[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Insulet Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":151},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,51,75,99,121],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100637152","efficacy-of-the-omnipod-6-system-compared-with-the-omnipod-5-system-100637152",false,"NCT07579702","Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System","Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes and Suboptimal Glycemia","STRIVE 2","Inclusion Criteria:\n\n* Age at time of consent 14-75 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months or type 2 diabetes diagnosis for at least 1 year, based on Investigator's clinical judgment\n* Basal\u002FBolus insulin delivery via multiple daily doses or insulin pump with or without automation\n* HbA1c ≥ 7.5%\n* Average # of user-initiated boluses less than 4 per day over the 14 days prior to screening through review of device data or self-reported if non-pump user\n* Average # of user-initiated boluses less than 4 per day over 14 days, during Standard Therapy Phase through review of device data or self-reported if non-pump user\n* Currently using a continuous glucose monitor\n* Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic equivalents.\n* Participant agrees to provide their own insulin for the duration of the study\n* Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and\u002For caregiver can safely operate all study devices and can adhere to the protocol\n* Deemed appropriate for study participation per Investigator's assessment; Investigator has confidence that the participant and\u002For caregiver can safely operate all study devices and can adhere to the protocol\n* If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor (T2D only), or other) or weight-reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.\n* Willing to wear the system continuously throughout the study\n* Willing and able to sign the Informed Consent Form (ICF) or has a parent\u002Fguardian willing and able to sign the ICF. Assent will be obtained from adolescent participants aged \\\u003C 18 years per local regulatory requirements\n* Able to read and understand English and operate the study device in English\n* If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n* Any medical condition, which in the opinion of the investigator, would put the participant at an unacceptable safety risk\n* Current or known history of coronary artery disease that is not stable with medical management per investigator judgment, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening\n* Any planned surgery during the study which could be considered major in the judgment of the investigator\n* History of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered mental and\u002For physical status, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n* History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness or infusion failure\n* Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement\n* Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n* Use of hydroxyurea\n* Plans to receive blood transfusion over the course of the study\n* Has taken systemic steroids (oral or injectable) within 4 weeks or has had a local steroid injection (e.g. intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study\n* Has type 1 diabetes and is taking non insulin glucose lowering medication other than metformin and GLP1, in the 4 weeks prior to screening.\n* Has type 2 diabetes and is taking sulfonylureas in the 4 weeks prior to screening\n* Pregnant or lactating, or of childbearing potential and not on acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner).\n* Participation in another clinical study using an investigational drug or device within 30-days or intends to participate in any other study during this study period\n* Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n* Participant is an employee of Insulet, an Investigator or Investigator's study team, or immediate family member of any of the aforementioned","ALL","14 Years","75 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"NA","This multi-center, randomized, cross-over trial will evaluate the efficacy of the Omnipod 6 System compared with the Omnipod 5 System in individuals with type 1 or type 2 diabetes and suboptimal glycemia.",[28,29],"Type 2 Diabetes Mellitus","Type 1 Diabetes Mellitus",[31,32,33,34,35,36,37],"Omnipod","Automated Insulin Delivery","T2D","T1D","Type 2 Diabetes","Type 1 Diabetes","AID","RECRUITING","2026-06-30",{"date":41,"type":42},"2026-07-02","ACTUAL",{"date":44,"type":42},"2026-05-13",{"date":46,"type":22},"2027-02-01",{"name":48,"class":49},"Insulet Corporation","INDUSTRY",12,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":59,"maxAge":19,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":68,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100633037","evaluation-of-the-fully-closed-loop-omnipod-system-in-type-2-diabetes-100633037","NCT07521475","Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes","EVOLVE: Evaluation of the Fully Closed Loop Omnipod® System for Safety and Efficacy in Adults With Type 2 Diabetes","EVOLVE","Inclusion Criteria:\n\n1. Age at time of consent 18-75 years (inclusive)\n2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months at time of screening\n3. On insulin therapy for at least 3 months at time of screening, with no change to insulin regimen for 6 weeks prior (AID use within past 3 months excluded) to initiating baseline CGM data collection.