[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638445":3},{"organization":4,"outcomesModule":7,"designInfo":168,"detailedDescription":175,"studyPopulation":167,"armGroups":176,"interventions":183,"overallOfficials":189,"centralContacts":193,"locations":198,"responsibleParty":215,"collaborators":217,"id":221,"slug":167,"hasResults":222,"nctId":223,"briefTitle":224,"officialTitle":224,"acronym":225,"eligibilityCriteria":226,"healthyVolunteers":222,"sex":227,"minAge":228,"maxAge":229,"enrollmentInfo":230,"targetDuration":167,"studyType":233,"phases":234,"briefSummary":235,"conditions":236,"keywords":239,"overallStatus":244,"whyStopped":167,"lastUpdateSubmitDate":245,"lastUpdatePostDateStruct":246,"startDateStruct":249,"completionDateStruct":251,"leadSponsor":253,"locationsCount":254},{"fullName":5,"class":6},"Poznan University of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":167},[9,13],{"measure":10,"description":11,"timeFrame":12},"Time in range","Percentage of time spent in target glucose values - 63-140 mg\u002FdL (3.5-7.8 mmol\u002FL)","From enrollment to the delivery",{"measure":14,"description":15,"timeFrame":12},"Mean sensor glycemia","Average value of glucose concentration measured by the sensor (mg\u002FdL and mmol\u002FL)",[17,19,21,23,25,27,29,32,33,34,35,36,37,41,44,45,46,47,48,49,52,53,54,55,56,57,60,61,62,63,64,65,66,67,68,69,70,71,74,75,76,77,78,79,82,83,84,85,86,87,90,91,92,93,94,95,99,103,107,110,114,117,120,123,126,129,132,135,138,142,145,149,153,157,161,164],{"measure":10,"description":11,"timeFrame":18},"Week 18",{"measure":10,"description":11,"timeFrame":20},"Week 22",{"measure":10,"description":11,"timeFrame":22},"Week 26",{"measure":10,"description":11,"timeFrame":24},"Week 30",{"measure":10,"description":11,"timeFrame":26},"Week 34",{"measure":10,"description":11,"timeFrame":28},"Week 37",{"measure":30,"description":31,"timeFrame":18},"Time in tight range","Percentage of time spent in target glucose values - 63-120 mg\u002FdL (3.5-6.7 mmol\u002FL)",{"measure":30,"description":31,"timeFrame":20},{"measure":30,"description":31,"timeFrame":22},{"measure":30,"description":31,"timeFrame":24},{"measure":30,"description":31,"timeFrame":26},{"measure":30,"description":31,"timeFrame":28},{"measure":38,"description":39,"timeFrame":40},"Change in the time in range values","Change in percentage of time spent in target glucose values - 63-140 mg\u002FdL (3.5-7.8 mmol\u002FL)","From the recruitment to delivery",{"measure":42,"description":43,"timeFrame":18},"Time above range","Percentage of time spent above target glucose values - \\>140 mg\u002FdL (\\>7.8 mmol\u002FL)",{"measure":42,"description":43,"timeFrame":20},{"measure":42,"description":43,"timeFrame":22},{"measure":42,"description":43,"timeFrame":24},{"measure":42,"description":43,"timeFrame":26},{"measure":42,"description":43,"timeFrame":28},{"measure":50,"description":51,"timeFrame":18},"Time above tight range","Percentage of time spent above target glucose values - \\>120 mg\u002FdL (\\>6.7 mmol\u002FL)",{"measure":50,"description":51,"timeFrame":20},{"measure":50,"description":51,"timeFrame":22},{"measure":50,"description":51,"timeFrame":24},{"measure":50,"description":51,"timeFrame":26},{"measure":50,"description":51,"timeFrame":28},{"measure":58,"description":59,"timeFrame":18},"Time below range","Percentage of time spent below target glucose values - \\\u003C63 mg\u002FdL (\\\u003C3.5 mmol\u002FL)",{"measure":58,"description":59,"timeFrame":20},{"measure":58,"description":59,"timeFrame":22},{"measure":58,"description":59,"timeFrame":24},{"measure":58,"description":59,"timeFrame":26},{"measure":58,"description":59,"timeFrame":28},{"measure":14,"description":15,"timeFrame":18},{"measure":14,"description":15,"timeFrame":20},{"measure":14,"description":15,"timeFrame":22},{"measure":14,"description":15,"timeFrame":24},{"measure":14,"description":15,"timeFrame":26},{"measure":14,"description":15,"timeFrame":28},{"measure":72,"description":73,"timeFrame":18},"Coefficient of variation (%CV)","Metric of glycemic variability measured by the sensor (%)",{"measure":72,"description":73,"timeFrame":20},{"measure":72,"description":73,"timeFrame":22},{"measure":72,"description":73,"timeFrame":24},{"measure":72,"description":73,"timeFrame":26},{"measure":72,"description":73,"timeFrame":28},{"measure":80,"description":81,"timeFrame":18},"Standard deviation (SD)","Metric of glycemic variability measured by the sensor (mg\u002FdL and