Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-01-20 @ 3:03 AM
Study NCT ID:
NCT03334318
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERL Continuous Glucose Monitoring (CGM) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003928', 'term': 'Diabetic Nephropathies'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013995', 'term': 'Time'}, {'id': 'D000493', 'term': 'Allopurinol'}], 'ancestors': [{'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-11-02', 'lastUpdatePostDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'iGFR at the end of the PERL trial', 'timeFrame': 'Week 164 of the PERL trial', 'description': 'Glomerular filtration rate (GFR) at the end of the PERL trial, measured by the plasma clearance of non-radioactive iohexol (iGFR) and adjusted for the iGFR at baseline.'}], 'secondaryOutcomes': [{'measure': 'HbA1c at week 80 of the PERL trial', 'timeFrame': 'Week 80 of the PERL Trial', 'description': 'Hba1c value at week 80 of the PERL trial'}, {'measure': 'HbA1c at week 96 of the PERL trial', 'timeFrame': 'Week 96 of the PERL Trial', 'description': 'Hba1c value at week 96 of the PERL trial'}, {'measure': 'HbA1c at week 112 of the PERL trial', 'timeFrame': 'Week 112 of the PERL Trial', 'description': 'Hba1c value at week 112 of the PERL trial'}, {'measure': 'HbA1c at week 128 of the PERL trial', 'timeFrame': 'Week 128 of the PERL Trial', 'description': 'Hba1c value at week 128 of the PERL trial'}, {'measure': 'HbA1c at week 142 of the PERL trial', 'timeFrame': 'Week 142 of the PERL Trial', 'description': 'Hba1c value at week 142 of the PERL trial'}, {'measure': 'HbA1c at week 156 of the PERL trial', 'timeFrame': 'Week 156 of the PERL Trial', 'description': 'Hba1c value at week 156 of the PERL trial'}, {'measure': 'HbA1c at week 164 of the PERL trial', 'timeFrame': 'Week 164 of the PERL Trial', 'description': 'Hba1c value at week 164 of the PERL trial'}, {'measure': 'Mean blood glucose', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Mean of blood glucose values measured by continuous glucose monitoring'}, {'measure': 'CV (coefficient of variation) of blood glucose', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Coefficient of variation of blood glucose values measured by continuous glucose monitoring'}, {'measure': '% time 70-180 mg/dL', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Percentage of time with blood glucose in the 70-180 mg/dL range (as measured by continuous glucose monitoring)'}, {'measure': '% time below 54 mg/dL', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Percentage of time with blood glucose below 54 mg/dL (as measured by continuous glucose monitoring)'}, {'measure': '% time above 180 mg/dL', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Percentage of time with blood glucose above 180 mg/dL (as measured by continuous glucose monitoring)'}, {'measure': '% time above 250 mg/dL', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Percentage of time with blood glucose above 250 mg/dL (as measured by continuous glucose monitoring)'}, {'measure': 'MAGE (Mean amplitude of glucose excursions)', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Mean amplitude of glucose excursions as measured by continuous glucose monitoring'}, {'measure': 'LBGI (Low blood glucose index)', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'Low blood glucose index based on blood glucose values measured by continuous glucose monitoring'}, {'measure': 'HBGI (High blood glucose index)', 'timeFrame': 'From week 80 to week 164 of the PERL trial', 'description': 'High blood glucose index based on blood glucose values measured by continuous glucose monitoring'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Nephropathies']}, 'descriptionModule': {'briefSummary': 'Seven-point capillary profiles have shown that mean glucose correlates with both diabetic retinopathy and nephropathy risk. However, there remains great controversy as to whether the degree of variability around mean glucose may also contribute to these microvascular complications. The PERL trial (NCT02017171), testing whether treatment with allopurinol can slow down kidney function loss in type 1 diabetes, provides a unique opportunity to assess the role of glycemic variability in the progression of diabetic kidney disease in individuals who already have mild to moderate kidney disease. By applying Continuous Glucose Monitoring (CGM) in the PERL Study population, the investigators will be able to better understand how metrics of glycemia (mean, time above and below range, and various measures of variability) are associated with renal outcomes in the PERL population as a whole, but also in important subgroups (e.g., albuminuric vs. normoalbuminuric subjects with ongoing GFR decline, allopurinol vs. placebo arms). The nvestigators also aim to obtain precise information on the range of blood glucose corresponding to any given HbA1c value in this population since previous studies generally excluded patients with renal disease.', 'detailedDescription': 'Participants who consent to the study will have an Abbott Freestyle Libre Pro sensor placed on the back of their upper arm at their first PERL visit after this ancillary study has begun and at all subsequent PERL Visits. The sensor will be continuously worn by participants for 14 days. At the end of the 14 days, the sensor will be removed and mailed by the participant to the Coordinating center. Since subjects are at various stages of the PERL protocol, the number of remaining visits at which the CGM will be applied will vary among subjects.\n\nSTUDY AIMS\n\n1. To assess the effect of glycemic variability, as measured by the coefficient of variation of CGM glucose (CV, the ratio of standard deviation and the mean of CGM glucose values), on the PERL renal functional endpoint (iohexol GFR at the end of study).\n2. To assess the effect of other glycemic parameters measured by CGM (mean glucose, % time 70-180 mg/dL, % time below 54 mg/dL, % time below 70 mg/dL, % time above 180 mg/dL, % time above 250 mg/dL, mean amplitude of glucose excursions \\[MAGE\\], low blood glucose index \\[LBGI\\], high blood glucose index \\[HBGI\\]) on the PERL renal functional endpoint.