[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605654":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":41,"locations":48,"responsibleParty":63,"collaborators":46,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":46,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":46,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":88,"overallStatus":97,"whyStopped":46,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Texas at Austin","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Device: Injection Port for Insulin Administration",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Device: Single-Use Insulin Needles",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],[27,28],"i-port","Insulin Port Device",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"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.",[15],[34,35],"Disposable Needles","Standard Insulin Needles",[37],{"name":38,"affiliation":39,"role":40},"Lorie Harper","University of Texas at Austin, Dell Medical School","PRINCIPAL_INVESTIGATOR",[42],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},"Jessica Montgomery, MD","CONTACT","734-377-8208",null,"jessica.montgomery2@ascension.org",[49],{"facility":39,"status":46,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":61},"Austin","Texas","78705","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-97.74306,30.26715,{"lat":59,"lon":58},[62],{"name":43,"role":44,"phone":45,"phoneExt":46,"email":47},{"type":64,"investigatorFullName":46,"investigatorTitle":46,"investigatorAffiliation":46,"oldNameTitle":46,"oldOrganization":46},"SPONSOR","100605654","injection-ports-vs-single-use-needles-for-insulin-in-pregnancy-effects-on-adherence-and-satisfaction-100605654",false,"NCT07165327","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","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","FEMALE","18 Years","50 Years",{"count":76,"type":77},44,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.",[83,84,85,86,87],"Gestatiaonl Diabetes Mellitus","Pregnancy","Diabetes in Pregnancy","Insulin Dependent Diabetes Mellitus","Insulin",[89,90,91,9,92,93,94,95,96],"Gestational diabetes","Type 2 diabetes in pregnancy","Insulin administration","Single-use needles","Dose adherence","Patient satisfaction","Insulin delivery devices","Pregnancy diabetes management","NOT_YET_RECRUITING","2025-09-02",{"date":100,"type":101},"2025-09-10","ACTUAL",{"date":103,"type":77},"2025-10",{"date":105,"type":77},"2026-10",{"name":5,"class":6},1]