\n\n   * Regimen is defined as (1) Basal-bolus insulin therapy (a) using multiple daily injections of insulin (MDI), (b) non-automated insulin pump, or (c) MDI with premix insulin; or (2) basal insulin only (without bolus insulin).\n   * Basal-bolus insulin therapy defined as use of a basal insulin (either long-acting or intermediate-acting (e.g., NPH) plus at least one mealtime insulin dose per day, or a non-automated insulin pump\n   * Inhaled insulin may be used in addition to or instead of mealtime injections pre-study and as part of the Control group\n4. For basal only users, screening A1C ≥7.5% and \\\u003C14.0%. For basal bolus users (i.e., all others), screening A1C ≥6.0% and \\\u003C14.0%.\n\n   • A1C measurement within 28 days prior to enrollment is acceptable\n5. Willing to use only the following types of U-100 insulin while using the study pump: Humalog, Novolog, Admelog, Kirsty, Fiasp, Lyumjev or their generic\u002Fbiosimilar equivalents\n6. Willing to use only study-provided Libre 2 Plus or 3 Plus sensor during the study and not use another sensor\n7. Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n8. No anticipated need to newly initiate noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose lowering effect during the 26-week RCT phase. (Additions or changes in these medications will be permitted during the Extension Phase)\n9. If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications that have a glucose-lowering effect, prescribed dose has been stable for 6 weeks prior to baseline CGM collection; and there is not an anticipated need to increase the dose during the 26-week trial phase (dose reductions will be permitted for safety).\n10. Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol\n11. Willing to wear the system, including Pods, continuously throughout the 26-week trial phase\n12. Willing and able to sign the Informed Consent Form (ICF)\n13. Able to read and understand English\n14. If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n1. Use of an automated insulin delivery pump within 3 months prior to screening\n2. Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.\n3. Current or known history of coronary artery disease that is not stable with medical management in the opinion of the investigator, including unstable angina, despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening\n4. Any planned surgery during the study which could be considered major in the opinion of the Investigator\n5. History of more than 1 episode of severe hypoglycemia in the past 6 months. Severe hypoglycemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions.\n6. History of more than 1 episode of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis\n7. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement\n8. Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n9. Plans to receive blood transfusion over the course of the 26-week trial phase.\n10. Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilization such as tubal ligation or hysterectomy, or vasectomized partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).\n11. Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to baseline CGM collection or plans to take oral or injectable steroids during the 26-week trial phase.\n12. Participation in another clinical study using an investigational drug or device within prior 30 days or intends to participate in any other interventional study during the 26-week trial phase\n13. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n14. Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned","18 Years",{"count":61,"type":22},350,[25],"A multi-center, 26-week randomized controlled trial (RCT) to evaluate the safety and efficacy of the fully closed loop Omnipod M System in adults with type 2 diabetes using basal\u002Fbolus insulin therapy or basal-only insulin therapy, with the primary endpoint after 15 weeks and secondary analysis at 26 weeks; followed by an extension phase after completion of the 26-week trial where the Intervention group will continue to use Omnipod M and the Control group will crossover to use Omnipod M for 26 weeks",[28],[32,33,35,31,37,66,67],"Fully closed loop","FCL",{"date":41,"type":42},{"date":70,"type":42},"2026-04-30",{"date":72,"type":22},"2027-09-23",{"name":48,"class":49},19,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":82,"targetDuration":84,"studyType":85,"phases":4,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},"100617321","omnipod-5-a-french-prospective-multicentric-study-in-real-world-optimal-b-100617321","NCT07317102","Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)","Inclusion Criteria:\n\n* Patient with T1D aged ≥ 2 years.