[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"type-1-diabetes-mellitus-with-hypoglycemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:type-1-diabetes-mellitus-with-hypoglycemia":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,74],{"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":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100497812","phase-2-a-study-of-the-effect-of-zt-01-on-night-time-hypoglycemia-in-type-1-diabetes-100497812",false,"NCT05762107","A Study of the Effect of ZT-01 on Night-time Hypoglycemia in Type 1 Diabetes","A Phase 2a Randomized, Double-blind, Placebo-controlled, Multiple-dose, Crossover Study of the Effect of ZT-01 on Frequency of Nocturnal Hypoglycemia in Type 1 Diabetes Mellitus","ZONE","Inclusion Criteria:\n\n* Has type 1 diabetes for at least 5 years\n* is at risk of nocturnal hypoglycemia (if using personal CGM, time below 54 mg\u002FdL at least 1% over previous 4 weeks at screening; if not using personal CGM then recent history suggestive of nocturnal hypoglycemia at screening and time below 54 mg\u002FdL at least 1% over 4 weeks using blinded study CGM during additional screening)\n* HbA1c at screening \\\u003C\u002F= 10.0%\n* Body mass index (BMI) at screening \\>\u002F=18.5 to \\\u003C33 kg\u002Fm2\n\nExclusion Criteria:\n\n* Has been hospitalized for diabetic ketoacidosis (DKA) more than once within previous 6 months\n* Has experienced \\>\u002F= 1 severe hypoglycemia (requiring assistance) during previous 4 weeks or \\>2 in previous 3 months\n* Diagnosis of type 2 diabetes, pheochromocytoma, insulinoma, glucagonoma, acromegaly, Cushing's disease, glycogen storage disease, adrenal insufficiency\n* Clinically significant kidney disease\n* Abnormal liver function","ALL","18 Years","75 Years",{"count":21,"type":22},186,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn about the effect of the study drug (ZT-01) on low blood sugar (hypoglycemia) in adults with type 1 diabetes (T1D) who have been having low blood sugars (\"hypos\") at night. ZT-01 increases the amount of a hormone called glucagon during low blood sugar, and this may help prevent the occurrence of hypos. The main questions this trial aims to answer are whether ZT-01 lowers the number of hypos happening at night, and what its effects are on blood sugar levels. The safety of ZT-01 will also be measured.\n\nParticipants will be asked to wear a study-provided continuous glucose monitor (CGM) during two 4-week periods when they will self-inject the study drug before bed. They will get ZT-01 at one of three dose levels during one period, and placebo (which looks like the study drug but doesn't contain the active ingredient) during the other. Neither the participant nor the study site will know what they are receiving during each treatment period or see data from the CGM. The participant will continue to use their usual methods of measuring blood sugar (including their personal CGM) and giving insulin during the study. The participant will be asked to complete a short diary each evening, and will be asked to upload the CGM data to a study phone every day.\n\nIf a participant uses their own CGM and is willing to share information on how often they have low blood sugar with the study site at the first visit to see if they meet study entry requirements, they will have 6 study visits, 2 study phone calls, and be in the study for about 16 weeks. If they don't use CGM or don't want to share their information, then they will be asked to wear a study CGM for an extra 4 weeks to find out how many low blood sugars they have, and will have an extra visit.\n\nStudy participants will be asked to give blood and urine for testing to see whether they meet the requirements to enter the study, and at the start and end of each treatment period to see if the study treatment has any effects. They will also have their blood pressure and temperature taken at each study visit, and have an ECG at 4 visits to measure the electrical activity of their heart.\n\nSome participants will be asked to also take part in a sub-study where their blood level of ZT-01 and glucagon is measured, after the first and last dose. They will be asked to stay at the study site overnight for each set of measurements (4 in total).",[28],"Type 1 Diabetes Mellitus With Hypoglycemia",[30],"nocturnal hypoglycemia","RECRUITING","2026-04-23",{"date":34,"type":35},"2026-04-29","ACTUAL",{"date":37,"type":35},"2023-07-28",{"date":39,"type":22},"2027-05",{"name":41,"class":42},"Zucara Therapeutics Inc.","INDUSTRY",46,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100545472","glycemic-excursions-in-patients-with-type-1-diabetes-mellitus-using-closed-loop-systems-100545472","NCT06382350","Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems","Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study","SAFEDRIVE","Inclusion criteria\n\nStudy group:\n\n* type 1 diabetes\n* patients aged ≥18 year\n* diabetes duration ≥3 years\n* regularly driving (non-professional drivers only)\n* treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment\n* willing to fill in the study questionnaires\n* signed patient's informed consent form\n\nControl group:\n\n* type 1 diabetes\n* patients aged ≥18 years\n* diabetes duration ≥3 years\n* regularly driving (non-professional drivers only)\n* treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months\n* willing to fill in the study questionnaires\n* signed patient's informed consent form\n\nExclusion Criteria (for study and control groups)\n\n* professional drivers\n* pregnancy\n* inability to be present at the follow-up visit\n* inability to complete the study questionnaires\n* participation in another clinical study within the last 3 