Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-05 @ 2:20 AM
Study NCT ID:
NCT03353792
Status:
TERMINATED
Last Update Posted:
2022-11-18
First Post:
2017-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'raimund.herzog@yale.edu', 'phone': '(877) 925-3637', 'title': 'Raimund Herzog, MD, MHS', 'organization': 'Associate Professor of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'This study experienced low enrollment prior to being paused due to COVID19. Upon restart of the study, it was determined that there were not sufficient funds to fully resume the trial. The overall enrollment did not provide adequate numbers to perform statistical analyses outside of providing summary statistics on those that were enrolled and those that completed the study.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 10 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Alternate Fuel Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.855', 'spread': '10.642', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up', 'categories': [{'measurements': [{'value': '7.28', 'spread': '8.888', 'groupId': 'OG000'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '3.57', 'spread': '1.754', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 - 10 weeks', 'description': 'Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline.\n\nAstrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted."', 'unitOfMeasure': 'percent enrichment of Gln4', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 2 participants (per protocol complete cases) in the intervention had data that was analyzable due to technical issues that occured with the usual care group.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Function: MOCA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '23', 'spread': '0', 'groupId': 'OG000'}, {'value': '27', 'spread': '2', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up', 'categories': [{'measurements': [{'value': '25.5', 'spread': '0.707', 'groupId': 'OG000'}, {'value': '29', 'spread': '0', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '-2.5', 'spread': '0.707', 'groupId': 'OG000'}, {'value': '-2', 'spread': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. Change was calculated by subtracting follow up from baseline. https://www.parkinsons.va.gov/resources/MoCA-Instructions-English.pdf', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those that completed both assessments (did not drop out) were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Function: Trail Test A', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '63', 'spread': '39', 'groupId': 'OG000'}, {'value': '28', 'spread': '11', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up', 'categories': [{'measurements': [{'value': '34', 'spread': '3', 'groupId': 'OG000'}, {'value': '21', 'spread': '5', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '29', 'spread': '42', 'groupId': 'OG000'}, {'value': '7', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'Trail making test (TMT) A is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time is measured in seconds. The typical average time to complete the test is 29 seconds, a "deficient" performance would be \\>78 seconds; most people are able to complete in 90 seconds. Change was calculated by subtracting follow up from baseline.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those that completed both assessments (did not drop out) were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Function: Trail Test B', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '86', 'spread': '22', 'groupId': 'OG000'}, {'value': '54', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up', 'categories': [{'measurements': [{'value': '68', 'spread': '23', 'groupId': 'OG000'}, {'value': '42', 'spread': '7', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '18', 'spread': '1', 'groupId': 'OG000'}, {'value': '12', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'Trail making test (TMT) B is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time will be measured in seconds. The typical average time to complete the test is 75 seconds, a "deficient" performance would be \\>273 seconds; most people are able to complete in 180 seconds. Change was calculated by subtracting follow up from baseline.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those that completed both assessments (did not drop out) were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Change in Cognitive Function: Grooved Pegboard Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'OG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '105', 'spread': '64', 'groupId': 'OG000'}, {'value': '78', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'Follow Up', 'categories': [{'measurements': [{'value': '100', 'spread': '53', 'groupId': 'OG000'}, {'value': '73', 'spread': '18', 'groupId': 'OG001'}]}]}, {'title': 'Change', 'categories': [{'measurements': [{'value': '5', 'spread': '11', 'groupId': 'OG000'}, {'value': '5', 'spread': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'The grooved pegboard test is a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consists of a small board of holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. The task was completed using the dominant hand. Time was measured in seconds.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only those that completed both assessments (did not drop out) were included in the analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'FG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Participant Unable to Manage Device', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CL/AP System', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.\n\nCL/AP system: CL/AP system enabled insulin pump/CGM combination'}, {'id': 'BG001', 'title': 'Usual Care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.\n\nusual diabetic care: usual diabetic care (insulin pump therapy) along with CGM recording'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age Categorized', 'categories': [{'title': '50-59 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '60-69 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': '70-79 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Participants that were randomized.