\n* Patient prescribed, less than a year ago, a commercially available confi guration of the Omnipod 5 System using a FreeStyle Libre 2 Plus sensor.\n* Patient has never used the Omnipod 5 System prior to inclusion.\n* Patient has not objected to the use of their personal data for this study.\n* Patient or legal guardian has an email address and mobile phone number.\n* Patient (and legal guardians if the patient is a minor) is able to understand study information and Non-Opposition form.\n* Patient (and legal guardians if the patient is a minor) is able to understand and complete questionnaires in French.\n* Patient is covered by the local social security system\n\nExclusion Criteria:\n\n* Patient is currently pregnant.\n* Patient presents an allergy to the materials of the Omnipod 5 System (patch, cannula, CGM).\n* Patient is unable to be followed by the same investigation site for the duration of the study or is unwilling or unable to maintain contact with the healthcare professional.\n* Patient is already participating in a clinical trial or in another study precluding their participation in other studies.\n* Adult under guardianship, curatorship or tutorship.\n* Adult otherwise deprived of liberty.","2 Years",{"count":83,"type":22},152,"12 Months","OBSERVATIONAL","The purpose of this postmarket clinical investigation is to evaluate the levels of glycemic control, quality of life, and satisfaction, as well as the patient experience, and acute diabetes complication rates provided by the Omnipod 5 Automated Insulin Delivery System (referred to as the Omnipod 5 System) in a real-world setting.",[88,36,89],"Diabetes","Diabetes Mellitus",[31,32,91],"Post-market Registry",{"date":41,"type":42},{"date":94,"type":42},"2026-03-16",{"date":96,"type":22},"2027-11",{"name":48,"class":49},24,{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":85,"phases":4,"briefSummary":108,"conditions":109,"keywords":110,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100527191","post-market-registry-for-the-omnipod-5-system-in-children-and-adults-with-type-1-diabetes-100527191","NCT06144554","Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes","Post Market Registry to Collect Real-World Safety and Effectiveness Data for the Omnipod 5 System in Children and Adults With Type 1 Diabetes","Inclusion Criteria:\n\n1. Self-reported type 1 diabetes\n2. Prescribed, obtained, and have been using the Omnipod 5 System for no more than two weeks or plan to start using the system within the next two weeks\n3. Willing to use only the following types of U-100 insulin during the study: Humalog U-100, Novolog, or Admelog\n4. Able to read and speak English or Spanish (when available) fluently and reside full time in the United States\n5. Willing to collect A1C samples using a provided home kit and send the samples to the registry specific core laboratory at baseline and 3, 6, 9 and 12 months\n6. Willing and able to complete registry assessments every two weeks\n7. Willing and able to complete registry outcome questionnaires at baseline, 6 months and end of study (or at withdrawal)\n8. Is not currently pregnant or planning to become pregnant in the next 12 months and is using a reliable form of birth control\n9. Access to internet via phone, tablet and\u002For computer to use the registry online platform\n10. Willing to provide CGM and insulin delivery data collected prior to using the Omnipod 5 System, if available (participants will not be excluded if data is not provided)\n11. Willing and able to provide informed consent (or assent) and\u002For has a parent\u002Fguardian willing and able to provide informed consent as applicable\n\nExclusion Criteria:\n\n1. Diagnosed with sickle cell anemia and\u002For hemoglobinopathy\n2. Planned blood transfusions over the course of the study or has received a blood transfusion within 3 months prior to starting on Omnipod 5\n3. Adults that are unable to provide informed consent",{"count":107,"type":22},2200,"This is a decentralized observational clinical registry to collect real-world evidence related to the safety and effectiveness of the Omnipod 5 system in children and adults with Type 1 Diabetes.",[36],[36,31,32,111],"Registry","2026-06-29",{"date":114,"type":42},"2026-07-01",{"date":116,"type":42},"2023-09-25",{"date":118,"type":22},"2028-09",{"name":48,"class":49},1,{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":127,"eligibilityCriteria":128,"healthyVolunteers":129,"sex":17,"minAge":130,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":135,"conditions":136,"keywords":138,"overallStatus":142,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":120},"100638053","evaluating-glucose-control-using-a-next-generation-aid-algorithm-in-adults-with-t1d-100638053","NCT07593625","Evaluating