months",{"count":53,"type":22},120,"OBSERVATIONAL","The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy",[57,28,58],"Type 1 Diabetes Mellitus","Drive",[60,61,62],"Type 1 diabetes mellitus","Driving","Closed-loop system","2024-06-02",{"date":65,"type":35},"2024-06-04",{"date":67,"type":35},"2024-05-29",{"date":69,"type":22},"2026-05",{"name":71,"class":72},"University Hospital, Motol","OTHER",1,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":82,"targetDuration":4,"studyType":23,"phases":84,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":73},"100456266","pilot-study-evaluating-safety-of-exolin-in-patients-with-poorly-controlled-type-1-diabetes-100456266","NCT05221359","Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes","An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes With High Glucose Fluctuations, Prone to Severe Hypoglycemia","Pilot'Ex","Inclusion Criteria:\n\n1. Adult men or women (age ≥ 18 years);\n2. Diagnosis of Type 1 Diabetes (T1D) for more than 2 years at the start of screening;\n3. Body mass index (BMI) \\> 16 kg\u002Fm2 and \\\u003C 35 kg\u002Fm2;\n4. Well managed intensive SubCutaneous (SC) insulin therapy, i.e. patient using for at least 3 months:\n\n   * CSII, whatever the insulin pump used, and\n   * Continuous Glucose Monitoring (CGM), by using Dexcom G6;\n5. 7.0% \\\u003C Serum HbA1c \\\u003C 12.0%;\n6. Patient characterized by one of the following conditions:\n\n   * Unstable diabetes\u002Fpoor glycemic control, meaning patient presenting:\n\n     * at least one episode of severe hypoglycemia during the 12 months prior to study screening. Severe hypoglycemia is defined by American Diabetes Association (ADA) standards as \"severe cognitive impairment requiring assistance from another person for recovery\" (as per ADA's definition in \"standards of care in diabetes\");\n     * or glycemic excursions (post-prandial hyperglycemic or nocturnal hypoglycemic episodes) considered as too frequent and of high amplitude by the investigator, during the previous month;\n   * Presence of adverse side effects of SC insulin-therapy:\n\n     * SC insulin resistance;\n     * or severe acquired lipodystrophy resistant to pump treatment;\n     * or genetic skin atrophy or lipodystrophy.\n\nExclusion Criteria:\n\n1. Renal glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73m2 as per Chronic Kidney Disease - Epidemiology Collaboration (CDK-EPI) calculation;\n2. Immunocompromised patient;\n3. Local or systemic acute or chronic inflammation (rheumatoid arthritis, sclerodermia);\n4. Active infection or inflammation;\n5. Known history of skin affliction that could impact ExOlin® tolerance;\n6. Ongoing active anticoagulant therapy;\n7. Severe wound healing issues;\n8. Parietal reinforcement prostheses;\n9. Known allergy to one of the devices' components, including known allergy to fixation systems (e.g. patch, plaster) for SC administration devices such as external pumps and CGM, or chronic allergy related to prolonged wearing of such systems;\n10. Known allergy to insulin NovoRapid®;\n11. Known allergy to anesthetics, or products containing iodine and its derivates, or antibiotics used during surgery (cefazolin, and combination of clindamycin and gentamycin);\n12. Activity contraindicated as per external pump and CGM use recommendations;\n13. Patient willing to practice activities with risks of trauma or major change in the environment pressure such as combat sport or scuba diving;\n14. Cardiac condition incompatible with surgery requirements as per anesthesiologist's opinion;\n15. Unstable diabetic retinopathy (as per ophthalmologist's review within 6 months before screening);\n16. Current or history of unresolved malignancy within 5 years before screening (with exceptions for squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast carcinoma without lymph node metastases, well-differentiated thyroid carcinoma or other non-invasive lesion that, in the opinion of the investigator, is considered as cured with minimal risk of recurrence within 5 years);\n17. Other surgical or medical condition that, in the judgment of the investigator, might warrant exclusion or be contraindicated, like for instance visual or hand-use symptoms;\n18. Mental handicap or psychiatric condition incompatible with appropriate handling of devices or compliance to treatment or investigation-related tasks;\n19. Known active alcohol or drug abuse;\n20. Having received corticoid treatment within 4 weeks prior to enrollment;\n21. Having received an investigational product within 12 weeks prior to enrollment, or currently participating in another clinical trial, with the exception of observational \u002F non-interventional; registries, for which written prior approval of Defymed is needed;\n22. Women planning for pregnancy, being pregnant or breastfeeding or unwilling to use adequate contraceptive methods for the duration of the study (oral hormonal contraceptives, implants, injectables, hormonal or copper intrauterine device, or vasectomized partner);\n23. Person under guardianship, trusteeship or deprived of liberty;\n24. Person not affiliated to one of the French social security systems;\n25. Unwilling to give written informed consent to participation in the study, or unable to do so for psychiatric, cognitive or linguistic reasons.",{"count":83,"type":22},8,[85],"NA","First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia",[88,28],"Type 1 Diabetes",[90,91,88,92,93,94,95,96],"Safety","Pilot","High glucose fluctuations","Severe Hypoglycemia","Hypoglycemia unawareness","Extraperitoneal","Insulin","2022-07-26",{"date":99,"type":35},"2022-07-27",{"date":101,"type":35},"2022-05-05",{"date":103,"type":22},"2027-04",{"name":105,"class":42},"Defymed"]