Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2026-02-24 @ 10:06 AM
Study NCT ID:
NCT01341067
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
2011-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark@idahomed.com', 'phone': '208-528-9642', 'title': 'Mark Sulik, PharmD CCRP', 'organization': 'Rocky Mountain Diabetes and Osteoporosis Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'description': '0 serious adverse events were recorded. 3 device related adverse events were recorded.', 'eventGroups': [{'id': 'EG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents', 'otherNumAtRisk': 30, 'otherNumAffected': 3, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Insertion site irritation', 'notes': 'Includes mild irritation at the site of insertion that has been deemed to be device related by the Primary Investigator.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 30, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in HgbA1c', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.9', 'spread': '1.1', 'groupId': 'OG000', 'lowerLimit': '-3.0', 'upperLimit': '-.8'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at 6 months', 'unitOfMeasure': 'percentage of glycosylated hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Time Spent at Glycemic Levels <65 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents'}], 'classes': [{'categories': [{'measurements': [{'value': '.04', 'spread': '1.0', 'groupId': 'OG000', 'lowerLimit': '-.6', 'upperLimit': '1.4'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and at 6 months', 'unitOfMeasure': 'percentage of time spent < 65 mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.5', 'spread': '16.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Measured at baseline and 6 months', 'unitOfMeasure': 'percentage of time spent >180 mg/dl', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Basal Insulin Dose From Baseline Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '16.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Assessed at baseline and 6 months', 'unitOfMeasure': 'units of insulin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Basal Insulin, Approved Oral Medications', 'description': 'Basal insulin, with or without approved oral agents'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58', 'spread': '12.4', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-01', 'studyFirstSubmitDate': '2011-04-21', 'resultsFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2011-04-22', 'lastUpdatePostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-04-01', 'studyFirstPostDateStruct': {'date': '2011-04-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-05-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HgbA1c', 'timeFrame': 'Measured at 6 months'}], 'secondaryOutcomes': [{'measure': 'Percentage of Time Spent at Glycemic Levels <65 mg/dl', 'timeFrame': 'Measured at baseline and at 6 months'}, {'measure': 'Change in Percentage of Time Spent at Glycemic Levels >180 mg/dl', 'timeFrame': 'Measured at baseline and 6 months'}, {'measure': 'Change in Basal Insulin Dose From Baseline Values', 'timeFrame': 'Assessed at baseline and 6 months'}]}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to examine the effect CGM (continuous glucose monitoring) has on subjects with type 2 diabetes. It is anticipated that patients using the device will obtain tighter control of their blood sugars resulting in measureable health benefits and improved confidence in their ability to manage their diabetes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects of all adult ages (18 and older) with type 2 diabetes.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with type 2 diabetes mellitus\n* Have an HgbA1c value ≥ 7% and ≤17%.\n* Are on basal insulin, with or without oral agents\n* Are not on basal bolus insulin therapy.\n* Have had no severe hypoglycemic episodes in the 6 months prior to enrollment in the study. Severe hypoglycemia will be defined as any hypoglycemia that is both neurologically impairing and absolutely requires assistance from a third party in the form of carbohydrates, glucagon shots, or attention from a paramedic or other healthcare professional.\n* Have no known allergy to medical tape or sensors.\n* Are capable of and willing to test their blood glucose (BG) on an average of 4 times per day.\n* Are willing to not use Acetaminophen while enrolled in the study.\n* Are willing not to undergo a MRI procedure while wearing the CGM sensor.\n* Are willing and capable of performing self insertions of the device sensor.\n* Women of child bearing potential must be willing to use an approved form of birth control while enrolled in the study.\n* Women of child bearing potential must be willing to perform pregnancy tests monthly while enrolled in the study.\n* Can understand and speak English fluently.\n\nExclusion Criteria\n\n* Have been on pump therapy in the 6 months prior to enrollment in the study.\n* Are receiving basal- bolus insulin therapy\n* Are taking any medication that is not approved to be taken with insulin.\n* Are pregnant or have intentions of becoming pregnant during the duration of the study.\n* Have any skin condition that would inhibit the proper wearing of the CGM sensor including severe psoriasis, burns, eczema, scarring, excessive tattoos, etc.\n* Have a hematocrit ≤30% or ≥55%\n* Are currently enrolled in another clinical study (subjects must have ended participation in other studies at least 30 days prior to enrolling in this study.\n* Are employed by any company that manufactures or is developing a CGM device.\n* Are deemed incapable of participating in the study by the Primary Investigator for any reason.'}, 'identificationModule': {'nctId': 'NCT01341067', 'acronym': 'DexlonT2', 'briefTitle': 'Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rocky Mountain Diabetes and Osteoporosis Center'}, 'officialTitle': 'Continuous Glucose Monitoring in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': 'RMDC-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Basal insulin, approved oral medications'}]}, 'contactsLocationsModule': {'locations': [{'zip': '83404', 'city': 'Idaho Falls', 'state': 'Idaho', 'country': 'United States', 'facility': 'Rocky Mountain Diabetes and Osteoporosis Center', 'geoPoint': {'lat': 43.46658, 'lon': -112.03414}}], 'overallOfficials': [{'name': 'David R. Liljenquist, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rocky Mountain Diabetes and Osteoporosis Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rocky Mountain Diabetes and Osteoporosis Center', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'David Liljenquist, M.D.', 'investigatorAffiliation': 'Rocky Mountain Diabetes and Osteoporosis Center'}}}}