Glucose Control Using a Next-Generation AID Algorithm in Adults With T1D","Evaluation Glucose Control Using a Next-Generation Automated Insulin Delivery Algorithm in Adults With Type 1 Diabetes: EVOLUTION T1D","EVOLUTIONT1D","Inclusion Criteria:\n\n* Age at time of consent 16-70 years (inclusive)\n* Type 1 diabetes diagnosis for at least 6 months, based on Investigator assessment\n* Basal\u002FBolus insulin delivery via multiple daily injections or insulin pump with or without automation\n* Willing to use the following types of U-100 insulin during the study: Humalog U-100, Novorapid or their generic equivalents\n* Deemed appropriate for pump therapy per Investigator's assessment considering previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities\n* If using noninsulin glucose-lowering medications or weight reduction medications, dose has been stable for 6-weeks prior to screening; and participant is willing to not change the dose unless required for safety purposes.\n* Investigator has confidence that the participant can safely operate all study devices and can adhere to the protocol\n* Willing to wear the system continuously throughout the study\n* Willing and able to sign the Informed Consent Form (ICF)\n* Able to read and understand English\n* If of childbearing potential, willing and able to have pregnancy testing\n\nExclusion Criteria:\n\n* Any medical condition, which in the opinion of the Investigator, would put the participant at an unacceptable safety risk. This may include untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, unstable proliferative retinopathy, unstable psychiatric conditions such as eating disorders, drug or alcohol abuse.\n* Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or a history of myocardial infarction, percutaneous coronary intervention, coronary artery bypass grafting, or arrhythmias requiring intervention within the 12 months prior to screening\n* Any planned surgery during the study which could be considered major in the opinion of the Investigator\n* History of more than 1 severe hypoglycaemia in the past 6 months. Severe hypoglycaemia is defined as an event that requires the assistance of another person due to altered consciousness, and requires another person to actively administer carbohydrate, glucagon, or other resuscitative actions\n* History of more than 1 diabetic ketoacidosis (DKA) or hyperosmolar hyperglycaemic state (HHS) in the past 6 months, unrelated to an intercurrent illness; kinked, dislodged, or occluded cannula; or initial diabetes diagnosis Unable to tolerate adhesive tape or has any unresolved skin condition that could impact sensor or pump placement\n* Blood disorder or dyscrasia within 3 months prior to screening, which in the Investigator's opinion could interfere with determination of HbA1c\n* Use of hydroxyurea\n* Plans to receive blood transfusion over the course of the study\n* Has taken systemic corticosteroids (oral or injectable) within 4 weeks or has had a local steroid injection (intraarticular, epidural) within 1 week prior to screening or plans to take oral or injectable steroids during the study\n* Use of non-insulin glucose-lowering medication or weight loss medications other than metformin and\u002For GLP1, in the 4 weeks prior to screening. Participants taking metformin and\u002For GLP1 should remain on a steady dose without dose increases during study participation\n* Pregnant or lactating, or is of childbearing potential and not using an acceptable form of birth control (acceptable forms of contraception include abstinence, barrier methods such as condoms, hormonal contraceptives, intrauterine device, surgical sterilisation such as tubal ligation or hysterectomy, or vasectomised partner); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months post-menopausal).\n* In the past 30-days, has participated in a clinical study using any investigational drug or any investigational device. Additionally, may not intend to participate in any other interventional clinical study during this study period\n* Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment\n* Participant is an employee of Insulet, an Investigator or a member of Investigator's study team, or immediate family member of any of the aforementioned",true,"16 Years","70 Years",{"count":133,"type":22},40,[25],"Single-arm feasibility study to evaluate the safety and feasibility of the Omnipod M System in adults with type 1 diabetes. This study will enroll up to 40 adult participants to have a minimum of 24 participants to initiate the use of the study device. The study will include hotel and outpatient evaluation periods.",[36,29,137],"Diabetes (DM)",[36,34,31,139,140,37,141,67],"Omnipod M","Automated Insulin Delivery System","fully closed loop","NOT_YET_RECRUITING","2026-05-15",{"date":145,"type":42},"2026-05-19",{"date":147,"type":22},"2026-05-25",{"date":149,"type":22},"2026-08-30",{"name":48,"class":49},""]