{"protocolSection":{"identificationModule":{"nctId":"NCT01856790","orgStudyIdInfo":{"id":"1211011156"},"organization":{"fullName":"Yale University","class":"OTHER"},"briefTitle":"Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes","officialTitle":"Effect of Liraglutide on Automated Closed-loop Glucose Control in Type 1 Diabetes"},"statusModule":{"statusVerifiedDate":"2020-01","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-02"},"primaryCompletionDateStruct":{"date":"2015-11","type":"ACTUAL"},"completionDateStruct":{"date":"2015-11","type":"ACTUAL"},"studyFirstSubmitDate":"2013-05-14","studyFirstSubmitQcDate":"2013-05-14","studyFirstPostDateStruct":{"date":"2013-05-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2016-04-18","resultsFirstSubmitQcDate":"2020-01-28","resultsFirstPostDateStruct":{"date":"2020-01-30","type":"ACTUAL"},"lastUpdateSubmitDate":"2020-01-28","lastUpdatePostDateStruct":{"date":"2020-01-30","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Jennifer Sherr","investigatorTitle":"Instructor","investigatorAffiliation":"Yale University"},"leadSponsor":{"name":"Jennifer Sherr","class":"OTHER"},"collaborators":[{"name":"Juvenile Diabetes Research Foundation","class":"OTHER"},{"name":"Yale University","class":"OTHER"}]},"oversightModule":{"oversightHasDmc":true},"descriptionModule":{"briefSummary":"\"Closed loop artificial pancreas\" systems have been under development for the control of blood sugars in those living with diabetes. These systems consist of a continuous glucose sensor, which sends a signal to a computer program that automatically determines how much insulin to give. The computer program then tells an insulin pump to deliver the insulin. While such systems have been tested under a number of conditions, post-meal blood sugars are difficult to control. This study is designed to see if liraglutide, a glucagon like peptide receptor agonist, can help minimize the post meal blood sugar spikes in subjects with type 1 diabetes while they are on a closed loop system.","detailedDescription":"Open-label, crossover study comparing the peak post-prandial glucose levels and the incremental post-prandial glucose area under the curve (AUC) during closed loop (CL) control alone and during CL control with liraglutide in an inpatient research setting. Data generated during outpatient baseline evaluation and liraglutide dose titration phases of the study will be compared to assess the short-term efficacy of this agent during open-loop continuous subcutaneous insulin infusion (CSII) pump treatment."},"conditionsModule":{"conditions":["Type 1 Diabetes"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["EARLY_PHASE1"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":15,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Closed Loop Insulin Delivery","type":"EXPERIMENTAL","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.\n\nFollowing the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.","interventionNames":["Device: ePID closed loop system","Drug: liraglutide"]}],"interventions":[{"type":"DEVICE","name":"ePID closed loop system","description":"Insulin pump controlled by closed loop unit and algorithm","armGroupLabels":["Closed Loop Insulin Delivery"]},{"type":"DRUG","name":"liraglutide","description":"Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist","armGroupLabels":["Closed Loop Insulin Delivery"],"otherNames":["Victoza"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Peak Post-prandial Venous Glucose Levels","description":"peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide","timeFrame":"48 hours"}],"secondaryOutcomes":[{"measure":"the Incremental Meal-related Glucose Area Under Curve (AUC)","timeFrame":"5-hour post prandial period after breakfast, lunch, and dinner"}],"otherOutcomes":[{"measure":"Mean 24-hour Glucose Levels","timeFrame":"24- hours"},{"measure":"Mean Time to Peak Post-meal Glucose Value","timeFrame":"5- hour postprandial period"},{"measure":"Mean Daytime Glucose Levels","timeFrame":"8a.m.-11p.m."},{"measure":"Incremental Glucagon Peak","timeFrame":"5 hours"},{"measure":"AUC Plasma Glucagon During MMTT","timeFrame":"2 hours"},{"measure":"Differences in Daily Insulin Requirements","timeFrame":"24 hours"},{"measure":"Prandial Insulin Delivery During Closed Loop Therapy","timeFrame":"Average of the 5-hour post prandial period for breakfast, lunch, dinner combined"},{"measure":"Mean Nocturnal Glucose Levels","timeFrame":"11p.m.-6a.m."}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n1. age 18-40 years\n2. clinical diagnosis of Type 1 diabetes (T1D) (formal antibody and/or genetic testing will not be required)\n3. duration of T1D ≥ 1 year\n4. HbA1c ≤ 9 %\n5. Treated with CSII for at least 3 months\n6. Body weight \\> 50 kg (to accommodate phlebotomy)\n7. Be in good general health without other medical or psychiatric illnesses that would, in the judgment of the investigator, interfere with subject safety or study conduct\n\nExclusion Criteria:\n\n1. Insulin resistant (defined as requiring \\> 1.5 units/kg/day at time of study enrollment)\n2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct\n3. Use of any medications (besides insulin) known to blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 4 weeks of admission to the hospital research unit (HRU). Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control\n4. History of hypoglycemic seizure within last 3 months\n5. Anemic (low hematocrit), evidence of renal insufficiency (elevated serum creatinine, BUN) or elevated liver function tests.\n6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy\n7. History of celiac disease gastroparesis, gastroesophageal reflux disease (GERD), disorder of gastric emptying, or disorder of intestinal motility\n8. Taking a medication known to affect gastric motility\n9. History of pancreatitis, gallstones, alcoholism or high triglyceride levels\n10. Personal or family history of thyroid cancer or multiple endocrine neoplasia type 2 (MEN2)\n11. Subjects unable to give consent","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","maximumAge":"40 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Jennifer Sherr, MD, PhD","affiliation":"Yale University","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"Yale University School of Medicine","city":"New Haven","state":"Connecticut","zip":"06520","country":"United States","geoPoint":{"lat":41.30815,"lon":-72.92816}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"All Study Participants","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.\n\nFollowing the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"periods":[{"title":"Closed Loop Control","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"15"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"13"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]},{"title":"Closed Loop Control + Liraglutide","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"13"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"11"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"2"}]}],"dropWithdraws":[{"type":"Withdrawal by Subject","reasons":[{"groupId":"FG000","numSubjects":"2"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Baseline Subject Characteristics","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback.\n\nFollowing the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"11"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"22","spread":"3.4"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"7"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"4"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"10"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"11"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"0"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Peak Post-prandial Venous Glucose Levels","description":"peak post-prandial venous glucose levels obtained after breakfast, lunch, and dinner between closed loop (CL) alone and CL + liraglutide","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Error","unitOfMeasure":"mg/dL","timeFrame":"48 hours","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"98","spread":"24"},{"groupId":"OG001","value":"76","spread":"17"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.05","statisticalMethod":"Wilcoxon Matched Pairs signed rank tests"}]},{"type":"SECONDARY","title":"the Incremental Meal-related Glucose Area Under Curve (AUC)","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg*hr/dL","timeFrame":"5-hour post prandial period after breakfast, lunch, and dinner","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"789","spread":"176"},{"groupId":"OG001","value":"500","spread":"151"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.002","statisticalMethod":"Wilcoxon Matched Pairs signed rank tests"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean 24-hour Glucose Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"24- hours","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"130","spread":"51"},{"groupId":"OG001","value":"135","spread":"45"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Time to Peak Post-meal Glucose Value","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"hours","timeFrame":"5- hour postprandial period","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.8","spread":"0.5"},{"groupId":"OG001","value":"1.8","spread":"0.6"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.97","statisticalMethod":"Wilcoxon Matched Pairs signed rank tests"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Daytime Glucose Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"8a.m.