\n3. To assess the relationship between CGM-measured glycemic parameters and HbA1c at various levels of renal function.\n4. To compare the effects of CGM metrics on the PERL renal endpoint and the corresponding effect of HbA1c.\n5. To assess the effect of allopurinol treatment on all of the different glycemic metrics including HbA1c, CV, etc. and on their association with the PERL renal endpoint.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants of the PERL Clinical Trial', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n• Being an active participant in the PERL clinical trial\n\nExclusion Criteria:\n\n* Having completed PERL Visit 16\n* Pregnancy\n* History of skin reactions in relation to the application of Abbott Freestyle Libre Pro'}, 'identificationModule': {'nctId': 'NCT03334318', 'briefTitle': 'PERL Continuous Glucose Monitoring (CGM) Study', 'organization': {'class': 'OTHER', 'fullName': 'Joslin Diabetes Center'}, 'officialTitle': 'PERL (Preventing Early Renal Loss in Diabetes) Continuous Glucose Monitoring (CGM) Study', 'orgStudyIdInfo': {'id': '2018PG-T1D014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Allopurinol-treated', 'description': 'Participants in the PERL Clinical Trial (NCT02017171) randomized to allopurinol', 'interventionNames': ['Other: Mean blood glucose', 'Other: Blood glucose CV', 'Other: % time 70-180 mg/dL', 'Other: % time below 54 mg/dL', 'Other: % time above 180 mg/dL', 'Other: % time above 250 mg/dL', 'Other: MAGE (Mean amplitude of glucose excursions)', 'Other: LBGI (Low Blood Glucose Index)', 'Other: HBGI (High Blood Glucose Index)', 'Drug: Allopurinol']}, {'label': 'Placebo-treated', 'description': 'Participants in the PERL Clinical Trial (NCT02017171) randomized to placebo', 'interventionNames': ['Other: Mean blood glucose', 'Other: Blood glucose CV', 'Other: % time 70-180 mg/dL', 'Other: % time below 54 mg/dL', 'Other: % time above 180 mg/dL', 'Other: % time above 250 mg/dL', 'Other: MAGE (Mean amplitude of glucose excursions)', 'Other: LBGI (Low Blood Glucose Index)', 'Other: HBGI (High Blood Glucose Index)', 'Drug: Placebo']}], 'interventions': [{'name': 'Mean blood glucose', 'type': 'OTHER', 'description': 'Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': 'Blood glucose CV', 'type': 'OTHER', 'description': 'Coefficient of variation of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': '% time 70-180 mg/dL', 'type': 'OTHER', 'description': 'Percent of time with blood glucose in the 70-180 mg/dL range as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': '% time below 54 mg/dL', 'type': 'OTHER', 'description': 'Percent of time with blood glucose below 54 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': '% time above 180 mg/dL', 'type': 'OTHER', 'description': 'Percent of time with blood glucose above 180 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': '% time above 250 mg/dL', 'type': 'OTHER', 'description': 'Percent of time with blood glucose above 250 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': 'MAGE (Mean amplitude of glucose excursions)', 'type': 'OTHER', 'description': 'Mean amplitude of glucose excursions as measured by continuous glucose monitoring as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': 'LBGI (Low Blood Glucose Index)', 'type': 'OTHER', 'description': 'Low blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': 'HBGI (High Blood Glucose Index)', 'type': 'OTHER', 'description': 'High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.', 'armGroupLabels': ['Allopurinol-treated', 'Placebo-treated']}, {'name': 'Allopurinol', 'type': 'DRUG', 'description': 'Oral allopurinol tablets administered in the PERL Clinical Trial', 'armGroupLabels': ['Allopurinol-treated']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo tablets administered in the PERL Clinical Trial', 'armGroupLabels': ['Placebo-treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Barbara Davis Center / University of Colorado Denver', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University - Grady Memorial Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Joslin Diabetes Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48105', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Brehm Center for Diabetes Research / University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'ICAHN School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine / Montefiore Medical Center', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart Medical Center', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': 'T2T 5C7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Unversity of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G2E1', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Y 3W2', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'BC Diabetes', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'M5T-3L9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'University of Toronto', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Alessandro Doria, MD PhD MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Joslin Diabetes Center'}, {'name': 'Irl Hirsch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Washington'}, {'name': 'Janet McGill, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University, St. Louis, MO'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Joslin Diabetes Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Leona M. and Harry B. Helmsley Charitable Trust', 'class': 'OTHER'}, {'name': 'University of Minnesota', 'class': 'OTHER'}, {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, {'name': 'University of Michigan', 'class': 'OTHER'}, {'name': 'Northwestern University Feinberg School of Medicine', 'class': 'OTHER'}, {'name': 'Albert Einstein College of Medicine', 'class': 'OTHER'}, {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, {'name': 'University of Washington', 'class': 'OTHER'}, {'name': 'Providence Medical Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Investigator', 'investigatorFullName': 'Alessandro Doria', 'investigatorAffiliation': 'Joslin Diabetes Center'}}}}