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-07-25', 'size': 4454618, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-09-30T16:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'The intervention consists of treatment with a CL/AP-enabled insulin pump/CGM combination; subjects in the control group will continue their usual diabetes care (insulin pump therapy) along with CGM recording .'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The design is a single-site, parallel group, randomized clinical trail. Following enrollement and CGM documentation of hypoglycemia during the 4-week run-in period, study participants are randomized to intervention and control groups.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Initial difficulty with recruitment was exasperated by COVID pause of the study and then the end of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-16', 'studyFirstSubmitDate': '2017-11-09', 'resultsFirstSubmitDate': '2022-09-30', 'studyFirstSubmitQcDate': '2017-11-22', 'lastUpdatePostDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-30', 'studyFirstPostDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Alternate Fuel Uptake', 'timeFrame': 'Baseline to 8 - 10 weeks', 'description': 'Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline.\n\nAstrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted."'}], 'secondaryOutcomes': [{'measure': 'Change in Cognitive Function: MOCA', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. Change was calculated by subtracting follow up from baseline. https://www.parkinsons.va.gov/resources/MoCA-Instructions-English.pdf'}, {'measure': 'Change in Cognitive Function: Trail Test A', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'Trail making test (TMT) A is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time is measured in seconds. The typical average time to complete the test is 29 seconds, a "deficient" performance would be \\>78 seconds; most people are able to complete in 90 seconds. Change was calculated by subtracting follow up from baseline.'}, {'measure': 'Change in Cognitive Function: Trail Test B', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'Trail making test (TMT) B is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time will be measured in seconds. The typical average time to complete the test is 75 seconds, a "deficient" performance would be \\>273 seconds; most people are able to complete in 180 seconds. Change was calculated by subtracting follow up from baseline.'}, {'measure': 'Change in Cognitive Function: Grooved Pegboard Test', 'timeFrame': 'Baseline to 8-10 weeks', 'description': 'The grooved pegboard test is a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consists of a small board of holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. The task was completed using the dominant hand. Time was measured in seconds.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Type1 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.', 'detailedDescription': 'The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR). For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide signed and dated informed consent form\n* Male or female\n* Age 50-75 years (at least 50% over the age of 65)\n* T1DM (\\>20 years duration)\n* C-peptide undetectable\n* HbA1c of \\< 8%\n* Insulin pump therapy\n* History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values \\< 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment\n* BMI \\<27 kg/m2\n* Good general health as evidenced by medical history and blood screening\n* Willing to comply with all study procedures and be available for the duration of the study\n* Willing to fast for a limited time period on the morning of a clamp study\n\nExclusion Criteria:\n\n* Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)\n* Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism\n* Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.\n* Heavy exercise on a regular basis (i.e. marathon runners)\n* Known allergic reactions to components of the study product(s)\n* Treatment with another investigational drug or other intervention\n* Active infection including hepatitis C, hepatitis B, HIV\n* Any past or current history of alcohol or substance abuse\n* Psychiatric or neurological disorders under active treatment\n* Baseline hemoglobin \\< 10.5 g/dL in females, or \\< 12.5 g/dL in males. Blood donation within 30 days of the study\n* History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)\n* Co-existing cardiac, liver, and kidney disease\n* Abnormal liver function tests\n* Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.\n* Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes'}, 'identificationModule': {'nctId': 'NCT03353792', 'acronym': 'T1DM AP', 'briefTitle': 'Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients', 'organization': {'class': 'OTHER', 'fullName': 'Yale University'}, 'officialTitle': 'Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System', 'orgStudyIdInfo': {'id': '2000020059'}, 'secondaryIdInfos': [{'id': '1R01DK101984-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1R01DK101984-01A1', 'type': 'NIH'}, {'id': '1DP3DK112227-01', 'link': 'https://reporter.nih.gov/quickSearch/1DP3DK112227-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CL/AP system', 'description': 'To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.', 'interventionNames': ['Device: CL/AP system']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'usual care', 'description': 'Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.', 'interventionNames': ['Device: usual diabetic care']}], 'interventions': [{'name': 'CL/AP system', 'type': 'DEVICE', 'description': 'CL/AP system enabled insulin pump/CGM combination', 'armGroupLabels': ['CL/AP system']}, {'name': 'usual diabetic care', 'type': 'DEVICE', 'description': 'usual diabetic care (insulin pump therapy) along with CGM recording', 'armGroupLabels': ['usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}], 'overallOfficials': [{'name': 'Raimund Herzog, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yale School of Medicine Department of Endocrinology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yale University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}