-11p.m.","groups":[{"id":"OG000","title":"ePID Closed Loop System Without Liraglutide","description":"ePID closed loop system alone\n\nePID closed loop system: Insulin pump controlled by closed loop unit and algorithm"},{"id":"OG001","title":"ePID Closed Loop System With Liraglutide","description":"liraglutide + ePID closed loop system\n\nePID closed loop system: Insulin pump controlled by closed loop unit and algorithm\n\nliraglutide: Liraglutide is a long-acting analog of human glucagon-like peptide 1 (GLP-1) that works as a GLP-1 receptor agonist"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"143","spread":"55"},{"groupId":"OG001","value":"146","spread":"47"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Incremental Glucagon Peak","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg/mL/min","timeFrame":"5 hours","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"29","spread":"16"},{"groupId":"OG001","value":"35","spread":"20"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"AUC Plasma Glucagon During MMTT","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"pg*min/mL","timeFrame":"2 hours","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"10"},{"groupId":"OG001","value":"10"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1904","spread":"651"},{"groupId":"OG001","value":"1801","spread":"906"}]}]}]},{"type":"OTHER_PRE_SPECIFIED","title":"Differences in Daily Insulin Requirements","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units","timeFrame":"24 hours","groups":[{"id":"OG000","title":"Pre-Liraglutide Treatment","description":"Baseline characteristics prior to liraglutide therapy"},{"id":"OG001","title":"Post-Liraglutide Treatment","description":"Characteristics following 3 week outpatient dose titration phase of liraglutide"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"51.5","spread":"14"},{"groupId":"OG001","value":"37.5","spread":"12.9"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":".001","statisticalMethod":"Wilcoxon Matched Pairs signed rank tests"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Prandial Insulin Delivery During Closed Loop Therapy","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"units","timeFrame":"Average of the 5-hour post prandial period for breakfast, lunch, dinner combined","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.6","spread":"8.4"},{"groupId":"OG001","value":"16.3","spread":"8.3"}]}]}],"analyses":[{"groupIds":["OG000","OG001"],"nonInferiorityType":"SUPERIORITY_OR_OTHER_LEGACY","pValue":"0.005","statisticalMethod":"Wilcoxon Matched Pairs signed rank tests"}]},{"type":"OTHER_PRE_SPECIFIED","title":"Mean Nocturnal Glucose Levels","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"mg/dL","timeFrame":"11p.m.-6a.m.","groups":[{"id":"OG000","title":"Closed Loop Insulin Delivery","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback."},{"id":"OG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"11"},{"groupId":"OG001","value":"11"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"104","spread":"23"},{"groupId":"OG001","value":"113","spread":"24"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","description":"Adverse events were recorded in categories with gastrointestinal disorders encompassing nausea, decreased appetite, constipation, bloating and/or diarrhea","eventGroups":[{"id":"EG000","title":"Closed Loop Only","description":"Each participant recruited into the study will undergo two inpatient closed loop admissions.\n\nThe first admission will be utilizing closed loop control alone, using the Medtronic external Physiological Insulin Delivery (ePID) algorithm. The ePID controller uses a proportional-integral-derivative algorithm modified to include insulin feedback","seriousNumAffected":0,"seriousNumAtRisk":13,"otherNumAffected":0,"otherNumAtRisk":13},{"id":"EG001","title":"Closed Loop + Liraglutide","description":"Following the first closed loop admission, each participant is initiated on adjunctive once daily liraglutide therapy. They undergo a 3-4 week dose titration period.\n\nParticipants are then admitted for a second closed loop admission to assess the combined effects of closed loop control with adjunctive once daily liraglutide therapy.","seriousNumAffected":0,"seriousNumAtRisk":11,"otherNumAffected":6,"otherNumAtRisk":11}],"otherEvents":[{"term":"gastrointestinal distress","organSystem":"Gastrointestinal disorders","notes":"nausea, decreased appetite, constipation, bloating, and/or diarrhea","stats":[{"groupId":"EG000","numEvents":0,"numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":6,"numAtRisk":11}]},{"term":"headache","organSystem":"Nervous system disorders","notes":"headache","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":13},{"groupId":"EG001","numAffected":6,"numAtRisk":11}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Dr. Jennifer Sherr","organization":"Yale University School of Medicine","email":"jennifer.sherr@yale.edu","phone":"203-785-5831"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D003922","term":"Diabetes Mellitus, Type 1"}],"ancestors":[{"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"}]},"interventionBrowseModule":{"meshes":[{"id":"D000069450","term":"Liraglutide"}],"ancestors":[{"id":"D052216","term":"Glucagon-Like Peptide 1"},{"id":"D004763","term":"Glucagon-Like Peptides"},{"id":"D052336","term":"Proglucagon"},{"id":"D005768","term":"Gastrointestinal Hormones"},{"id":"D006728","term":"Hormones"},{"id":"D006730","term":"Hormones, Hormone Substitutes, and Hormone Antagonists"}]}},"hasResults":true}