mmol\u002FL)",{"measure":80,"description":81,"timeFrame":20},{"measure":80,"description":81,"timeFrame":22},{"measure":80,"description":81,"timeFrame":24},{"measure":80,"description":81,"timeFrame":26},{"measure":80,"description":81,"timeFrame":28},{"measure":88,"description":89,"timeFrame":18},"HbA1C","Blood glycated hemoglobin measurement (% and mmol\u002Fmol)",{"measure":88,"description":89,"timeFrame":20},{"measure":88,"description":89,"timeFrame":22},{"measure":88,"description":89,"timeFrame":24},{"measure":88,"description":89,"timeFrame":26},{"measure":88,"description":89,"timeFrame":28},{"measure":96,"description":97,"timeFrame":98},"Severe hypoglycemia episodes","Number of episodes of self-reported severe hypoglycemia.","From recruitment until delivery.",{"measure":100,"description":101,"timeFrame":102},"Gestational weight gain","Maternal gestational weight gain (kg)","From recruitment until delivery",{"measure":104,"description":105,"timeFrame":106},"Gestational weight gain from pre-pregnancy","Self-reported maternal gestational weight gain (kg)","From pre-pregnancy until delivery",{"measure":108,"description":109,"timeFrame":102},"Pregnancy hypertensive disorders","Preeclampsia, Eclampsia, Gestational hypertension",{"measure":111,"description":112,"timeFrame":113},"The mode of delivery","Vaginal, c-section, spontaneous, induction of labor","At delivery",{"measure":115,"description":116,"timeFrame":113},"Birth trauma","IADPSG criteria",{"measure":118,"description":119,"timeFrame":113},"Gestational birth weight","Neonatal birth weight in grams",{"measure":121,"description":122,"timeFrame":113},"Macrosomia","Gestational birth weight \\>4200g",{"measure":124,"description":125,"timeFrame":113},"Large-for-gestational-age (LGA)","Neonatal birth weight \\>90th percentile",{"measure":127,"description":128,"timeFrame":113},"Small-for-gestational-age (SGA)","Neonatal birth weight \\>10th percentile",{"measure":130,"description":131,"timeFrame":113},"Placental weight","Measured in grams",{"measure":133,"description":134,"timeFrame":113},"Gestational age","Timing of delivery",{"measure":136,"description":137,"timeFrame":113},"Preterm birth","\\\u003C37 weeks",{"measure":139,"description":140,"timeFrame":141},"Number of neonates with respiratory distress syndrome","Defined as the number of neonates diagnosed with respiratory distress syndrome during the postnatal hospital stay, based on clinical signs of respiratory distress and the need for respiratory support, with or without radiological confirmation, according to local neonatal clinical practice.","From delivery until hospital discharge, assessed up to 20 weeks postpartum",{"measure":143,"description":144,"timeFrame":141},"Number of neonates with jaundice requiring phototherapy","Defined as the number of neonates diagnosed with neonatal jaundice requiring phototherapy during the postnatal hospital stay. Phototherapy requirement will be determined according to local neonatal clinical practice based on serum or transcutaneous bilirubin assessment.",{"measure":146,"description":147,"timeFrame":148},"Number of neonates with neonatal hypoglycemia","Neonatal hypoglycemia - glucose concentrations in neonatal blood \\\u003C40 mg\u002FdL (2.2 mmol\u002FL) in a single laboratory measurement at least 3 hours after birth, in the first 24 hours of life","Assessed from delivery until 24 hours postpartum",{"measure":150,"description":151,"timeFrame":152},"Stillbirth","Pregnancy loss after 22 weeks","From week 22",{"measure":154,"description":155,"timeFrame":156},"Neonatal length of hospital stay","Duration of neonatal hospitalization, measured in days","From date of delivery until the date of hospital discharge, assessed up to 20 weeks",{"measure":158,"description":159,"timeFrame":160},"Length of stay in the neonatal intensive care unit (NICU)","Duration of NICU stay, measured in days","From date of NICU admission until the date of NICU discharge, assessed up to 20 weeks",{"measure":162,"description":163,"timeFrame":113},"Neonatal acidosis","Umbilical pH \\\u003C7.15",{"measure":165,"description":166,"timeFrame":113},"Apgar score","Apgar score \\\u003C8",null,{"allocation":169,"interventionModel":170,"interventionModelDescription":171,"primaryPurpose":172,"observationalModel":167,"timePerspective":167,"maskingInfo":173},"NA","SINGLE_GROUP","Single group longitudinal observational design","DIAGNOSTIC",{"masking":174,"maskingDescription":167,"whoMasked":167},"NONE","This study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.