two weeks, improves how well you stick to your insulin plan and how satisfied you are. You might be able to join if you are a woman between 18 and 50 years old with type 2 diabetes or gestational diabetes who needs multiple insulin doses. The study is currently unclear on its recruitment status.","The primary endpoints, compliance with insulin administration and patient satisfaction, are measured at two weeks.",158,"Participants will use either an injection port or single-use needles for all insulin doses for two weeks. The injection port is inserted and replaced approximately every 3 days.","Not stated in the trial record.",[],"v2"]