Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT02748434
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-08
First Post:
2016-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose Variability in Subclinical Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2016-04-20', 'studyFirstSubmitQcDate': '2016-04-21', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose levels', 'timeFrame': 'Continuously for 12 days', 'description': 'iPro2 Continuous Blood Glucose Monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['iPro2 Continuous Blood Glucose Recorder', 'Subclinical'], 'conditions': ['Diabetes Mellitus', 'Lipohypertrophy']}, 'descriptionModule': {'briefSummary': 'Evaluation of insulin absorption at sites affected by clinically apparent lipohypertrophy through short-term continuous glucose monitoring has shown inconsistent results and it is yet unknown how or if subclinical lipohypertrophy affects absorption. In this study investigators propose to enroll at least 20 people who participated in phase 1 and who were determined to have subclinical lipohypertrophy to examine the correlation between glycemic control and amount of insulin injected in subclinical hypertrophic areas using capillary blood glucose and continuous glucose monitoring.', 'detailedDescription': 'Patients will be randomized and data interpreters will be blinded to two alternating six-day protocols where the patients will be advised verbally and by written instruction to inject insulin in sites of subclinical lipohypertrophy or normal subcutaneous tissue. Patients will be asked to monitor and record their capillary blood glucose with meals and prior to bedtime using their own capillary blood glucose monitor. A trained research nurse at the Diabetes Centre will instrument each patient with an iPro 2 glucose sensor (Medtronic Canada). These sensors continuously measure blood glucose for periods of up to 7 days. A trained nurse will clean the skin with a superficial disinfectant and a small catheter will be inserted in the subcutaneous tissue at a non-lipohypertrophic site. The catheter will then be attached to a glucose sensor. Patients will wear this sensor for two periods of 6 days each at different sites. At the end of each of the two six day periods, the sensor will be removed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participation in phase 1\n* Type 1 or Type 2 diabetes for at least 2 years\n* Using insulin to manage diabetes\n* At least 19 years of age\n\nExclusion Criteria:\n\n* Taking insulin secretagogues (gliclazide, glyburide, glipizide\n* Taking other injectable diabetes medications (i.e. liraglutide, Victoza)\n* Taking systemic steroids (e.g. prednisone)\n* Not fluent in speaking and writing English (unless accompanied by a translator)'}, 'identificationModule': {'nctId': 'NCT02748434', 'briefTitle': 'Glucose Variability in Subclinical Hypertrophy', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Glucose Variability in Subclinical Hypertrophy', 'orgStudyIdInfo': {'id': 'H16-01025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Lipohypertrophy', 'description': 'Participants inject their insulin into the abdomen into areas of lipohypertrophy that were identified by ultrasound in Phase 1 of the study.', 'interventionNames': ['Other: Lipohypertrophy']}, {'type': 'OTHER', 'label': 'Normal Subcutaneous Tissue', 'description': 'Participants inject their insulin into the abdomen into areas with normal subcutaneous tissue.', 'interventionNames': ['Other: Normal Subcutaneous Tissue']}], 'interventions': [{'name': 'Lipohypertrophy', 'type': 'OTHER', 'armGroupLabels': ['Lipohypertrophy']}, {'name': 'Normal Subcutaneous Tissue', 'type': 'OTHER', 'armGroupLabels': ['Normal Subcutaneous Tissue']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Gerontology Research Lab', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Vancouver General Hospital Diabetes Centre', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Graydon Meneilly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Jordanna Kapeluto, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}, {'name': 'Breay Paty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, UBC Department of Medicine', 'investigatorFullName': 'Graydon Meneilly', 'investigatorAffiliation': 'University of British Columbia'}}}}