Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:27 AM
Study NCT ID:
NCT07165327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-10
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Injection Ports vs Single-Use Needles for Insulin in Pregnancy: Effects on Adherence and Satisfaction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}, {'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D017060', 'term': 'Patient Satisfaction'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062666', 'term': 'Vascular Access Devices'}], 'ancestors': [{'id': 'D057785', 'term': 'Catheters'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compliance with insulin administration', 'timeFrame': 'Two weeks', 'description': "Patients' compliance with their insulin administration during each arm will be assessed by determining the total number of insulin doses that were missed."}, {'measure': 'Patient satisfaction', 'timeFrame': 'Two weeks', 'description': "Patients' satisfaction with each method of insulin administration will be determined used the Insulin Delivery Satisfaction Survey"}], 'secondaryOutcomes': [{'measure': 'Glucose control', 'timeFrame': 'Two weeks', 'description': "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)."}, {'measure': 'Hypoglycemia episodes', 'timeFrame': 'Two weeks', 'description': 'Patients will be assessed on the frequency of hypoglycemia episodes in each arm'}, {'measure': 'Adverse reactions', 'timeFrame': 'Two weeks', 'description': 'Patients will be assessed for adverse reactions with each regimen, including allergic reactions or infections'}, {'measure': 'Device malfunctions', 'timeFrame': 'Two weeks', 'description': 'In each arm, patients will be asked if they experienced any device malfunctions and if so, what did they experience'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'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'], 'conditions': ['Gestatiaonl Diabetes Mellitus', 'Pregnancy', 'Diabetes in Pregnancy', 'Insulin Dependent Diabetes Mellitus', 'Insulin']}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07165327', 'briefTitle': 'Injection Ports vs Single-Use Needles for Insulin in Pregnancy: Effects on Adherence and Satisfaction', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Injection Ports Versus Single-Use Needles for Insulin Administration in Diabetic Pregnancies: Impact on Dose Adherence and Patient Satisfaction', 'orgStudyIdInfo': {'id': 'STUDY00007824'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Injection port', 'description': '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.', 'interventionNames': ['Device: Injection Port for Insulin Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single-use insulin needles', 'description': '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.', 'interventionNames': ['Device: Single-Use Insulin Needles']}], 'interventions': [{'name': 'Injection Port for Insulin Administration', 'type': 'DEVICE', 'otherNames': ['i-port', 'Insulin Port Device'], 'description': '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.', 'armGroupLabels': ['Injection port']}, {'name': 'Single-Use Insulin Needles', 'type': 'DEVICE', 'otherNames': ['Disposable Needles', 'Standard Insulin Needles'], 'description': '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.', 'armGroupLabels': ['Single-use insulin needles']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Jessica Montgomery, MD', 'role': 'CONTACT', 'email': 'jessica.montgomery2@ascension.org', 'phone': '734-377-8208'}], 'facility': 'University of Texas at Austin, Dell Medical School', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'centralContacts': [{'name': 'Jessica Montgomery, MD', 'role': 'CONTACT', 'email': 'jessica.montgomery2@ascension.org', 'phone': '734-377-8208'}], 'overallOfficials': [{'name': 'Lorie Harper', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas at Austin, Dell Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}