\n\nThis is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.\n\nParticipants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.\n\nThe main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg\u002FdL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.\n\nThis study will evaluate the use of the MiniMed 780G insulin pump system in pregnant women with type 2 diabetes. The aim is to assess whether this treatment can help participants achieve good glucose control during pregnancy and support favorable maternal and neonatal outcomes.\n\nThis is a single-arm interventional study. All participants will use the same insulin pump and continuous glucose monitoring system from recruitment until delivery. The study will include pregnant women with type 2 diabetes who enter the study at 16 weeks of pregnancy or less.\n\nParticipants will attend regular follow-up visits during pregnancy. Researchers will review glucose data, adjust insulin treatment, measure HbA1c, and assess pregnancy and neonatal outcomes.\n\nThe main outcome is the percentage of time spent in the pregnancy target glucose range of 63 to 140 mg\u002FdL from recruitment until delivery. The study will also assess mean glucose levels, maternal outcomes, and neonatal outcomes.",[177],{"label":178,"type":179,"description":180,"interventionNames":181},"Type 2 diabetes","EXPERIMENTAL","Pregnant patients with type 2 diabetes treated with automated insulin delivery system",[182],"Device: Automated insulin delivery system - Medtronic 780G",[184],{"type":185,"name":186,"description":187,"armGroupLabels":188,"otherNames":167},"DEVICE","Automated insulin delivery system - Medtronic 780G","Use of automated insulin delivery system in pregnant patients with type 2 diabetes",[178],[190],{"name":191,"affiliation":5,"role":192},"Ewa Wender-Ozegowska, Prof. MD PhD","PRINCIPAL_INVESTIGATOR",[194],{"name":191,"role":195,"phone":196,"phoneExt":167,"email":197},"CONTACT","+48 (61) 841-93-02","ewozegow@ump.edu.pl",[199],{"facility":200,"status":167,"city":201,"state":202,"zip":203,"country":204,"countryCode":205,"cosmosGeoPoint":206,"geoPoint":211,"contacts":212},"Heliodor Swiecicki Clinical Gynecology and Obstetrics Hospital of Poznan University of Medical Sciences","Poznan","Wielkopolska","60-535","Poland","PL",{"type":207,"coordinates":208},"Point",[209,210],16.92993,52.40692,{"lat":210,"lon":209},[213,214],{"name":191,"role":195,"phone":196,"phoneExt":167,"email":197},{"name":191,"role":192,"phone":167,"phoneExt":167,"email":167},{"type":216,"investigatorFullName":167,"investigatorTitle":167,"investigatorAffiliation":167,"oldNameTitle":167,"oldOrganization":167},"SPONSOR",[218],{"name":219,"class":220},"Medtronic","INDUSTRY","100638445",false,"NCT07602036","Type 2 Diabetes and Pregnancy a Single-arm Interventional Study","pUMPreg2","Inclusion Criteria:\n\n1. Women with diagnosed pregestational type 2 diabetes or HbA1c \\>6.5% in the 1st trimester (ADA, PTD)\n2. Age 18-45 years\n3. Gestational age of 16 weeks +0 days or less at baseline\n4. Singleton pregnancy\n5. HbA1c at baseline 5.0-10%\n6. A viable pregnancy at the recruitment\n7. Willingness to continue the treatment until delivery in the clinic\n\nExclusion Criteria:\n\n1. Other types of diabetes including T1D and Monogenic diabetes\n2. Major fetal congenital defects\n3. Severe nephropathy, psychiatric illness or other serious medical disorder that in the judgment of the investigator could affect completion of the trial\n4. Pump therapy before pregnancy","FEMALE","18 Years","45 Years",{"count":231,"type":232},20,"ESTIMATED","INTERVENTIONAL",[169],"This single-arm interventional study evaluates the MiniMed 780G insulin pump and continuous glucose monitoring (CGM) system in pregnant women with type 2 diabetes enrolled at ≤ 16 weeks gestation. From recruitment to delivery, participants attend regular clinical visits for active insulin adjustments. The primary objective is to measure the percentage of time spent in the target pregnancy glucose range (63-140 mg\u002FdL). Secondary outcomes track mean glucose, HbA1c, and overall maternal and neonatal health to ensure safety and efficacy.",[237,238],"Pregnancy","Type 2 Diabetes",[240,241,242,243],"type 2 diabetes","pregnancy","insulin pump","Automated insulin delivery system","NOT_YET_RECRUITING","2026-05-15",{"date":247,"type":248},"2026-05-22","ACTUAL",{"date":250,"type":232},"2026-05-01",{"date":252,"type":232},"2029-02",{"name":5,"class":6},1]